A Study to Evaluate the Efficacy, Safety, and Tolerability of an Oral Tablet Formulation of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
- Conditions
- MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-005987-23-FR
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 89
1. Participant is 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive
2. Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
3. Participant has a total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
4. Participant has a total Psoriasis area and severity index (PASI) >=12 at screening and baseline
5. Participant has a total Investigator Global Assessment (IGA) >=3 at screening and baseline
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
1. Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
2. Participant has current drug-induced psoriasis (for example, a new calcium channel blockers, or lithium)
3. Participant have previously received any other therapeutic agent directly targeted to interleukin 23 (including but not limited to guselkumab, tildrakizumab, or risankizumab)
4. 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 halflives, whichever is longer, of the first administration of study intervention
5. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.;Secondary Objective: 1. To assess the safety and tolerability of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.<br>2. To evaluate additional measures of efficacy of an oral tablet formulation ofJNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.;Primary end point(s): Proportion of participants achieving Psoriasis Area and Severity Index (PASI) 75 (=75% improvement in PASI).;Timepoint(s) of evaluation of this end point: Week 16
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Frequency and type of adverse events (AEs) and serious adverse events (SAEs).<br>2. Change from baseline in PASI total score.<br>3. Proportion of participants achieving PASI 90 (=90% improvement from baseline in PASI).<br>4. Proportion of participants achieving PASI 100 (100% improvement from baseline in PASI).<br>5. Proportion of participants achieving an Investigator Global Assessment (IGA) score of cleared (0) or minimal (1).<br>6. Proportion of participants achieving an IGA score of cleared (0).<br>7. Change from baseline in body surface area (BSA).;Timepoint(s) of evaluation of this end point: Week 16