A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 189
- 试验地点
- 62
- 主要终点
- Proportion of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12
研究概览
简要总结
The purpose of this study is to assess how well JNJ-95597528 works compared to placebo in participants with moderate to severe atopic dermatitis (AD).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- •Meets all the following disease activity criteria: a. Chronic atopic dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to screening visit; b. Eczema area and severity index (EASI) score greater than or equal to (>=) 16 at the screening and Week 0; c. validated investigator global assessment for atopic dermatitis (vIGA-AD) score >= 3 at screening and Week 0; d. >= 10% body surface area (BSA) of AD involvement at screening and Week 0; e. Documented history (within 6 months before screening) of either inadequate response or inadvisability to medicated topical treatments for AD or inadequate response to systemic therapies (within 12 months before screening)
- •Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
- •If willing to participate in the substudy, must sign a separate ICF for the corresponding substudy (or substudies)
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests, lifestyle restrictions, and other study procedures
排除标准
- •History of substance abuse or alcohol abuse within 1 year before screening
- •In the investigator's opinion, any clinically significant results from the 12-lead ECG, chemistry, hematology, or urinalysis laboratory tests obtained at the screening visit that would affect interpretation of study data or the participant's safety in the study
- •Known or suspected immunodeficiency, including history of invasive opportunistic infections
- •Previously received JNJ-95597528
- •Has known hypersensitivity or intolerance to JNJ-95597528 or its excipients or to any biologic medication or known allergies, or clinically significant reactions to murine, chimeric, monoclonal antibodies (mAbs), or antibody fragments
研究组 & 干预措施
Group 1: JNJ-95597528 (Dose 1)
Participants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24.
干预措施: JNJ-95597528 (Drug)
Group 4: Placebo and JNJ-95597528 (Dose 2 and 3)
Participants will receive placebo from Weeks 0 to 12 , then switch to receive JNJ-95597528 Dose 2 administered at Week 12 followed by Dose 3 at Week 24.
干预措施: JNJ-95597528 (Drug)
Group 4: Placebo and JNJ-95597528 (Dose 2 and 3)
Participants will receive placebo from Weeks 0 to 12 , then switch to receive JNJ-95597528 Dose 2 administered at Week 12 followed by Dose 3 at Week 24.
干预措施: Placebo (Drug)
Group 3: JNJ-95597528 (Dose 4 and 5)
Participants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5 on Weeks 12, and 24.
干预措施: JNJ-95597528 (Drug)
Group 2: JNJ-95597528 (Dose 2 and 3)
Participants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3 on Weeks 12, and 24.
干预措施: JNJ-95597528 (Drug)
结局指标
主要结局
Proportion of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12
时间窗: Week 12
EASI-75 response is defined as at least 75 percent (%) improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.
次要结局
- Proportion of Participants with EASI 90 Response at Week 12(Week 12)
- Proportion of Participants with EASI 100 Response at Week 12(Week 12)
- Percent Change from Baseline in Skin Pain NRS at Week 12(Baseline, Week 12)
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Up to approximately Week 12)
- Percent Change from Baseline in EASI Total Score at Week 12(Baseline, Week 12)
- Proportion of Participants with Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction of >= 2 Points from Baseline, at Week 12(Week 12)
- Proportion of Participants with vIGA-AD Score of 0 and a Reduction of >= 2 points from Baseline, at Week 12(Week 12)
- Proportion of Participants with >= 4-Point Improvement in Peak Pruritus Numeric(al) Rating Scale (PP-NRS) from Baseline, at Week 12(Week 12)
- Percent Change from Baseline in PP-NRS Score at Week 12(Baseline, Week 12)
- Percent Change from Baseline in Score of Item 2 of Atopic Dermatitis Sleep Scale (AD Sleep Scale) at Week 12(Baseline, Week 12)
- Proportion of Participants with >= 4 Point Improvement in Skin Pain Numeric Rating Scale (Skin Pain NRS) from Baseline, at Week 12(Week 12)