Status:
COMPLETED
A Long-term Extension 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
The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment 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
- Must have completed the Week 16 visit in Protocol 77242113PSO2001
- In the opinion of the investigator, may benefit from inclusion in this long term extension (LTE) study
- Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study
- Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or investigator's global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention
- Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention
Exclusion
- Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason
- Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001
- Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention
- Has received the bacille Calmette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention
- Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT05364554
Start Date
June 10 2022
End Date
September 29 2023
Last Update
September 12 2025
Active Locations (60)
Enter a location and click search to find clinical trials sorted by distance.
1
Pacific Skin Institute
Sacramento, California, United States, 95815
2
Renstar Medical Research
Ocala, Florida, United States, 34470
3
Forcare Clinical Research Inc
Tampa, Florida, United States, 33613
4
Arlington Dermatology
Rolling Meadows, Illinois, United States, 60008