Rifapentine

DOR/ISL is the first non-INSTI, two-drug regimen to demonstrate non-inferiority and a similar safety pro Week 48 to BIC/FTC/TAF in adults living with HIV-1 who had not previously received antiretroviral treatment DOR/ISL maintained virologic suppression at Week 96 in adults with virologically suppressed HIV-1 who switched from other oral antiretroviral therapies, including BIC/FTC/TAF RAHWAY, N.J.--(BUSINESS WIRE)-- $MRK #MRK --Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of results from three pivotal Phase 3 trials evaluating the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg), (MK-8591A)] in adults with HIV-1. The findings were shared in late-breaking presentations at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) being held in Denver. “We are proud to continue building on our 40-year history of HIV research with the presentation of compelling new data from our HIV pipeline at CROI this year,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “Islatravir blocks HIV-1 replication through multiple mechanisms, including reverse transcriptase translocation inhibition, and could serve as the anchor for a series of two-drug, non-INSTI, daily and weekly treatment regimens. If approved, DOR/ISL will be the first of these regimens in our portfolio and may provide an important new option to help meet the evolving treatment needs of people living with HIV.” The Phase 3, double-blind, clinical trial MK-8591A-053 evaluating DOR/ISL versus bictegravir/emtricitabine/tenofovir alafenamide i [(50 mg/200 mg/25 mg),(BIC/FTC/TAF)] in adults living with HIV-1 who had not previously received antiretroviral treatment (treatment-naïve), met its primary efficacy endpoint of percentage of participants achieving viral suppression (HIV-1 RNA 100,000 copies/mL). The primary efficacy endpoint was the percentage of participants with HIV-1 RNA 100,000 copies/mL, 10.3% had HIV-1 RNA >500,000 copies/mL and 17.2% had baseline CD4+ T-cell count 100,000 copies/mL (94.0% vs 87.6%, respectively) and >500,000 copies/mL (90.3% vs 84.4%, respectively). Drug-related AEs were reported in 14.1% of participants on DOR/ISL and 18.0% on BIC/FTC/TAF and discontinuations due to AEs (1.1% vs. 2.2%) were similar in both groups. Immune reconstitution was similar in DOR/ISL vs. comparator with no between-group differences in mean increases in CD4+ T-cell counts or total lymphocyte counts (TLC). About the Phase 3 data from MK-8591A-052 MK-8591A-052 is a Phase 3, randomized, active-controlled, double-blind, clinical trial to evaluate the efficacy and safety of a switch to investigational, once-daily DOR/ISL (100 mg/0.25 mg) in adults with HIV-1 infection that has been virologically suppressed on BIC/FTC/TAF (50 mg/200 mg/25 mg). In this trial, 513 adults with HIV-1 who had virologic suppression for three months or more on BIC/FTC/TAF, no history of treatment failure and no known resistance to DOR were randomized (2:1) and switched to DOR/ISL (n= 342) or continued treatment with BIC/FTC/TAF (n=171). The primary efficacy endpoint, the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 (non-inferiority margin 4%), was met, demonstrating non-inferiority to BIC/FTC/TAF; 1.5% of participants who switched to DOR/ISL had a viral load of ≥50 copies/mL at Week 48, compared to 0.6% on BIC/FTC/TAF (treatment difference 0.9%, 95% CI -1.9, 2.9). Results at Week 48 were recently published in The Lancet . At Week 96, DOR/ISL continued to demonstrate similar efficacy compared to BIC/FTC/TAF; 1.5% of participants on DOR/ISL had a viral load of ≥50 copies/mL compared to 1.2% of participants on BIC/FTC/TAF (treatment difference 0.3%, 95% CI -2.8, 2.4); 88.9% of participants on DOR/ISL maintained virologic suppression (HIV-1 RNA <50 copies/mL) compared to 90.1% of participants continuing BIC/FTC/TAF (treatment difference -1.2%, 95% CI -6.5, 5.0). No hypothesis testing was performed for these secondary endpoints. The safety pro DOR/ISL at Week 96 continued to be similar to BIC/FTC/TAF with no new safety findings. No additional drug-related serious adverse events were reported in any group between Week 48 and Week 96. At Week 96, rates of discontinuation due to AEs were similar for both groups (3.2% vs. 2.9%). There were no differences between trial arms in CD4+ T-cell count or TLC changes through Week 96. About the Phase 3 data from MK-8591A-051 MK-8591A-051 is a Phase 3, open-label randomized, active-controlled, clinical trial to evaluate the efficacy and safety of a switch to investigational, once-daily DOR/ISL (100 mg/0.25 mg) in adults with HIV-1 infection that has been virologically suppressed using bART. In this trial, 551 adults with HIV-1 RNA <50 copies/mL for three months or more on oral 2- or 3-drug ART, with no history of treatment failure and no known virologic resistance to DOR, were randomized 2:1 and switched to DOR/ISL (n= 366) or continued bART (n=185), stratified by bART regimen. The primary efficacy endpoint, percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 (non-inferiority margin 4%), was met, demonstrating DOR/ISL to be non-inferior to bART; 1.4% of participants who received DOR/ISL had a viral load of ≥50 copies/mL at Week 48, compared to 4.9% on bART (treatment difference -3.6%, 95% CI -7.8, -0.8). After Week 48 of the comparative portion of the study, all participants received open-label DOR/ISL through Week 144. Results at Week 48 were recently published in The Lancet . At Week 96, 1.9% of participants who continued on DOR/ISL for 96 weeks had HIV-1 RNA ≥50 copies/mL and 1.1% of participants who switched from bART to DOR/ISL at Week 48. Additionally, 92.6% of participants who were on DOR/ISL through 96 weeks and 96.6% of participants who switched to DOR/ISL at Week 48 maintained virologic suppression (HIV-1 RNA <50 copies/mL) at Week 96. At Week 96, there were similar rates of drug-related AEs between those who continued on DOR/ISL (13.7%) for 96 weeks and for those who switched from bART to DOR/ISL at Week 48 (11.3%) and rates of discontinuations due to AEs for those on DOR/ISL for 96 weeks (1.1%) and for those who switched from bART to DOR/ISL at Week 48 (0.6%) were similar. The mean percent change in total lymphocyte and CD4 counts were similar for participants who continued on DOR/ISL and switched from bART to DOR/ISL. No participants discontinued treatment due to decreased CD4+ T-cell count or TLC. About Islatravir (MK-8591) and Merck’s HIV Research Islatravir (MK-8591) is Merck’s investigational nucleoside analog that blocks HIV-1 replication by multiple mechanisms including inhibition of reverse transcriptase translocation, resulting in immediate chain termination and induction of structural changes in the viral DNA. Islatravir is under evaluation in multiple ongoing early and late-stage clinical trials in combination with other antiretrovirals for potential daily and once-weekly treatments for HIV-1, with islatravir serving as the anchor medicine in these two-drug regimens. Islatravir in combination with Gilead’s lenacapavir is in Phase 3 development as a novel oral once-weekly treatment for HIV-1 [ISLEND-1 ( NCT06630286 ) and ISLEND-2 ( NCT06630299 )], and islatravir in combination with our company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) ulonivirine (MK-8507) is in Phase 2b development (MK-8591B-060, NCT06891066 and MK-8591B-062, NCT07266831 ) as an oral once-weekly treatment. MK-8527 is the company’s investigational, novel, once-monthly, oral candidate for pre-exposure prophylaxis (PrEP) for HIV-1. The Phase 3 EXPrESSIVE-11 (MK-8527-011, NCT07044297 ) trial is evaluating the safety and efficacy of MK-8527 as PrEP to reduce the risk of sexually acquired HIV-1 infection among people likely to be exposed to HIV-1 in 16 countries. The Phase 3 EXPrESSIVE-10 (MK-8527-010, NCT07071623 ) trial is evaluating the safety and efficacy of MK-8527 as PrEP to reduce the risk of sexually acquired HIV-1 infection among women and adolescent girls in sub-Saharan Africa. Both trials are now enrolling. For an overview of Merck’s HIV treatment and prevention clinical development program, please click here . Indications and usage for PIFELTRO ® (doravirine) and DELSTRIGO ® (doravirine, lamivudine, and tenofovir disoproxil fumarate) in the U.S. PIFELTRO is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine. DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO. Selected Safety Information Warning: Posttreatment Acute Exacerbation of Hepatitis B Virus (HBV) for DELSTRIGO All patients with HIV-1 should be tested for the presence of HBV before initiating ARV therapy. Severe acute exacerbations of HBV have been reported in people with concomitant HIV-1 and HBV who have discontinued products containing lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Patients coinfected with HIV-1 and HBV who discontinue DELSTRIGO should be monitored with both clinical and laboratory follow-up for at least several months after stopping DELSTRIGO. If appropriate, initiation of anti-HBV therapy may be warranted. Contraindications PIFELTRO and DELSTRIGO are contraindicated when coadministered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John’s wort (Hypericum perforatum)), as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO and PIFELTRO. DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Warnings and Precautions Severe Skin Reactions Severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported during the postmarketing experience with doravirine-containing regimens. Discontinue PIFELTRO or DELSTRIGO, and other medications known to be associated with severe skin reactions, immediately if a painful rash with mucosal involvement or a progressive severe rash develops. Clinical status should be closely monitored, and appropriate therapy should be initiated. New or Worsening Renal Impairment Renal impairment, including cases of acute renal failure and Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in people living with HIV with risk factors for renal dysfunction who appeared stable on TDF. Prior to or when initiating DELSTRIGO, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue DELSTRIGO in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Discontinue DELSTRIGO if estimated creatinine clearance declines below 50 mL/min. Bone Loss and Mineralization Defects In clinical trials in adults living with HIV, TDF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher. Cases of osteomalacia associated with proximal renal tubulopathy have been reported with the use of TDF. The effects of TDF-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in adults are unknown. Immune Reconstitution Syndrome Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment. Drug Interactions Because DELSTRIGO is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. Coadministration of PIFELTRO with efavirenz, etravirine, or nevirapine is not recommended. If DELSTRIGO is coadministered with rifabutin, take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO. If PIFELTRO is coadministered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart). Consult the full Prescribing Information prior to and during treatment for more information on potential drug-drug interactions. Dosage and Administration/Specific Populations Renal Impairment Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL/min. Adverse Reactions The most common adverse reactions with DELSTRIGO (incidence ≥5%, all intensities) were dizziness (7%), nausea (5%), and abnormal dreams (5%). The most common adverse reactions with PIFELTRO (incidence ≥5%, all intensities) were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%), and abnormal dreams (5%). By week 96 in DRIVE-FORWARD, 2% of adult participants in the PIFELTRO group and 3% in the darunavir+ritonavir (DRV+r) group had adverse events leading to discontinuation of study medication. By week 96 in DRIVE-AHEAD, 3% of adult participants in the DELSTRIGO group and 7% in the efavirenz (EFV)/emtricitabine (FTC)/TDF group had adverse events leading to discontinuation of study medication. In DRIVE-FORWARD, mean changes from baseline at week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -4.6 