NCT07196722ClinicalTrials.gov
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
In brief
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).
Phase 2 / Phase 31,092 participants sought370 sites28 countries
Categories
Registered in 1 registry
- ClinicalTrials.govNCT07196722Open this record at ClinicalTrials.govSynced 3 weeks ago
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Trial information is shown as published by the registry, in its original language.
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2025-09-29; recorded start 2025-10-03
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Present: Uses blinding (masking)A masking level is recorded in the record
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 228 other studies in this databaseCounted from the lead sponsor named in the record (Janssen Research & Development, LLC)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: industry.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding13/20
Double-blind
- Control arm13/15
Placebo / sham control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre8/8
Multi-centre: 367 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A large study, international in scope: 1,092 participants (target), run at 370 sites, across 28 countries.
How this score is built
- Enrolment30/40
1,092 participants (target)
- Site count25/25
367 sites
- Country count15/15
28 countries
- Planned duration10/10
Planned over about 85 months
- Sponsor scale9/10
Janssen Research & Development, LLC has led 226 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
Summary
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).
Conditions
- Crohn Disease
Eligibility
| Sex | All |
|---|---|
| Ages | 18 Years – No maximum |
| Healthy volunteers | No |
Eligibility as written in the registry
Eligibility in plain statements
This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.
Study design
| Study type | Interventional |
|---|---|
| Phase | Phase 2 / Phase 3 |
| Allocation | Randomised |
| Intervention model | PARALLEL |
| Primary purpose | TREATMENT |
| Masking | DOUBLE (2) |
| Enrolment | 1,092 participants sought |
Sponsor and collaborators
- Janssen Research & Development, LLC Sponsor
Arms and interventions
- Induction Study 1: Icotrokinra Dose 1EXPERIMENTAL
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.
- Induction Study 1: Icotrokinra Dose 2EXPERIMENTAL
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.
- Induction Study 1: PlaceboPLACEBO_COMPARATOR
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.
- Induction Study 2: IcotrokinraEXPERIMENTAL
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.
- Induction Study 2: PlaceboPLACEBO_COMPARATOR
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.
- Maintenance Study: Icotrokinra Dose 1EXPERIMENTAL
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).
- Maintenance Study: Icotrokinra Dose 2EXPERIMENTAL
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.
- Maintenance Study: PlaceboPLACEBO_COMPARATOR
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.
Interventions
- Drug Icotrokinra
Icotrokinra will be administered orally, daily.
- Drug Placebo
Matching placebo will be administered orally, daily.
Outcome measures
Primary outcome
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
Primary outcome
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
Primary outcome
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
Primary outcome
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
Primary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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)
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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)
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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)
Dates
| Start date | October 3, 2025 (actual) |
|---|---|
| Primary completion | September 19, 2028 (estimated) |
| Completion | October 10, 2032 (estimated) |
| First posted | September 29, 2025 (actual) |
| Last updated | August 28, 2026 |
| Results posted | Not stated in the registry record |
| Status last verified | August 2026 |
Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.
Locations
361 sites are recruiting
Argentina
| Facility | City | State or region | Status |
|---|---|---|---|
| GEDYT | AAI | Recruiting | |
| Hospital Aleman | Buenos Aires | Recruiting | |
| Hospital Britanico de Buenos Aires | CABA | Recruiting | |
| Clinica Universitaria Reina Fabiola | Córdoba | Recruiting | |
| Hospital Privado de Cordoba | Córdoba | Recruiting | |
| Sanatorio Maipu | Maipu | Recruiting | |
| HIGEA | Mendoza | Recruiting |
Australia
| Facility | City | State or region | Status |
|---|---|---|---|
| Monash Health | Clayton | Recruiting | |
| Concord Repatriation General Hospital | Concord | Recruiting | |
| St Vincents Hospital Melbourne | Fitzroy | Recruiting | |
| Fiona Stanley Hospital | Murdoch | Recruiting | |
| John Hunter Hospital | New Lambton Heights | Recruiting | |
| Mater Hospital Brisbane | South Brisbane | Recruiting |
Belgium
| Facility | City | State or region | Status |
|---|---|---|---|
| Cliniques Universitaires Saint Luc | Brussels | Recruiting | |
| CHU Saint-Pierre | Brussels | Recruiting | |
| AZ St. Lucas | Ghent | Recruiting | |
| Ghent University Hospital | Ghent | Recruiting | |
| Universitair Ziekenhuis Leuven | Leuven | Recruiting | |
| Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman | Liège | Recruiting | |
| AZ Oostende | Ostend | Recruiting | |
| CHwapi | Tournai | Recruiting |
Brazil
| Facility | City | State or region | Status |
|---|---|---|---|
| Faculdade de Medicina Universidade Federal de Minas Gerais | Belo Horizonte | Recruiting | |
| UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu | Botucatu | Recruiting | |
| Chronos Clinica Medica Ltda | Brasília | Recruiting | |
| L2IP Instituto de Pesquisas Clinicas | Brasília | Recruiting | |
| CDC - Centro Digestivo de Curitiba | Curitiba | Recruiting | |
| ATO Terapias | Fortaleza | Recruiting | |
| CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda | Jaú | Recruiting | |
| Galileo Medical Research Ltda | Juiz de Fora | Recruiting | |
| Cliged | Macaé | Recruiting | |
| Liga Norte Riograndense Contra O Cancer | Natal | Recruiting | |
| Complexo Hospitalar de Niteroi | Niterói | Recruiting | |
| Hospital De Clinicas De Porto Alegre | Porto Alegre | Recruiting | |
| Hospital Ernesto Dornelles | Porto Alegre | Recruiting | |
| Hospital Moinhos de Vento | Porto Alegre | Recruiting | |
| Platano Centro De Pesquisa Clinica LTDA | Recife | Recruiting | |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto | Ribeirão Preto | Recruiting | |
| Clinica Ibis Medicina Ltda | Salvador | Recruiting | |
| Pesquisare Saude | Santo André | Recruiting | |
| Irmandade da Santa Casa da Misericórdia de Santos | Santos | Recruiting | |
| Funfarme Sjrp | São José do Rio Preto | Recruiting | |
| Hospital Santa Catarina | São Paulo | Recruiting | |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | São Paulo | Recruiting | |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP | São Paulo | Recruiting | |
| Solare Trials | São Paulo | Recruiting | |
| BR Trials | São Paulo | Recruiting | |
| INTEGRAL Pesquisa e Ensino | Votuporanga | Recruiting |
Canada
| Facility | City | State or region | Status |
|---|---|---|---|
| Barrie GI Associates | Barrie | Ontario | Recruiting |
| South Edmonton Gastroenterology Research Clinic | Edmonton | Alberta | Recruiting |
| Viable Clinical Research | Kentville | Nova Scotia | Recruiting |
320 further sites are listed in the registry record.
Study documents
No documents are linked in this registry record.
Changes over time
- August 28, 2026
Site added
2 sites added (370 total)
368370
- July 31, 2026
Site added
1 site added (368 total)
367368