NCT06095102进行中（未招募）3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 311
- 试验地点
- 139
- 主要终点
- Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2 Grade Improvement From Baseline at Week 16
研究概览
简要总结
The purpose of the study is to see how effective JNJ-77242113 is in participants with plaque psoriasis affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
- •Candidate for phototherapy or systemic treatment for plaque psoriasis
- •Need to meet criteria: Total body surface area (BSA) greater than or equal to (>=)1 percent (%) at screening and baseline, and investigator global assessment (IGA) (overall) >=2 at screening and baseline and at least one of the following: scalp-specific investigator global assessment (ss-IGA) score >=3 at screening and baseline, and/or static physician's global assessment of genitalia (sPGA-G) >=3 at screening and baseline, and/or physician's global assessment of hands and feet (hf-PGA) score >=3 at screening and baseline
- •Failed to respond to at least 1 topical therapy (example, corticosteroids, calcineurin inhibitors, and/or vitamin D analogs) used for treatment of psoriasis
- •Confirmation of plaque psoriasis in a non-special area (example, areas excluding scalp, genital, palmoplantar) at screening and baseline
排除标准
- •Nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
- •Dermatoses other than plaque psoriasis (such as contact dermatitis) or palmoplantar pustulosis of the palmoplantar area (if hf-PGA >=3 at baseline)
- •Current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- •A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo from Week 0 through Week 16 and thereafter will receive JNJ-77242113 from Week 16 through Week 156.
干预措施: JNJ-77242113 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo from Week 0 through Week 16 and thereafter will receive JNJ-77242113 from Week 16 through Week 156.
干预措施: Placebo (Drug)
JNJ-77242113
Experimental
Participants will receive JNJ-77242113 from Week 0 through Week 156.
干预措施: JNJ-77242113 (Drug)
结局指标
主要结局
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2 Grade Improvement From Baseline at Week 16
时间窗: Baseline and Week 16
Percentage of participants who achieve an IGA score of 0 or 1 and \>=2 grade improvement from baseline at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
次要结局
- Percentage of Participants Achieving a Physician's Global Assessment of Hands and Feet (hf-PGA) Score of 0 or 1 at Week 16(Week 16)
- Percentage of Participants Achieving >=4-Point Improvement From Baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16(Baseline and Week 16)
- Change from Baseline in PASI Total Score at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16(Week 16)
- Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 at Week 16(Week 16)
- Percentage of Participants Achieving Psoriasis Scalp Severity Index (PSSI) 90 at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 at Week 16(Week 16)
- Percentage of Participants Achieving Psoriasis Symptom and Sign Diary (PSSD) Symptoms Score of 0 at Week 16(Week 16)
- Percentage of Participants Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 score of 0 or 1 at Week 16(Week 16)
- Change From Baseline in BSA at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving >=4 Point Improvement From Baseline in PSSD Itch Score at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving PASI 75 Response at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving >=4-Point Improvement From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Genital Itch NRS Score at Week 16(Baseline and Week 16)
- Number of Participants with Adverse Events (AEs)(Up to 165 weeks)
- Number of Participants with Serious Adverse Events (SAEs)(Up to 165 weeks)
- Percent Change From Baseline in Modified Nail Psoriasis Areas and Severity Index (mNAPSI) Score at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving an IGA Score of 0 at Week 16(Week 16)
- Change From Baseline in PSSD Symptom Score at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI) score of 0 or 1 at Week 16(Week 16)
- Change From Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-25 (PROMIS-25) Score at Week 16(Baseline and Week 16)
- Change From Baseline in Palmoplantar Quality of Life Instrument (ppQLI) Score at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving PSSD Symptom Score of 0 at Week 8(Week 8)
- Change From Baseline in PSSD Sign Score at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving >=4-Point Improvement From Baseline in PSSD Itch Score at Week 4(Baseline and Week 4)
- Percentage of Participants Achieving PSSD Sign Score of 0 at Week 16(Week 16)
- Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16(Week 16)
- Change From Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16(Baseline and Week 16)
- Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16(Baseline and Week 16)
研究者
研究点 (139)
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相关资讯
JNJ-2113 Shows Promise for Psoriasis, Infigratinib for Achondroplasia, and Gildeuretinol Gains FDA Support for Stargardt Disease- Phase 3 trials of JNJ-2113 demonstrate potential as a first-in-class oral peptide targeting the IL-23 receptor for moderate-to-severe plaque psoriasis in patients aged 12 years and older.
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- In ICONIC-LEAD, 64.7% of patients on JNJ-2113 achieved IGA 0/1 at week 16, versus 8.3% on placebo, with PASI 90 achieved by 49.6% versus 4.4%, respectively.
- Week 24 results from ICONIC-LEAD showed further improvement, with 74.1% achieving IGA 0/1 and 64.9% achieving PASI 90 with JNJ-2113.
- ICONIC-TOTAL also met its primary endpoint of IGA 0/1 at week 16, reinforcing JNJ-2113's potential as a novel oral treatment for plaque psoriasis.last year