mg/dL in the PIFELTRO group vs 9.5 mg/dL in the DRV+r group. Non-HDL-C: -5.4 mg/dL in the PIFELTRO group vs 13.7 mg/dL in the DRV+r group. The clinical benefits of these findings have not been demonstrated. In DRIVE-AHEAD, mean changes from baseline at week 48 in LDL-C and non-HDL-C were pre-specified. LDL-C: -2.1 mg/dL in the DELSTRIGO group vs 8.3 mg/dL in the EFV/FTC/TDF group. Non-HDL-C: -4.1 mg/dL in the DELSTRIGO group vs 12.7 mg/dL in the EFV/FTC/TDF group. The clinical benefits of these findings have not been demonstrated. In DRIVE-SHIFT, mean changes from baseline at week 24 in LDL-C and non-HDL-C were pre-specified. LDL-C: -16.3 mg/dL in the DELSTRIGO group vs -2.6 mg/dL in the PI + ritonavir group. Non-HDL-C: -24.8 mg/dL in the DELSTRIGO group vs -2.1 mg/dL in the PI + ritonavir group. The clinical benefits of these findings have not been demonstrated. In DRIVE-AHEAD, neuropsychiatric adverse events were reported in the three pre-specified categories of sleep disorders and disturbances, dizziness, and altered sensorium. Twelve percent of adult participants in the DELSTRIGO group and 26% in the EFV/FTC/TDF group reported neuropsychiatric adverse events of sleep disorders and disturbances; 9% in the DELSTRIGO group and 37% in the EFV/FTC/TDF group reported dizziness; and 4% in the DELSTRIGO group and 8% in the EFV/FTC/TDF group reported altered sensorium. The safety of DELSTRIGO in virologically suppressed adults was based on week 48 data from participants in the DRIVE-SHIFT trial. Overall, the safety pro virologically suppressed adult participants was similar to that in participants with no ARV treatment history. Serum ALT and AST Elevations: In the DRIVE-SHIFT trial, 22% and 16% of participants in the immediate switch group experienced ALT and AST elevations greater than 1.25 X ULN, respectively, through 48 weeks on DELSTRIGO. For these ALT and AST elevations, no apparent patterns with regard to time to onset relative to switch were observed. One percent of participants had ALT or AST elevations greater than 5 X ULN through 48 weeks on DELSTRIGO. The ALT and AST elevations were generally asymptomatic, and not associated with bilirubin elevations. In comparison, 4% and 4% of participants in the delayed switch group experienced ALT and AST elevations of greater than 1.25 X ULN through 24 weeks on their baseline regimen. Pregnancy/Breastfeeding There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PIFELTRO or DELSTRIGO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Inform individuals with HIV-1 infection of the potential risks of breastfeeding, including: (1) HIV-1 transmission (in HIV-1–negative infants), (2) developing viral resistance (in HIV-1–positive infants), and (3) serious adverse reactions in a breastfed infant similar to those seen in adults. Merck’s Commitment to HIV For 40 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has been pioneering in the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV. We are researching for real life and want to ensure people are not defined by HIV. Our work focuses on transformational innovations, collaborations with others in the global HIV community, and access initiatives aimed at the goal of helping to end the HIV epidemic for everyone. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U. Contacts Media Contacts: Eilyn Segura (203) 940-6259 Deb Wambold (215) 779-2234 Investor Contacts: Peter Dannenbaum (732) 594-1579 Damini Chokshi (732) 594-1577 Read full story here

注册号： Registration number： ChiCTR2600119266 最近更新日期： Date of Last Refreshed on： 2026-02-25 09:33:22 注册时间： Date of Registration： 2026-02-25 00:00:00 注册号状态： 预注册Registration Status： Prospective registration注册题目： 评价CMS-D001在中度至重度特应性皮炎患者中的有效性和安全性的多中心、 随机、双盲、安慰剂对照的Ⅱ期临床研究Public title： A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study evaluating the efficacy and safety of CMS-D001 in patients with moderate to severe atopic dermatitis注册题目简写：English Acronym：研究课题的正式科学名称： 评价CMS-D001在中度至重度特应性皮炎患者中的有效性和安全性的多中心、 随机、双盲、安慰剂对照的Ⅱ期临床研究Scientific title： A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study evaluating the efficacy and safety of CMS-D001 in patients with moderate to severe atopic dermatitis研究课题代号(代码)： Study subject ID：在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：申请注册联系人： 陈权  研究负责人： 崔勇 Applicant： Chen Quan  Study leader： Cui yong 申请注册联系人电话： Applicant telephone： +86 177 0885 7150 研究负责人电话： Study leader's telephone： +86 157 0162 5913申请注册联系人传真 ： Applicant Fax： 研究负责人传真： Study leader's fax：申请注册联系人电子邮件： Applicant E-mail： chenquan@cms.net.cn 研究负责人电子邮件： Study leader's E-mail： wuhucuiyong@vip.163.com申请单位网址(自愿提供)： Applicant website(voluntary supply)： 研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：申请注册联系人通讯地址： 中国广东省深圳市南山区南头街道马家龙社区南山大道3186号莲花广场B栋801 研究负责人通讯地址： 中国北京市朝阳区文学馆路47号Applicant address： Room 801, Building B, Lianhua Plaza, 3186 Nanshan Avenue, Majalong Community, Nantou Street, Nanshan District, Shenzhen, Guangdong, China Study leader's address： No. 47, Wenxueguan Road, Chaoyang District, Beijing, China申请注册联系人邮政编码： Applicant postcode： 研究负责人邮政编码： Study leader's postcode：申请人所在单位： 海南德镁医药科技有限责任公司Applicant's institution： Hainan Dermavon Pharmaceutical Technology Co., Ltd.研究负责人所在单位： 中日友好医院Affiliation of the Leader： China-Japan Friendship Hospital是否获伦理委员会批准： 是Approved by ethic committee： Yes伦理委员会批件文号： Approved No. of ethic committee： YW2025-097-01 伦理委员会批件附件： Approved file of Ethical Committee： 查看附件View批准本研究的伦理委员会名称： 中日友好医院药物（器械）临床试验伦理委员会Name of the ethic committee： Ethics Committee for Drug (Device) Clinical Trials at Sino-Japanese Friendship Hospital伦理委员会批准日期： Date of approved by ethic committee： 2025-12-29 00:00:00伦理委员会联系人： 郤思远Contact Name of the ethic committee： Xi Siyuan伦理委员会联系地址： 中国北京市朝阳区樱花东街2号制剂楼415Contact Address of the ethic committee： No. 415, Preparation Building, Yinghua Dong Street, Chaoyang District, Beijing, China伦理委员会联系人电话： Contact phone of the ethic committee： +86 10 8420 6086 伦理委员会联系人邮箱： Contact email of the ethic committee：研究实施负责（组长）单位： 中日友好医院Primary sponsor： China-Japan Friendship Hospital研究实施负责（组长）单位地址： 中国北京市朝阳区文学馆47号Primary sponsor's address： No. 47, Wenxueguan Road, Chaoyang District, Beijing, China试验主办单位(项目批准或申办者)： Secondary sponsor： 国家： 中国 省(直辖市)： 海南 市(区县)： Country： China Province： Hainan City： 单位(医院)： 海南德镁医药科技有限责任公司 具体地址： 中国海南省海口市国家高新技术产业开发区科技大道22号海口国科中心C座6楼整层 Institution hospital： Hainan Dermavon Pharmaceutical Technology Co., Ltd. Address： 6th Floor, Block C, Haikou National Science and Technology Center, No. 22 Science and Technology Avenue, National High tech Industrial Development Zone, Haikou, Hainan, China经费或物资来源： 海南德镁医药科技有限责任公司Source(s) of funding： Hainan Dermavon Pharmaceutical Technology Co., Ltd.