A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet

This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).

开始日期2020-08-24

申办/合作机构

Provention Bio, Inc.

NCT02637141

/ Completed临床2期

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease

This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.

开始日期2016-04-13

申办/合作机构

Amgen, Inc.

100 项与 Ordesekimab 相关的临床结果

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100 项与 Ordesekimab 相关的转化医学

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100 项与 Ordesekimab 相关的专利（医药）

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项与 Ordesekimab 相关的文献（医药）

2025-05-05·INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE

Comparative Efficacy of Interleukin-7 and -15 Blockade in Alleviating Experimental Chronic Uveitis and Suppressing Pathogenic Memory CD4⁺ T Cells

Article

作者: Shayan, Maryam ; Chen, Yihe ; Zhu, Qiurong ; Huckfeldt, Rachel M.

Purpose:

We have previously demonstrated the pathogenic function of memory CD4+ T cells, which express IL-7 receptor (IL-7R) and IL-15R, in experimental chronic autoimmune uveitis (CAU). Here, we aimed to compare the therapeutic efficacy of blocking IL-7 or IL-15 in CAU.

Methods:

C57BL/6J mice were induced for CAU, then intraperitoneally injected with an anti-IL-7 antibody (Ab), an anti-IL-15 Ab, or an IgG control for 2 weeks. Disease was evaluated by weekly fundoscopy, optical coherence tomography (OCT), and full-field electroretinography for four weeks from the initiation of treatment. At week 4, retina and cervical lymph nodes (CLN) were collected for flow cytometry analysis of T-cell response.

Results:

The anti-IL-7 Ab led to progressively reduced retinal infiltration and structural damage, with rapid recovery of retinal function. The anti-IL-15 Ab resulted in moderately reduced retinal infiltration and structural damage, along with a delayed, partial functional improvement. Compared to the control group, the anti-IL-7 Ab group exhibited significantly reduced disease scores from baseline on fundoscopy and OCT at week 4, and substantially improved dark-adapted (DA) a-wave and light-adapted b-wave responses at week 2; although the anti-IL-15 Ab group showed significantly improved disease from baseline only on OCT and increased DA b-waves at week 4. Both treatments effectively depleted the retinal infiltrating T cells and reduced memory Th17 cells in the CLN.

Conclusions:

Our proof-of-concept study demonstrates that blocking IL-7 or IL-15 leads to specific depletion of the uveitogenic memory CD4+ T cells and disruption of disease chronicity in uveitis.

2022-12-31·Journal of immunotoxicology

Strategies to evaluate potential effector function of glycan variants: A case study of ordesekimab (AMG 714 or PRV-015)

Review

作者: Werner, Jonathan ; Kuhns, Scott ; Lebrec, Hervé ; Wegesser, Teresa ; Wang, Xiaoting ; Wei, Yu-Ling

The potential for effector functions of therapeutic antibodies, including antibody-dependent cell-mediated cytotoxicity (ADCC), is a biological activity of interest for characterization, regardless of if ADCC is an intended primary pharmacological effect. The composition of the conserved antibody F_c glycan can vary as a function of post-translational processing which may affect the binding affinity to F_c receptors, leading to a change of effector activity. Ordesekimab (AMG 714 or PRV-015), a fully human immunoglobulin G₁-kappa anti-interleukin (IL)-15 monoclonal antibody, is in clinical development for celiac disease. The binding of ordesekimab to IL-15 inhibits the interaction of IL-15 with the IL-2Rβ and common γ chain of the IL-15 receptor complex, but not with the IL-15Rα chain. Therefore, the simultaneous binding of ordesekimab to the F_cγ receptor (R) IIIα expressed on natural killer (NK) cells and to the IL-15/IL-15Rα complex on cells such as monocytes may theoretically enable ADCC toward the IL-15Rα-expressing cells. The high mannose (HM) levels on the F_c glycan were found to vary in different lots of ordesekimab resulting from refinements to the manufacturing process, and the impact on ordesekimab-mediated ADCC activity was evaluated in in vivo and in vitro studies. A review of nonclinical and clinical data found no evidence of ordesekimab-induced depletion of monocytes, or cytotoxicity in organs with wide IL-15Rα expression, suggesting a lack of in vivo ADCC activity. In addition, in vitro peripheral blood mononuclear cells-based ADCC assay did not reveal any cytolytic effect of ordesekimab with various levels of HM content when cocultured with recombinant human IL-15. Taken together, these data demonstrate that ADCC is not a potential liability for ordesekimab and does not contribute to the reduction of IL-15-mediated inflammation, the intended pharmacological effect.

