NCT06095102Active, not recruitingPhase 3
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
Janssen Research & Development, LLC139 sites in 7 countries311 target enrollmentStarted: October 12, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 311
- Locations
- 139
- Primary Endpoint
- 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
Study Overview
Brief Summary
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).
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 (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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: Placebo (Drug)
JNJ-77242113
Experimental
Participants will receive JNJ-77242113 from Week 0 through Week 156.
Intervention: JNJ-77242113 (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 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).
Secondary Outcomes
- 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)
Investigators
Study Sites (139)
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