研究疾病： 特应性皮炎  Target disease： Atopic dermatitis研究疾病代码：Target disease code：研究类型： 干预性研究Study type： Interventional study研究所处阶段： II期临床试验 Study phase： 2研究设计： 随机平行对照 Study design： Parallel 研究目的： 主要目的： 评价CMS-D001在中度至重度特应性皮炎参与者中的初步有效性。 次要目的： 评价CMS-D001在中度至重度特应性皮炎参与者中的安全性和耐受性。 评价CMS-D001及其主要代谢产物（如适用）在中度至重度特应性皮炎参与者中的药代动力学（PK）特征。 评价CMS-D001及其主要代谢产物（如适用）在中度至重度特应性皮炎参与者中的暴露-效应（E-R）关系。  Objectives of Study： Primary Objective: To evaluate the preliminary efficacy of CMS-D001 in participants with moderate to severe atopic dermatitis. Secondary objective: Evaluate the safety and tolerability of CMS-D001 in participants with moderate to severe atopic dermatitis. Evaluate the pharmacokinetic (PK) profile of CMS-D001 and its major metabolites (if applicable) in participants with moderate to severe atopic dermatitis. Evaluate the exposure-response (E-R) relationship of CMS-D001 and its major metabolites (if applicable) in participants with moderate to severe atopic dermatitis.药物成份或治疗方案详述： Description for medicine or protocol of treatment in detail： 纳入标准： 入选标准： 参与者必须符合下列所有标准才能参加试验： (1) 自愿签署知情同意书（ICF），能够和研究者进行良好的沟通，并且理解和遵守本研究的各项要求和限制条件； (2) 签署ICF时，年龄≥18周岁且≤75周岁，性别不限； (3) 筛选/基线访视时按照Hanifin & Rajka标准（1980）经研究者确诊为AD（附录1），且自首次出现AD相关皮疹/症状至筛选时病程≥1年； (4) 筛选和基线时，根据研究者评估，符合中重度AD标准： 湿疹面积和严重程度指数（EASI）评分≥16； 研究者总体评估（IGA）评分≥3； 受累体表面积（BSA）≥10%； 瘙痒数字评分量表（Itch NRS）评分≥4； (5) 经研究者判断，参与者具有对外用皮质类固醇（TCS）或外用钙调神经磷酸酶抑制剂（TCI）治疗反应不佳或不耐受的病史，或其他医学上考虑不建议进行外用治疗； (6) 能够且愿意从基线前至少7天开始，仅使用由申办者统一提供的不含影响疗效评价成分的润肤剂，并在研究期间持续使用； (7) 所有具有生育潜能的女性参与者及所有男性参与者需自签署ICF至研究末次给药后至少3个月无怀孕或捐精计划，必须遵守避孕的相关规定，至少采用一种高效的避孕方法避孕。（注：与有生育潜能的女性伴侣同居的男性参与者，必须愿意在其伴侣使用高效避孕方法的基础上再使用安全套）。Inclusion criteria Inclusion criteria: Participants must meet all of the following criteria to participate in the trial: (1) Voluntarily sign an informed consent form (ICF), be able to communicate well with the researcher, and understand and comply with the requirements and limitations of this study; (2) When signing the ICF, the age should be between 18 and 75 years old, with no gender restrictions; (3) During screening/baseline visits, the patient was diagnosed with AD by the researcher according to Hanifin&Rajka criteria (1980) (Appendix 1), and the disease duration from the first appearance of AD related rash/symptoms to screening was >= 1 year; (4) During screening and baseline, according to the researcher's evaluation, it meets the criteria for moderate to severe Alzheimer's disease: Eczema area and severity index (EASI) score >= 16; Researcher's overall assessment (IGA) score >= 3; Affected body surface area (BSA) >= 10%; Itch NRS score >= 4; (5) According to the researchers' judgment, the participants have a history of poor response or intolerance to external corticosteroids (TCS) or external calcineurin inhibitors (TCI) treatment, or other medical considerations do not recommend external treatment; (6) Able and willing to use only moisturizers provided by the sponsor that do not contain ingredients that affect efficacy evaluation, starting at least 7 days before baseline, and continue to use them during the study period; (7) All female participants with reproductive potential and all male participants must sign the ICF and have no pregnancy or sperm donation plan for at least 3 months after the last dose of the study. They must comply with contraception regulations and use at least one highly effective contraceptive method . (Note: Male participants who cohabit with female partners with reproductive potential must be willing to use condoms on the basis of their partner's use of efficient contraceptive methods).排除标准： 排除标准： 必须排除符合下列任一排除标准的参与者： (1) 患有其他混淆AD诊断或影响疗效评估的其他皮肤病（如全身性红皮病、银屑病、红斑狼疮、Netherton综合征等）、皮肤感染，或在患处有色素沉着、瘢痕、胎斑、纹身等情况经研究者判断可能影响对皮肤病变的评价； (2) 有严重带状疱疹或严重单纯疱疹既往史（包括但不限于播散型带状疱疹、泛发型带状疱疹、中枢神经系统带状疱疹、眼带状疱疹、复发性带状疱疹（2年内发生2次或以上）或有单纯疱疹、带状疱疹感染现病史； (3) 首次给药前3个月内存在需住院或静脉抗感染治疗的细菌、真菌或病毒感染史； (4) 首次给药前4周内存在需口服抗感染治疗的细菌、真菌或病毒感染史； (5) 首次给药前7天内，存在活动性感染或急性疾病状态（如发热、恶心、呕吐或腹泻）； (6) 筛选或基线时，存在慢性或复发性感染性疾病者，包括但不限于慢性肾脏感染、复发性尿路感染、慢性胸部感染、真菌感染（指甲浅表真菌感染除外）或感染性的皮肤伤口或溃疡，经研究者评估可能增加参与者安全性风险； (7) 符合以下任一项结核筛查标准： 有活动性结核感染的现病史或既往病史； 在筛选期间，研究者判断存在活动性结核病的体征或症状； 胸部CT提示当前或既往活动性结核感染； γ-干扰素释放试验结果显示潜伏性结核感染证据，定义为：筛选时γ-干扰素释放试验检测呈阳性或连续两次γ-干扰素释放试验结果不确定，且无临床症状。除非有记录表明参与者已经完成充分的结核潜伏感染的治疗，或者在首次给药前至少4周开始预防性治疗，并且同意完成后续预防性治疗疗程，预防措施的整个疗程不必在首次给药前完成。 注： 1）不允许使用利福平或利福喷丁进行结核预防。 2）如结核检测结果为不确定者，可进行1次复测。 (8) 首次给药前4周内接种减毒活疫苗，或计划在治疗期间的任何时间或研究完成后8周内接种减毒活疫苗者； (9) 首次给药前6个月内存在重大或不稳定的消化/肝胆、肾脏/泌尿、心血管、呼吸、内分泌、血液、免疫、中枢神经系统疾病者，根据研究者判断不具备临床研究条件者，例如但不限于胰腺炎、不稳定型心绞痛、心肌梗死、症状性充血性心力衰竭（纽约心脏病协会III级或IV级）、需要治疗的心律失常、药物控制不佳的高血压（收缩压≥160mmHg，舒张压≥100mmHg）、肺动脉高压、呼吸衰竭、脑卒中（包含短暂性脑缺血发作）、肝硬化、静脉血栓栓塞症等； (10) 首次给药前5年内患有恶性肿瘤（经过彻底治疗且没有任何复发迹象的皮肤原位鳞癌、基底细胞癌和原位宫颈癌除外）或淋巴组织增生性疾病； (11) 目前患有其它自身免疫性疾病（如类风湿性关节炎、系统性红斑狼疮、炎症性肠病等）； (12) 患有或疑似先天性或获得性免疫缺陷病史者，或研究者认为会损害参与者免疫状态的情况（如脾切除术史、原发性免疫缺陷）； (13) 患有精神相关疾病或病史（如抑郁症），影响用药依从性或研究者从临床上判断有自杀风险者； (14) 既往接受过或计划接受器官移植手术且需服用免疫抑制剂的参与者（如肝肾移植）； 15．