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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06143878
Registration number
NCT06143878
Ethics application status
Date submitted
14/11/2023
Date registered
22/11/2023
Date last updated
22/05/2024
Titles & IDs
Public title
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
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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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77242113PSO3002
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Secondary ID [2]
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77242113PSO3002
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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:
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 to Week 16
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Assessment method [1]
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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).
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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 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).
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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 From Baseline to 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, Week 4, and Week 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 >=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 >=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).
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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 Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16
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Assessment method [6]
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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.
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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 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.
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Timepoint [7]
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Baseline, Week 4, and Week 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, Week 16, and Week 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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0
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, Week 16 and Week 24
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Secondary outcome [11]
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0
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 90 Response at Weeks 16 and 24
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Assessment method [11]
0
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, Week 16, and Week 24
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Secondary outcome [12]
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0
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 100 Response at Weeks 16 and 24
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Assessment method [12]
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0
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.
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Timepoint [12]
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0
Baseline, Week 16, and Week 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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0
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.
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Timepoint [13]
0
0
Week 16
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Secondary outcome [14]
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0
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 Total Score at Week 16
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Assessment method [17]
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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.
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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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0
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]
0
0
Baseline and Week 16
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Secondary outcome [19]
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0
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
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Assessment method [19]
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0
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).
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Timepoint [19]
0
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]
0
0
Baseline and Week 16
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Secondary outcome [22]
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0
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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0
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 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.
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Timepoint [23]
0
0
Baseline and Week 16
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Secondary outcome [24]
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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 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.
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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]
0
0
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.
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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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0
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) 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 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]
0
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]
0
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 Weeks 16 and 24
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Assessment method [31]
0
0
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.
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Timepoint [31]
0
0
Weeks 16 and 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
Query!
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.
Query!
Timepoint [32]
0
0
Baseline and from Week 24 through Week 156
Query!
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
Query!
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
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/01/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/06/2027
Query!
Actual
Query!
Sample size
Target
750
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
North Eastern Health Specialists - Campbelltown
Query!
Recruitment hospital [2]
0
0
Paratus Clinical Research Woden - Canberra
Query!
Recruitment hospital [3]
0
0
Sinclair Dermatology - East Melbourne
Query!
Recruitment hospital [4]
0
0
Skin Health Institute Inc. - Melbourne
Query!
Recruitment hospital [5]
0
0
Veracity Clinical Research - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
5074 - Campbelltown
Query!
Recruitment postcode(s) [2]
0
0
2606 - Canberra
Query!
Recruitment postcode(s) [3]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [4]
0
0
3053 - Melbourne
Query!
Recruitment postcode(s) [5]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Michigan
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Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Missouri
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Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nevada
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Hampshire
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Jersey
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Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
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Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Ohio
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oklahoma
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oregon
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
South Dakota
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Virginia
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Washington
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Buenos Aires
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Caba
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
La Plata
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Rosario
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
San Miguel De Tucuman
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Santo Andre
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
British Columbia
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Newfoundland and Labrador
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Ontario
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Berlin
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Bramsche
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Dresden
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Duesseldorf
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Hamburg
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Kiel
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Langenau
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Leipzig
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Lubeck
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Mannheim
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Munchen
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Potsdam
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Rostock
Query!
Country [48]
0
0
Hungary
Query!
State/province [48]
0
0
Borgyogyaszati Klinika
Query!
Country [49]
0
0
Hungary
Query!
State/province [49]
0
0
Budapest
Query!
Country [50]
0
0
Hungary
Query!
State/province [50]
0
0
Debrecen
Query!
Country [51]
0
0
Hungary
Query!
State/province [51]
0
0
Kaposvar
Query!
Country [52]
0
0
Hungary
Query!
State/province [52]
0
0
Szeged
Query!
Country [53]
0
0
Hungary
Query!
State/province [53]
0
0
Szolnok
Query!
Country [54]
0
0
Hungary
Query!
State/province [54]
0
0
Veszprem
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Fukuoka
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Fukutsu
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Gifu
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Gunma
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Hokkaido
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Isehara
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Itabashi Ku
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Kawasaki City
Query!
Country [63]
0
0
Japan
Query!
State/province [63]
0
0
Kitakyushu-shi
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Nagoya
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Nishihara
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Obihiro-shi
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Osaka Sayama shi
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Osaka
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Sakai-shi
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Sapporo shi
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Sendai
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Suita-shi
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Tachikawa
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Takaoka-shi
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Tokyo
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Tsu
Query!
Country [77]
0
0
Korea, Republic of
Query!
State/province [77]
0
0
Busan
Query!
Country [78]
0
0
Korea, Republic of
Query!
State/province [78]
0
0
Gyeonggi-do
Query!
Country [79]
0
0
Korea, Republic of
Query!
State/province [79]
0
0
Seoul
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Bialystok
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Elblag
Query!
Country [82]
0
0
Poland
Query!
State/province [82]
0
0
Krakow
Query!
Country [83]
0
0
Poland
Query!
State/province [83]
0
0
Lodz
Query!
Country [84]
0
0
Poland
Query!
State/province [84]
0
0
Osielsko
Query!
Country [85]
0
0
Poland
Query!
State/province [85]
0
0
Poznan
Query!
Country [86]
0
0
Poland
Query!
State/province [86]
0
0
Warszawa
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Wroclaw
Query!
Country [88]
0
0
Spain
Query!
State/province [88]
0
0
Alicante
Query!
Country [89]
0
0
Spain
Query!
State/province [89]
0
0
Barakaldo
Query!
Country [90]
0
0
Spain
Query!
State/province [90]
0
0
Barcelona
Query!
Country [91]
0
0
Spain
Query!
State/province [91]
0
0
Granada
Query!
Country [92]
0
0
Spain
Query!
State/province [92]
0
0
L'Hospitalet de Llobregat
Query!
Country [93]
0
0
Spain
Query!
State/province [93]
0
0
Madrid
Query!
Country [94]
0
0
Spain
Query!
State/province [94]
0
0
Valencia
Query!
Country [95]
0
0
Taiwan
Query!
State/province [95]
0
0
Hsin Chu
Query!
Country [96]
0
0
Taiwan
Query!
State/province [96]
0
0
Kaohsiung City
Query!
Country [97]
0
0
Taiwan
Query!
State/province [97]
0
0
New Taipei City
Query!
Country [98]
0
0
Taiwan
Query!
State/province [98]
0
0
Taipei
Query!
Country [99]
0
0
Taiwan
Query!
State/province [99]
0
0
Taoyuan
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
London
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
Reading
Query!
Country [102]
0
0
United Kingdom
Query!
State/province [102]
0
0
Salford
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Country [103]
0
0
United Kingdom
Query!
State/province [103]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT06143878
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
Query!
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
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
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/ct2/show/NCT06143878
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