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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: JNJ-77242113


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: JNJ-77242113 Dose 1 Once Daily (QD)<br>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. | Drug: JNJ-77242113<br>* JNJ-77242113 tablet will be administered orally.<br>|
| Experimental: Group 2: JNJ-77242113 Dose 2 QD<br>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. | Drug: JNJ-77242113<br>* JNJ-77242113 tablet will be administered orally.<br>|
| Experimental: Group 3: JNJ-77242113 Dose 3 QD<br>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. | Drug: JNJ-77242113<br>* JNJ-77242113 tablet will be administered orally.<br>|
| Experimental: Group 4: JNJ-77242113 Dose 1 Twice Daily (BID)<br>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. | Drug: JNJ-77242113<br>* JNJ-77242113 tablet will be administered orally.<br>|
| Experimental: Group 5: JNJ-77242113 Dose 3 BID<br>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. | Drug: JNJ-77242113<br>* JNJ-77242113 tablet will be administered orally.<br>|
| Experimental: Group 6: JNJ-77242113 Dose 3 QD<br>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. | Drug: JNJ-77242113<br>* JNJ-77242113 tablet will be administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at 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. | Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving PASI 90 Score at Week 36 | Percentage of participants achieving PASI 90 score (>=90% 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. | Week 36 | 
| Percentage of Participants Achieving PASI 100 Score at Week 36 | Percentage of participants achieving PASI 100 score (>=100% 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. | Week 36 | 
| Change From Baseline in PASI Total Score at Week 36 | Change from baseline of the originating study (77242113PSO2001) in PASI total score 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. | Baseline and Week 36 | 
| Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 36 | Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) at Week 36 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Week 36 | 
| Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 36 | Change from baseline of originating Study (77242113PSO2001) in PSSD symptoms scores at Week 36 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. | Baseline and Week 36 | 
| Change from Baseline in PSSD Signs Score at Week 36 | Change from baseline of originating study (77242113PSO2001) in PSSD signs score at Week 36 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. | 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 | Percentage of participants achieving PSSD symptoms score=0 at Week 36 among participants with a baseline (in the originating study 77242113PSO2001) symptoms score >=1 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. | 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 | Percentage of participants achieving PSSD signs score=0 at week 36 among participants with a baseline (in the originating study) signs score >=1 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. | Week 36 | 
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. | Up to Week 40 | 
| Number of Participants with Serious Adverse Events (SAEs) | SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | Up to Week 40 |