筛选时任何显著的临床和实验室异常，研究者认为可能影响参与者安全者，包括但不限于： 血常规：白细胞＜3.0×10^9/L，中性粒细胞＜1.5×10^9/L，淋巴细胞计数<0.5×10^9/L；血小板计数＜100.0×10^9/L，血红蛋白＜100g/L； 肾功能：估算的肾小球滤过率（eGFR）＜60mL/min/1.73m^2； 肝功能：丙氨酸转氨酶（ALT）或天冬氨酸转氨酶（AST）≥2×ULN（正常值上限）；总胆红素≥1.5×ULN； 任何其它实验室检查结果异常且有临床意义，经研究者评估如果参与研究将可能对参与者构成不可接受的风险； (16) 筛选或基线时，生命体征、体格检查、12-导联心电图、胸部CT（可接受1个月内的CT检查结果）异常且有临床意义，经研究者评估如果参与研究将可能对参与者构成不可接受的风险； (17) 筛选访视时存在下列任一感染者： 乙型肝炎：表面抗原（HBsAg）阳性；或核心抗体（HBcAb）阳性，且乙型肝炎病毒脱氧核糖核酸（HBV-DNA）拷贝数阳性（定义为超过研究中心检测值正常范围上限）； 丙型肝炎（HCV）抗体阳性，且HCV-RNA拷贝数阳性（定义为超过研究中心检测值正常范围上限）； 人类免疫缺陷病毒抗体（HIV Ab）阳性； 梅毒特异性抗体试验阳性（梅毒非特异性抗体RPR或TRUST结果为阴性，并经研究者判断为过去曾感染梅毒但已治愈的参与者除外）； (18) 随机前规定的洗脱期内接受了以下任何一种治疗者： 3个月内（或5个半衰期，以时间较长者为准）接受过生物疗法，包括但不限于度普利尤单抗、司普奇拜单抗等； 4周内（或5个半衰期，以时间较长者为准）接受过已知或可能影响特应性皮炎的系统治疗，包括但不限于JAK1/2/3抑制剂、系统性皮质类固醇或促肾上腺皮质激素类似物、环孢菌素、甲氨蝶呤、硫唑嘌呤或其他系统性免疫抑制或免疫调节剂（如霉酚酸酯或他克莫司）； 4周内接受过紫外光治疗或长时间暴露于自然或人工紫外线辐射源（如阳光或日光浴），和/或有意在研究期间接受此类暴露者； 4周内接受过长效抗凝药物（如华法林、氯吡格雷等）或需要持续使用抗凝药物治疗者（≤100mg/天的阿司匹林除外）； 2周内接受过已知或可能影响特应性皮炎的外用药物治疗，包括外用糖皮质激素（TCS）、钙调磷酸酶抑制剂（TCI）、磷酸二酯酶4（PDE4）抑制剂等； 2周内接受过用于治疗特应性皮炎的口服中草药或中成药（以下中药需洗脱4周：含明确免疫抑制/强免疫调节成分的中药或中成药，包括但不限于：雷公藤及其制剂、复方甘草酸苷等；组方复杂且成分不清、或无法明确主要有效/活性成分及其停用时间的中药治疗；研究者判断可能对疾病严重程度或免疫状态产生持续影响，干扰疗效评估或增加风险者）； (19) 既往暴露于TYK2抑制剂治疗者，或既往接受过系统性JAK1/2/3抑制剂治疗且疗效不佳或因安全性原因停药的参与者； (20) 筛选前3个月内有酗酒史和/或药物滥用史； (21) 存在任何可能影响药物吸收的情况者，包括但不限于：吸收不良综合征、乳糜泻、胃切除术、肠切除术（阑尾切除术除外）； (22) 首次给药前4周或5个半衰期（以时间较长者为准）内使用过或在研究期间不能避免使用CYP3A强诱导剂或抑制剂的药物（见附录7）者； (23）首次给药前7天内食用了圣·约翰草（贯叶连翘）制品、葡萄柚，或拒绝在整个研究期间（包括随访期）避免食用此类物质者； (24) 筛选前3个月内献血或失血≥ 400mL或计划在研究期间献血者； (25) 已知或怀疑对试验药物中任何一种成分过敏者，或任何其他显著的药物过敏（如过敏性休克或肝毒性）； (26) 妊娠或哺乳期女性； (27) 首次给药前3个月或5个半衰期内（以时间较长者为准）使用其他临床试验药物或目前正在参加其他临床研究者； (28) 研究者认为不适宜参加本临床研究的其他情况。Exclusion criteria： Exclusion criteria: Participants who meet any of the following exclusion criteria must be excluded: (1) Suffering from other skin diseases (such as systemic erythroderma, psoriasis, lupus erythematosus, Netherton syndrome, etc.) that may confuse the diagnosis of AD or affect the evaluation of treatment efficacy, skin infections, or pigmentation, scars, fetal spots, tattoos, etc. at the affected area, which may affect the evaluation of skin lesions according to the researcher's judgment; (2) Have a history of severe herpes zoster or severe herpes simplex (including but not limited to disseminated herpes zoster, generalized herpes zoster, central nervous system herpes zoster, ocular herpes zoster, recurrent herpes zoster (occurring twice or more within 2 years), or a current history of herpes simplex or herpes zoster infection; (3) History of bacterial, fungal, or viral infections requiring hospitalization or intravenous anti infective treatment within 3 months prior to the first administration; (4) History of bacterial, fungal, or viral infections requiring oral anti infective treatment within 4 weeks prior to the first administration; (5) Within 7 days before the first administration, there is an active infection or acute disease state (such as fever, nausea, vomiting, or diarrhea); (6) In screening or baseline, the presence of chronic or recurrent infectious diseases, including but not limited to chronic kidney infection, recurrent urinary tract infection, chronic chest infection, fungal infection (except for superficial nail fungal infection) or infectious skin wounds or ulcers, may increase the safety risk of participants as assessed by the investigator; (7) Meet any of the following tuberculosis screening criteria: Present or past medical history of active tuberculosis infection; During the screening period, the researcher judged that there were signs or symptoms of active tuberculosis; Chest CT indicates current or previous active tuberculosis infection; The results of the interferon gamma release test show evidence of latent tuberculosis infection, defined as: positive interferon gamma release test during screening or uncertain results from two consecutive interferon gamma release tests, and no clinical symptoms. Unless there is a record indicating that the participant has completed sufficient treatment for latent tuberculosis infection, or started preventive treatment at least 4 weeks before the first dose, and agrees to complete subsequent preventive treatment courses, the entire course of preventive measures does not need to be completed before the first dose. Note: 1)The use of rifampicin or rifampicin for tuberculosis prevention is not allowed. 2)If the tuberculosis test result is uncertain, a retest can be conducted once. (8) Those who have received attenuated live vaccine within 4 weeks before the first administration, or plan to receive attenuated live vaccine at any time during the treatment period or within 8 weeks after the completion of the study; (9) Patients with significant or unstable digestive/hepatobiliary, renal/urinary, cardiovascular, respiratory, endocrine, hematological, immune, or central nervous system diseases within 6 months prior to the first administration, who, according to the researcher's judgment, do not meet the clinical research conditions, such as but not limited to pancreatitis, unstable angina, myocardial infarction, symptomatic congestive heart failure (New York Heart Association Class III or IV), arrhythmia requiring treatment, poorly controlled hypertension (systolic blood pressure >= 160mmHg, diastolic blood pressure >= 100mmHg), pulmonary hypertension, respiratory failure, stroke (including transient ischemic attack), cirrhosis, venous thromboembolism, etc; (10) Suffering from malignant tumors (excluding skin squamous cell carcinoma in situ, basal cell carcinoma, and cervical cancer in situ that have been thoroughly treated and show no signs of recurrence) or lymphoproliferative diseases within 5 years before the first administration; (11) Currently suffering from other autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc.); (12) Individuals with or suspected of having a history of congenital or acquired immunodeficiency, or conditions that researchers believe may impair the immune status of participants (such as a history of splenectomy, primary immunodeficiency); (13) Individuals with mental illness or medical history (such as depression) that affects medication adherence or is clinically judged by researchers to be at risk of suicide; (14) Participants who have undergone or plan to undergo organ transplantation surgery and require immunosuppressants (such as liver and kidney transplantation); (15) Any significant clinical and laboratory abnormalities during screening that researchers believe may affect the safety of participants, including but not limited to: Blood routine: White blood cell count<3.0 × 10^9/L, neutrophil count<1.5 × 10^9/L, lymphocyte count<0.5 × 10^9/L; platelet count<100.0 × 10^9/L, hemoglobin<100g/L; Renal function: Estimated glomerular