A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

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
NCT06220604
Other Study ID Numbers:
77242113PSO3004
First Submitted
January 14, 2024
First Posted
January 23, 2024
Results First Posted
April 14, 2026
Last Update Posted
July 6, 2026
Last Verified
June 2026

ClinicalTrials.gov processed this data on July 2026Link 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 Enrollment731 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 DateMarch 8, 2024
Actual Primary Completion DateNovember 14, 2024
Actual Study Completion Date1yr 2mos 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 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 and 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, greater than (\>) 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; 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 the time of first study drug administration date.
  2. Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response 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 Response 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 were 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 Response 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 were 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 Response 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 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 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25mm; 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 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 Response 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 were 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 Response 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 were 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 Response 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 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.
  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 were 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 were 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 From Baseline 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 From Baseline 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 a 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. Baseline = 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 scores 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 scores 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
    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.
  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 that is 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 or at 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 Symptoms Score of 0 at Week 24 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.
  30. Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24
  31. Percentage of Participants Achieving PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24
  32. Percentage of Participants Achieving 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 Treatment-emergent Adverse Events (TEAEs)
  34. Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

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
Alliance Dermatology and MOHS Center P C | Phoenix Arizona, United States, 85032California Dermatology & Clinical Research Institute | Encinitas California, United States, 92024T Joseph Raoof Md Inc | Encino California, United States, 91436UCSF Fresno | Fresno California, United States, 93701University of California Los Angeles - Division of Dermatology | Los Angeles California, United States, 90024Wallace Medical Group, Inc | Los Angeles California, United States, 90056Dermatologist Medical Group of North County, Inc. | Oceanside California, United States, 92056Miami Dermatology And Laser Institute | Miami Florida, United States, 33133Bioclinical Research Alliance Inc. | Miami Florida, United States, 33155Forcare Clinical Research Inc | Tampa Florida, United States, 33613Southeast Dermatology Specialists | Douglasville Georgia, United States, 30135Arlington Dermatology | Rolling Meadows Illinois, United States, 60008Skin Sciences, PLLC | Louisville Kentucky, United States, 40217Qualmedica Research | Owensboro Kentucky, United States, 42301DermAssociates, PC | Rockville Maryland, United States, 20850Metro Boston Clinical Partners | Brighton Massachusetts, United States, 02135ActivMed Practices and Research | Methuen Massachusetts, United States, 01844University of Michigan | Ann Arbor Michigan, United States, 48109Great Lakes Research Group | Bay City Michigan, United States, 48706The Derm Institute of West Michigan | Caledonia Michigan, United States, 49316Hamzavi Dermatology | Canton Michigan, United States, 48187Somerset Skin Centre | Troy Michigan, United States, 48084Cleaver Dermatology | Kirksville Missouri, United States, 63501Bexley dermatology research | Bexley Ohio, United States, 43209Essential Medical Research | Tulsa Oklahoma, United States, 74137Oregon Dermatology & Research Center | Portland Oregon, United States, 97210-2996Paddington Testing Co, Inc. | Philadelphia Pennsylvania, United States, 19103Clinical Research Center of the Carolinas LLC | Charleston South Carolina, United States, 29407Palmetto Clinical Trial Services, LLC | Greenville South Carolina, United States, 29615Arlington Research Center, Inc. | Arlington Texas, United States, 76011UT Southwestern Medical Center | Dallas Texas, United States, 75390Dermatology Clinical Research Center of San Antonio | San Antonio Texas, United States, 78229Center for Clinical Studies | Webster Texas, United States, 77598Cope Family Medicine - Ogden Clinic | Bountiful Utah, United States, 84010Springville Dermatology CCT Research | Springville Utah, United States, 84663Kalo Clinical Research | West Valley