A Phase 2/3 interventional study of Icotrokinra and Placebo in Crohn Disease, sponsored by Janssen Research & Development, LLC. Recruiting at 395 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 2/3, Interventional, and Treatment
Among 63 studies in Crohn Disease by Johnson & Johnson — 16 open to participants now, 23 under way, 10 of them phase 3. Crohn Disease · Johnson & Johnson.
Among the 63 studies in Crohn Disease by Johnson & Johnson, this one is the 3rd largest by planned enrollment of the 40 interventional ones that give a count, is one of 4 that started in 2025, is one of 3 in phase 2/3, reaches primary completion later than 10 of the 22 other live ones, and was the 52nd registered.
1,992 studies on the registry are indexed under Crohn Disease; 477 are open to participants now.
Browse Crohn Disease studies →16 of the 63 studies in Crohn Disease by Johnson & Johnson are open now, in 12 countries. Recruiting first, the newest first:
Janssen Research & Development, LLC · Sites in United States
Ages 18+ · Women only
Janssen-Cilag Pharma GmbH · Sites in Austria
Ages 18+
Janssen Research & Development, LLC · Sites in United States, Argentina, Australia and 27 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in Saudi Arabia
Ages 18+
Janssen Research & Development, LLC · Sites in United States, Austria, Belgium and 14 more countries
Ages 18+
By country, each count listing its studies:
Of the 353 Crohn Disease studies recruiting now, 154 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 95 take children under 18; 56 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
63 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 10 · Phase 3 26 · Phase 4 5
First in 1995; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,092 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Median enrollment 189 across the 40 interventional studies, 200 across the 22 observational. Of the 38 that completed or were terminated, 16 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Janssen Research & Development, LLC, one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
6 of the studies in Crohn Disease by Johnson & Johnson that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05347095Phase 3Janssen-Cilag Ltd.A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | 2027-03-25 |
| NCT06408935Phase 3Janssen-Cilag Ltd.Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | 2027-06-08 |
| NCT05092269Phase 3Janssen Research & Development, LLCA Long-term Extension Study of Ustekinumab in Pediatric Participants | 2027-09-29 |
| NCT05923073Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease | 2027-10-27 |
| NCT07654751Janssen Research & Development, LLCA Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically | 2027-08-31 |
Add all 6 to your calendar (.ics) → With an account.
Among the 63 studies in Crohn Disease by Johnson & Johnson, from their registry updates:
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The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Drug: Icotrokinra
Participants 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.
Drug: Icotrokinra
Participants 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.
Drug: Placebo
Participants 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.
Drug: Icotrokinra
Participants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Drug: Placebo
Participants 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).
Drug: Icotrokinra
Participants 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.
Drug: Icotrokinra
Participants 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.
Drug: Icotrokinra · Drug: Placebo
Icotrokinra will be administered orally, daily.
Also known as: JNJ-77242113
Matching placebo will be administered orally, daily.
Induction Study 1: Number of Participants with Clinical Response 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.
Time frame: At Week 12
Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint)
Clinical remission is defined as CDAI score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Time frame: At Week 12
Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint)
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.
Time frame: At Week 12
Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint)
Clinical remission is defined as CDAI score \< 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Time frame: At Week 40
Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint)
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.
Time frame: At Week 40
Induction Study 1: Number of Participants with Clinical Remission at Week 12
Clinical remission is defined as CDAI score \< 150. CDAI scores ranging from 0 to approximately 600. Higher score indicates higher disease activity.
Time frame: At Week 12
Induction Study 1: Number of Participants with Endoscopic Response at Week 12
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.
Time frame: At Week 12
Induction Study 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Time frame: Up to 4 weeks after last dose of study drug (i.e., up to Week 16)
Induction Study 2: Number of Participants with Patient Reported Outcomes (PRO)-2 Remission at Week 12
PRO-2 remission is defined as an abdominal pain (AP) mean daily score less than or equal to (\<=) 1 and stool frequency (SF) mean daily score \<= 2.8, and no worsening of AP or SF from baseline.
Time frame: At Week 12
Induction Study 2: Number of Participants with Clinical Response at Week 12
Clinical response is defined as a \>= 100-point reduction from baseline in CDAI score.