filtration rate (eGFR)<60mL/min/1.73m^2; Liver function: Alanine transaminase (ALT) or aspartate transaminase (AST) >= 2 × ULN (upper limit of normal); Total bilirubin >= 1.5 × ULN; Any other laboratory test results that are abnormal and clinically significant, as assessed by the researcher, may pose an unacceptable risk to the participants if they participate in the study; (16) When screening or baseline, if vital signs, physical examination, 12 lead electrocardiogram, and chest CT (CT scan results within 1 month are acceptable) are abnormal and clinically significant, and the researcher evaluates that participating in the study may pose an unacceptable risk to the participants; (17) During the screening visit, any of the following infected individuals were identified: Hepatitis B: HBsAg positive; Or the core antibody (HBcAb) is positive, and the copy number of hepatitis B virus deoxyribonucleic acid (HBV-DNA) is positive (defined as exceeding the upper limit of the normal range of the research center's detection value); Hepatitis C (HCV) antibody positive and HCV-RNA copy number positive (defined as exceeding the upper limit of the normal range of detection values in the research center); Positive for Human Immunodeficiency Virus Antibody (HIV Ab); Positive syphilis specific antibody test (excluding participants who tested negative for syphilis non-specific antibody RPR or TRUST and were diagnosed by the researcher as having previously been infected with syphilis but have been cured); 18. Individuals who received any of the following treatments within the designated elution period prior to randomization: Received biological therapy within 3 months (or 5 half lives, whichever is longer), including but not limited to Dupilumab, Sprucubizumab, etc; Within 4 weeks (or 5 half lives, whichever is longer), have received systemic treatments known or likely to affect atopic dermatitis, including but not limited to JAK1/2/3 inhibitors, systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulatory agents (such as mycophenolate mofetil or tacrolimus); Individuals who have received UV treatment within 4 weeks or have been exposed to natural or artificial UV radiation sources (such as sunlight or sunbathing) for a prolonged period of time, and/or who intend to receive such exposure during the study period; Those who have received long-acting anticoagulants (such as warfarin, clopidogrel, etc.) within 4 weeks or require continuous use of anticoagulants (excluding aspirin <= 100mg/day); Within 2 weeks, have received external medication treatment known or likely to affect atopic dermatitis, including topical corticosteroids (TCS), calcineurin inhibitors (TCI), phosphodiesterase 4 (PDE4) inhibitors, etc; Have received oral Chinese herbal medicine or traditional Chinese patent medicines and simple preparations for the treatment of atopic dermatitis within 2 weeks (the following Chinese medicines need to be eluted for 4 weeks: Chinese herbal medicine or traditional Chinese patent medicines and simple preparations containing clear immunosuppressive/strong immunomodulatory ingredients, including but not limited to: tripterygium wilfordii and its preparations, compound glycyrrhizin, etc.; Chinese herbal medicine treatment with complex formula and unclear ingredients, or the main effective/active ingredients and their stopping time cannot be clear; the researcher judges those who may have a continuous impact on disease severity or immune status, interfere with efficacy evaluation, or increase the risk); (19) Participants who have been previously exposed to TYK2 inhibitor therapy, or who have previously received systemic JAK1/2/3 inhibitor therapy with poor efficacy or have discontinued medication for safety reasons; (20) History of alcohol and/or drug abuse within the past 3 months prior to screening; (21) Individuals with any conditions that may affect drug absorption, including but not limited to: malabsorption syndrome, celiac disease, gastrectomy, and intestinal resection (excluding appendectomy); (22) Those who have used CYP3A strong inducers or inhibitors within 4 weeks or 5 half lives (whichever is longer) before the first administration, or who cannot avoid using CYP3A strong inducers or inhibitors during the study period (see Appendix 7); (23) Those who consumed St. John's wort (Forsythia suspensa) products or grapefruit within 7 days prior to the first administration, or refused to avoid such substances throughout the entire study period (including follow-up); (24) Select individuals who have donated blood or lost ≥ 400mL of blood within the previous 3 months or plan to donate blood during the study period; (25) Individuals who are known or suspected to be allergic to any component of the investigational drug, or to any other significant drug allergy (such as anaphylactic shock or hepatotoxicity); (26) Pregnant or lactating women; (27) Those who use other clinical trial drugs or are currently participating in other clinical studies within 3 months or 5 half lives before the first administration (whichever is longer); (28) Other circumstances that the researcher deems unsuitable for participation in this clinical study.研究实施时间： Study execute time： 从 From 2025-12-29 00:00:00至 To 2026-12-31 00:00:00 征募观察对象时间： Recruiting time： 从 From 2026-03-06 00:00:00 至 To 2026-12-31 00:00:00干预措施： Interventions： 组别： 50mg QD组 样本量： 40 Group： 50mg QD group Sample size： 干预措施： 空腹口服给药，每日服药一次，持续服药 12 周。 干预措施代码： Intervention： Take the medication on an empty stomach, once a day, for a duration of 12 weeks. Intervention code： 组别： 100mg QD 组 样本量： 40 Group： 100mg QD group Sample size： 干预措施： 空腹口服给药，每日服药一次，持续服药 12 周。 干预措施代码： Intervention： Take the medication on an empty stomach, once a day, for a duration of 12 weeks. Intervention code： 组别： 200mg QD组 样本量： 40 Group： 200mg QD group Sample size： 干预措施： 空腹口服给药，每日服药一次，持续服药 12 周。 干预措施代码： Intervention： Take the medication on an empty stomach, once a day, for a duration of 12 weeks. Intervention code： 组别： 安慰剂组 样本量： 40 Group： Placebo Sample size： 干预措施： 空腹口服给药，每日服药一次，持续服药 12 周。 