A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Ustekinumab; Drug: Matching Placebo to Ustekinumab; Drug: Matching Placebo to JNJ-77242113; Drug: JNJ-77242113

Study type: Interventional

Funder types: Industry

Identifiers

NCT06934226

77242113PSO3006 (Other Identifier)

2024-515706-77-00 (Registry Identifier)

Details and patient eligibility

About

The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.

Enrollment: 675 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), 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 [e.g.], erythrodermic, guttate, or pustular)
• Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
• Major surgical procedure 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
• Transplanted organ (with exception of a corneal transplant greater than [>] 12 weeks before the first administration of study intervention)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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675 participants in 3 patient groups, including a placebo group

Arm 1: JNJ 77242113

Experimental group

Description:

Participants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maintain the blind.

Treatment:

Drug: JNJ-77242113

Drug: Matching Placebo to Ustekinumab

Arm 2: Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104.

Treatment:

Drug: JNJ-77242113

Drug: Matching Placebo to JNJ-77242113

Drug: Matching Placebo to Ustekinumab

Arm 3: Ustekinumab

Active Comparator group

Description:

Participants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28.

Treatment:

Drug: JNJ-77242113

Drug: Matching Placebo to JNJ-77242113

Drug: Ustekinumab