NCT07377838尚未招募3 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of ADSTEM Inj. for Moderate to Severe Subacute and Chronic Atopic Dermatitis Patients
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 286
- 主要终点
- Percentage of participants who achieve a score of 0 or 1 on the validated Investigator's Global Assessment (vIGA) scale at Visit 6, and demonstrate at least a 2-point reduction from baseline(Visit 2)
研究概览
简要总结
Study of ADSTEM Injection for Patients with Moderate to Severe Subacute and Chronic Atopic Dermatitis
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 to 70 years at the time of informed consent.
- •Diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria at screening.
- •History of atopic dermatitis for at least 24 weeks prior to screening.
- •Moderate-to-severe atopic dermatitis at screening, defined as:
- •EASI score ≥16
- •SCORAD score ≥25
- •Body Surface Area (BSA) involvement ≥10%
- •vIGA score ≥3
- •Inadequate response to prior standard topical and/or systemic treatments for atopic dermatitis, or inability to receive such treatments due to safety concerns.
- •Voluntary written informed consent provided.
排除标准
- •Presence of clinically significant comorbidities at screening, including:
- •Active infection requiring antimicrobial treatment within 2 weeks prior to baseline, or superficial skin infection within 1 week prior to baseline;
- •Skin diseases that require ongoing treatment or may interfere with safety or efficacy assessments;
- •Uncontrolled asthma requiring oral corticosteroids;
- •Positive test results for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis;
- •Other uncontrolled or clinically significant medical conditions that may affect study participation or assessments;
- •Clinically significant abnormal laboratory results at screening (e.g., AST or ALT > 3 × ULN, serum creatinine > 2 × ULN).
- •History of prohibited treatments prior to baseline, including:
- •Use of JAK inhibitors within 4 weeks;
- •Use of biologic therapies for atopic dermatitis within 12 weeks;
- •Use of systemic immunosuppressants, immunomodulators, or systemic corticosteroids within 4 weeks;
- •Use of topical corticosteroids, topical PDE-4 inhibitors, or topical calcineurin inhibitors within 2 weeks;
- •Participation in another clinical trial with an investigational drug or device within 4 weeks prior to screening;
- •Prior treatment with cell therapy or gene therapy.
- •History of malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer without recurrence.
- •History of tanning within 4 weeks prior to baseline.
- •Pregnant or breastfeeding women, or women planning pregnancy during the study period.
- •Women of childbearing potential who are unwilling to use adequate contraception from the time of informed consent through the end of the study.
- •Known or suspected hypersensitivity to the investigational product or any of its components.
- •Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
研究组 & 干预措施
ADSTEM Inj.
Experimental
干预措施: ADSTEM Inj. (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of participants who achieve a score of 0 or 1 on the validated Investigator's Global Assessment (vIGA) scale at Visit 6, and demonstrate at least a 2-point reduction from baseline(Visit 2)
时间窗: From baseline to Weeks 16
validated Investigator's Global Assessment \[vIGA\], 0-4, higher scores indicate worse disease severity
次要结局
- Change from baseline (Visit 2) in vIGA score(From baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of participants with a vIGA score reduction of 1 point or ≥2 points from baseline (Visit 2)(From baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of participants with a vIGA score of 0 or 1 at Week 24(From baseline to Week 24)
- Percentage of participants with a ≥50% reduction in total EASI score from baseline (Visit 2)(From baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of participants with a ≥75% reduction in total EASI score from baseline (Visit 2)(From baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of participants with a ≥90% reduction in total EASI score from baseline (Visit 2)(From baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Change from baseline (Visit 2) in total EASI score(From baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of participants with a ≥50% reduction in total SCORAD score from baseline (Visit 2)(From baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of participants with a ≥75% reduction in total SCORAD score from baseline (Visit 2)(From baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Change from baseline (Visit 2) in total SCORAD score(From baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Change from baseline (Visit 2) in individual SCORAD item scores(From baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Change from baseline (Visit 2) in DLQI score(From baseline to Weeks 8, 16, and 24)
- Percentage of participants using rescue medication, number of uses, and total amount used(From Week -6 (Visit 1) to Weeks 4, 8, 12, 16, 20, and 24)
研究者
相似试验
招募中
不适用
Double-blind, Randomized, Non-inferiority Trial in Atopic Dermatitis: Comparison of Lipikar Balm and Relipid+ Balm in the Treatment of Mild to Moderate Atopic Dermatitis in Children and AdultsEmollientsAtopic DermatitisNCT07358000University Hospital, Caen86
招募中
不适用
This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic TreatmentAtopic DermatitisNCT07290803Sanofi1,000
招募中
3 期
Long-Term Safety and Efficacy evaluation of amlitelimab in participants of previous amlitelimab moderate to severe atopic dermatitis clinical trials2023-506548-18-00Sanofi-Aventis Recherche & Developpement410
招募中
2 期
Cardamom and Topical Roseomonas in Atopic DermatitisEczemaAtopic DermatitisNCT06096857National Institute of Allergy and Infectious Diseases (NIAID)120
尚未招募
不适用
Treatment of Moderate-to-Severe Atopic Dermatitis With Ivarmacitinib in Adolescents and AdultsNCT07276620Xiangya Hospital of Central South University1,000