2019-12-01·The lancet. Gastroenterology & hepatology1区 · 医学

Safety and efficacy of AMG 714 in patients with type 2 refractory coeliac disease: a phase 2a, randomised, double-blind, placebo-controlled, parallel-group study

1区 · 医学

Article

作者: Samuli Rounioja ; Nadine Cerf-Bensussan ; Ashleigh Palmer ; David Sanders ; Georgia Malamut ; Valerie Byrnes ; George Vlad ; Tom van Gils ; Sherine Khater ; Joseph Murray ; Anne Blanchard ; Raquel Perez Maseda ; Garbiñe Roy Ariño ; Laura Crespo ; Keijo Viiri ; Michel Azizi ; Amelie Trinquand ; Carlota García-Hoz ; Peter H. R. Green ; Anthony DiMarino ; Sheila E. Crowe ; Elizabeth Macintyre ; Olivier Hermine ; Chris J. Mulder ; Pekka Collin ; Beth Llewellyn ; Govind Bhagat ; Christophe Cellier ; Michael Schumann ; Ciaran P. Kelly ; Marios Hadjivassiliou ; Jane R. Parnes ; Ralph Raymond ; Hetty Bontkes ; Bertrand Meresse ; Wayne Tsuji ; Knut E. A. Lundin ; Gerd Bouma ; Francisco Leon ; Eric Butz ; Jack Bui ; Bana Jabri

BACKGROUND:

Refractory coeliac disease type 2 is a rare subtype of coeliac disease with high mortality rates; interleukin 15 (IL-15) is strongly implicated in its pathophysiology. This trial aimed to investigate the effects of AMG 714, an anti-IL-15 monoclonal antibody, on the activity and symptoms of refractory coeliac disease type 2.

METHODS:

This was a randomised, double-blind, placebo-controlled, phase 2a study of adults with a confirmed diagnosis of refractory coeliac disease type 2. Patients were randomly assigned at a 2:1 ratio to receive seven intravenous doses over 10 weeks of AMG 714 (8 mg/kg) or matching placebo. Biopsy samples were obtained at baseline and week 12 for cellular analysis and histology. The change in the proportion of aberrant intraepithelial lymphocytes from baseline to week 12 with respect to all intraepithelial lymphocytes was the primary endpoint and was quantified using flow cytometry. Secondary endpoints were the change in aberrant intraepithelial lymphocytes with respect to intestinal epithelial cells; intestinal histological scores (villous height-to-crypt depth ratio; VHCD); intraepithelial lymphocyte counts; Marsh score; and patient-reported symptom measures, including the Bristol stool form scale (BSFS) and gastrointestinal symptom rating scale (GSRS). Main analyses were done in the per-protocol population of patients who received their assigned treatment, provided evaluable biopsy samples, and did not have major protocol deviations; only patients with non-atypical disease were included in the analyses of aberrant intraepithelial lymphocytes, including the primary analysis. Safety was assessed in all patients who received at least one dose of study drug. This study is registered at ClinicalTrials.gov (NCT02633020) and EudraCT (2015-004063-36).

FINDINGS:

From April 13, 2016, to Jan 19, 2017, 28 patients were enrolled and randomly assigned to AMG 714 (n=19) and placebo (n=9). Six patients were not included in the primary analysis because of protocol deviation (one in the AMG 714 group), insufficient biopsy samples (one in the AMG 714 group), and atypical intraepithelial lymphocytes (three in the AMG 714 group and one in the placebo group). At 12 weeks, the least square mean difference between AMG 714 and placebo in the relative change from baseline in aberrant intraepithelial lymphocyte percentage was -4·85% (90% CI -30·26 to 20·56; p=0·75). The difference between the AMG 714 and placebo groups in aberrant intraepithelial lymphocytes with respect to epithelial cells at 12 weeks was -38·22% (90% CI -95·73 to 19·29; nominal p=0·18); the difference in change in Marsh score from baseline was 0·09% (95% CI -1·60-1·90; nominal p=0·92); the difference in VHCD ratio was 10·67% (95% CI -38·97 to 60·31; nominal p=0·66); and the difference in change in total intraepithelial lymphocyte count was -12·73% (95% CI -77·57-52·12); nominal p=0·69). Regarding symptoms, the proportion of patients with diarrhoea per the BSFS score decreased from ten (53%) of 19 at baseline to seven (37%) of 19 at week 12 in the AMG 714 group and increased from two (22%) of nine at baseline to four (44%) of nine at week 12 in the placebo group (nominal p=0·0008); and the difference between the groups in change in GSRS score was -0·14 (SE 0·19; nominal p=0·48). Eight (89%) patients in the placebo group and 17 (89%) in the AMG 714 group had treatment-emergent adverse events, including one (11%) patient in the placebo group and five (26%) in the AMG 714 group who had serious adverse events. The most common adverse event in the AMG 714 group was nasopharyngitis (eight [42%] patients vs one [11%] in the placebo group).

