NCT07143864尚未招募不适用
Efficacy and Safety of Stapokibart for Primary Cutaneous Amyloidosis: A Randomized, Double-blind, Placebo-controlled Study
First Affiliated Hospital of Chongqing Medical University0 个研究点目标入组 40 人开始时间: 2025年9月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- The percentage of subjects achieving AASI-75 at Week 16 of treatment
研究概览
简要总结
This trial is planned to investigate the efficacy and safety of Stapokibart (an IL-4 receptor antagonist) in patients with PCA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 to 75 years, with a diagnosis of PCA confirmed by skin biopsy, and an IGA score of ≥3, a AASI score of ≥5, and a BSA involvement of ≥5%.
- •Subjects who have received at least 4 weeks of mid-to-high potency or at least 2 weeks of very high potency topical corticosteroids (TCS) or an adequate course of systemic corticosteroids within the 6 months prior to screening, but with an inadequate response; or subjects who are unable to receive the above treatments due to adverse reactions or potential risks.
- •Prior to the first dose, subjects must have used a moisturizer continuously for at least 1 week, once daily, and must continue to use it throughout the study period.
- •Able to understand and complete study-related questionnaires.
- •Able to read, understand, and are willing to sign the informed consent form.
- •Willing and able to comply with study visits and related procedures.
- •Women of childbearing potential must agree to use contraception (such as intrauterine devices, oral contraceptives, or condoms) during the study and for 6 months after the study ends; must have a negative serum pregnancy test within 7 days before the first dose and must not be breastfeeding; male subjects must agree to use contraception during the study and for 6 months after the study ends.
排除标准
- •Use of any of the following treatments within 4 weeks prior to randomization: a. Immunosuppressants or immunomodulators, such as systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon gamma (IFN-γ), azathioprine, methotrexate, and Janus kinase (JAK) inhibitors; b. UV phototherapy; c. Systemic traditional Chinese medicine (TCM) treatment.
- •Use of topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), TCM, or phosphodiesterase 4 (PDE-4) inhibitors within 2 weeks prior to randomization.
- •Receipt of anti-IL-4R monoclonal antibodies, anti-IgE monoclonal antibodies, or other biologics within 12 weeks or 5 half-lives (whichever is longer) prior to randomization.
- •Receipt of live attenuated vaccines within 12 weeks prior to randomization or planned vaccination during the study period.
- •Use of antihistamines within 1 week prior to randomization (subjects who have been on a stable dose of antihistamines for at least 7 days prior to randomization and plan to continue during the study period may be included).
- •Receipt of allergen-specific immunotherapy (desensitization therapy) within 6 months prior to randomization.
- •Presence of any skin comorbidities that may interfere with study assessments, including but not limited to scabies, cutaneous T-cell lymphoma, psoriasis, etc.
- •Previous receipt of at least 12 consecutive doses of anti-IL-4Rα or IL-13 monoclonal antibodies with inadequate clinical response (defined as failure to achieve AASI 50 during treatment).
- •Presence of any other significant medical history that the investigator deems would pose a risk to the subject's safety or be poorly controlled if the subject participates in the study, in addition to PCA.
- •History of known or suspected immunosuppression (immunodeficiency), including a history of invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis), even if the infection has resolved; or unusual frequency, recurrence, or chronicity of infections (at the investigator's discretion).
- •Subjects with any type of active malignancy or a history of malignancy (except for cervical cancer that has been cured for more than 5 years prior to the screening period, or non-metastatic squamous cell carcinoma of the skin, basal cell carcinoma, and papillary thyroid cancer).
- •Presence of active Mycobacterium tuberculosis infection.
- •Subjects with severe liver or kidney function impairment during the screening period, such as aspartate aminotransferase or alanine aminotransferase >2 times the upper limit of normal (ULN), total bilirubin >1.5 times ULN, serum creatinine >1.2 times ULN, etc.
- •Presence of active hepatitis during the screening period, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and HBV-DNA, or positive for hepatitis C virus (HCV) antibody and HCV-RNA.
- •Positive for HIV antibody during the screening period, or history of HIV infection.
- •Positive for Treponema pallidum antibody during the screening period (subjects who have undergone standard treatment and have a negative non-treponemal antigen serological test may participate in the study).
- •Participation in another clinical trial of a drug or medical device within 12 weeks prior to randomization.
- •Presence of chronic active or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to randomization. After resolution of the infection, the subject may be re-screened once.
- •Subjects who plan to undergo major surgical procedures during the study period.
- •Pregnant or breastfeeding women.
- •Subjects with a history of alcoholism, drug abuse, or known drug dependence.
- •History of atopic keratoconjunctivitis involving the cornea.
- •Any medical or psychiatric conditions that the investigator deems would pose a risk to the subject, interfere with participation in the study, or confound the interpretation of study results.
研究组 & 干预措施
Stapokibart
Experimental
干预措施: Stapokibart (Biological)
Placebo
Placebo Comparator
干预措施: Placebo drug (Other)
结局指标
主要结局
The percentage of subjects achieving AASI-75 at Week 16 of treatment
时间窗: At the end of treatment at 16 weeks
AASI: Amyloidosis Area and Severity Index. The minimum and maximum values: 0-72. Higher scores mean more serious situations. AASI-75: A 75% or greater improvement from baseline in the AASI. The minimum and maximum values: 0%-100%. Higher scores mean a better outcome.
次要结局
- The percentage of subjects with a weekly average reduction of≥4 points in PP-NRS score at Week 16 of treatment compared to baseline(At the end of treatment at 16 weeks)
- The percentage of subjects with an IGA score of 0 or 1 and a reduction of≥2 points compared to baseline.(At the end of treatment at 16 weeks)
- The percentage of subjects achieving AASI-50 compared to baseline.(At the end of treatment at 16 weeks)
- The percentage of subjects with a weekly average reduction of≥3 points in PP-NRS score compared to baseline(At the end of treatment at 16 weeks)
- Change rates in BSA involvement compared to baseline.(At the end of treatment at 16 weeks)
- Changes in DLQI scores compared to baseline.(At the end of treatment at 16 weeks)
- Changes in absolute eosinophil counts in complete blood counts compared to baseline.(At the end of treatment at 16 weeks)
- Changes in IgE levels in complete blood counts compared to baseline.(At the end of treatment at 16 weeks)
- Changes in histopathology of skin lesions compared to baseline in some subjects(At the end of follow-up at 28 weeks)
研究者
Aijun Chen
Department of Dermatology, The First Affiliated Hospital of Chongqing Medical University
First Affiliated Hospital of Chongqing Medical University
相似试验
已完成
2 期
A Safety and Efficacy Study of Carboplatin, Paclitaxel, Bevacizumab and CA4P in Non-Small Cell Lung CancerTumorsNCT00653939Mateon Therapeutics63
进行中（未招募）
4 期
Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in IndiaNCT07109297Sanofi110
尚未招募
4 期
Study of monoclonal antibody nirsevimab against Respiratory Syncytial Virus (RSV) in participants up to 24 months of age in India.CTRI/2025/05/087740Sanofi Healthcare India Pvt Ltd110
已完成
1 期
A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum DisordersNeuromyelitis Optica Spectrum DisordersNCT04146285Bio-Thera Solutions15
Unknown
4 期
Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque PsoriasisChronic Plaque PsoriasisNCT00707070Universita di Verona100