NCT06881251终止2 期
95475939ADM2001: 95475939ADM2001 Ph IIB Trial (N=210)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 256
- 试验地点
- 127
- 主要终点
- Percentage 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 evaluate how well JNJ-95475939 works as compared to placebo in participants with moderate to severe 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
- Triple (Participant, Care Provider, 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
- •Chronic Atopic Dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to the screening visit
- •Eczema Area and Severity Index (EASI) score greater than and equal to (>=) 16 at the screening and baseline visits
- •Validated investigator global assessment for AD (vIGA-AD) score >= 3 at the screening and baseline visits
- •>= 10% body surface area (BSA) of AD involvement at the screening and baseline visits
- •Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of >=4
- •Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12 months before screening)
- •Participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit
排除标准
- •Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents (eg, severe ocular surface disease, dupilumab-associated facial redness) inhibiting IL-4Rα, IL-4, and/or IL-13 signaling (eg, dupilumab, lebrikizumab, or tralokinumab)
- •Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study
- •Active skin disease other than AD including eczema herpeticum, molluscum contagiosum, impetigo, psoriasis or has any other ongoing significant skin condition including skin infections, that, according to the investigator, could interfere with efficacy assessments
- •Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum
- •History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, untreated latent tuberculosis), recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers.
- •Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization
- •Had major surgery (eg, requiring general anesthesia and hospitalization), within 8 weeks before screening, or will not have fully recovered from surgery, or has such surgery planned during the time the participant is expected to participate in the study
研究组 & 干预措施
Group A: Dupilumab
Active Comparator
Participants will receive Dupilumab dose regimen 1 subcutaneously through Week 22.
干预措施: Dupilumab (Drug)
Group D: JNJ-95475939
Experimental
Participants will receive JNJ-95475939 dose regimen 3 subcutaneously through Week 22.
干预措施: JNJ-95475939 (Drug)
Group E: Placebo
Placebo Comparator
Participants will receive matching placebo subcutaneously through Week 10, then switch to receive JNJ-95475939 dose regimen 1 subcutaneously between Week 12 and Week 22.
干预措施: JNJ-95475939 (Drug)
Group E: Placebo
Placebo Comparator
Participants will receive matching placebo subcutaneously through Week 10, then switch to receive JNJ-95475939 dose regimen 1 subcutaneously between Week 12 and Week 22.
干预措施: Placebo (Drug)
Group B: JNJ-95475939
Experimental
Participants will receive JNJ-95475939 dose regimen 1 subcutaneously through Week 22.
干预措施: JNJ-95475939 (Drug)
Group C: JNJ-95475939
Experimental
Participants will receive JNJ-95475939 dose regimen 2 subcutaneously through Week 22.
干预措施: JNJ-95475939 (Drug)
结局指标
主要结局
Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12
时间窗: Baseline, Week 12
EASI-75 response is defined as at least 75 percent (%) improvement in EASI total score. EASI-75 response is defined as at least 75% improvement from baseline in EASI total score. The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting a higher severity of AD.
次要结局
- Percentage of Participants With EASI-90 Response at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction From Baseline of Greater Than Equal to (>=) 2 Points at Week 12(Baseline, Week 12)
- Percent Change From Baseline in the EASI Total Score at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 12(Baseline, Week 12)
- Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 12(Baseline, Week 12)
- Percent Change from Baseline in Skin Pain NRS Score at Week 12(Baseline, Week 12)
- Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 12(Baseline, Week 12)
- Percentage of Participants with EASI-90 Response at Week 16(Baseline, Week 16)
- Percentage of Participants with EASI-100 Response at Week 16(Week 16)
- Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 16(Baseline, Week 16)
- Percent Change from Baseline in PP-NRS Score at Week 16(Baseline, Week 16)
- Percent Change from Baseline in Skin Pain NRS Score at Week 16(Baseline, Week 16)
- Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 16(Baseline, Week 16)
- Percentage of Participants with EASI-75 Response at Week 24(Baseline, Week 24)
- Percentage of Participants with EASI-100 Response at Week 24(Week 24)
- Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 24(Baseline, Week 24)
- Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 24(Baseline, Week 24)
- Percentage of Participants With EASI-90 Response at Week 12(Baseline, Week 12)
- Percentage of Participants With EASI-100 Response at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction From Baseline of Greater Than Equal to (>=) 2 Points at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 12(Baseline, Week 12)
- Percent Change From Baseline in the EASI Total Score at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 12(Baseline, Week 12)
- Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 12(Baseline, Week 12)
- Percent Change from Baseline in Skin Pain NRS Score at Week 12(Baseline, Week 12)
- Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score From Baseline Through Week 12(From Baseline through Week 12)
- Percentage of Participants with EASI-75 Response at Week 16(Baseline, Week 16)
- Percentage of Participants with EASI-90 Response at Week 16(Baseline, Week 16)
- Percentage of Participants with EASI-100 Response at Week 16(Week 16)
- Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 16(Baseline, Week 16)
- Percent Change from Baseline in the EASI Total Score at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain Numerical Rating Scale (NRS) Score From Baseline to Week 16(Baseline, Week 16)
- Percent Change from Baseline in PP-NRS Score at Week 16(Baseline, Week 16)
- Percent Change from Baseline in Skin Pain NRS Score at Week 16(Baseline, Week 16)
- Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving a >= 4-Point Reduction in PP-NRS Score From Baseline Through Week 24(From Baseline Through Week 24)
- Percentage of Participants with EASI-75 Response at Week 24(Baseline, Week 24)
- Percentage of Participants with EASI-90 Response at Week 24(Week 24)
- Percentage of Participants with EASI-100 Response at Week 24(Week 24)
- Percentage of Participants Achieving vIGA-AD Score of 0 or 1 and a Reduction From Baseline of >= 2 Points at Week 24(Baseline, Week 24)
- Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 24(Baseline, Week 24)
- Percent Change from Baseline in the EASI Total Score at Week 24(Baseline, Week 24)
- Percent Change from Baseline in Skin Pain NRS Score at Week 24(Baseline, Week 24)
- Percentage of Participants Achieving a >= 4-Point Reduction in Skin Pain NRS Score From Baseline to Week 24(Baseline, Week 24)
- Percent Change From Baseline in PP-NRS Score at Week 24(Baseline, Week 24)
- Percent Change from Baseline in the Score of Item 2 of the AD Sleep Scale at Week 24(Baseline, Week 24)
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Baseline up to Week 36)
研究者
研究点 (127)
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