干预措施代码： Intervention： Take the medication on an empty stomach, once a day, for a duration of 12 weeks. Intervention code：研究实施地点： Countries of recruitment and research settings： 国家： 中国 省(直辖市)： 北京  市(区县)： Country： China Province： Beijing City： 单位(医院)： 中日友好医院  单位级别： 三甲  Institution hospital： China-Japan Friendship Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 广东  市(区县)： Country： China Province： Guangdong City： 单位(医院)： 南方医科大学皮肤病医院  单位级别： 三甲  Institution hospital： Southern Medical University Dermatology Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 上海  市(区县)： Country： China Province： Shanghai City： 单位(医院)： 上海市皮肤病医院  单位级别： 三甲  Institution hospital： Shanghai Skin Disease Hospita Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 湖北  市(区县)： Country： China Province： Hubei City： 单位(医院)： 武汉市第一医院  单位级别： 三甲  Institution hospital： Wuhan First Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 浙江  市(区县)： Country： China Province： Zhejiang City： 单位(医院)： 杭州市第一人民医院  单位级别： 三甲  Institution hospital： Hangzhou First People's Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 浙江  市(区县)： Country： China Province： Zhejiang City： 单位(医院)： 浙江省人民医院  单位级别： 三甲  Institution hospital： Zhejiang Provincial People's Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 四川  市(区县)： Country： China Province： Sichuan City： 单位(医院)： 四川省人民医院  单位级别： 三甲  Institution hospital： Sichuan Provincial People's Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 河北  市(区县)： Country： China Province： Hebei City： 单位(医院)： 河北医科大学第二医院  单位级别： 三甲  Institution hospital： The Second Hospital of Hebei Medical University Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 广东  市(区县)： Country： China Province： Guangdong City： 单位(医院)： 北京大学深圳医院  单位级别： 三甲  Institution hospital： Peking University Shenzhen Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 宁夏回族自治区  市(区县)： Country： China Province： Ningxia Hui Autonomous Region City： 单位(医院)： 宁夏医科大学总医院  单位级别： 三甲  Institution hospital： General Hospital of Ningxia Medical University Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 海南  市(区县)： Country： China Province： Hainan City： 单位(医院)： 海南省第五人民医院  单位级别： 三甲  Institution hospital： Hainan Provincial Fifth People's Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 江苏  市(区县)： Country： China Province： Jiangsu City： 单位(医院)： 江苏大学附属医院  单位级别： 三甲  Institution hospital： Affiliated Hospital of Jiangsu University Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 河南  市(区县)： Country： China Province： Henan City： 单位(医院)： 郑州市中心医院  单位级别： 三甲  Institution hospital： Zhengzhou Central Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 浙江  市(区县)： Country： China Province： Zhejiang City： 单位(医院)： 杭州市第三人民医院  单位级别： 三甲  Institution hospital： Hangzhou Third People's Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 天津  市(区县)： Country： China Province： Tianjin City： 单位(医院)： 天津医科大学总医院  单位级别： 三甲  Institution hospital： General Hospital of Tianjin Medical University Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 北京  市(区县)： Country： China Province： Beijing City： 单位(医院)： 首都医科大学附属北京同仁医院  单位级别： 三甲  Institution hospital： Beijing Tongren Hospital, Capital Medical University Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 山东  市(区县)： Country： China Province： Shandong City： 单位(医院)： 山东大学齐鲁医院  单位级别： 三甲  Institution hospital： Qilu Hospital of Shandong University Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 四川  市(区县)： Country： China Province： Sichuan City： 单位(医院)： 四川大学华西医院  单位级别： 三甲  Institution hospital： West China Hospital, Sichuan University Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 辽宁  市(区县)： Country： China Province： Liaoning City： 单位(医院)： 沈阳市中西医结合医院  单位级别： 三甲  Institution hospital： Shenyang Integrated Traditional Chinese and Western Medicine Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 辽宁  市(区县)： Country： China Province： Liaoning City： 单位(医院)： 沈阳医学院附属中心医院  单位级别： 三甲  Institution hospital： Central Hospital Affiliated to Shenyang Medical College Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 福建  市(区县)： Country： China Province： Fujian City： 单位(医院)： 福建医科大学附属第一医院  单位级别： 三甲  Institution hospital： The First Affiliated Hospital of Fujian Medical University Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 陕西  市(区县)： Country： China Province： Shaanxi City： 单位(医院)： 陕西省人民医院  单位级别： 三甲  Institution hospital： Shaanxi Provincial People's Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 山东  市(区县)： Country： China Province： Shandong City： 单位(医院)： 滨州医学院附属医院  单位级别： 三甲  Institution hospital： Affiliated Hospital of Binzhou Medical University Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 河北  市(区县)： Country： China Province： Hebei City： 单位(医院)： 华北理工大学附属医院  单位级别： 三甲  Institution hospital： Affiliated Hospital of North China University of Science and Technology Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 江苏  市(区县)： Country： China Province： Jiangsu City： 单位(医院)： 苏州市立医院  单位级别： 三甲  Institution hospital： Suzhou Municipal Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 湖北  市(区县)： Country： China Province： Hubei City： 单位(医院)： 十堰市人民医院  单位级别： 三甲  Institution hospital： Shiyan People's Hospital Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 上海  市(区县)： Country： China Province： Shanghai City： 单位(医院)： 上海中医药大学附属岳阳中西医结合医院  单位级别： 三甲  Institution hospital： Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine Level of the institution： Tertiary A 国家： 中国 省(直辖市)： 北京  市(区县)： Country： China Province： Beijing City： 单位(医院)： 北京怀柔医院  单位级别： 三甲  Institution hospital： Beijing Huairou Hospital Level of the institution： Tertiary A测量指标： Outcomes： 指标中文名： 湿疹面积和严重程度指数较基线改善至少75%（EASI 75）的参与者比例 指标类型： 主要指标 Outcome： Proportion of participants with at least 75% improvement from baseline in the Eczema Area and Severity Index (EASI 75) Type： Primary indicator 测量时间点： 第12周 测量方法： Measure time point of outcome： Week 12 Measure method： 指标中文名： 湿疹面积和严重程度指数较基线改善至少75%（EASI 75）的参与者比例 指标类型： 次要指标 Outcome： The proportion of participants whose eczema area and severity index improved by at least 75% compared to baseline (EASI 75) Type： Secondary indicator 测量时间点： 第2、4、8周 测量方法： Measure time point of outcome： At