注册号:
Registration number:
ChiCTR2600120745 最近更新日期:
Date of Last Refreshed on:
2026-03-19 09:01:18 注册时间:
Date of Registration:
2026-03-19 00:00:00 注册号状态:
预注册Registration Status:
Prospective registration注册题目:
评价 CMS-D001 片治疗中度至重度斑块状银屑病成人患者的有效性和安 全性的多中心、随机、双盲、安慰剂对照 II/III 期临床研究Public title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of CMS-D001 Tablets in Adult Patients with Moderate to Severe Plaque Psoriasis.注册题目简写:English Acronym:研究课题的正式科学名称:
评价 CMS-D001 片治疗中度至重度斑块状银屑病成人患者的有效性和安全性的多中心、随机、双盲、安慰剂对照 II/III 期临床研究Scientific title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of CMS-D001 Tablets in Adult Patients with Moderate to Severe Plaque Psoriasis.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:
李姗姗
研究负责人:
张福仁 Applicant:
Shanshan Li
Study leader:
Furen Zhang 申请注册联系人电话:
Applicant telephone:
+86 182 0134 6463
研究负责人电话:
Study leader's telephone:
+86 136 0892 1718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:
lishanshan@cms.net.cn
研究负责人电子邮件:
Study leader's E-mail:
zhangfuren@hotmail.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:
北京市朝阳区东四环中路82号
研究负责人通讯地址:
山东省济南市槐荫区经十路27397号Applicant address:
No. 82, East Fourth Ring Road, Chaoyang District, Beijing
Study leader's address:
No. 27397, Jingshi Road, Huaing District, Jinan City, Shandong Province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 Kangzhe Beautiful Technology Co.,Ltd.研究负责人所在单位:
山东第一医科大学附属皮肤病医院Affiliation of the Leader:
Shandong First Medical University Affiliated Dermatology 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:
20260112YWLC001
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:
山东第一医科大学附属皮肤病医院医学伦理委员会Name of the ethic committee:
Medical Ethics Committee of Shandong First Medical University Affiliated Dermatology Hospital伦理委员会批准日期:
Date of approved by ethic committee:
2026-01-12 00:00:00伦理委员会联系人:
赵伟Contact Name of the ethic committee:
Wei Zhao伦理委员会联系地址:
山东省济南市槐荫区经十路27397号Contact Address of the ethic committee:
No. 27397, Jingshi Road, Huaing District, Jinan City, Shandong Province伦理委员会联系人电话:
Contact phone of the ethic committee:
+86 531 8729 8817
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:
山东第一医科大学附属皮肤病医院Primary sponsor:
Shandong First Medical University Affiliated Dermatology Hospital研究实施负责(组长)单位地址:
山东省济南市槐荫区经十路27397号Primary sponsor's address:
No. 27397, Jingshi Road, Huaing District, Jinan City, Shandong Province试验主办单位(项目批准或申办者):
Secondary sponsor:
国家:
中国
省(直辖市):
海南省
市(区县):
海口市
Country:
China
Province:
Hainan Province
City:
Haikou City
单位(医院):
海南德镁医药科技有限责任公司
具体地址:
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
Institution
hospital:
Dermavon Holdings Limited
Address:
No. 22, Science Avenue, National High-tech Industrial Development Zone, Haikou City, Hainan Province. 6th Floor, Building C, Haikou Guoke Center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 Kangzhe Beautiful Technology Co.,Ltd.研究疾病:
斑块状银屑病 Target disease:
Plaque psoriasis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-III期临床试验 Study phase:
2-3研究设计:
随机平行对照 Study design:
Parallel 研究目的:
Ⅱ期临床研究阶段
主要目的
评价CMS-D001片治疗中度至重度斑块状银屑病的初步有效性。
次要目的
评价CMS-D001片治疗中度至重度斑块状银屑病的安全性和耐受性;
评价CMS-D001及其主要代谢产物(如适用)在中度至重度斑块状银屑病中的药代动力学特征;
如果数据允许,评价CMS-D001及其主要代谢产物(如适用)在中度至重度斑块状银屑病患者中的暴露-效应(E-R)关系。
其他目的
探索口服CMS-D001片后的药效动力学(PD)特征。
Ⅲ期临床研究阶段
主要目的
评价CMS-D001片治疗中度至重度斑块状银屑病患者的有效性。
次要目的
评价CMS-D001片治疗中度至重度斑块状银屑病患者的安全性和耐受性;
评价CMS-D001及其主要代谢产物(如适用)在中度至重度斑块状银屑病中的药代动力学特征;
如果数据允许,评价CMS-D001及其主要代谢产物(如适用)在中度至重度斑块状银屑病患者中的暴露-效应(E-R)关系。
其他目的
探索口服CMS-D001片后的药效动力学(PD)特征。 Objectives of Study:
Phase Ⅱ clinical study
Main Objective
To evaluate the preliminary efficacy of CMS-D001 tablet in the treatment of moderate to severe plaque psoriasis.
