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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06220604
Registration number
NCT06220604
Ethics application status
Date submitted
15/01/2024
Date registered
24/01/2024
Titles & IDs
Public title
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)
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Scientific title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
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Secondary ID [1]
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77242113PSO3004
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Secondary ID [2]
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77242113PSO3004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis
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Condition category
Condition code
Skin
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0
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-77242113
Treatment: Drugs - JNJ-77242113 Matching Placebo
Treatment: Drugs - Deucravacitinib
Treatment: Drugs - Deucravacitinib Matching Placebo
Experimental: JNJ-77242113 - Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.
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.
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 from Week 24 through Week 156.
Treatment: Drugs: JNJ-77242113
JNJ-77242113 will be administered orally.
Treatment: Drugs: JNJ-77242113 Matching Placebo
JNJ-77242113 matching placebo will be administered orally.
Treatment: Drugs: Deucravacitinib
Deucravacitinib will be administered orally.
Treatment: Drugs: Deucravacitinib Matching Placebo
Deucravacitinib matching placebo will be administered orally.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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 at Week 16
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Assessment method [1]
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Percentage of participants achieving an IGA score of 0 or 1 and \>=2 grade improvement from baseline 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).
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Timepoint [1]
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Baseline and Week 16
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Primary outcome [2]
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JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and Week 16
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Secondary outcome [1]
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JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an IGA Score of 0 at Week 16
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Assessment method [1]
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Percentage of participants achieving 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)
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Weeks 4 and 16
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Weeks 4 and 16
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Secondary outcome [3]
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JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 90 Response at Week 8
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and Week 8
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Secondary outcome [4]
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JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and Week 16
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Secondary outcome [5]
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JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 and a >=2-grade Improvement From Baseline at Week 16
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Assessment method [5]
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Percentage of participants achieving ss-IGA score of 0 or 1 and a \>=2-grade improvement from baseline at 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).
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Timepoint [5]
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Baseline and Week 16
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Secondary outcome [6]
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JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Symptom and Sign Diary (PSSD) Symptoms Score of 0 at Weeks 8 and 16
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Assessment method [6]
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Percentage of participants achieving PSSD symptoms score of 0 at Weeks 8 and 16 will be reported. The PSSD is a self-administered patient-reported outcome (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.
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Timepoint [6]
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Weeks 8 and 16
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Secondary outcome [7]
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JNJ-77242113 and Placebo Group: Percentage of Participants Achieving >=4 Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16
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Assessment method [7]
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Percentage of participants achieving \>=4 Point improvement from baseline in PSSD itch score at Weeks 4 and 16 will be reported. 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.
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Timepoint [7]
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Baseline, Weeks 4 and 16
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Secondary outcome [8]
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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
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Assessment method [8]
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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).
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Timepoint [8]
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Baseline, Weeks 16 and 24
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Secondary outcome [9]
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JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving an IGA Score of 0 at Weeks 16 and 24
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Assessment method [9]
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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).
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Timepoint [9]
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Weeks 16 and 24
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Secondary outcome [10]
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JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 75 Response at Weeks 16 and 24
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Assessment method [10]
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0
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.
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Timepoint [10]
0
0
Baseline, Weeks 16 and 24
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Secondary outcome [11]
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JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 90 Response at Weeks 16 and 24
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Assessment method [11]
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0
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.
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Timepoint [11]
0
0
Baseline, Weeks 16 and 24
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Secondary outcome [12]
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JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 100 Response at Weeks 16 and 24
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Assessment method [12]
0
0
Percentage of participants achieving PASI 100 response (\>=100% improvement in PASI) 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.
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Timepoint [12]
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0
Weeks 16 and 24
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Secondary outcome [13]
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JNJ-77242113 and Deucravacitinib Group: Percentage of Participants With PSSD Symptom Score of 0 at Week 16
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Assessment method [13]
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Percentage of participants achieving PSSD symptom score 0 at Week 16 will be reported. 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.
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Timepoint [13]
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0
Week 16
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Secondary outcome [14]
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Number of Participants with Adverse Events (AEs)
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Assessment method [14]
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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.
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Timepoint [14]
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Up to 165 weeks
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Secondary outcome [15]
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Number of Participants with Serious Adverse Events (SAEs)
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Assessment method [15]
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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.
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Timepoint [15]
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Up to 165 weeks
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Secondary outcome [16]
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Change From Baseline in Body Surface Area (BSA) at Week 16
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Assessment method [16]
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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).
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Timepoint [16]
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Baseline and Week 16
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Secondary outcome [17]
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Change from Baseline in PASI Score at Week 16
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Assessment method [17]
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Change from baseline in PASI 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.
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Timepoint [17]
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Baseline and Week 16
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Secondary outcome [18]
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Percent Improvement in PASI Score From Baseline at Week 16
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline and Week 16
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Secondary outcome [19]
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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 >=2-grade Improvement From Baseline to Week 16
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Assessment method [19]
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Percentage of participants achieving a sPGA-G Score of 0 or 1 and \>=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).
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Timepoint [19]
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0
Baseline and Week 16
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Secondary outcome [20]
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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
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Assessment method [20]
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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).
