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 Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Retreatment
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 684
- 试验地点
- 317
- 主要终点
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
研究概览
简要总结
The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.
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, for at least 26 weeks prior to the first administration of study intervention
- •Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
- •Total psoriasis area and severity index (PASI) >=12 at screening and baseline
- •Total investigator global assessment (IGA) >=3 at screening and baseline
- •Candidate for phototherapy or systemic treatment for plaque psoriasis
- •A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention
排除标准
- •Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
- •Current drug-induced psoriasis (for 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
- •Major surgical procedures, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from a surgical procedure or has a surgical procedure planned during the time the participant is expected to participate in the study
研究组 & 干预措施
Placebo
Adolescent and adult participants will receive JNJ-77242113 matching placebo from Week 0 to Week 16. Participants will cross-over to receive JNJ-77242113 from Week 16 through Week 156.
干预措施: Placebo (Drug)
Placebo
Adolescent and adult participants will receive JNJ-77242113 matching placebo from Week 0 to Week 16. Participants will cross-over to receive JNJ-77242113 from Week 16 through Week 156.
干预措施: JNJ-77242113 (Drug)
JNJ-77242113
Adolescent and adult participants will receive JNJ-77242113 from Week 0 through Week 156. At Week 24, adult participants who are psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieve an IGA score of 0 or 1 and have >=2-grade improvement from baseline) will be re-randomized either to continue JNJ-77242113 or to placebo (and will be retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Adult participants identified as both PASI 75 and IGA 0 or 1 score non-responders will continue to receive JNJ-77242113 through Week 52. From Week 52 to Week 156, all adult participants will receive JNJ-77242113. Adolescents will not participate in re-randomization regardless of their PASI score or IGA score at Week 24. Adolescents will continue to 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 Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
时间窗: Baseline to Week 16
Percentage of participants achieving PASI 90 response (\>=90% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
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 to Week 16
时间窗: Baseline to Week 16
Percentage of participants who achieve an IGA score of 0 or 1 and \>=2-grade improvement from baseline to 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 PASI 75 Response at Weeks 4 and 16(Baseline to Weeks 4 and 16)
- Time to Loss of PASI 90(Week 24 up to Week 52)
- Change from Baseline in PASI Total Score to Week 16(Baseline to Week 16)
- Change From Baseline in PSSD Symptom Score to Week 16(Baseline to Week 16)
- Change From Baseline in PSSD Sign Score to Week 16(Baseline to Week 16)
- Percentage of Participants Achieving an IGA Score of 0 at Week 16(Week 16)
- Percentage of Participants Achieving >=4-Point Improvement From Baseline in PSSD Itch Score to Weeks 4 and 16(Baseline to Weeks 4 and 16)
- Time to Loss of PASI 75(Week 24 up to Week 52)
- Percent Improvement in PASI Score From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and at Least a 2-grade Improvement in Genital Psoriasis From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants Achieving Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16(Weeks 8 and 16)
- Change from Baseline in Body Surface Area (BSA) at Week 16(Baseline to Week 16)
- Percent of Participants Achieving Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16(At Week 16)
- Percentage of Adolescent Participants Achieving IGA Score of 0 or 1 and >=2 Improvement From Baseline to Week 52(Baseline to Week 52)
- Percentage of Adolescent Participants Achieving PASI 75 Response at Week 52(Baseline to Week 52)
- Percentage of Participants Achieving PASI 90 Response at Week 8(Baseline to Week 8)
- Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 and >=2 Grade Improvement Baseline to Week 16(Baseline to Week 16)
- Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16(Baseline to Week 16)
- Percentage of Participants Achieving PASI 100 Response at Week 16(Week 16)
- Number of Participants with Treatment-emergent Adverse Events (AEs)(Up to 160 weeks)
- Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)(Up to 160 weeks)
- Percentage of Participants Achieving a Physician's Global Assessment of Hands and Feet (hf-PGA) Score of 0 or 1 and at Least a 2-grade Improvement 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 to Week 16)
- Change From Baseline in the Domain Scores of the PROMIS-25 Pediatric Score at Week 16(Baseline to Week 16)
- Percentage of Participants Achieving IGA Score of 0 at Week 52(Week 52)
- 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)
- Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16(Week 16)
- Percentage of Participants Achieving PASI 100 Response at Week 52(Week 52)
- Time to Loss of IGA 0 to 1 Response(Week 24 to Week 52)
- Percentage of Adolescent Participants Achieving PASI 90 Response at Week 52(Baseline to Week 52)
- 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 Total DLQI Score at Week 16(Baseline to Week 16)
- Change From Baseline in CDLQI at Week 16(Baseline to Week 16)