jRCT2051240044招募中不适用
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-07275315 AND PF-07264660 IN ADULT PARTICIPANTS WITH MODERATE-SEVERE ATOPIC DERMATITIS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 主要终点
- EASI75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Must meet the following AD criteria:
- •Clinical diagnosis of chronic atopic dermatitis for at least 6 months prior to Day 1;
- •Either an inadequate response to treatment with t standard of care treatments (excluding systemic immunosuppressant treatments) for at least 4 consecutive weeks within 6 to 12 months of the first dose of the study intervention; OR documented reason why topical treatments are considered medically inappropriate;
- •Moderate to severe AD (defined as having an affected BSA >=10%, vIGA >=3, and EASI >=16 at both the screening and baseline visits).
- •Other Inclusion Criteria:
- •BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs).
排除标准
- •Medical Conditions:
- •Significant allergic or autoimmune diseases, other than AD and well controlled mild to moderate asthma, including but not limited to: SLE or other complement disorders; Type 1 diabetes; Irritable bowel syndrome; Multiple Sclerosis.
- •History of significant allergic reactions, including anaphylaxis and reactions to protein therapeutics, including hypersensitivity to PF-07275315 or PF-07264660 or to the excipients of the formulated drug products. Participants with significant reactions to single, identified, avoidable allergens (eg, peanut allergy) may be eligible if avoidance of these allergens during the study is feasible.
- •Any of the following acute or chronic infections or infection history:
- •a. Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to the screening;
- •b. Infection requiring hospitalization or systemic (eg, parenteral, oral) antimicrobial therapy within 60 days prior to Day 1;
- •c.Active chronic or acute skin infection requiring treatment with systemic ([not IV]) antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin infections (requiring no more than topical anti-infective treatments) within 1 week prior to Day
- •d. Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1;
- •History of or current evidence of inflammatory skin conditions (eg, psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that would interfere with evaluation of AD or response to treatment.
- •Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Prior/Concomitant Therapy:
- •Current use of any prohibited concomitant medication(s).
- •Phototherapy narrowband UVB (NB UVB) or broadband phototherapy or regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks prior to Day
- •Prior/Concurrent Clinical Study Experience:
- •Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
- •HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.
- •Evidence of active or latent TB, or inadequately treated infection with Mycobacterium TB. A participant who is currently being treated for active or latent TB infection must be excluded from this study.
结局指标
主要结局
EASI75
时间窗: Week 16
The number of participants achieving >=75% improvement from baseline
次要结局
- vIGA score clear or almost clear(all scheduled time points)
- EASI75(scheduled time points except Week 16)
- Percent change in EASI total score(scheduled time points)
- Treatment emergent AEs
- Clinically significant changes in vital signs
- Clinically significant changes in ECG
- Clinically significant changes in laboratory tests
研究者
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