Secondary Objectives
The safety and tolerability of CMS-D001 tablet in the treatment of moderate to severe plaque psoriasis were evaluated.
The pharmacokinetics of CMS-D001 and its major metabolites (if applicable) were evaluated in patients with moderate to severe plaque psoriasis.
If data permit, the exposure-effect (E-R) relationship of CMS-D001 and its major metabolites (if applicable) in patients with moderate-to-severe plaque psoriasis was evaluated.
Other Purposes
To explore the pharmacodynamic (PD) characteristics of CMS-D001 tablets after oral administration.
Phase Ⅲ clinical trial
Main Objective
To evaluate the efficacy of CMS-D001 tablets in the treatment of patients with moderate to severe plaque psoriasis.
Secondary Objectives
The safety and tolerability of CMS-D001 tablet in the treatment of patients with moderate to severe plaque psoriasis were evaluated.
The pharmacokinetics of CMS-D001 and its major metabolites (if applicable) were evaluated in patients with moderate to severe plaque psoriasis.
If data permit, the exposure-effect (E-R) relationship of CMS-D001 and its major metabolites (if applicable) in patients with moderate-to-severe plaque psoriasis was evaluated.
Other Purposes
To explore the pharmacodynamic (PD) characteristics of CMS-D001 tablets after oral administration.药物成份或治疗方案详述:
Description for medicine or protocol of treatment in
detail:
纳入标准:
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. 筛选时,由研究者评估患有斑块状银屑病,病史>=6个月,且处于稳定期;
4. 筛选和基线时研究者评估斑块状银屑病病情满足以下要求:银屑病面积与严重程度指数(PASI)评分>=12分;医生整体评价(PGA)评分>=3分;受累的体表面积(BSA)>=10%;
5. 研究者判断符合光疗或系统性治疗条件;
6. 有生育能力的参与者自签署知情同意书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,采取高效或可接受的避孕方法避孕(见附录1)。Inclusion criteria
1. Voluntarily sign the Informed Consent Form (ICF), be able to communicate well with the researchers, and understand and comply with the requirements and restrictions of the study;
2. The age of signing ICF was >=18 years old and <=75 years old, regardless of gender;
(3) stable plaque psoriasis with >=6 months of history, as assessed by the investigator at screening;
Investigator-assessed plaque psoriasis at screening and baseline met the following requirements: Psoriasis area and severity index (PASI) score >=12; Physician global assessment (PGA) score >=3; Affected body surface area (BSA) >=10%;
5. Eligible for phototherapy or systemic therapy as judged by the investigator;
6. Participants of childbearing potential who had no plans to become pregnant or to donate sperm for at least 3 months after the last dose of study dose were required to follow the contraceptive guidelines and use a highly effective or acceptable method of contraception (see Appendix 1).排除标准:
1. 基线前3个月内存在非斑块状银屑病(如点滴型、脓疱型、红皮病型或反向型银屑病);
2. 筛选或基线时,存在其它皮肤病病史或当前状态(如湿疹),经研究者判断可能影响研究评估;
3. 有药物(如β-受体阻滞剂、钙离子通道阻滞剂、抗疟药物或锂剂)诱发或加重的银屑病既往病史或现病史;
4. 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;
5. 首次给药前3个月内存在需住院或静脉抗感染治疗的严重细菌、真菌或病毒感染史;
6. 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;
7. 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);
8. 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;
9. 符合以下任一项结核筛查标准:
1) 有活动性结核感染的现病史或既往病史;
2) 在筛选期间,研究者判断存在活动性结核病的体征或症状;
3) 胸部CT提示当前或既往活动性结核感染;
4) 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:
不允许使用利福平或利福喷丁进行结核预防。
如结核检测结果为不确定者,可进行1次复测。
10. 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;
11. 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、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;
12. 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;
13. 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);
14. 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);
15. 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;
16. 既往使用过IL-12、IL-17和/或IL-23靶向药物且经研究者评估疗效不佳者,包括但不限于:Tildrakizumab(替瑞奇珠单抗)、Guselkumab(古塞奇尤单抗)、Ustekinumab(乌司奴单抗)、Secukinumab(司库奇尤单抗)Ixekizumab(依奇珠单抗)、Brodalumab(布罗利尤单抗)等;
