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JNJ-77242113

Phase 3

Plaque Psoriasis | Small molecule | Immunology |Johnson & Johnson|Last Updated: Jun 8, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials8
Total Enrollment3,824
FDA Designations
No designations recorded
Clinical Trials (8)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06934226A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque PsoriasisPHASE3 ACTIVE NOT_RECRUITING 752Apr 15, 2025Aug 20, 2027Jun 5, 2026160 United States, Argentina +11
NCT06220604A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)PHASE3 ACTIVE NOT_RECRUITING 731Mar 9, 2024Sep 20, 2027Mar 12, 2026128 United States, Australia +9
NCT06143878A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque PsoriasisPHASE3 ACTIVE NOT_RECRUITING 774Feb 1, 2024Jun 1, 2027Mar 12, 2026164 United States, Argentina +11
NCT06095102A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)PHASE3 ACTIVE NOT_RECRUITING 311Oct 12, 2023Feb 17, 2027Mar 13, 202690 United States, Argentina +9
NCT06095115A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque PsoriasisPHASE3 ACTIVE NOT_RECRUITING 684Oct 12, 2023Apr 6, 2027Jun 8, 2026170 United States, Argentina +14
NCT05357755A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque PsoriasisPHASE2 COMPLETED 90Jun 13, 2022Apr 10, 2023May 5, 202634 United States, Canada +4
NCT05364554A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque PsoriasisPHASE2 COMPLETED 227Jun 10, 2022Sep 29, 2023Jun 1, 202660 United States, Canada +8
NCT05223868A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque PsoriasisPHASE2 COMPLETED 255Feb 3, 2022Dec 15, 2022Feb 13, 202676 United States, Canada +8
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Study Endpoints
Primary Endpoints
JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16
Week 16

IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Week 16

PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score.

JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2 Grade Improvement From Baseline at Week 16
Baseline and Week 16

Percentage of participants achieving an IGA score of 0 or 1 and \>=2 grade improvement from baseline at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline to Week 16
Baseline and Week 16

Percentage of participants who achieve an IGA score of 0 or 1 and \>=2-Grade improvement from baseline to Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2 Grade Improvement From Baseline at Week 16
Baseline and Week 16

Percentage of participants who achieve an IGA score of 0 or 1 and \>=2 grade improvement from baseline at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

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
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,=0.5mm;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; 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 a 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.

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Week 16

Percentage of participants who achieved PASI 90 (at least 90% improvement from baseline in PASI score) response at Week 16 were 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.

Percentages of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 16
Baseline (Week 0), Week 16

Percentage of participants who achieved PASI-75 score (greater than or equal to \[\>=\] 75% improvement from baseline in PASI) at Week 16 were 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.

Percentage of Participants Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Psoriasis Area Severity Index Score (PASI-75) at LTE Week 36
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)

Percentage of participants who achieved \>=75% improvement from baseline in PASI score at LTE Week 36 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.

Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16
Baseline (Week 0), Week 16

Percentage of participants who achieved PASI-75 score (greater than or equal to \[\>=\] 75% 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 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.