INTERPRETATION:

In patients with refractory coeliac disease type 2 who were treated with AMG 714 or placebo for 10 weeks, there was no difference between the groups in terms of the primary endpoint of aberrant intraepithelial lymphocyte reduction from baseline. Effects on symptoms and other endpoints suggest that further research of AMG 714 may be warranted in patients with refractory coeliac disease type 2.

FUNDING:

Celimmune and Amgen.

项与 Ordesekimab 相关的新闻（医药）

2026-02-05

·药创新

全球唯一，白癜风患者迎来专属靶向药

国内首款白癜风靶向药获批。撰文丨蜉蝣 1月30日，康哲药业旗下德镁医药的磷酸芦可替尼乳膏正式获NMPA批准上市，用于治疗12岁及以上儿童和成人患者伴面部受累的非节段型白癜风。该药物是目前中国首个且唯一获批用于白癜风治疗的靶向药物，标志着我国在白癜风治疗领域实现了从传统疗法向精准靶向治疗的重要突破，有望为国内千万白癜风患者提供新的治疗选择。图片来源：康哲药业官微蓝海待掘白癜风是一种慢性、获得性色素脱失性疾病，病因复杂，涉及自身免疫、遗传、环境等多因素交互作用，好发于面部、颈部、手背等暴露部位。据估算，中国约有1030万人患有白癜风，其中约820万人患有非节段型白癜风。白癜风的发病机制/图片来源：Incyte官网目前的标准治疗，如外用激素或钙调神经磷酸酶抑制剂、光疗等，对许多患者疗效有限，且起效慢、易复发。手术治疗则主要适用于稳定期、局限型患者，门槛较高。这种控制而非根治的现状，是临床上面临的核心痛点。深受外貌困扰的青少年及青年患者群体，对于能够实现高效、持久复色，且安全性更优的新疗法抱有极高期待。根据DelveInsight的《2025年白癜风药物研发管线洞察报告》，全球目前有超过18家公司正在开发20多种白癜风药物。根据多家咨询机构统计，2024年国内白癜风治疗药物市场规模在30—60亿元。近年来，随着对白癜风自身免疫发病机制认识的不断深入，全球范围内已有多种新型疗法进入研发阶段，主要包括JAK抑制剂、PDE4抑制剂以及白介素抑制剂等。 JAK抑制剂通过阻断JAK-STAT信号通路，减少促炎细胞因子的释放，从而调节异常免疫反应。如芦可替尼、托法替布等。 PDE4抑制剂则通过抑制磷酸二酯酶4，降低炎症因子水平，同时促进黑素细胞功能。如阿普米司特。白介素是免疫系统中的重要通讯因子。IL-15是最热门的靶点。研究发现，白癜风的反复发作与皮损处存在的“组织驻留型记忆T细胞”（TRM）有关，而IL-15是维持这些“坏细胞”生存的关键。通过阻断IL-15，有望实现长期停药不复发的目标。如Teva的TEV-53408、安进的AMG 714。此外，泰恩康研发的非免疫抑制剂小分子药物CKBA软膏基于天然产物乙酰基-11-酮-β-乳香酸（AKBA）进行结构优化，属于FIC分子。其通过靶向ACC1和MFE2调节细胞脂代谢，有效抑制自身反应性CD8+TRM细胞产生IFN-γ，进而阻止其对黑素细胞的杀伤。目前，该软膏治疗白癜风的II期临床试验正在稳步推进。