A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified June 2026 by Janssen Research & Development, LLC
Sponsor
Janssen Research & Development, LLC
Information Provided by (Responsible Party)
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
NCT06143878
Other Study ID Numbers:
77242113PSO3002
First Submitted
November 13, 2023
First Posted
November 21, 2023
Results First Posted
April 14, 2026
Last Update Posted
July 6, 2026
Last Verified
June 2026

ClinicalTrials.gov processed this data on July 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Plaque Psoriasis
Drug: JNJ-77242113Drug: JNJ-77242113Drug: JNJ-77242113

Study Design

Study TypeInterventional
Actual Enrollment774 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA 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
Study Start DateJanuary 31, 2024
Actual Primary Completion DateSeptember 16, 2024
Actual Study Completion Date10mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
JNJ-77242113
Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.
Drug: JNJ-77242113
JNJ-77242113 will be administered orally.
Placebo
Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.
Drug: JNJ-77242113
JNJ-77242113 will be administered orally.
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.
Drug: JNJ-77242113
JNJ-77242113 will be administered orally.

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16
    IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema, scaling, each using 5 point scale. Induration:0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25 millimeters(mm); 2=mild plaque elevation,=0.5 mm; 3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation,\>1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe(4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.
  2. Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
    Percentage of participants who achieved PASI-90 score (\>=90% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Secondary Outcome Measures
  1. Percentage of Participants Who Achieved IGA Score of 0 at Week 16
    The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
  2. Percentage of Participants Who Achieved PASI 75 at Weeks 4 and 16
    Percentage of participants who achieved PASI-75 score (\>=75% improvement from baseline in PASI) at Weeks 4 and 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  3. Percentage of Participants Who Achieved PASI 90 at Week 8
    Percentage of participants who achieved PASI-90 score (\>=90% improvement from baseline in PASI) at Week 8 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  4. Percentage of Participants Who Achieved PASI 100 at Week 16
    Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  5. Percentage of Participants Who Achieved a Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2
    The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  6. Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0
    PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (\>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  7. Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16 Among Participants With a Baseline PSSD Itch Score >=4
    PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.
  8. Percentage of Participants Who Achieved an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Weeks 16 and 24
    IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation, =0.25 mm; 2=mild plaque elevation, =0.5 mm; 3=moderate plaque elevation, =0.75 mm; 4=severe plaque elevation, \>1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over \<5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.
  9. Percentage of Participants Who Achieved an IGA Score of 0 at Weeks 16 and 24
    The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
  10. Percentage of Participants Who Achieved PASI 75 at Weeks 16 and 24
    Percentage of participants who achieved PASI-75 score (\>=75% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  11. Percentage of Participants Who Achieved PASI 90 at Weeks 16 and 24
    Percentage of participants who achieved PASI-90 score (\>=90% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  12. Percentage of Participants Who Achieved PASI 100 at Weeks 16 and 24
    Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  13. Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With a Baseline Symptom Score >0
    PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (\>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date
  14. Change From Baseline in Body Surface Area (BSA) at Week 16
    A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  15. Change From Baseline in PASI Total Score at Week 16
    Change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  16. Percent Change From Baseline in PASI Total Score at Week 16
    Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  17. Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-grade Improvement at Week 16 Among Participants With a Baseline sPGA-G Score >=2
    The sPGA-G was 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 was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Higher score indicates more severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  18. Percentage of Participants Who Achieved Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and a >=2-grade Improvement at Week 16 Among Participants With a Baseline Hf-PGA Score >=2
    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. hf-PFA was categorized from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher score indicates more severity. Meeting the hf-PGA 0 or 1 criteria defined as having an hf-PGA score of clear (0) or almost clear (1) and a \>=2-grade improvement from baseline. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  19. Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With a Baseline mNAPSI Score >0
    Percent change from baseline in mNAPSI score at week 16 was reported. The mNAPSI was an index used for assessing and grading the severity of nail psoriasis. Each of the participant's ten fingernails were evaluated on 7 features. The first three features were each scored from 0 to 3 in severity and were 1 = onycholysis and oil-drop dyschromia, 2 = pitting, and 3 = nail plate crumbling. Next four features was each scored 0 absent or 1 present, and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in lunula. Each fingernail was rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). Total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). Higher the score the more severe the nail bed psoriasis. Baseline = closest measurement taken prior to or at the time of the first study drug administration date.
