Status:
COMPLETED
A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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.
Detailed 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, targe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05357755
Start Date
June 13 2022
End Date
April 10 2023
Last Update
May 25 2025
Active Locations (34)
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1
Stoll Dermatology
Beverly Hills, California, United States, 90212
2
Northshore University Healthsystem
Skokie, Illinois, United States, 60077
3
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas, United States, 66210
4
Dermatology Specialists
Louisville, Kentucky, United States, 40241