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
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 684
- Locations
- 317
- Primary Endpoint
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Study Overview
Brief Summary
The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: JNJ-77242113 (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
- 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)