17. 既往使用过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;
18. 首次给药前,规定的时间内接受了以下任何一种治疗者:
2周内使用可能影响银屑病病情的局部用药/治疗(包括但不限于:糖皮质激素、维A酸类、维生素D3衍生物、钙调磷酸酶抑制剂、本维莫德、抗人IL-8单克隆抗体乳膏、焦油、水杨酸、地蒽酚等)或含有上述成分的洗浴产品,或可能影响银屑病病情的中成药外用剂、中医非药物疗法;
4 周内使用可能影响银屑病病情的非生物制剂系统治疗,包括但不限于JAKs抑制剂、糖皮质激素、维A酸 类、环孢素、甲氨蝶呤、黄芪、雷公藤、苦参、复方甘草酸铵、硫唑嘌呤、吗替麦考酚酯、中成药及传统中草药(对于无明确临床证据可能改善银屑病病情的中成药或传统中草药,可缩短为给药前2周内)、抗疟药、干扰素或锂制剂等;
4周内接受过肝药酶调节相关的中药治疗(如甘草、五味子等);
4周内进行物理治疗,包括但不限于:紫外线疗法、光化学疗法、采用日光浴床自我治疗等;
3个月或5个半衰期内(以时间较长者为准)接受除靶向IL-12、IL-17和/或IL-23外的其他生物制剂治疗;
6个月内接受靶向IL-12、IL-17和/或IL-23的生物制剂治疗;
6个月内接受过利妥昔单抗或其他免疫细胞耗竭治疗;
24个月内接受过来氟米特(经来氟米特药物清除剂进行洗脱者可缩短至6个月);19. 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;
20. 筛选或基线时,存在以下任何一种实验室检查异常:
外周血白细胞计数<3×10^9/L;
淋巴细胞计数<0.5×10^9/L;
中性粒细胞计数<1.5×10^9/L;
血小板<100×10^9/L;
血红蛋白<100 g/L;
估算的肾小球滤过率(eGFR)<=60 mL/min/1.73 m^2(使用慢性肾脏病流行病学协作方程,CKD-EPI,详见附录2);
丙氨酸转氨酶(ALT)或天冬氨酸转氨酶(AST)或总胆红素>=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;
21. 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;
22. 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);
23. 筛选前3个月内有酗酒史和/或药物滥用史;
24. 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);
25. 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3)者;
26. 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;
27. 筛选前3个月内献血或失血>= 400 mL或计划在研究期间献血者;
28. 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);
29. 妊娠或哺乳期女性;
30. 研究者认为不合适参加本研究的其他原因。Exclusion criteria:
1. Presence of nonplaque psoriasis (e.g., guttate, pustular, erythroderma, or inverse psoriasis) within 3 months before baseline;
2. A history of other skin diseases or current conditions (e.g., eczema) at screening or baseline that, in the investigator's judgment, may have affected the study assessment;
3. Previous or present history of psoriasis induced or exacerbated by drugs (e.g., β-blockers, calcium channel blockers, antimalarials, or lithium);
4. Previous 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, herpes zoster ophthalmicus, recurrent herpes zoster (2 or more episodes within 2 years) or present history of herpes simplex or herpes zoster infection;
5. A history of severe bacterial, fungal, or viral infection requiring hospitalization or intravenous antibiotic therapy within 3 months before the first dose;
6. A history of bacterial, fungal, or viral infection requiring oral anti-infective treatment within 4 weeks before the first dose of oral anti-infective treatment;
7. Presence of active infection or acute illness (e.g., fever, nausea, vomiting, or diarrhea) within 7 days before the first dose;
8. At screening or baseline, participants with chronic or recurrent infectious conditions, including but not limited to chronic kidney infection, recurrent urinary tract infection, chronic chest infection, fungal infection (other than superficial nail fungal infection), or infectious skin wounds or ulcers, were assessed by the investigator as potentially increasing risks to the participant's safety;
9. Meeting any of the following TB screening criteria:
1) present or past history of active tuberculosis infection;
2) presence of signs or symptoms of active tuberculosis as judged by the investigator during screening;
3) chest CT showed current or previous active tuberculosis infection;
4) Ifn-γ release assay results showed evidence of LTBI, defined as a positive Ifn-γ release assay at screening or two consecutive indeterminate Ifn-γ release assays, and no clinical symptoms. The full course of prophylaxis did not have to be completed before the first dose, unless it was recorded that the participant had completed adequate treatment for latent tuberculosis infection or had started prophylaxis at least 4 weeks before the first dose and had agreed to complete subsequent courses of prophylaxis.
