A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Study Details
Study Description
Brief Summary
The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JNJ-77242113 Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24. |
Drug: JNJ-77242113
JNJ-77242113 will be administered orally.
Drug: JNJ-77242113 Matching Placebo
JNJ-77242113 matching placebo will be administered orally.
|
| Placebo Comparator: Placebo Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156. |
Drug: JNJ-77242113
JNJ-77242113 will be administered orally.
Drug: JNJ-77242113 Matching Placebo
JNJ-77242113 matching placebo will be administered orally.
Drug: Deucravacitinib Matching Placebo
Deucravacitinib matching placebo will be administered orally.
|
| Active Comparator: Deucravacitinib Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 through Week 156. |
Drug: JNJ-77242113
JNJ-77242113 will be administered orally.
Drug: Deucravacitinib
Deucravacitinib will be administered orally.
Drug: Deucravacitinib Matching Placebo
Deucravacitinib matching placebo will be administered orally.
|
Outcome Measures
Primary Outcome Measures
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline to Week 16 [Baseline and Week 16]
Percentage of participants who achieve an IGA score of 0 or 1 and >=2-Grade improvement from baseline to Week 16 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).
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 [Baseline and Week 16]
Percentage of participants achieving PASI 90 response (>=90% improvement in PASI from baseline) at Week 16 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 Outcome Measures
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an IGA Score of 0 at Week 16 [Week 16]
Percentage of participants who achieve an IGA score of 0 at Week 16 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).
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to Weeks 4 and 16 [Baseline, Week 4, and Week 16]
Percentage of participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Weeks 4 and 16 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.
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 90 Response at Week 8 [Baseline and Week 8]
Percentage of participants achieving PASI 90 response (>=90% improvement in PASI from baseline) at Week 8 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.
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16 [Baseline and Week 16]
Percentage of participants achieving PASI 100 response (100% improvement in PASI from baseline) at Week 16 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.
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 and >=2 Grade Improvement From Baseline at Week 16 [Baseline and Week 16]
Percentage of participants achieving ss-IGA score of 0 or 1 and >=2 grade improvement from baseline to Week 16 will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 [Weeks 8 and 16]
Percentage of participants achieving PSSD symptom score of 0 at Weeks 8 and 16 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.
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving >=4 Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16 [Baseline, Week 4, and Week 16]
Percentage of participants achieving >=4 Point improvement from baseline in PSSD itch score at Weeks 4 and 16 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.
- JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16 and 24 [Baseline, Week 16, and Week 24]
Percentage of participants who achieve an IGA score of 0 or 1 and >=2 grade improvement from baseline at Weeks 16 and 24 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).
- JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving an IGA Score of 0 at Weeks 16 and 24 [Weeks 16 and 24]
Percentage of participants who achieve an IGA score of 0 at Weeks 16 and 24 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).
- JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 75 Response at Weeks 16 and 24 [Baseline, Week 16 and Week 24]
Percentage of participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Weeks 16 and 24 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.
- JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 90 Response at Weeks 16 and 24 [Baseline, Week 16, and Week 24]
Percentage of participants achieving PASI 90 response (>=90% improvement in PASI from baseline) at Weeks 16 and 24 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.
- JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 100 Response at Weeks 16 and 24 [Baseline, Week 16, and Week 24]
Percentage of participants achieving PASI 100 response (100% improvement in PASI from baseline) at Weeks 16 and 24 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.
- JNJ-77242113 and Deucravacitinib Group: Percentage of Participants With PSSD Symptom Score of 0 at Week 16 [Week 16]
Percentage of participants achieving PSSD symptom score 0 at Week 16 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.
- Number of Participants with Adverse Events (AEs) [Up to 165 weeks]
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
- Number of Participants with Serious Adverse Events (SAEs) [Up to 165 weeks]
SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.
- Change From Baseline in Body Surface Area (BSA) at Week 16 [Baseline and Week 16]
Change from baseline in BSA at Week 16 will be reported. BSA is a commonly used measure of extent of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed (that is, plaque psoriasis).
- Change from Baseline in PASI Total Score at Week 16 [Baseline and Week 16]
Change from baseline in PASI total score at Week 16 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 are 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.
- Percent Improvement in PASI Score From Baseline at Week 16 [Baseline and Week 16]
Percent improvement in PASI score from Baseline at Week 16 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.
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline to Week 16 [Baseline and Week 16]
Percentage of participants achieving a sPGA-G Score of 0 or 1 and at least a 2-grade improvement from baseline to Week 16 will be reported. The sPGA-G is a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving a Physician's Global Assessment of Hands and Feet (hf-PGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline to Week 16 [Baseline and Week 16]
Percentage of participants achieving a hf-PGA score of 0 or 1 and at least a 2-grade improvement from baseline to Week 16 will be reported. The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet as: clear (0), almost clear (1), mild (2), moderate (3), and severe (4).
