A Phase 2b Multicenter, Long-Term Extension, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 227
- Locations
- 119
- Primary Endpoint
- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 36
Study Overview
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, 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: JNJ-77242113 (Drug)
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.
Intervention: JNJ-77242113 (Drug)
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.
Intervention: JNJ-77242113 (Drug)
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.
Intervention: JNJ-77242113 (Drug)
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.
Intervention: JNJ-77242113 (Drug)
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.
Intervention: JNJ-77242113 (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 36
Time Frame: Week 36
Percentage of participants achieving PASI 75 score (greater than or equal to \[\>=\] 75 percent \[%\] improvement in PASI from baseline of the originating study \[77242113PSO2001\]) at Week 36 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
Secondary Outcomes
- Change From Baseline in PASI Total Score at Week 36(Baseline and Week 36)
- Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 36(Week 36)
- Percentage of Participants Achieving PASI 100 Score at Week 36(Week 36)
- Change from Baseline in PSSD Signs Score at Week 36(Baseline and Week 36)
- Number of Participants with Serious Adverse Events (SAEs)(Up to Week 40)
- Percentage of Participants Achieving PASI 90 Score at Week 36(Week 36)
- Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Signs Score >=1(Week 36)
- Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 36(Baseline and Week 36)
- Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Symptoms Score >=1(Week 36)
- Number of Participants with Adverse Events (AEs)(Up to Week 40)