国内首款白癜风靶向药芦可替尼通过选择性抑制JAK/STAT信号通路，干预免疫介导的色素脱失过程，为白癜风治疗提供了全新的作用机制。此前，该药已获得美国FDA与欧洲EMA批准，成为全球首个用于非节段型白癜风复色的靶向外用药。两项关键性国际III期临床试验（TRuE-V1与TRuE-V2）结果显示：该产品治疗24周后达到主要疗效指标面部白癜风面积评分指数改善至少75%（F-VASI 75）的患者比例均为29.9%，显著高于安慰剂组的7.5%和12.9%，持续使用至52周，复色效果持续，提示长期治疗可带来持续获益。此外，所有次要疗效终点也均支持主要终点所呈现的积极趋势，表明白斑复色效果随治疗时间延长而逐步改善。芦可替尼TRuE-V1与TRuE-V2临床数据/图片来源：Incyte官网在中国，得益于海南博鳌乐城国际医疗旅游先行区等地的“先行先试”政策，芦可替尼已于获批前在限定区域内开展临床使用与真实世界研究。截至获批，博鳌超级医院已为超过7000名非节段型白癜风患者提供该药物治疗，并在广州、深圳、北京、天津等地的二十余家医院开展处方服务。相关真实世界研究结果与全球关键临床试验一致。在乐城先行区收集的安全性监测信息中，未报告新的安全性风险，未出现导致停药或退出的不良事件，也未发生与药物相关的严重不良事件，初步证实其在中国患者中具有良好的耐受性。值得关注的是，芦可替尼在中国的临床开发计划并未止步于白癜风。目前，该药用于轻中度特应性皮炎患者的中国III期临床试验已取得阳性结果，相关新药上市申请正在积极推进中。若未来该适应症获批，将进一步拓展该药物的临床价值与市场空间。市场表现强劲芦可替尼是由Incyte公司开发、并与诺华合作商业化的首个上市JAK1/JAK2抑制剂,2022年12月2日，康哲药业通过德镁医药与Incyte签订合作与许可协议，获得了这款药在中国大陆、香港、澳门、台湾及东南亚十一国区域内研发、注册和商业化产品的独家权利，以及在该区域内的非独占生产许可。芦可替尼片剂于2011年11月在美国首次获批，用于中高危骨髓纤维化。之后陆续获批真性红细胞增多症（片剂）、移植物抗宿主病（片剂）、特应性皮炎（乳膏）。2022年7月芦可替尼乳膏剂型治疗白癜风的适应症获批，成为FDA批准的首个白癜风疗法。随着其适应症的拓展，芦可替尼整体销售表现持续走强。 2024年芦可替尼全球销售额已突破47亿美元，市场基础坚实。尤其值得关注的是，其乳膏剂型自2022年获批用于白癜风治疗后呈现爆发式增长，2024年，乳膏剂型全球销售额迅速攀升至5.1亿美元。在中国市场，芦可替尼片剂于2017年3月通过优先审评程序获批上市，用于骨髓纤维化治疗。随后于2019年被纳入国家医保，2023年4月移植物抗宿主病适应症国内获批。当前，芦可替尼在国内市场的竞争格局正在逐步演变。诺华目前在国内开展针对红细胞增多症及移植物抗宿主病等适应症的IV期临床试验，进一步拓展其治疗边界。值得关注的是，2024年，成都苑东生物制药率先拿下磷酸芦可替尼片的首仿获批，随后青峰医药与南京正科医药同日获批，2026年1月8日，山东新时代药业的磷酸芦可替尼片再次获批。形成国产仿制四强格局，国产替代进程明显提速。不过，仿制药厂商均需在2028年6月芦可替尼的盐专利到期前规避专利风险或等待专利到期。乳膏剂型目前国内仅有康哲药业一家获批。结语国内首款白癜风靶向药磷酸芦可替尼乳膏的获批，填补了我国在该领域精准治疗的空白，更为千万白癜风患者带来了复色的新希望。未来，随着更多创新疗法的推进，白癜风患者将迎来更多安全、高效的治疗选择，重拾自信与光彩。 END 往期精彩内容信达生物2025年产品收入破百亿，同比增长45% 2026热门BD赛道！头部药企集体扫货，押注下一代FIC与BIC 周虹将离开默克，转战诺和诺德