- JNJ-77242113 and Placebo Group: Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 [Baseline and Week 16]
Percent change from baseline in mNAPSI score at Week 16 will be reported. The mNAPSI is an index used for assessing and grading the severity of nail psoriasis. Each of the participant's 10 fingernails are evaluated for 7 features. The first 3 features are each scored from 0 to 3 in severity and are (1) onycholysis and oil-drop dyschromia, (2) pitting, and (3) nail plate crumbling. The next 4 features are scored 0 - absent or 1 - present and are (1) leukonychia, (2) splinter hemorrhages, (3) nail bed hyperkeratosis, and (4) red spots in the lunula. The score ranges from 0 to 13 per nail and 0 to 130 for all fingernails.
- JNJ-77242113 and Placebo Group: Percent of Participants Achieving Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 [Week 16]
Percent of participants achieving f-PGA score of 0 or 1 at Week 16 will be reported. The f-PGA is used to evaluate the current status of a participant's fingernail psoriasis on a scale of 0 to 4 (clear [0], minimal [1], mild [2], moderate [3], or severe [4]).
- JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Symptom Score at Week 16 [Baseline and Week 16]
Change from baseline in PSSD symptom score at Week 16 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.
- JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Sign Score at Week 16 [Baseline and Week 16]
Change from baseline in PSSD sign score at Week 16 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.
- JNJ-77242113 and Placebo Group: Percentage of Participants With PSSD Sign Score of 0 at Week 16 [Week 16]
Percentage of participants with PSSD sign score of 0 at Week 16 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.
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 [Week 16]
Percentage of participants achieving GenPs-SFQ Item 2 score of 0 or 1 at Week 16 will be reported. The GenPs-SFQ is a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days. Item 1 assesses overall frequency of sexual activity in the last 7 days (none/zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (never [0], rarely [1], sometimes [2], often [3], or always [4]).
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 [Week 16]
Percentage of participants achieving DLQI score of 0 or 1 at Week 16 will be reported. The DLQI is a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.
- JNJ-77242113 and Placebo Group: Change From Baseline in Total DLQI Score at Week 16 [Baseline and Week 16]
Change from baseline in total DLQI score at Week 16 will be reported. The DLQI is a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.
- JNJ-77242113 and Placebo Group: Change from Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16 [Baseline and Week 16]
Change from baseline in domain scores of the PROMIS-29 score at Week 16 will be reported. The PROMIS-29 is a 29-item generic HRQoL survey, assessing each of the 7 PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities) with 4 questions for each domain. The questions are ranked on a 5-point Likert scale. There is also a numerical rating scale that ranges from 0 (No pain) to 10 (Worst pain imaginable) for pain intensity. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores on anxiety, depression, fatigue, sleep disturbance, and pain interference indicate more severe symptoms. Higher scores on physical function and social participation indicate better health outcomes.
- JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 16 and 24 [Weeks 16 and 24]
Percentage of participants achieving DLQI score of 0 or 1 at Weeks 16 and 24 will be reported. The DLQI is a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.
- JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PSSD Symptom Score of 0 at Weeks 16 and 24 [Weeks 16 and 24]
Percentage of participants achieving PSSD symptom score of 0 at Weeks 16 and 24 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.
- Percentage of Participants Who Achieve PASI 75 Response After Week 24 Among PASI 75 Non-responders to Deucravacitinib at Week 24 [Baseline and from Week 24 through Week 156]
Percentage of participants who achieve PASI 75 response (>=75% improvement in PASI) after Week 24 among PASI 75 Non-responders to deucravacitinib at Week 24 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.
- Percentage of Participants Who Achieve PASI 90 Response After Week 24 Among PASI 90 Non-responders to Deucravacitinib at Week 24 [Baseline and from Week 24 through Week 156]
Percentage of participants who achieve PASI 90 response (>=90% improvement in PASI) after Week 24 among PASI 90 non-responders to deucravacitinib at Week 24 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.
- Percentage of Participants Achieving IGA Score of 0 or 1 after Week 24, Among Participants with IGA score >=2 at Week 24 in the Deucravacitinib Group [From Week 24 through Week 156]
Percentage of participants achieving IGA score of 0 or 1 after Week 24, among participants with IGA score >=2 at Week 24 in the deucravacitinib group 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
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Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
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Total psoriasis area and severity index (PASI) >=12 at screening and baseline
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Total investigator global assessment (IGA) >=3 at screening and baseline
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Candidate for phototherapy or systemic treatment for plaque psoriasis
Exclusion Criteria:
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Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
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Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
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A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
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Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
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Major surgical procedure, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 77242113PSO3002
- 77242113PSO3002