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Icotrokinra

Phase 3FDA approved

Arthritis, Psoriatic | Small molecule | Immunology |Johnson & Johnson|Trials Updated: Sep 28, 2026

Icotrokinra development status

FDA approval on record Mar 17, 2026 as Icotyde
Approval holderJanssen Biotech
ApplicationNDA220149
Highest phase Phase 3
Registered trials 16 across 2 sponsors since Sep 2021

Label indication ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. FDA label

Icotrokinra target and mechanism

ModalitySmall molecule

Also known as JNJ-77242113

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials14
Total Enrollment7,371

FDA Designations

No designations recorded

Icotrokinra clinical trials

Icotrokinra · 14 trials · 6 indications

Phase 3 9Phase 2 5
NCT07196748A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative ColitisColitis, Ulcerative
RECRUITING882 Analytics
NCT06934226A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque PsoriasisPlaque Psoriasis
ACTIVE NOT_RECRUITING752 Analytics
NCT06878404A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic ArthritisArthritis, Psoriatic
ACTIVE NOT_RECRUITING552 Analytics
NCT06807424A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic ArthritisArthritis, Psoriatic
RECRUITING750 Analytics
NCT06220604A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)Plaque Psoriasis
ACTIVE NOT_RECRUITING731 Analytics
NCT06295692A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic PsoriasisGeneralized Pustular Psoriasis
ACTIVE NOT_RECRUITING19 Analytics
NCT06143878A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque PsoriasisPlaque Psoriasis
ACTIVE NOT_RECRUITING774 Analytics
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)Plaque Psoriasis
ACTIVE NOT_RECRUITING311 Analytics
NCT06095115A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque PsoriasisPlaque Psoriasis
ACTIVE NOT_RECRUITING684 Analytics
PHASE3RECRUITING
A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
Colitis, UlcerativeUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
Plaque PsoriasisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
Arthritis, PsoriaticUnlock trial analytics
PHASE3RECRUITING
A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis
Arthritis, PsoriaticUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)
Plaque PsoriasisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Generalized Pustular PsoriasisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque PsoriasisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A 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)
Plaque PsoriasisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis
Plaque PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12
At Week I-12

Percentage of adult participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40
At Week M-40

Percentage of adult participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40
At Week M-40

Percentage of adolescent participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

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.

Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16
Week 16

The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).

Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
Week 16

The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).

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,= 0.5 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.

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 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.

Percentage of Participants With Generalized Pustular Psoriasis (GPP) Who Experienced Treatment Success at Week 16
Week 16

Percentage of participants with GPP who experienced treatment success at Week 16 was reported. Treatment success for GPP was defined as at least "minimally improved" rating in Clinical Global Impression (CGI) scale for GPP based on Japanese Dermatological Association (JDA) total score. JDA severity index includes skin symptoms (area of erythema with pustules, total area of erythema, and area of edema; each scored 0-3) and systemic/laboratory findings (fever, white blood cell count, C-reactive protein, and serum albumin; each scored 0-2). JDA total score was sum of 2 assessments ranging from 0 (best) to 17 (worst). CGI ratings were defined as: 1=Very much improved (greater than or equal to \[\>=\]3-point reduction in JDA total score), 2=Much improved (1-2-point reduction), 3=Minimally improved (no change in JDA total score, but \>=20 percent (%) reduction in area of erythema with pustules or meaningful improvement in \>=1 other parameter), 4=No change, 5=Worsened. Higher score = worsening.

Percentage of Participants With Erythrodermic Psoriasis (EP) Who Experience Treatment Success at Week 16
Week 16

Percentage of participants with EP who experienced treatment success at Week 16 was reported. Treatment success for EP was defined as at least "minimally improved" rating in CGI scale for EP. The CGI scale is a clinician-rated 5-point scale with the following categories: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Worsened. Higher score indicated worsening.

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
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.

