A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis (ICONIC-LEAD)

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: JNJ-77242113; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06095115

2023-505120-59-00 (Registry Identifier)

77242113PSO3001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.

Enrollment: 684 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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684 participants in 2 patient groups

JNJ-77242113

Experimental group

Description:

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.

Treatment:

Drug: JNJ-77242113

Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-77242113