weeks 2, 4, and 8 Measure method： 指标中文名： 达到EASI 50/90的参与者比例 指标类型： 次要指标 Outcome： Proportion of participants reaching EASI 50/90 Type： Secondary indicator 测量时间点： 第2、4、8、12周 测量方法： Measure time point of outcome： At weeks 2, 4, 8, and 12 Measure method： 指标中文名： 达到IGA 0或1分且较基线改善≥2分的参与者比例 指标类型： 次要指标 Outcome： The proportion of participants who achieved IGA score of 0 or 1 and improved by >= 2 points from baseline Type： Secondary indicator 测量时间点： 第2、4、8、12周 测量方法： Measure time point of outcome： At weeks 2, 4, 8, and 12 Measure method： 指标中文名： 达到IGA 0分或1分的参与者比例 指标类型： 次要指标 Outcome： The proportion of participants who achieved 0 or 1 IGA score Type： Secondary indicator 测量时间点： 第2、4、8、12周 测量方法： Measure time point of outcome： At weeks 2, 4, 8, and 12 Measure method： 指标中文名： Itch NRS评分较基线改善≥4分的参与者比例 指标类型： 次要指标 Outcome： The proportion of participants whose Itch NRS scores improved by >= 4 points from baseline Type： Secondary indicator 测量时间点： 第2、4、8、12周 测量方法： Measure time point of outcome： At weeks 2, 4, 8, and 12 Measure method： 指标中文名： EASI评分较基线的百分比变化 指标类型： 次要指标 Outcome： Percentage change in EASI score compared to baseline Type： Secondary indicator 测量时间点： 第2、4、8、12周 测量方法： Measure time point of outcome： At weeks 2, 4, 8, and 12 Measure method： 指标中文名： SCORAD评分较基线的百分比变化 指标类型： 次要指标 Outcome： Percentage change in SCORAD score compared to baseline Type： Secondary indicator 测量时间点： 第2、4、8、12周 测量方法： Measure time point of outcome： At weeks 2, 4, 8, and 12 Measure method： 指标中文名： Itch NRS评分较基线的变化 指标类型： 次要指标 Outcome： Changes in Itch NRS score compared to baseline Type： Secondary indicator 测量时间点： 第2、4、8、12周 测量方法： Measure time point of outcome： At weeks 2, 4, 8, and 12 Measure method： 指标中文名： 受累体表面积（BSA）较基线的百分比变化 指标类型： 次要指标 Outcome： Percentage changes in affected body surface area (BSA) compared to baseline Type： Secondary indicator 测量时间点： 第2、4、8、12周 测量方法： Measure time point of outcome： At weeks 2, 4, 8, and 12 Measure method： 指标中文名： 皮肤病学生活质量指数（DLQI）评分较基线的变化 指标类型： 次要指标 Outcome： Changes in Dermatology Quality of Life Index (DLQI) scores from baseline Type： Secondary indicator 测量时间点： 第2、4、8、12周 测量方法： Measure time point of outcome： At weeks 2, 4, 8, and 12 Measure method： 指标中文名： 不良事件、实验室检查、生命体征、心电图检查、体格检查等 指标类型： 附加指标 Outcome： Adverse events, laboratory tests, vital signs, electrocardiogram examination, physical examination, etc Type： Additional indicator 测量时间点： 测量方法： Measure time point of outcome： Measure method： 指标中文名： 评价CMS-D001及其主要代谢产物（如适用）在中重度特应性皮炎参与者中的PK特征 指标类型： 附加指标 Outcome： Evaluate the PK characteristics of CMS-D001 and its major metabolites (if applicable) in participants with moderate to severe atopic dermatitis Type： Additional indicator 测量时间点： 测量方法： Measure time point of outcome： Measure method： 指标中文名： 群体药代动力学（PopPK）分析 指标类型： 附加指标 Outcome： Population pharmacokinetic (PopPK) analysis Type： Additional indicator 测量时间点： 测量方法： Measure time point of outcome： Measure method： 指标中文名： 暴露-效应分析：CMS-D001及其主要代谢产物（如适用）的暴露与疗效和不良事件之间的关系 指标类型： 附加指标 Outcome： Exposure effect analysis: The relationship between exposure to CMS-D001 and its major metabolites (if applicable) and efficacy and adverse events Type： Additional indicator 测量时间点： 测量方法： Measure time point of outcome： Measure method： 指标中文名： 评价血清胸腺活化调节趋化因子（TARC）和免疫球蛋白E（IgE）等生物标志物水平及其较基线变化随时间的变化 指标类型： 附加指标 Outcome： Evaluate the levels of biomarkers such as serum thymic activation regulatory chemokine (TARC) and immunoglobulin E (IgE) and their changes over time compared to baseline Type： Additional indicator 测量时间点： 测量方法： Measure time point of outcome： Measure method：采集人体标本： Collecting sample(s) from participants： 标本中文名： 血液 组织： 无 Sample Name： Blood Tissue： None 人体标本去向 使用后销毁   说明 无 Fate of sample： Destruction after use Note： None征募研究对象情况： Recruiting status： 尚未开始 Not yet recruiting 年龄范围： Participant age： 最小 Min age 18 岁 years 最大 Max age 75 岁 years性别： 男女均可 Gender： Both随机方法（请说明由何人用什么方法产生随机序列）： 本研究采用分层区组随机化方法，参与者的基线IGA评分（3分或4分）将作为随机分层因子，在每层内参与者将按照1:1:1:1比例随机分配至CMS-D001 50mg QD剂量组、100mg QD剂量组、200mg QD剂量组和安慰剂组。随机化将采用网络应答系统（IWRS）进行，该系统按照随机化编号自动随机分配治疗组。经过合适包装的研究药物，可一次或分若干次提供给研究中心。对符合纳入条件的参与者，将根据参与者的随机号，匹配对应的药物编号，分配药物。已完成随机的参与者，如果终止治疗或退出研究，无论其是否使用试验用药品、因任何原因终止治疗或退出研究，其随机号都不能分配给其他参与者再次使用。Randomization Procedure (please state who generates the random number sequence and by what method)： This study used a stratified block randomization method, where participants' baseline IGA scores (3 or 4 points) were used as random stratification factors. Within each layer, participants were randomly assigned to CMS-D001 50mg QD dose group, 100mg QD dose group, 200mg QD dose group, and placebo group in a 1:1:1:1 ratio. Randomization will be conducted using an Internet of Response System (IWRS), which automatically assigns treatment groups based on randomization numbers. The research drug, packaged appropriately, can be provided to the research center in one or several portions. For participants who meet the inclusion criteria, corresponding drug numbers will be matched based on their random numbers and drugs will be assigned. Participants who have completed randomization and terminate treatment or withdraw from the study, regardless of whether they use the investigational drug or terminate treatment or withdraw from the study for any reason, their randomization number cannot be assigned to other participants for reuse.是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: 不公开/Private盲法： 盲法可确保研究评估不受具体治疗分配的影响。本研究采用双盲设计，即研究治疗过程中参与者、研究者均不清楚随机分组治疗分配情况。Blinding： Blinding ensures that the research evaluation is not affected by specific treatment allocation. This study uses a double-blind design, meaning that neither the participants nor the researchers are aware of the random group treatment allocation during the treatment process.是否共享原始数据： IPD sharing 否No共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）： 无The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)： None数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC： 电子采集和管理系统Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture： Electronic Data Capture, EDC数据与安全监察委员会： Data and Safety Monitoring Committee： 无/No注册人： Name of Registration： 2026-02-25 09:33:15