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

Induction Study 1: Number of Participants with Clinical Response at Week 12
At Week 12

Clinical response is defined as a greater than or equal to (\>=) 100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) score. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint)
At Week 12

Clinical remission is defined as CDAI score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint)
At Week 12

Endoscopic response is defined as greater than (\>) 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint)
At Week 40

Clinical remission is defined as CDAI score \< 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint)
At Week 40

Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

Percentage of Participants with Clinical Response at Week 12
Week 12

Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.

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

DB Induction Study: Percentage of Adult Participants in Clinical Response at Week I-12
At Week I-12
DB Induction Study: Percentage of Adult Participants with Endoscopic Improvement at Week I-12
At Week I-12
DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-12
At Week I-12
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Double-blind (DB) Induction Study: IcotrokinraEXPERIMENTALAdult participants will be randomized to receive icotrokinra daily, orally starting at induction Week 0 (Week I-0). At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
DB Induction Study: PlaceboPLACEBO_COMPARATORAdult participants will be randomized to receive placebo daily, orally starting at Week I-0. At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
DB Maintenance Study: IcotrokinraEXPERIMENTALAdult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive icotrokinra daily, orally starting at maintenance Week 0 (Week M-0) through Week M-40. Participants who are clinical nonresponders to icotrokinra or placebo will also enter the Maintenance study directly and receive icotrokinra daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a long-term extension (LTE).
DB Maintenance Study: PlaceboPLACEBO_COMPARATORAdult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive placebo daily, orally starting at Week M-0 through Week M-40. Participants who are clinical responders to placebo will also enter the Maintenance study directly and continue to receive placebo daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a LTE.
Open-label (OL) Induction Phase: IcotrokinraEXPERIMENTALAdolescent participants will enter the Induction phase and receive icotrokinra daily, orally. At Week I-12 all participants will be evaluated for clinical response and will enter the Maintenance phase.
OL Maintenance Phase: IcotrokinraEXPERIMENTALAdolescent participants who are in clinical response to icotrokinra will enter the Maintenance phase at Week M-0 and continue to receive icotrokinra daily, orally up to Week M-40. Participants who are nonresponders to icotrokinra will also enter the Maintenance phase to receive icotrokinra daily. After completion of the Maintenance phase through Week M-40, eligible participants can participate in a LTE.
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.
Group I: Icotrokinra Dose 1EXPERIMENTALParticipants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.
Group II: Icotrokinra Dose 2EXPERIMENTALParticipants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2.
Group III: PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
Group IV: Active Reference ComparatorACTIVE_COMPARATORParticipants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.
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.
JNJ-77242113- Participants With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP)EXPERIMENTALParticipants with GPP or EP will receive JNJ-77242113 tablet orally.
Induction Study 1: Icotrokinra Dose 1EXPERIMENTALParticipants will receive Icotrokinra dose 1 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Induction Study 1: Icotrokinra Dose 2EXPERIMENTALParticipants will receive Icotrokinra dose 2 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Induction Study 1: PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Induction Study 2: IcotrokinraEXPERIMENTALParticipants will receive Icotrokinra at the dose regimen determined in Induction Study 1 up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Induction Study 2: PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Maintenance Study: Icotrokinra Dose 1EXPERIMENTALParticipants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 1. Participants receiving Icotrokinra Dose 1 and meeting criteria for loss of response during the Maintenance Study will be eligibile for a single blinded dose adjustment to Icotrokinra Dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in long-term extension (LTE).
Maintenance Study: Icotrokinra Dose 2EXPERIMENTALParticipants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 2. Participants who were non-responders at Week 12 of the induction studies will also receive icotrokinra maintenance dose 2 but will not be randomized. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
Maintenance Study: PlaceboPLACEBO_COMPARATORParticipants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 will be randomized to receive placebo. Participants receiving placebo in induction studies 1 or 2 and in response at Week 12 of the induction study will continue to receive placebo during maintenance on non-randomized basis. Placebo non-responders from induction study will receive icotrokinra maintenance dose 2 on a non-randomized basis and will be assessed for response at Week 12. Participants receiving placebo and meeting criteria for loss of response during the Maintenance Study will be eligible for a single blinded dose adjustment to icotrokinra dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
Group 1: JNJ-77242113 Dose-1EXPERIMENTALParticipants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.
Group 2: JNJ-77242113 Dose-2EXPERIMENTALParticipants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.
Group 3: JNJ-77242113 Dose-3EXPERIMENTALParticipants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.
Group 4: PlaceboEXPERIMENTALParticipants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76.
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
IcotrokinraDRUGIcotrokinra tablet will be administered orally.
PlaceboDRUGPlacebo tablet will be administered orally.
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.
Active reference comparatorDRUGActive reference drug will be administered.
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.
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites402