上市批准临床1期

2026-01-12

·FierceBiotech

Teva lines up $500M in Royalty Pharma funding for vitiligo drug

If Royalty Pharma is happy with the results of Teva\'s phase 2b vitiligo study, the company has the option to hand over the remaining $425 million.\n Teva has penned a second pact with Royalty Pharma, this time securing up to $500 million to support the clinical development of a drug for vitiligo.The deal centers around TEV-‘408, an anti-IL-15 antibody that is currently in a phase 2 study for celiac disease as well as a phase 1b trial for vitiligo. Both studies are set to read out this year.In the Jan. 11 release, Teva pointed to emerging information from the vitiligo study it claimed “provides preliminary support for IL-15 as a potential therapeutic target to treat a broad variety of autoimmune conditions.”The deal with Royalty will see the financing company potentially hand $500 million to fund the development of TEV-‘408 for vitiligo specifically. The first tranche of $75 million will be used to bankroll the launch of a phase 2b study in the indication this year.The only FDA-approved treatment for vitiligo, a chronic condition where skin loses pigment, is Incyte’s JAK inhibitor Opzelura. Attempts to develop new drugs for the condition ran into trouble last year, with both Incyte and Vyne Therapeutics scrapping their own candidates.Teva’s theory is that by blocking IL-15 activity, TEV-‘408 can reduce the immune-mediated destruction of pigment-producing cells called melanocytes, which otherwise results in white patches on the skin characteristic of vitiligo.If Royalty is happy with the results of the phase 2b vitiligo study, the company has the option to hand over the remaining $425 million, which would fund phase 3 development.In return, Teva will make a milestone payment to Royalty if the drug makes it to market, followed by royalties on worldwide net sales. The companies didn’t offer a breakdown of these financials. Royalty financing has gained popularity lately as traditional fundraising becomes increasingly difficult amid an overall biotech market cooldown. Teva’s previous agreement with Royalty dates back to 2023, when the Israeli company secured $100 million in funding to support the clinical development of olanzapine LAI, a long-acting version of Eli Lilly’s schizophrenia drug Zyprexa.As with that deal, Teva put its new agreement with Royalty deal in the context of the drugmaker’s “pivot to growth” strategy to accelerate its innovative pipeline and bring treatments to patients faster.“This agreement with Royalty Pharma enables us to advance our science more efficiently and accelerate our pipeline to deliver meaningful solutions for patients worldwide,” Teva CEO Richard Francis said in yesterday\'s release. “Vitiligo represents a significant unmet need, with only one approved topical treatment currently available and no systemic options.”Royalty Pharma CEO Pablo Legorreta said the company’s continued collaboration with Teva “underscores Royalty Pharma’s role as a long-term, trusted partner with a focus on funding innovation in potentially transformative and practice changing therapies.”