Note:
The use of rifampin or rifapentine for tuberculosis prophylaxis was not allowed.
If the tuberculosis test result was indeterminate, one repeat test could be performed.
10. Receive a live attenuated vaccine within 4 weeks before the first dose or plan to receive a live attenuated vaccine at any time during the treatment period or within 8 weeks after study completion;
11. Patients with major or unstable digestive/hepatobiliary, renal/urinary, cardiovascular, respiratory, endocrine, hematologic, immune, or central nervous system diseases within 6 months before the first dose, who are not eligible for clinical study according to the investigator's judgment, "Examples include, but are not limited to, pancreatitis, unstable angina, myocardial infarction, symptomatic congestive heart failure (New York Heart Association class III or IV), arrhythmia requiring treatment, pulmonary hypertension, respiratory failure, stroke (including transient ischemic attack), liver cirrhosis, venous thromboembolism, etc."
12. Malignant tumor (except thoroughly treated skin squamous cell carcinoma in situ, basal cell carcinoma and cervical cancer in situ) or lymphoproliferative disease within 5 years before the first dose;
13. Currently suffering from other autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc.);
14. Persons with or suspected of a history of congenital or acquired immunodeficiency or conditions that the investigator believes would compromise the participant's immune status (e.g., history of splenectomy, primary immunodeficiency);
15. Patients with a psychiatric disorder or medical history (e.g., depression) that interferes with medication adherence or is considered by the investigator to be at risk for suicide;
16. Previous use of IL-12, IL-17 and/or IL-23 targeted drugs with poor response as assessed by investigators, including but not limited to: Tildrakizumab, Guselkumab, Ustekinumab, Secukinumab, Ixekizumab, Brodalumab, etc.
17. Previous treatment with a TYK2 inhibitor or previous systemic JAK1/2/3 inhibitor therapy with poor response or discontinuation for safety reasons;
18. Received any of the following treatments within the specified time period before the first dose:
Topical medications/treatments that may affect the condition of psoriasis (including but not limited to: Glucocorticoids, retinoids, vitamin D3 derivatives, calcineurin inhibitors, benvimod, anti-human IL-8 monoclonal antibody cream, tar, salicylic acid, dithramol, etc.) or bath products containing the above ingredients, or topical Chinese patent medicine or non-drug therapy of traditional Chinese medicine that may affect the condition of psoriasis;
Systemic treatment with nonbiologic agents that may affect psoriasis within 4 weeks, Including, but not limited to, JAKs inhibitors, glucocorticoids, tretinoin, cyclosporine, methotrexate, Astragalus membranaceus, tripterygium wilfordii, matrine, compound ammonium glycyrrhizinate, azathioprine, mycophenolate mofetil, proprietary Chinese medicine and traditional Chinese medicine (for proprietary Chinese medicine or traditional Chinese medicine without clear clinical evidence that it may improve the condition of psoriasis, It can be shortened to within 2 weeks before administration), antimalarial drugs, interferon or lithium.
Patients had received traditional Chinese medicine (TCM) treatment related to liver drug enzyme regulation (such as licorice, Schisandrae chinensis, etc.) within 4 weeks;
Physical therapy including, but not limited to: ultraviolet therapy, photochemotherapy, self-treatment with sunbeds, etc. within 4 weeks;
Treatment with a biologic agent other than targeting IL-12, IL-17 and/or IL-23 within 3 months or 5 half-lives, whichever is longer;
Treatment with biological agents targeting IL-12, IL-17 and/or IL-23 within 6 months;
Rituximab or other immune-cell-depleting therapy within 6 months;
Receive flunomide within 24 months (or 6 months with leflunomide washout); 19. Use of another investigational drug or current enrollment in another clinical investigator within 3 months or 5 half-lives before the first dose, whichever is longer;
20. Presence of any of the following laboratory abnormalities at screening or baseline:
White blood cell count < 3×10^9/L;
Lymphocyte count < 0.5×10^9/L;
Neutrophil count < 1.5×10^9/L;
Platelet count < 100×10^9/L;
Hemoglobin < 100 g/L;
Estimated glomerular filtration rate (eGFR) <=60 mL/ minute /1.73 m^2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (see Appendix 2);
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin >=1.5×ULN;
Any other laboratory test result that is abnormal and clinically significant and that, as assessed by the investigator, would pose an unacceptable risk to the participant if participation in the study were to occur;
21. At screening or baseline, vital signs, physical examination, 12-lead electrocardiogram, or chest CT (within 1 month of acceptance) were abnormal and clinically significant and would pose an unacceptable risk to the participant if assessed by the investigator;
22. Presence of any of the following infections at the screening visit:
Hepatitis B: positive for surface antigen (HBsAg) or a positive core antibody (HBcAb) with a positive copy number of hepatitis B virus DNA (HBV-DNA) (defined as more than the upper limit of the normal range for the study site);
Positive for hepatitis C (HCV) antibodies and a positive HCV-RNA copy number (defined as more than the upper limit of the normal range for the site assay);
Human immunodeficiency virus antibody (HIV Ab) positive;
A positive test for syphilis specific antibodies was detected (except for participants who had a negative RPR or TRUST result for nonspecific syphilis antibodies and who had a past syphilis infection that had been cured, as judged by the investigator).