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Timepoint [20]
0
0
Baseline and Week 16
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Secondary outcome [21]
0
0
JNJ-77242113 and Placebo Group: Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16
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Assessment method [21]
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0
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.
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Timepoint [21]
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0
Baseline and Week 16
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Secondary outcome [22]
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JNJ-77242113 and Placebo Group: Percent of Participants Achieving Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16
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Assessment method [22]
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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 \[4\]).
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Timepoint [22]
0
0
Week 16
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Secondary outcome [23]
0
0
JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Symptom Score at Week 16
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Assessment method [23]
0
0
Change from baseline in PSSD symptom score at Week 16 will be reported. 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.
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Timepoint [23]
0
0
Baseline and Week 16
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Secondary outcome [24]
0
0
JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Sign Score at Week 16
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Assessment method [24]
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0
Change from baseline in PSSD sign score at Week 16 will be reported. 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.
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Timepoint [24]
0
0
Baseline and Week 16
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Secondary outcome [25]
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0
JNJ-77242113 and Placebo Group: Percentage of Participants With PSSD Sign Score of 0 at Week 16
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Assessment method [25]
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0
Percentage of participants with PSSD sign score of 0 at Week 16 will be reported. 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.
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Timepoint [25]
0
0
Week 16
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Secondary outcome [26]
0
0
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
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Assessment method [26]
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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 \[4\]).
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Timepoint [26]
0
0
Week 16
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Secondary outcome [27]
0
0
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 or 1 at Week 16
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Assessment method [27]
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0
Percentage of participants achieving DLQI total 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.
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Timepoint [27]
0
0
Week 16
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Secondary outcome [28]
0
0
JNJ-77242113 and Placebo Group: Change From Baseline in Total DLQI Score at Week 16
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Assessment method [28]
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0
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.
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Timepoint [28]
0
0
Baseline and Week 16
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Secondary outcome [29]
0
0
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
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Assessment method [29]
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0
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.
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Timepoint [29]
0
0
Baseline and Week 16
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Secondary outcome [30]
0
0
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 16 and 24
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Assessment method [30]
0
0
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.
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Timepoint [30]
0
0
Weeks 16 and 24
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Secondary outcome [31]
0
0
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PSSD Symptom Score of 0 at Week 24
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Assessment method [31]
0
0
Percentage of participants achieving PSSD symptom score of 0 at Week 24 will be reported. 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.
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Timepoint [31]
0
0
Week 24
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Secondary outcome [32]
0
0
Percentage of Participants Who Achieve PASI 75 Response After Week 24 Among PASI 75 Non-responders to Deucravacitinib at Week 24
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Assessment method [32]
0
0
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.
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Timepoint [32]
0
0
Baseline and from Week 24 through Week 156
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Secondary outcome [33]
0
0
Percentage of Participants Who Achieve PASI 90 Response After Week 24 Among PASI 90 Non-responders to Deucravacitinib at Week 24
Query!
Assessment method [33]
0
0
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.
Query!
Timepoint [33]
0
0
Baseline and from Week 24 through Week 156
Query!
Secondary outcome [34]
0
0
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
Query!
Assessment method [34]
0
0
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).
Query!
Timepoint [34]
0
0
From Week 24 through Week 156
Query!
Eligibility
Key inclusion criteria
* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
* Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
* Total psoriasis area and severity index (PASI) >=12 at screening and baseline
* Total investigator global assessment (IGA) >=3 at screening and baseline
* Candidate for phototherapy or systemic treatment for plaque psoriasis
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
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Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
* Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* 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
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113, deucravacitinib or to any of the excipients or components of the study intervention
* 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
Query!
Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
Query!
Actual
9/03/2024
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Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
20/09/2027
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Actual
Query!
