A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis

Study Purpose

The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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 Criteria:

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05364554
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Janssen Research & Development, LLC
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation	Janssen Research & Development, LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, France, Germany, Japan, Korea, Republic of, Poland, Spain, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Plaque Psoriasis

Additional Details

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, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. This is a long-term extension study of JNJ-77242113 in eligible participants who have completed the Week 16 visit of the originating Study 77242113PSO2001. The total duration of this study will be up to 40 weeks which will include a 36-week treatment period, and a 4-week safety follow-up period after the last study intervention administration. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.

Arms & Interventions

Arms

Experimental: Group 1: JNJ-77242113 Dose 1 Once Daily (QD)

Participants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study.

Experimental: Group 2: JNJ-77242113 Dose 2 QD

Participants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study.

Experimental: Group 3: JNJ-77242113 Dose 3 QD

Participants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.

Experimental: Group 4: JNJ-77242113 Dose 1 Twice Daily (BID)

Participants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study.

Experimental: Group 5: JNJ-77242113 Dose 3 BID

Participants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study.

Experimental: Group 6: JNJ-77242113 Dose 3 QD

Participants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.

Interventions

Drug: - JNJ-77242113

JNJ-77242113 tablet will be administered orally.

Contact a Trial Team

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Pacific Skin Institute, Sacramento, California

Status

Recruiting

Address

Pacific Skin Institute

Sacramento, California, 95815

Site Contact

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