  20. Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With Baseline f-PGA Score >=2
    Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  21. Change From Baseline in PSSD Symptom Score at Week 16
    Change from baseline in PSSD symptoms score at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (\>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date
  22. Change From Baseline in PSSD Sign Score at Week 16
    Change from baseline in PSSD sign score at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (\>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  23. Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0
    PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (\>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  24. Percentage of Participants Who Achieved Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With a Baseline GenPS-SFQ Item 2 Score >=2 and With a Baseline sPGA-G Score >=3
    The GenPs-SFQ was 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 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, or 4 = always). Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  25. Percentage of Participants Who Achieved Dermatological Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1
    The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could 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. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  26. Change From Baseline in Total DLQI Score at Week 16
    Change from baseline in total DLQI score at Week 16 was reported. The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could 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. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  27. Change From Baseline in Domain Scores of the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
    PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T-score=more of concept being measured i.e. higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date.
  28. Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1
    The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could 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. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
  29. Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 24 Among Participants With Baseline Symptom Score >0
    PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (\>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date
  30. Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24
  31. Percentage of Participants Who Achieved PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24
  32. Percentage of Participants Who Achieved IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24
  33. Number of Participants With Adverse Events (AEs)
  34. Number of Participants With Serious Adverse Events (SAEs)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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
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

Contacts and Locations

Sponsors and CollaboratorsJanssen Research & Development, LLC
Locations
Medical Dermatology Specialists | Phoenix Arizona, United States, 85006Center for Dermatology and Plastic Surgery | Scottsdale Arizona, United States, 85260Johnson Dermatology | Fort Smith Arkansas, United States, 72916First OC Dermatology | Fountain Valley California, United States, 92708Center for Dermatology Clinical Research | Fremont California, United States, 94538Integrative Skin Science and Research | Sacramento California, United States, 95815Southern California Dermatology | Santa Ana California, United States, 92701Clinical Science Institute | Santa Monica California, United States, 90403Driven Research LLC | Miami Florida, United States, 33126Ziaderm Research LLC | North Miami Beach Florida, United States, 33162Renstar Medical Research | Ocala Florida, United States, 34470Forcare Clinical Research Inc | Tampa Florida, United States, 33613Hamilton Research LLC | Alpharetta Georgia, United States, 30022Skin Care Physicians of Georgia | Macon Georgia, United States, 31217DeNova Research | Chicago Illinois, United States, 60602Arlington Dermatology | Rolling Meadows Illinois, United States, 60008Endeavor Health | Skokie Illinois, United States, 60077Dundee Dermatology | West Dundee Illinois, United States, 60118Dawes Fretzin Clinical Research Group LLC | Indianapolis Indiana, United States, 46250Indiana Clinical Trial Center | Plainfield Indiana, United States, 46168Dermatology Specialists | Louisville Kentucky, United States, 40241Dermatology and Advanced Aesthetics | Lake Charles Louisiana, United States, 70605Tufts Medical Center | Boston Massachusetts, United States, 02111David Fivenson MD, Dermatology | Ann Arbor Michigan, United States, 48103Michigan Center of Medical Research | Clarkston Michigan, United States, 48346Henry Ford Medical Center | Detroit Michigan, United States, 48202Hamzavi Dermatology | Fort Gratiot Michigan, United States, 48059MediSearch Clinical Trials | Saint Joseph Missouri, United States, 64506Skin Specialists | Omaha Nebraska, United States, 68144Fife Dermatology | Las Vegas Nevada, United States, 89119StracSkin | Portsmouth New Hampshire, United States, 03801Schweiger Dermatology Group | East Windsor New Jersey, United States, 08520Schweiger Dermatology Group 1 | Hackensack New Jersey, United States, 07601Derm Research Center of New York, Inc. | Stony Brook New York, United States, 11790Wilmington Dermatology Center | Wilmington North Carolina, United States, 28405Oakview Dermatology | Athens Ohio, United States, 45701Optima Research | Boardman Ohio, United States, 44512Central Sooner Research | Oklahoma City Oklahoma, United States, 73170Oregon Medical Research Center | Portland Oregon, United States, 97201Health Concepts | Rapid City South Dakota, United States, 57702Modern Research Associates | Dallas Texas, United States, 75231Center for Clinical Studies 1 | Houston Texas, United States, 77004Austin Institute for Clinical Research 1 | Houston Texas, United States, 77056Austin Institute for Clinical Research | Pflugerville Texas, United States, 78660Progressive Clinical Research | San Antonio Texas, United States, 78213Texas Dermatology and Laser Specialists | San Antonio Texas, United States, 78218Center for Clinical Studies | Webster Texas, United States, 77598National Clinical Research | Richmond Virginia, United States, 23294Frontier Derm Partners CRO, LLC | Mill Creek Washington, United States, 98012Premier Clinical Research | Spokane Washington, United States, 99202Instituto Medico De Alta Complejidad (IMAC) | Buenos Aires , Argentina, B1643CROARCIS Salud SRL Aprillus asistencia e investigacion | Buenos Aires , Argentina, C1406AGAHalitus Instituto Medico S.A. - Dermatologia y Estetica | Caba , Argentina, C1122AAFHospital Italiano de Buenos Aires | Caba , Argentina, C1199ABDInstituto de Neumonologia y Dermatologia | CABA , Argentina, C1425BEAHospital Italiano de La Plata | La Plata , Argentina, B1900AXIInstituto Caici Srl. | Rosario , Argentina, S2000PBJCentro de Investigaciones Medicas Tucuman | San Miguel de Tucumán , Argentina, T4000AXLNorth Eastern Health Specialists | Campbelltown , Australia, 5074Paratus Clinical Research Woden | Canberra , Australia, 2606Sinclair Dermatology | East Melbourne , Australia, 3002Skin Health Institute Inc. | Melbourne , Australia, 3053Veracity Clinical Research | Woolloongabba , Australia, 4102Fundacao do ABC Centro Universitario FMABC | Santo André , Brazil, 09060-870Enverus Medical | Surrey British Columbia, Canada, V3V 0C6Karma Clinical Trials Inc. | St. John's Newfoundland and Labrador, Canada, A1A 4Y3CCA Medical Research Corporation | Ajax Ontario, Canada, L1S7K8SimcoDerm Medical and Surgical Dermatology Centre | Barrie Ontario, Canada, L4M 7G1Dermatrials Research | Hamilton Ontario, Canada, L8N 1Y2York Dermatology Clinic and Research Centre | Richmond Hill Ontario, Canada, L4B1L1Alliance Clinical Trials | Waterloo Ontario, Canada, N2J 1C4XLR8 Medical Research | Windsor Ontario, Canada, N8T 1E6ISA - Interdisciplinary Study Association GmbH | Berlin , Germany, 10789Hautarztpraxis 3 | Bramsche , Germany, 49565Klinische Forschung Dresden GmbH | Dresden , Germany, 01069Praxis füer Dermatologie und Venerologie | Dresden , Germany, 01097Universitaetsklinikum Duesseldorf | Düsseldorf , Germany, 40225Universitaetsklinikum Hamburg Eppendorf | Hamburg , Germany, 20246MensingDerma research GmbH | Hamburg , Germany, 22391Universitaetsklinikum Schleswig Holstein Campus Kiel | Kiel , Germany, 24105Studienzentrum Dr Schwarz Germany | Langenau , Germany, 89129Universitatsklinikum Leipzig AOR | Leipzig , Germany, 04103Universitatsklinikum Schleswig Holstein Campus Lubeck | Lübeck , Germany, 23562Universitaetsklinikum Mannheim | Mannheim , Germany, 68167Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein | München , Germany, 80802Hautarztpraxis 1 | Potsdam , Germany, 14467Universitaetsmedizin Rostock | Rostock , Germany, 18057Pecsi Tudomanyegyetem | Borgyogyaszati Klinika , Hungary, 7632Obudai Egeszsegugyi Centrum Kft | Budapest , Hungary, 1036Derma-B Kft | Debrecen , Hungary, 4031Debreceni Egyetem Klinikai Kozpont | Debrecen , Hungary, 4032Somogy Varmegyei Kaposi Mor Oktato Korhaz | Kaposvár , Hungary, 7400SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika | Szeged , Hungary, 6720Allergo-Derm Bakos Kft. | Szolnok , Hungary, 5000Medmare Egeszsegugyi Es Szolgaltato Bt. | Veszprém , Hungary, 8200Fukuoka University Hospital | Fukuoka , Japan, 814-0180Hino Dermatology Clinic | Fukutsu , Japan, 811-3217Gifu University Hospital | Gifu , Japan, 501-1112University of the Ryukyus Hospital | Ginowan , Japan, 901 2725Gunma University Hospital | Gunma , Japan, 371 8511JR Sapporo Hospital | Hokkaido , Japan, 060-0033Asahikawa Medical University Hospital | Hokkaido , Japan, 078 8510Tokai University Hospital | Isehara , Japan, 259-1193Teikyo University Hospital | Itabashi Ku , Japan, 173 8606St Marianna University Hospital | Kawasaki , Japan, 216 8511Hospital of the University of Occupational and Environmental Health | Kitakyushu-shi , Japan, 807-8556Nagoya City University Hospital | Nagoya , Japan, 467 8602Kume Clinic | Nishiku , Japan, 593-8324Takagi Dermatological Clinic | Obihiro Shi , Japan, 080 0013Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital | Osaka , Japan, 550 0006Kindai University Hospital | Sakai , Japan, 590 0197Sapporo Skin Clinic | Sapporo , Japan, 060 0063Tohoku University Hospital | Sendai , Japan, 980 8574The University of Osaka Hospital | Suita , Japan, 565 0871Jitaikai Tachikawa dermatology clinic | Tachikawa , Japan, 190 0023Shirasaki Dermatology Clinic | Takaoka Shi , Japan, 933-0871Tokyo Medical University Hospital | Tokyo , Japan, 160-0023Mie University Hospital | Tsu , Japan, 514 8507Osteo-Medic s.c A. Racewicz, J Supronik | Bialystok , Poland, 15-351Specderm Poznanska sp j | Bialystok , Poland, 15-375Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska | Elblag , Poland, 82 300Centrum Medyczne dr Rajzer Sp z o o | Krakow , Poland, 30 438Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna | Krakow , Poland, 30-002Centrum Medyczne Promed | Krakow , Poland, 31-411Dermed Centrum Medyczne Sp z o o | Lodz , Poland, 90-265Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna | Lodz , Poland, 90-338Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C | Osielsko , Poland, 86031SOLUMED Centrum Medyczne | Poznan , Poland, 60 529Clinical Research Center sp z o o MEDIC R s k | Poznan , Poland, 61 731Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna | Warsaw , Poland, 01 817Klinika Ambroziak Dermatologia | Warsaw , Poland, 02 953DERMMEDICA Sp.z o.o. | Wroclaw , Poland, 51 503Wro Medica | Wroclaw , Poland, 51 685Centrum Medyczne Oporow | Wroclaw , Poland, 52 416Pusan National University Hospital | Busan , South Korea, 49241Seoul National University Bundang Hospital | Seongnam-si , South Korea, 13620Seoul National University Hospital | Seoul , South Korea, 03080Hanyang University Medical Center | Seoul , South Korea, 04763Konkuk University Medical Center | Seoul , South Korea, 05030The Catholic University of Korea Seoul St Marys Hospital | Seoul , South Korea, 06591Kyung Hee University Hospital | Seoul , South Korea, 130 050Hosp. Gral. Univ. Dr. Balmis | Alicante , Spain, 03010Hosp. Univ. de Cruces | Barakaldo , Spain, 48902Hosp. de La Santa Creu I Sant Pau | Barcelona , Spain, 08041Hosp. Univ. San Cecilio | Granada , Spain, 18016Hosp. Univ. de Bellvitge | L'Hospitalet de Llobregat , Spain, 08907Grupo Dermatologico Y Estetico Pedro Jaen | Madrid , Spain, 28002Hosp. Univ. de La Princesa | Madrid , Spain, 28006Hosp. Gral. Univ. Gregorio Maranon | Madrid , Spain, 28007Hosp. Univ. Infanta Leonor | Madrid , Spain, 28031Hosp. Univ. 12 de Octubre | Madrid , Spain, 28041Hosp. Univ. de La Paz | Madrid , Spain, 28046Hosp. Univ. I Politecni La Fe | Valencia , Spain, 46026National Taiwan University Hospital Hsin Chu Branch | Hsinchu , Taiwan, 30059Chang Kung Memorial Hospital | Kaohsiung City , Taiwan, 833Taipei Medical University Shuang Ho Hospital | New Taipei City , Taiwan, 235National Taiwan University Hospital | Taipei , Taiwan, 10048Taipei Mackay Memorial Hospital | Taipei , Taiwan, 10449Taipei Veterans General Hospital | Taipei , Taiwan, 112Linkou Chang Gung Memorial Hospital | Taoyuan , Taiwan, 33382Guys and St Thomas NHS Foundation Trust | London , United Kingdom, SE1 9RTRoyal Berkshire Hospital | Reading , United Kingdom, RG1 5ANSalford Royal Hospital | Salford , United Kingdom, M6 8HDUniversity Hospital Southampton NHS Foundation Trust | Southampton , United Kingdom, SO16 6YD
Investigators
Study Director: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
Study Documents (Full Text)
Documents provided by Janssen Research & Development, LLC: Study Protocol  December 5, 2023Documents provided by Janssen Research & Development, LLC: Statistical Analysis Plan  December 3, 2024