A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 3

Conditions: Plaque Psoriasis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06220604

77242113PSO3004 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 731 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

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731 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

Drug: JNJ-77242113 Matching Placebo

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

Drug: JNJ-77242113 Matching Placebo