City Utah, United States, 84120Virginia Dermatology Skin Cancer Center Pllc | Norfolk Virginia, United States, 23502The Skin Centre | Benowa , Australia, 4217Monash Medical Centre | Clayton , Australia, 3168Premier Specialists | Kogarah , Australia, 2217The Alfred Hospital | Melbourne , Australia, 3004ISHI dermatology | Mitcham , Australia, 3132Royal Melbourne Hospital | Parkville , Australia, 3050UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu | Botucatu , Brazil, 18618-686Chronos Clinica Medica LTDA Chronos Pesquisa Clinica | Brasília , Brazil, 72.145-450Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP | Ribeirão Preto , Brazil, 14048 900Fundacao do ABC Centro Universitario FMABC | Santo André , Brazil, 09060 870Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base | São José do Rio Preto , Brazil, 15090 000Hospital Das Clinicas Da Faculdade De Medicina Da USP | São Paulo , Brazil, 05403 900Dr. Chih ho Hong Medical | Surrey British Columbia, Canada, V3R 6A7Wiseman Dermatology Research Inc. | Winnipeg Manitoba, Canada, R3M 3Z4Lovegrove Dermatology | London Ontario, Canada, N6A 5R9Lynderm Research Inc. | Markham Ontario, Canada, L3P 1X2DermEdge Research | Mississauga Ontario, Canada, L4Y 4C5Skin Centre for Dermatology | Peterborough Ontario, Canada, K9J 5K2North York Research Inc | Toronto Ontario, Canada, M2N 3A6Toronto Research Centre | Toronto Ontario, Canada, M3H 5Y8XLR8 Medical Research | Windsor Ontario, Canada, N8T 1E6Innovaderm Research Inc. | Montreal Quebec, Canada, H2X 2V1Centre De Recherche Dermatologique Du Quebec Metropolitain | Québec Quebec, Canada, G1V 4X7Hautarztpraxis Dr. Mihaescu | Augsburg , Germany, 86150Fachklinik Bad Bentheim | Bad Bentheim , Germany, 48455CRS Clinical Research Services Berlin GmbH | Berlin , Germany, 13627Niesmann & Othlinghaus GbR | Bochum , Germany, 44793Klinikum Darmstadt GmbH - Hautklinik | Darmstadt , Germany, 64283Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden | Dresden , Germany, 01307Hautzentrum Dulmen | Dülmen , Germany, 48249Privatpraxis Dr. Hilton & Partner | Düsseldorf , Germany, 40212Derma-Study-Center Friedrichshafen GmbH | Friedrichshafen , Germany, 88045Eurofins bioskin GmbH | Hamburg , Germany, 20095Universitaetsklinikum Heidelberg | Heidelberg , Germany, 69120Hautarztpraxis | Mahlow , Germany, 15831Universitatsmedizin der Johannes Gutenberg Universitat Mainz | Mainz , Germany, 55131Hautmedizin Saar Science Hms GmbH | Merzig , Germany, 66663Universitaetsklinikum Muenster | Münster , Germany, 48149Klinikum Oldenburg | Oldenburg , Germany, 26133Hautarztpraxis 1 | Witten , Germany, 58453CentroDerm GmbH | Wuppertal , Germany, 42287Uno Medical Trials Ltd. | Budapest , Hungary, 1152Bugat Pal Korhaz | Gyöngyös , Hungary, 3200Synexus Magyarorszag Kft | Gyula , Hungary, 5700Bacs Kiskun Varmegyei Oktatokorhaz | Kecskemét , Hungary, 6000Synexus Magyarorszag Kft 1 | Zalaegerszeg , Hungary, H-8900Renew Clinic | Bialystok , Poland, 15 797Care Clinic | Katowice , Poland, 40 568Centrum Medyczne Angelius Provita | Katowice , Poland, 40 611Prywatny Gabinet Dermatologiczny Elzbieta Klujszo | Kielce , Poland, 25-316SGD s.c. | Krakow , Poland, 30-002Krakowskie Centrum Badan Klinicznych | Krakow , Poland, 30-303Jagiellonskie Centrum Innowacji | Krakow , Poland, 30-348Diamond Clinic | Krakow , Poland, 31 559Etyka Osrodek Badan Klinicznych | Olsztyn , Poland, 10-117Carpe Diem Centrum Medycyny Estetycznej | Warsaw , Poland, 02 661Synexus Polska Sp z o o Oddzial w Warszawie | Warsaw , Poland, 02 672Royalderm Agnieszka Nawrocka | Warsaw , Poland, 02-962WroMedica I Bielicka A Strzalkowska s c | Wroclaw , Poland, 51 685Cabinet Medical Dermato-Venerologie | Cluj-Napoca , Romania, 400105Centrul Medical Vitaplus | Craiova , Romania, 200541Spitalul Clinic Judetean de Urgenta | Craiova , Romania, 200642Sc Iasiprest Srl | Iași , Romania, 700381Spitalul Clinic Judetean de Urgenta Bihor | Oradea , Romania, 410167Spitalul Clinic Judetean Mures | Târgu Mureş , Romania, 540342New Derm Clinic | Timișoara , Romania, 300757Korea University Ansan Hospital | Ansan-si , South Korea, 15355Hallym University Sacred Heart Hospital | Anyang-si , South Korea, 14068The Catholic University of Korea Bucheon St Mary s Hospital | Bucheon-si , South Korea, 14647Chosun university hospital | Gwangju , South Korea, 61453CHA Bundang Medical Center, CHA University | Seongnam , South Korea, 13496Asan Medical Center | Seoul , South Korea, 05505Korea University Guro Hospital | Seoul , South Korea, 8308Hosp. Univ. Fundacion Alcorcon | Alcorcón , Spain, 28922Hosp. Univ. Germans Trias I Pujol | Badalona , Spain, 08916Hosp Clinic de Barcelona | Barcelona , Spain, 08036Hosp. de Manises | Manises , Spain, 46940Hosp Clinico Univ de Salamanca | Salamanca , Spain, 37007Clinica Gaias | Santiago de Compostela , Spain, 15702Hosp. Clinico Univ. de Santiago | Santiago de Compostela , Spain, 15706Hosp. Virgen Macarena | Seville , Spain, 41009Hosp. Ntra. Sra. de Valme | Seville , Spain, 41014Hosp. de La Marina Baixa | Villajoyosa , Spain, 03570Hosp. Clinico Univ. Lozano Blesa | Zaragoza , Spain, 50009Kaohsiung Medical University Chung Ho Memorial Hospital | Kaohsiung City , Taiwan, 80756Kaohsiung Veterans General Hospital | Kaohsiung City , Taiwan, 81362Chung Shan Medical University Hospital | Taichung , Taiwan, 40201Taichung Veterans General Hospital | Taichung , Taiwan, 40705National Cheng Kung University Hospital | Tainan , Taiwan, 710Taipei Medical University | Taipei , Taiwan, 110Taipei Municipal Wanfang Hospital | Taipei , Taiwan, 116
Investigators
Study Director: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC
Study Documents (Full Text)
Documents provided by Janssen Research & Development, LLCStudy Protocol  February 20, 2024Documents provided by Janssen Research & Development, LLCStatistical Analysis Plan  December 3, 2024