A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis (SUMMIT)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: JNJ-77242113; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05357755

77242113PSO2003 (Other Identifier)

2021-005987-23 (EudraCT Number)

CR109193

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.

Full description

The population of people living with moderate to severe psoriasis is approximately 3.5 billion who 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 and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. The hypothesis of this study is that an oral tablet formulation of JNJ-77242113 will result in superior efficacy compared with placebo as determined by the percentage of participants achieving Psoriasis Area and Severity Index (PASI) 75 (greater than or equal to [>=] 75 percentage [%] improvement in PASI) (PASI 75) response at Week 16. 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 placebo- controlled treatment period, and a follow-up visit approximately 4 weeks after the last administration of study intervention. Safety assessments include adverse events (AEs) monitoring, clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs, physical examinations, concomitant medication monitoring, pregnancy testing, Columbia Suicide Severity Rating Scale (C-SSRS) and tuberculosis evaluations.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
• Participant has a total Body Surface Area (BSA) greater than or equal to (>=) 10 percentage (%) at screening and baseline
• Participant has a total Psoriasis Area and Severity Index (PASI) >= 12 at screening and baseline
• Participant has a total Investigator's Global Assessment (IGA) >= 3 at screening and baseline
• Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis

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 (including but not limited to guselkumab, tildrakizumab, or risankizumab)
• Participant has received any therapeutic agent directly targeted to interleukin 17 (IL-17), interleukin 17 receptor (IL-17R) or interleukin 12/23 (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received biological therapy targeting tumor necrosis factor (TNF) (including, but not limited to adalimumab, infliximab, or etanercept) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
• Participant has received proton pump inhibitors (including but not limited to omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole, or zegerid) within 1 week of first administration of study intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Group 1: JNJ-77242113 Dose 1

Experimental group

Description:

Participants will receive JNJ-77242113 Dose 1 as delayed release tablets orally once daily from Week 0 through Week 16.

Treatment:

Drug: JNJ-77242113

Group 2: JNJ-77242113 Dose 2

Experimental group

Description:

Participants will receive JNJ-77242113 Dose 2 as delayed release tablets orally once daily from Week 0 through Week 16.

Treatment:

Drug: JNJ-77242113

Group 3: Placebo

Placebo Comparator group

Description:

Participants will receive oral dose of matching placebo once daily from Week 0 through Week 16.

Treatment:

Drug: Placebo