23. A history of alcohol and/or substance abuse within 3 months prior to screening;
24. Presence of any condition that may affect drug absorption, including but not limited to: malabsorption syndrome, celiac disease, gastrectomy, bowel resection (except appendectomy);
25. Drugs that had been used within 4 weeks before the first dose or within 5 half-life periods (whichever was longer) or that could not be avoided during the study (see Appendix 3);
26. Who had consumed St. John's wort (St. John's wort) products, grapefruit within 7 days before the first dose, or who refused to avoid such substances for the entire study period (including the follow-up period);
27. Donors or blood loss >= 400 mL within 3 months prior to screening or planned to donate blood during the study;
28. Known or suspected allergy to any component of the trial drug, or any other significant drug allergy (e.g., anaphylactic shock or hepatotoxicity);
29. Pregnant or lactating women;
30. Other reasons for not participating in the study as deemed by the investigator.研究实施时间:
Study execute time:
从
From
2026-01-12 00:00:00至
To
2028-05-30 00:00:00
征募观察对象时间:
Recruiting time:
从
From
2026-03-20 00:00:00
至
To
2026-05-30 00:00:00干预措施:
Interventions:
组别:
II期-试验组1
样本量:
40
Group:
Phase II - Treatment Group 1
Sample size:
干预措施:
CMS-D001 片 50 mg,每天一次,服用 12 周。
干预措施代码:
Intervention:
CMS-D001 tablet, 50 mg, taken once a day, for 12 weeks
Intervention code:
组别:
II期-试验组2
样本量:
40
Group:
Phase II - Treatment Group 2
Sample size:
干预措施:
CMS-D001 片 100 mg,每天一次,服用 12 周。
干预措施代码:
Intervention:
CMS-D001 tablet, 100 mg, taken once a day, for 12 weeks
Intervention code:
组别:
II期-安慰剂组
样本量:
40
Group:
Phase II - placebo group
Sample size:
干预措施:
安慰剂(不含CMS-D001活性成份),每天一次,服用12周。
干预措施代码:
Intervention:
Placebo (without the active ingredient CMS-D001), taken once a day for 12 weeks
Intervention code:
组别:
III期-试验组1
样本量:
168
Group:
Phase III - Treatment Group 1,Phase II - Treatment Group 2,placebo group
Sample size:
干预措施:
SMS-D001片 50mg,每天一次。
干预措施代码:
Intervention:
CMS-D001 tablet, 50 mg, taken once a day
Intervention code:
组别:
III期-试验组2
样本量:
168
Group:
Phase III - Treatment Group 1,Phase II - Treatment Group 2,placebo group
Sample size:
干预措施:
CMS-D001 片 100 mg,每天一次。
干预措施代码:
Intervention:
CMS-D001 tablet, 100 mg, taken once a day
Intervention code:
组别:
III期-安慰剂组
样本量:
84
Group:
Phase III - Treatment Group 1,Phase II - Treatment Group 2,placebo group
Sample size:
干预措施:
安慰剂(不含CMS-D001活性成份),每日1次。
干预措施代码:
Intervention:
Placebo (without the active ingredient CMS-D001), taken once a day
Intervention code:研究实施地点:
Countries of recruitment and research settings:
国家:
中国
省(直辖市):
山东
市(区县):
Country:
China
Province:
Shandong
City:
单位(医院):
山东第一医科大学附属皮肤病医院
单位级别:
三甲
Institution
hospital:
Shandong First Medical University Affiliated Dermatology 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):
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):
杭州市第三人民医院
单位级别:
三甲
Institution
hospital:
The Third People's Hospital of Hangzhou City
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):
江苏
市(区县):
Country:
China
Province:
Jiangsu
City:
单位(医院):
无锡市第二人民医院
单位级别:
三甲
Institution
hospital:
Wuxi Second 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):
石家庄市中医院
单位级别:
三甲
Institution
hospital:
Shijiazhuang City Traditional Chinese Medicine Hospital
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):
三门峡市中心医院
单位级别:
三甲
Institution
hospital:
Sanmenxia Central 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):
南方医科大学珠江医院
单位级别:
三甲
Institution
hospital:
Southern Medical University Zhujiang Hospital
Level of the institution:
Tertiary A
国家:
中国
省(直辖市):
安徽
市(区县):
Country:
China
Province:
Anhui
City:
单位(医院):
皖南医学院第一附属医院
单位级别:
三甲
Institution
hospital:
Wannan Medical College First Affiliated Hospital
Level of the institution:
Tertiary A
国家:
中国
省(直辖市):
安徽
市(区县):
Country:
China
Province:
Anhui
City:
单位(医院):
蚌埠医科大学第一附属医院
单位级别:
三甲
Institution
hospital:
The First Affiliated Hospital of Bengbu 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):
承德医学院附属医院
单位级别:
三甲
Institution
hospital:
Affiliated Hospital of Chengde Medical College
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):
南阳市中心医院
单位级别:
三甲
Institution
hospital:
Nanyang Central Hospital
Level of the institution:
Tertiary A
国家:
中国
省(直辖市):
黑龙江
市(区县):
Country:
China
Province:
Heilongjiang
City:
单位(医院):
哈尔滨医科大学附属第二医院
单位级别:
三甲
Institution
hospital:
The Second Affiliated Hospital of Harbin Medical University
Level of the institution:
Tertiary A
国家:
中国
省(直辖市):
吉林
市(区县):
Country:
China
Province:
Jilin
City:
单位(医院):
吉林大学第一医院
单位级别:
三甲
Institution
hospital:
The First Hospital of Jilin University
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 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):
济宁市第一人民医院
单位级别:
三甲
Institution
hospital:
Jining First 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):
河北医科大学第四医院
单位级别:
三甲
Institution
hospital:
The Fourth Hospital of Hebei 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):
河北
市(区县):
Country:
China
Province:
Hebei
City:
单位(医院):
河北工程大学附属医院
单位级别:
三甲
Institution
hospital:
Affiliated Hospital of Hebei University of Engineering
Level of the institution:
Tertiary A
国家:
中国
省(直辖市):
吉林
市(区县):
Country:
China
Province:
Jilin
City:
单位(医院):
吉林大学第二医院
单位级别:
三甲
Institution
hospital:
Jilin University Second Hospital
Level of the institution:
Tertiary A测量指标:
Outcomes:
指标中文名:
II期:第12周,达到银屑病面积和严重程度指数较基线至少改善75%的参与 者比例(PASI 75应答)
指标类型:
主要指标
Outcome:
Phase Ⅱ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Type:
Primary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
II期:第2、4、8周,达到PASI 75应答的参与者比例
指标类型:
次要指标
Outcome:
Phase Ⅱ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
II期:第2、4、8、12周,医生整体评估(PGA)评分为0或1的参与者比例;
指标类型:
次要指标
Outcome:
Phase Ⅱ:Number of participants achieving a Physicians Global Assessment (PGA) score of 0 or 1.
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
II期:第2、4、8、12周,达到PASI50/90/100应答的参与者比例;
指标类型:
次要指标
Outcome:
Phase Ⅱ:Number of participants achieving at least 50%, 90%, or 100% improvement in PASI (PASI 50/90/100)
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
II期:第2、4、8、12周,PASI较基线的变化值和百分比;
指标类型:
次要指标
Outcome:
Phase Ⅱ:Change and percentage change in PASI score from baseline
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
II期:第2、4、8、12周,受累的体表面积(BSA)较基线的变化值和百分比;
指标类型:
次要指标
Outcome:
Phase Ⅱ:Change and percentage change in affected Body Surface Area (BSA) from baseline
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
II期:第2、4、8、12周,皮肤病生活质量指数(DLQI)评分与基线相比的变化。
指标类型:
次要指标
Outcome:
Phase Ⅱ:Change in Dermatology Life Quality Index (DLQI) score from baseline
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
II期:不良事件、治疗期出现的不良事件和严重不良事件的发生率
指标类型:
附加指标
Outcome:
Phase II: Incidence of adverse events, treatment-emergent adverse events, and serious 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:
II期:常规安全性参数,包括实验室检查、生命体征测量、12导联心电图 (ECG)和体格检查等
指标类型:
附加指标
Outcome:
Phase II: Routine safety parameters, including laboratory tests, vital signs measurements, 12-lead electrocardiogram (ECG), and physical examinations.