Secondary Endpoints
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Week 16
Week 16
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16
Week 16
JNJ-77242113 and Placebo Group: Percentage of Participants with IGA Score of 0 at Week 16
Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: JNJ 77242113EXPERIMENTALParticipants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maintain the blind.
Arm 2: PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104.
Arm 3: UstekinumabACTIVE_COMPARATORParticipants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28.
JNJ-77242113EXPERIMENTALParticipants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.
PlaceboPLACEBO_COMPARATORParticipants 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.
DeucravacitinibACTIVE_COMPARATORParticipants 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.
Group 1: JNJ-77242113 Dose 1EXPERIMENTALParticipants will receive JNJ-77242113 Dose 1 as delayed release tablets orally once daily from Week 0 through Week 16.
Group 2: JNJ-77242113 Dose 2EXPERIMENTALParticipants will receive JNJ-77242113 Dose 2 as delayed release tablets orally once daily from Week 0 through Week 16.
Group 3: PlaceboPLACEBO_COMPARATORParticipants will receive oral dose of matching placebo once daily from Week 0 through Week 16.
Group 1: JNJ-77242113 Dose 1 Once Daily (QD)EXPERIMENTALParticipants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study.
Group 2: JNJ-77242113 Dose 2 QDEXPERIMENTALParticipants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study.
Group 3: JNJ-77242113 Dose 3 QDEXPERIMENTALParticipants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.
Group 4: JNJ-77242113 Dose 1 Twice Daily (BID)EXPERIMENTALParticipants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study.
Group 5: JNJ-77242113 Dose 3 BIDEXPERIMENTALParticipants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study.
Group 6: JNJ-77242113 Dose 3 QDEXPERIMENTALParticipants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.
Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and PlaceboEXPERIMENTALParticipants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Group 2: JNJ-77242113 Dose 2 QD and PlaceboEXPERIMENTALParticipants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Group 3: JNJ-77242113 Dose 3 QD and PlaceboEXPERIMENTALParticipants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and PlaceboEXPERIMENTALParticipants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Group 5: JNJ-77242113 Dose 3 BID and PlaceboEXPERIMENTALParticipants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Group 6: PlaceboPLACEBO_COMPARATORParticipants will receive placebo BID from Week 0 through Week 16.
Interventions
NameTypeDescription
JNJ-77242113DRUGJNJ-77242113 will be administered orally.
Matching Placebo to JNJ-77242113DRUGMatching placebo will be administered orally.
UstekinumabDRUGUstekinumab will be administered subcutaneously.
Matching Placebo to UstekinumabDRUGMatching placebo will be administered subcutaneously.
JNJ-77242113 Matching PlaceboDRUGJNJ-77242113 matching placebo will be administered orally.
DeucravacitinibDRUGDeucravacitinib will be administered orally.
Deucravacitinib Matching PlaceboDRUGDeucravacitinib matching placebo will be administered orally.
PlaceboDRUGPlacebo will be administered orally.
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites160

Inclusion Criteria: * Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), 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 (P...

Countries:United StatesArgentinaAustraliaAustriaBelgiumCanadaDenmarkGermanyHungaryPolandPortugalSpainUnited KingdomBrazilRomaniaSouth KoreaTaiwanJapanTurkey (Türkiye)ChinaFranceItaly
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Recent Changes (Last 90 Days)
LOWJun 8, 2026NCT06095115lastUpdatePostDate: changed
LOWJun 8, 2026NCT06095115lastUpdatePostDate: changed
MEDIUMJun 5, 2026NCT05357755TRIAL_REMOVED: changed
LOWJun 5, 2026NCT06934226lastUpdatePostDate: changed
MEDIUMJun 5, 2026NCT05357755TRIAL_REMOVED: changed
LOWJun 5, 2026NCT06934226lastUpdatePostDate: changed
MEDIUMJun 5, 2026NCT05357755TRIAL_REMOVED: changed
LOWJun 5, 2026NCT06934226lastUpdatePostDate: changed
MEDIUMJun 5, 2026NCT05357755TRIAL_REMOVED: changed
LOWJun 5, 2026NCT06934226lastUpdatePostDate: changed
MEDIUMJun 5, 2026NCT05357755TRIAL_REMOVED: changed
MEDIUMJun 5, 2026NCT05357755TRIAL_REMOVED: changed
LOWJun 2, 2026NCT06095115lastUpdatePostDate: changed
LOWJun 2, 2026NCT06095115lastUpdatePostDate: changed
LOWJun 2, 2026NCT06095115lastUpdatePostDate: changed
LOWMay 28, 2026NCT06934226lastUpdatePostDate: changed
LOWMay 28, 2026NCT06934226lastUpdatePostDate: changed