临床2期上市批准引进/卖出

2025-12-22

·征战罕见D研习室

#003-2：黄褐斑和白癜风在最近3年有哪些诊疗最新进展？（2025）

（👆，征战罕见病，我们一起努力。）根据卫健委公布的罕见病目录（共两批，207种），美国Healsan恒祥医学科技将持续对所有罕见病进行解读和大数据分析，以其能够为从事罕见病研究的生物制药公司、医生科学家及患者提供一些有用的信息。 👇本专辑介绍罕见病的最新诊疗进展，仅供学术交流用。在皮肤科领域，黄褐斑（Melasma）与白癜风（Vitiligo）一直被视为“难治性”色素障碍性疾病的两座大山。前者是色素的“失控堆积”，后者是色素的“免疫逃逸”。在过去三年（2022-2025），这两个领域发生了翻天覆地的变化：黄褐斑从单一的“祛斑”走向了“血管-屏障-色素”的整体调控；而白癜风则正式迎来了JAK抑制剂时代，甚至触摸到了“功能性治愈”的门槛。本文将为您深度梳理这两种疾病在筛查、药物及基因治疗方面的最新硬核进展。 #003-1：白化病解读第二弹：肤色里的“隐秘战争”：你为什么会长斑？从黄褐斑到白癜风，解码人类色素的生成与失控一、黄褐斑（Melasma）：走出“越治越黑”的怪圈黄褐斑不再被仅仅视为“黑色素过多”。近三年的研究彻底重塑了我们对它的认知：它是一种光老化、炎症性、血管性的皮肤综合征。1. 筛查与诊断：AI 与皮肤镜的“透视眼” 传统的伍德灯（Wood's lamp）已不足以满足精准治疗的需求。皮肤镜与 VISIA 的进阶应用：现在的诊断强调区分血管型与色素型。皮肤镜下观察到的毛细血管扩张程度，直接决定了是否需要联合抗血管治疗（如染料激光或微针射频）。人工智能（AI）辅助分型：基于深度学习的图像分析系统现在能更精准地计算 MASI 评分（黄褐斑面积和严重程度指数），并预测患者对激光治疗发生“反黑”（PIH）的风险。 2. 药物治疗新星：挑战氢醌的霸主地位虽然氢醌（Hydroquinone）曾是金标准，但其细胞毒性和副作用限制了长期使用。近三年涌现了强有力的挑战者。 Thiamidol（异丁酰氨基噻唑间苯二酚）：机制：这是一种并在人体酪氨酸酶上表现出极高抑制效率的成分。进展：2024年的多项临床研究表明，含 Thiamidol 的制剂在改善黄褐斑方面效果显著，且耐受性优于氢醌，尤其适合深肤色人群（Fitzpatrick III-V型），不易引起白斑或过敏。半胱胺（Cysteamine）：机制：一种天然存在的抗氧化剂，具有强大的脱色能力。进展：新型的脂质体包裹技术解决了其难闻气味和不稳定性的问题。它成为氢醌不耐受患者的首选替代方案之一。口服氨甲环酸（TXA）的优化：口服 TXA 依然是治疗的“中流砥柱”。最新的共识更倾向于低剂量、长疗程（如250mg/天，持续3-6个月），以平衡血栓风险与疗效。 3. “老药新用”与国产突破复方制剂的回归：2024年，国内药企（如孚诺医药）推出了获批上市的复方氟轻松乳膏（氟轻松+氢醌+维A酸），这是经典的“Kligman三联方”的标准化制剂。这种“抗炎+祛斑+代谢”的黄金组合在临床上展现了快速起效的能力，但需严格遵医嘱控制使用时长以避免激素依赖。二、白癜风（Vitiligo）：JAK 时代的曙光如果说黄褐斑的进展是“优化”，那么白癜风的进展则是“革命”。我们终于找到了导致黑色素细胞死亡的直接“凶手”：JAK-STAT 通路。1. 筛查与评估：不仅看皮，还要看血生物标志物 CXCL10：研究发现，活动期白癜风患者血液和皮肤中的 CXCL10 水平显著升高。这不仅用于辅助诊断，更成为了判断疾病是否“正在扩散”以及评估治疗效果的量化指标。甲状腺伴随筛查：近年的指南更加强调对自身免疫性甲状腺疾病的常规筛查（TSH, TPOAb, TGAb），因为两者不仅共病率高，且存在共同的遗传易感性。 2. 治疗革命：JAK 抑制剂的全面爆发这是近三年皮肤科最重磅的新闻。