Status:
COMPLETED
A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed 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, ta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT05223868
Start Date
February 3 2022
End Date
December 15 2022
Last Update
December 30 2025
Active Locations (76)
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1
Medical Dermatology Specialists
Phoenix, Arizona, United States, 85006
2
Pacific Skin Institute
Sacramento, California, United States, 95815
3
Renstar Medical Research
Ocala, Florida, United States, 34470
4
Forcare Clinical Research Inc
Tampa, Florida, United States, 33613