Inclusion Criteria: * Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC * Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChinaCzechiaFranceGermanyGreeceHungaryIndiaIsraelItalyJapanMalaysiaNetherlandsPolandPortugalRomaniaSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)United KingdomAustriaDenmarkBulgariaHong KongThailandMexico
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Recent Changes (Last 90 Days)

LOWSep 28, 2026NCT06295692lastUpdatePostDate: changed
LOWSep 28, 2026NCT06220604lastUpdatePostDate: changed
LOWSep 28, 2026NCT06143878lastUpdatePostDate: changed
LOWSep 28, 2026NCT06095115lastUpdatePostDate: changed
LOWSep 28, 2026NCT06295692lastUpdatePostDate: changed
LOWSep 28, 2026NCT06220604lastUpdatePostDate: changed
LOWSep 28, 2026NCT06143878lastUpdatePostDate: changed
LOWSep 28, 2026NCT06095115lastUpdatePostDate: changed
LOWSep 25, 2026NCT06807424lastUpdatePostDate: changed
LOWSep 25, 2026NCT07196748lastUpdatePostDate: changed
LOWSep 25, 2026NCT07196722Completion: 2032-10-10 → 2032-10-16
LOWSep 25, 2026NCT06878404lastUpdatePostDate: changed
LOWSep 25, 2026NCT06095102lastUpdatePostDate: changed
LOWSep 25, 2026NCT06934226lastUpdatePostDate: changed
LOWSep 25, 2026NCT07196748lastUpdatePostDate: changed
LOWSep 25, 2026NCT06807424lastUpdatePostDate: changed
LOWSep 25, 2026NCT07196722Completion: 2032-10-10 → 2032-10-16
LOWSep 25, 2026NCT06095102lastUpdatePostDate: changed
LOWSep 25, 2026NCT06878404lastUpdatePostDate: changed
LOWSep 25, 2026NCT06934226lastUpdatePostDate: changed

Frequently asked questions about Icotrokinra

What is Icotrokinra used for?

Icotrokinra is an investigational small molecule being developed for immune-mediated inflammatory conditions. It is in clinical trials for psoriatic arthritis, ulcerative colitis, and Crohn's disease. It is not approved by the FDA and remains in clinical development.

What does Icotrokinra target?

Icotrokinra is an oral small molecule that targets the IL-23 receptor, blocking the signaling pathway involved in inflammation. By inhibiting this receptor, it aims to reduce the inflammatory response driving conditions like psoriatic arthritis, ulcerative colitis, and Crohn's disease.

Who makes Icotrokinra?

Icotrokinra is being developed by Johnson & Johnson, a company traded on the NYSE under the ticker JNJ. The drug is also known by the code name JNJ-77242113 in some clinical trial records.

What phase is Icotrokinra in?

Icotrokinra is in Phase 3 clinical trials for psoriatic arthritis and ulcerative colitis, and Phase 2 for Crohn's disease. It is an investigational drug and has not received FDA approval.

What clinical trials is Icotrokinra in?

Icotrokinra is being studied in several trials. NCT06807424 and NCT06878404 are Phase 3 trials in psoriatic arthritis. NCT07196748 is a Phase 3 trial in ulcerative colitis, and NCT07196722 is a Phase 2 trial in Crohn's disease. All are actively recruiting or ongoing.

Is Icotrokinra the same as JNJ-77242113?

Yes, Icotrokinra is also known as JNJ-77242113. Clinical trial records use both names interchangeably, with JNJ-77242113 being the code name assigned during early development.