The trial is taking place at:
R

Renstar Medical Research | Ocala, FL

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A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

J

Janssen (J&J Innovative Medicine)

Status and phase

Enrolling
Phase 3

Conditions

Plaque Psoriasis

Treatments

Drug: Deucravacitinib Matching Placebo
Drug: JNJ-77242113
Drug: JNJ-77242113 Matching Placebo
Drug: Deucravacitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06143878
77242113PSO3002 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

Enrollment

750 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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

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, deucravacitinib, or to any of the excipients or components of the study intervention Major surgical procedure, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

750 participants in 3 patient groups, including a placebo group

JNJ-77242113
Experimental group
Description:
Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.
Treatment:
Drug: JNJ-77242113
Drug: Deucravacitinib Matching Placebo
Placebo
Placebo Comparator group
Description:
Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.
Treatment:
Drug: JNJ-77242113 Matching Placebo
Drug: JNJ-77242113
Drug: Deucravacitinib Matching Placebo
Deucravacitinib
Active Comparator group
Description:
Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.
Treatment:
Drug: Deucravacitinib
Drug: JNJ-77242113 Matching Placebo
Drug: JNJ-77242113

Trial contacts and locations

164

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Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

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