Time frame: At Week 12
Induction Study 2: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 12
Clinical remission is defined as CDAI score \< 150. 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. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response at the participant level.
Time frame: At Week 12
Induction Study 2: Number of Participants with Clinical Response at Week 4
Clinical response is defined as a \>= 100-point reduction from baseline in CDAI score.
Time frame: At Week 4
Induction Study 2: Number of Participants with Endoscopic Remission at Week 12
Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.
Time frame: At Week 12
Induction Study 2: Number of Participants with Deep Remission at Week 12
Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as CDAI score \< 150-point. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.
Time frame: At Week 12
Induction Study 2: Number of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
IBDQ remission is defined as IBDQ score \>= 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Time frame: At Week 12
Induction Study 2: Number of Participants with Fatigue Response at Week 12
Fatigue response is defined as a \>= 7 point reduction in the patient reported outcomes measurement information system (PROMIS)-Fatigue Short Form 7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). Item responses are rated on a five-point scale ranging from "never" to "always". Higher scores indicate more fatigue.
Time frame: At Week 12
Induction Study 2: Number of Participants with Clinical Remission at Week 4
Clinical remission is defined as CDAI score\< 150.
Time frame: At Week 4
Induction Study 2: Number of Participants Reporting Both Histologic Remission and Endoscopic Remission at Week 12
Histologic remission is defined as a Robarts Histopathology Index score \<=3, where each of the items of lamina propria neutrophils, neutrophils in epithelium, and erosions or ulcerations must be equal to 0. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component. This is a composite endpoint defined as achieving both histologic remission and endoscopic remission at the participant level.
Time frame: At Week 12
Induction Study 2: Number of Participants with AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Time frame: Up to 4 weeks after last dose of study drug (i.e., up to Week 16)
Maintenance Study: Number of Participants with PRO-2 remission at Week 40
PRO-2 remission is defined as an abdominal pain (AP) mean daily score \<= 1 and stool frequency (SF) mean daily score \<= 2.8, and no worsening of AP or SF from baseline.
Time frame: At Week 40
Maintenance Study: Number of Participants with Endoscopic Remission at Week 40
Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.
Time frame: At Week 40
Maintenance Study: Number of Participants with 90-Day Corticosteroid-Free Clinical Remission at Week 40
90-day corticosteroid-free clinical remission is defined as the clinical remission at the visit and not receiving corticosteroids for at least 90 days prior to the visit. Clinical remission is defined as CDAI score \< 150.
Time frame: At Week 40
Maintenance Study: Number of Participants with Maintenance of Clinical Remission at Week 40
Participants with clinical remission at Week 40 among those with clinical remission at Week 0 of the maintenance study will be analyzed. Clinical remission is defined as CDAI score \< 150.
Time frame: At Week 40
Maintenance Study: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 40
Clinical remission is defined as CDAI score \< 150. 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. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response at the participant level.
Time frame: At Week 40
Maintenance Study: Number of Participants with Deep Remission at Week 40
Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as CDAI score \< 150. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.
Time frame: At Week 40
Maintenance Study: Number of Participants Reporting Both Histologic Remission and Endoscopic Remission at Week 40
Histologic remission is defined as a Robarts Histopathology Index score \<=3, where each of the items of lamina propria neutrophils, neutrophils in epithelium, and erosions or ulcerations must be equal to 0. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component. This is a composite endpoint defined as achieving both histologic remission and endoscopic remission at the participant level.
Time frame: At Week 40
Maintenance Study: Number of Participants with IBDQ Remission at Week 40
IBDQ remission is defined as IBDQ score \>= 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific HRQoL across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Time frame: At Week 40
Maintenance Study: Number of Participants with Fatigue Response at Week 40
Fatigue response is defined as a \>= 7 point reduction in the PROMIS-Fatigue Short Form 7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). Item responses are rated on a five-point scale ranging from "never" to "always". Higher scores indicate more fatigue.
Time frame: At Week 40
Maintenance Study : Number of Participants with AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Time frame: Up to 4 weeks after last dose of study drug (i.e., up to Week 44)
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Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Sep 2028, 35 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Icotrokinra
Janssen Research & Development, LLC →