Type:
Additional indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
II期:评价CMS-D001及其主要代谢产物(如适用)在斑块状银屑病患者中 的 PK 特 征 , 计 算 以 下 参 数 : 血 浆 谷 浓 度 ( Ctrough ) 、 峰浓度 (Cmax)
指标类型:
附加指标
Outcome:
Phase II: To evaluate the PK characteristics of CMS-D001 and its major metabolites (if applicable) in patients with plaque psoriasis, and to calculate the following parameters: trough plasma concentration (Ctrough) and peak concentration (Cmax).
Type:
Additional indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
II期:如数据允许,还将基于群体药代动力学(PopPK)分析方法,探索 CMS-D001及其主要代谢产物(如适用)在斑块状银屑病患者中的PK 特征及暴露与疗效及不良事件之间的关系
指标类型:
附加指标
Outcome:
Phase II: If data permit, population pharmacokinetic (PopPK) analysis will also be employed to explore the pharmacokinetic (PK) characteristics of CMS-D001 and its major metabolites (if applicable) in patients with plaque psoriasis, as well as the relationships between drug exposure 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:
II期:第2、4、8、12、16周,血清IL-17A等生物标志物水平较基线的变化 值和百分比
指标类型:
附加指标
Outcome:
Phase II: Changes from baseline in serum biomarker levels (e.g., IL-17A) at Weeks 2, 4, 8, 12, and 16 (both absolute and percentage changes)
Type:
Additional indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
III期:第16周,达到银屑病面积和严重程度指数较基线至少改善75%的参与者比例(PASI 75应答)
指标类型:
主要指标
Outcome:
Phase Ⅲ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Type:
Primary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
III期:第16周,达到PGA评分为0或1的参与者比例(PGA-TS)
指标类型:
主要指标
Outcome:
Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) (PGA-TS)
Type:
Primary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
III期:第2、4、8、12周及扩展期各访视点,达到PASI 75应答的参与者比例;
指标类型:
次要指标
Outcome:
Phase Ⅲ:Number of participants achieving at least 75% improvement in PASI (PASI 75)
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
III期:第2、4、8、12、16周及扩展期各访视点,达到PASI 90/100应答的参与者比例;
指标类型:
次要指标
Outcome:
Phase Ⅲ:Number of participants achieving at least 90% or 100% improvement in PASI (PASI 90/100)
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
III期:第2、4、8、12周及扩展期各访视点,PGA评分为0或1的参与者比例;
指标类型:
次要指标
Outcome:
Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear)
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
III期:第2、4、8、12、16周及扩展期各访视点,PASI评分相对于基线的变化和相对于基线的变化百分比;
指标类型:
次要指标
Outcome:
Phase Ⅲ:Change and percentage change in PASI score from baseline
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
III期:第2、4、8、12、16周及扩展期各访视点,BSA相对于基线的变化和相对于基线变化的百分比;
指标类型:
次要指标
Outcome:
Phase Ⅲ:Change and percentage change in affected Body Surface Area (BSA) from baseline
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
III期:第2、4、8、12、16周及扩展期各访视点,DLQI评分与基线相比的变化。
指标类型:
次要指标
Outcome:
Phase Ⅲ:Change in Dermatology Life Quality Index (DLQI) score from baseline
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
III期:不良事件、治疗期出现的不良事件和严重不良事件的发生率
指标类型:
附加指标
Outcome:
Phase Ⅲ:Incidence of adverse events, treatment-emergent adverse events, and serious 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:
III期:常规安全性参数,包括实验室检查、生命体征测量、12导联心电图 (ECG)和体格检查等
指标类型:
附加指标
Outcome:
Phase Ⅲ:Routine safety parameters, including laboratory tests, vital signs measurements, 12-lead electrocardiogram (ECG), and physical examinations.
Type:
Additional indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
III期:评价CMS-D001及其主要代谢产物(如适用)在斑块状银屑病患者中 的PK特征,计算以下参数:Ctrough
指标类型:
附加指标
Outcome:
Phase Ⅲ:Evaluate the PK characteristics of CMS-D001 and its major metabolites (if applicable) in patients with plaque psoriasis, and calculate the following parameter: Ctrough
Type:
Additional indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
III期:如数据允许,还将基于PopPK分析方法,探索CMS-D001及其主要代 谢产物(如适用)在斑块状银屑病患者中的PK特征及暴露与疗效及不 良事件之间的关系
指标类型:
附加指标
Outcome:
Phase Ⅲ:If data permit, population pharmacokinetic (PopPK) analysis will also be conducted to explore the pharmacokinetic (PK) characteristics of CMS-D001 and its major metabolites (if applicable) in patients with plaque psoriasis, as well as the relationships between exposure 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:
III期:第2、4、8、12、16、20、28、36、44、52周,血清IL-17A等生物标 志物水平较基线的变化值和百分比
指标类型:
附加指标
Outcome:
Phase Ⅲ:Changes from baseline in serum biomarker levels (e.g., IL-17A) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52, expressed as absolute changes and percentage changes.
