A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis (FRONTIER 1)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: JNJ-77242113

Study type: Interventional

Funder types: Industry

Identifiers

NCT05223868

CR109138

77242113PSO2001 (Other Identifier)

2021-003700-41 (EudraCT Number)

Details and patient eligibility

About

Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

Full description

The populations of people living with moderate to severe psoriasis is approximately 3.5 billion which are mostly managed with topical and conventional therapies. JNJ-77242113, investigational drug, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and psoriatic arthritis (PsA) and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.

Enrollment: 255 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 6 months prior to the first administration of study intervention
• Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis
• Participant has a total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
• Participant has a total Psoriasis area and severity index (PASI) >=12 at screening and baseline
• Participant has a total Investigator global assessment (IGA) >=3 at screening and baseline

Exclusion criteria

• Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
• Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Participant have previously received any other therapeutic agent directly targeted to interleukin 23 receptor (IL-23R) (including but not limited to guselkumab, tildrakizumab, or risankizumab)
• Participant has received any therapeutic agent directly targeted to interleukin 17 receptor (IL-17) or interleukin 12/23 receptor (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received anti-tumor necrosis factor [TNF]-alpha biologic therapy (including, but not limited to adalimumab) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
• Participant has received agents that deplete B cells (including, but not limited to, rituximab, or alemtuzumab) within 26 weeks of the first administration of study intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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255 participants in 6 patient groups, including a placebo group

Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and Placebo

Experimental group

Description:

Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Treatment:

Drug: JNJ-77242113

Drug: Placebo

Group 2: JNJ-77242113 Dose 2 QD and Placebo

Experimental group

Description:

Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Treatment:

Drug: JNJ-77242113

Drug: Placebo

Group 3: JNJ-77242113 Dose 3 QD and Placebo

Experimental group

Description:

Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Treatment:

Drug: JNJ-77242113

Drug: Placebo

Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and Placebo

Experimental group

Description:

Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Treatment:

Drug: JNJ-77242113

Drug: Placebo

Group 5: JNJ-77242113 Dose 3 BID and Placebo

Experimental group

Description:

Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Treatment:

Drug: JNJ-77242113

Drug: Placebo

Group 6: Placebo

Placebo Comparator group

Description:

Participants will receive placebo BID from Week 0 through Week 16.

Treatment:

Drug: Placebo