Sample size
Target
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Accrual to date
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Final
731
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Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
The Skin Centre - Benowa
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Recruitment hospital [2]
0
0
Monash Medical Centre - Clayton
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Recruitment hospital [3]
0
0
Premier Specialists - Kogarah
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Recruitment hospital [4]
0
0
The Alfred Hospital - Melbourne
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Recruitment hospital [5]
0
0
ISHI dermatology - Mitcham
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Recruitment hospital [6]
0
0
Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
0
0
4217 - Benowa
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Recruitment postcode(s) [2]
0
0
3168 - Clayton
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Recruitment postcode(s) [3]
0
0
2217 - Kogarah
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Recruitment postcode(s) [4]
0
0
3004 - Melbourne
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Recruitment postcode(s) [5]
0
0
3132 - Mitcham
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Recruitment postcode(s) [6]
0
0
3050 - Parkville
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Illinois
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Kentucky
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Maryland
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Massachusetts
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Michigan
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Missouri
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Ohio
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Oklahoma
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Oregon
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Pennsylvania
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Country [15]
0
0
United States of America
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State/province [15]
0
0
South Carolina
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Texas
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Utah
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Virginia
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Country [19]
0
0
Brazil
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State/province [19]
0
0
Botucatu
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Country [20]
0
0
Brazil
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State/province [20]
0
0
Brasilia
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Country [21]
0
0
Brazil
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State/province [21]
0
0
Ribeirao Preto
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Country [22]
0
0
Brazil
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State/province [22]
0
0
Santo Andre
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Country [23]
0
0
Brazil
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State/province [23]
0
0
Sao Jose do Rio Preto
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Country [24]
0
0
Brazil
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State/province [24]
0
0
Sao Paulo
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Country [25]
0
0
Canada
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State/province [25]
0
0
British Columbia
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Country [26]
0
0
Canada
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State/province [26]
0
0
Manitoba
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Country [27]
0
0
Canada
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State/province [27]
0
0
Ontario
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Country [28]
0
0
Canada
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State/province [28]
0
0
Quebec
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Country [29]
0
0
Germany
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State/province [29]
0
0
Augsburg
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Country [30]
0
0
Germany
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State/province [30]
0
0
Bad Bentheim
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Country [31]
0
0
Germany
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State/province [31]
0
0
Berlin
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Country [32]
0
0
Germany
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State/province [32]
0
0
Bochum
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Country [33]
0
0
Germany
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State/province [33]
0
0
Darmstadt
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Country [34]
0
0
Germany
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State/province [34]
0
0
Dresden
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Country [35]
0
0
Germany
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State/province [35]
0
0
Dulmen
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Country [36]
0
0
Germany
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State/province [36]
0
0
Dusseldorf
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Country [37]
0
0
Germany
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State/province [37]
0
0
Friedrichshafen
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Country [38]
0
0
Germany
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State/province [38]
0
0
Hamburg
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Country [39]
0
0
Germany
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State/province [39]
0
0
Heidelberg
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Country [40]
0
0
Germany
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State/province [40]
0
0
Mahlow
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Country [41]
0
0
Germany
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State/province [41]
0
0
Mainz
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Country [42]
0
0
Germany
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State/province [42]
0
0
Merzig
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Country [43]
0
0
Germany
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State/province [43]
0
0
Muenster
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Country [44]
0
0
Germany
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State/province [44]
0
0
Oldenburg
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Country [45]
0
0
Germany
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State/province [45]
0
0
Witten
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Country [46]
0
0
Germany
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State/province [46]
0
0
Wuppertal
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Country [47]
0
0
Hungary
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State/province [47]
0
0
Budapest
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Country [48]
0
0
Hungary
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State/province [48]
0
0
Gyongyos
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Country [49]
0
0
Hungary
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State/province [49]
0
0
Gyula
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Country [50]
0
0
Hungary
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State/province [50]
0
0
Kecskemet
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Country [51]
0
0
Hungary
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State/province [51]
0
0
Zalaegerszeg
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Country [52]
0
0
Korea, Republic of
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State/province [52]
0
0
Ansan-si
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Country [53]
0
0
Korea, Republic of
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State/province [53]
0
0
Anyang-si
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Country [54]
0
0
Korea, Republic of
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State/province [54]
0
0
Bucheon si
Query!
Country [55]
0
0
Korea, Republic of
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State/province [55]
0
0
Gwangju
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Country [56]
0
0
Korea, Republic of
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State/province [56]
0
0
Seongnam
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Country [57]
0
0
Korea, Republic of
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State/province [57]
0
0
Seoul
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Country [58]
0
0
Poland
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State/province [58]
0
0
Bialystok
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Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Katowice
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Country [60]
0
0
Poland
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State/province [60]
0
0
Kielce
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Country [61]
0
0
Poland
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State/province [61]
0
0
Krakow
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Country [62]
0
0
Poland
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State/province [62]
0
0
Olsztyn
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Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Warsaw
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Warszawa
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Wroclaw
Query!
Country [66]
0
0
Romania
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State/province [66]
0
0
Cluj-Napoca
Query!
Country [67]
0
0
Romania
Query!
State/province [67]
0
0
Craiova
Query!
Country [68]
0
0
Romania
Query!
State/province [68]
0
0
Iasi
Query!
Country [69]
0
0
Romania
Query!
State/province [69]
0
0
Oradea
Query!
Country [70]
0
0
Romania
Query!
State/province [70]
0
0
Targu Mures
Query!
Country [71]
0
0
Romania
Query!
State/province [71]
0
0
Timisoara
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Alcorcon
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Badalona
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Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Barcelona
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Manises
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Salamanca
Query!
Country [77]
0
0
Spain
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State/province [77]
0
0
Santiago de Compostela
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Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Sevilla
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Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Villajoyosa
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Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Zaragoza
Query!
Country [81]
0
0
Taiwan
Query!
State/province [81]
0
0
Kaohsiung
Query!
Country [82]
0
0
Taiwan
Query!
State/province [82]
0
0
Taichung
Query!
Country [83]
0
0
Taiwan
Query!
State/province [83]
0
0
Tainan
Query!
Country [84]
0
0
Taiwan
Query!
State/province [84]
0
0
Taipei
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
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Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of the study is to evaluate how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06220604
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinicaltrial
Query!
Address
0
0
Janssen Research & Development, LLC
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Study Contact
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-434-4210
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Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06220604