FDA 和 EMA 相继批准了相关药物，中国临床应用也在加速。芦可替尼乳膏（Ruxolitinib Cream）：地位：全球首个获批用于白癜风复色的外用 JAK 抑制剂。数据：在两项 III 期临床试验中，约 50% 的患者在使用 52 周后，面部皮损实现了 75% 以上的复色（F-VASI75）。优势：它是外用药，避免了口服 JAK 抑制剂潜在的系统性风险（如感染、血栓），适合面颈部等关键部位。口服 JAK 抑制剂（乌帕替尼、利特昔替尼等）：对于大面积、非节段型白癜风，外用药鞭长莫及。乌帕替尼（Upadacitinib，JAK1抑制剂）和利特昔替尼（Ritlecitinib，JAK3/TEC抑制剂）的 II/III 期临床数据令人振奋，展现了强大的全身控制能力。艾伯维（AbbVie）的乌帕替尼甚至获得了 FDA 的突破性疗法认定。 3. 外科治疗的微创化 ReCell 技术与微粒移植：针对稳定期（6个月以上无扩散）患者，新型的自体表皮细胞悬液移植技术愈发成熟。创伤更小，复色更均匀，且受皮区不再呈现“鹅卵石样”外观。三、基因治疗与未来：从“控制”到“治愈” 虽然目前的药物能有效控制病情，但患者停药后往往面临复发。根本原因在于皮肤中残留了“自身免疫记忆 T 细胞”（TRM）。这正是下一代疗法的主战场。1. 靶向 IL-15：拔除疾病的“根” 机制：TRM 细胞依赖 IL-15（白细胞介素-15）生存。如果能阻断 IL-15 信号，理论上就能“饿死”这些记忆细胞，从而实现长久不复发。新药 AMG 714（抗 IL-15 单抗）：安进（Amgen）等公司正在研发针对这一靶点的生物制剂。早期数据显示，它不仅能促进复色，更重要的是在停药后，复色效果维持时间远超现有的 JAK 抑制剂。这是目前最接近“功能性治愈”的策略。 2. 基因编辑（CRISPR）：尚在路上的终极幻想虽然基因编辑在遗传性皮肤病（如大疱性表皮松解症）中已有突破，但在黄褐斑和白癜风领域，目前仍处于临床前研究阶段。白癜风：研究人员正在尝试利用基因编辑技术修饰黑色素细胞，使其能够抵抗 T 细胞的免疫攻击（例如下调 MHC-I 类分子的表达），但这距离临床应用还有很长的路要走。注意：市面上任何宣称“基因针”治斑治白的疗法，目前大概率是商业噱头，请务必甄别。总结与建议维度黄褐斑 (Melasma)白癜风 (Vitiligo)核心机制更新血管参与 + 光老化 + 屏障受损JAK-STAT 通路 + TRM 记忆细胞明星药物 (近3年)Thiamidol、新三联乳膏、口服氨甲环酸芦可替尼乳膏 (外用)、乌帕替尼 (口服)治疗趋势温和抗炎、抗血管、避免激进激光靶向免疫调节、早期干预未来希望针对血管内皮生长因子的靶向药抗 IL-15 抗体 (防复发) 黄褐斑患者：请放弃“快速祛斑”的幻想，那往往伴随着反弹。拥抱“氨甲环酸+防晒+修护+温和光电”的联合慢治疗模式。白癜风患者：如果你处于进展期，JAK 抑制剂是目前的最佳武器。尽早使用，效果越好。对于稳定期的大面积白斑，不要灰心，新型移植技术是最后的防线。温馨提示：上述内容基于最新文献和指南总结，仅供学术交流用，不能替代个体化医疗建议；具体诊疗方案仍需和儿童或成人内分泌专家共同制定。本公众号由美国Healsan (恒祥医学科技)运营。投稿及商务联系微信号：healsan；提供特惠码MELT99，可以获得优惠。美国Healsan专长于Healsan医学大数据分析（Healsan™）、及基于大数据的Hanson临床科研服务（HansonCR™）和医学编辑服务（MedEditing™）。主要为医生科学家、生物制药公司和医院科研处等提供文献计量分析和SCI论文润色、编辑、选刊等服务，成为诸多机构的“临床科研外挂”。网址： https://healsan.com/ （👆，征战罕见病，我们在行动！）更多阅读：（点击👆图片，进入自己感兴趣的专辑。或点击“资源”，浏览本公众号所有资源。