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:
Sample Name:
Blood
Tissue:
人体标本去向
使用后销毁
说明
Fate of sample:
Destruction after use
Note: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):
接受筛选的参与者将获得筛选号,本试验中筛选号不得重复使用。将对符合方案要求的参与者使用交互式网络应答系统(Interactive Web Response System,IWRS)进行随机化,各研究中心竞争入组。由负责本试验的统计分析单位非盲统计师用SAS 9.4(或更新版本)统计软件,以银屑病严重程度(PGA评分3/4)为分层因素,生成连续编号的随机表。随机表用文件的形式写出随机号及对应的组别,且随机表具有可重现性,随机表将导入到IWRS。筛选合格的Ⅱ期参与者将按照1:1:1的比例随机分配至CMS-D001片 50 mg QD、100 mg QD及安慰剂组,筛选合格的Ⅲ期参与者将按照2:2:1的比例随机分配至CMS-D001片 50 mg QD、100 mg QD(或基于Ⅱ期研究结果确定的推荐剂量组)及安慰剂组。Randomization Procedure (please state who
generates the
random number sequence and by what method):
Participants who pass screening will be assigned a unique screening number, which must not be reused in this trial. Eligible participants will be randomized using an Interactive Web Response System (IWRS), with centers competing for enrollment. A non-blinded statistician from the statistical analysis unit responsible for this trial will generate a sequentially numbered randomization schedule using SAS 9.4 (or a later version), stratifying by psoriasis severity (PGA score of 3 or 4). The randomization schedule—listing each randomization number and its corresponding treatment group—will be saved as a file, ensuring reproducibility, and then imported into the IWRS. Qualified Phase II participants will be randomized in a 1:1:1 ratio to receive either CMS-D001 tablets 50 mg once daily (QD), 100 mg QD, or placebo. Qualified Phase III participants will be randomized in a 2:2:1 ratio to receive either CMS-D001 tablets 50 mg QD, 100 mg QD (or the recommended dose determined based on Phase II results), or placebo.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:
双盲,对研究参与者和研究者设盲Blinding:
Double-blind, with both the research participants and the researchers being blinded.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:
申办者将负责本研究的数据管理,包括数据的质量检查。将通过使用eCRFs,由研究中心负责将数据手动输入电子数据采集系统(Electronic data capture,EDC)。如果数据不一致,申办者将要求研究中心澄清数据,研究中心将在 EDC 系统中解决数据质疑。研究实施方案所需的EDC系统之外的其他数据,如中心实验室的数据将直接发送给申办者,根据申办者的标准程序处理和加工这些数据的电子传输。
数据管理将在经验证的EDC系统中进行。通过使用申办者指定的EDC系统完成eCRFs。研究中心将接受培训并获得相应的eCRF填写手册。eCRFs将以电子方式提交给申办者,并按申办者的指示处理。所有eCRFs应由研究中心经过培训的指定工作人员完成。eCRFs应由研究者或指定人员审查并以电子方式签名和注明日期。Data collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture:
The sponsor will be responsible for the data management of this study, including the quality check of the data. The data will be manually input into the electronic data capture system (EDC) by the research center using eCRFs. If the data is inconsistent, the sponsor will require the research center to clarify the data, and the research center will resolve the data doubts in the EDC system. Other data required by the study implementation plan, such as the data from the central laboratory, will be directly sent to the sponsor and processed and processed electronically according to the sponsor's standard procedures.
Data management will be carried out in the verified EDC system. eCRFs will be completed using the EDC system designated by the sponsor. The research center will receive training and obtain the corresponding eCRF filling manual. eCRFs will be submitted electronically to the sponsor and processed according to the sponsor's instructions. All eCRFs should be completed by the designated staff of the research center who have received training. eCRFs should be reviewed by the investigator or designated personnel and signed and dated electronically.数据与安全监察委员会:
Data and Safety Monitoring Committee:
有/Yes注册人:
Name of Registration:
2026-03-19 09:01:11