基因疗法核酸药物临床3期上市批准

100 项与 Ordesekimab 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
白癜风	临床2期	美国	Amgen, Inc.	2020-12-11
乳糜泻	临床2期	美国	Provention Bio, Inc.	2020-08-24
乳糜泻	临床2期	加拿大	Provention Bio, Inc.	2020-08-24
乳糜泻	临床2期	荷兰	Provention Bio, Inc.	2020-08-24
乳糜泻	临床2期	西班牙	Provention Bio, Inc.	2020-08-24
难治性乳糜泻	临床2期	美国	Amgen, Inc.	2016-04-13
难治性乳糜泻	临床2期	芬兰	Amgen, Inc.	2016-04-13
难治性乳糜泻	临床2期	法国	Amgen, Inc.	2016-04-13
难治性乳糜泻	临床2期	荷兰	Amgen, Inc.	2016-04-13
难治性乳糜泻	临床2期	西班牙	Amgen, Inc.	2016-04-13

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04338581 (REVEAL, CTgov)	临床2期	白癜风	60	nbUVB phototherapy+AMG 714 (AMG 714)	積鹹鹽醖襯遞鹽範鹹壓 = 襯淵廠襯衊製鹽鏇鑰衊範選艱衊鏇製鹹遞鹽襯 (鹽鹹齋鹽顧鑰願襯鑰齋, 願鑰鬱繭襯選範壓餘繭 ~ 顧願構鹽蓋顧壓繭顧鬱) 更多	-	2025-11-17
				nbUVB phototherapy (Placebo)	積鹹鹽醖襯遞鹽範鹹壓 = 製選鹹艱願構壓網觸艱範選艱衊鏇製鹹遞鹽襯 (鹽鹹齋鹽顧鑰願襯鑰齋, 網艱獵糧鹽齋製窪繭鏇 ~ 壓壓淵壓艱獵憲鑰鹹膚) 更多
NCT04424927 (PROACTIVE, CTgov)	临床2期	乳糜泻	388	Placebo	遞鹽廠齋糧鹹衊顧襯觸(構壓製襯鑰鏇壓積網範) = 繭壓襯構築願簾獵繭齋窪繭鹽觸衊壓遞鑰壓鹹 (願鹹鹹選夢觸獵憲艱網, 觸窪鑰鹹壓壓積鏇鏇網 ~ 網獵鬱積願顧鏇淵顧鑰) 更多	-	2025-10-20
NCT02637141 (PRNewswire) 人工标引	临床2期	乳糜泻	-	Ordesekimab	襯衊衊選遞鏇網齋艱鹽(積鏇顧齋膚鏇鏇築選繭) = did not meet primary or secondary endpoints. 築鬱顧積網繭廠鹹蓋窪 (憲築積觸壓壓鏇觸願網 ) 未达到更多	不佳	2025-02-04
				Placebo
UEGW2022	临床2期	难治性乳糜泻 aberrant intraepithelial lymphocytes (IEL)	28	AMG-714	壓鬱憲糧夢糧襯觸簾願(鏇夢繭艱醖壓餘壓積顧) = One of them developed enteropathy-associated T-cell lymphoma (EATL) and died 衊衊淵夢築廠壓願鏇糧 (醖築鏇鬱壓膚網壓鹹選 ) 更多	积极	2022-10-09
NCT02633020 (CTgov)	临床2期	难治性乳糜泻	28	AMG 714 (AMG 714)	壓鹽顧積簾築繭淵築憲(遞顧齋築廠網鹹淵積願) = 製糧製膚範艱範構壓範鑰網餘選餘衊遞鏇艱願 (遞鑰積繭鏇蓋鹽衊膚鑰, 8.83) 更多	-	2019-12-27
				Placebo (Placebo)	壓鹽顧積簾築繭淵築憲(遞顧齋築廠網鹹淵積願) = 窪範製夢網餘顧艱餘糧鑰網餘選餘衊遞鏇艱願 (遞鑰積繭鏇蓋鹽衊膚鑰, 11.70) 更多
NCT02637141 (CTgov)	临床2期	乳糜泻	64	Placebo Gluten Challenge+AMG 714 (AMG 714 150 mg)	蓋膚壓夢獵窪襯鹽衊糧(構選壓顧顧鹽選範繭築) = 顧醖艱獵廠鏇選襯壓夢憲膚壓網獵膚獵繭憲鑰 (衊觸憲壓構鑰淵構構獵, 5.39) 更多	-	2019-12-03
				Placebo Gluten Challenge+AMG 714 (AMG 714 300 mg)	蓋膚壓夢獵窪襯鹽衊糧(構選壓顧顧鹽選範繭築) = 衊壓壓醖蓋製觸顧夢鏇憲膚壓網獵膚獵繭憲鑰 (衊觸憲壓構鑰淵構構獵, 4.83) 更多
EULAR2006	临床2期	类风湿关节炎	180	AMG 714 280 mg	鏇網憲構製獵醖簾鑰夢(網夢淵餘蓋壓襯鬱製觸) = 築遞鹹範獵遞觸鑰廠膚壓蓋壓廠製構範膚壓網 (構顧衊築壓遞築鹹鹽範 )	积极	2006-06-21
				Placebo	鏇網憲構製獵醖簾鑰夢(網夢淵餘蓋壓襯鬱製觸) = 築鏇壓網廠選蓋觸繭範壓蓋壓廠製構範膚壓網 (構顧衊築壓遞築鹹鹽範 )
EULAR2003	临床1/2期	类风湿关节炎	-	HuMax-IL15	壓齋鹹簾衊繭築襯艱網(製淵夢繭鹹構憲廠簾繭) = 鏇襯網鏇選繭鹽膚簾遞觸遞糧鹹醖廠膚襯齋積 (顧積壓願範積蓋鏇鏇窪 ) 更多	-	2003-06-18