Testing Icotrokinra against a placebo for ulcerative colitis
Official title: A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis
- Phase 3
- 6 groups
- Sites in Edmonton, Vancouver and 7 more cities
- Recruiting
Interventions
- Medication
Icotrokinra
Icotrokinra tablet will be administered orally.
- Medication
Placebo
Placebo tablet will be administered orally.
Canadian Sites (11)
11 of 11 recruiting
- Recruiting
South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta
- Recruiting
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta
- Recruiting
GIRI Gastrointestinal Research Institute
Vancouver, British Columbia
- Recruiting
Viable Clinical Research
Kentville, Nova Scotia
- Recruiting
Barrie GI Associates
Barrie, Ontario
- Recruiting
London Digestive Disease Institute
London, Ontario
- Recruiting
West GTA Research Inc
Mississauga, Ontario
- Recruiting
ABP Research Services Corp.
Oakville, Ontario
- Recruiting
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario
- Recruiting
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec
- Recruiting
Clinique IMD
Montreal, Quebec
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Moderately to severely active UC, defined as a baselineBaselineYour starting measurements, taken before treatment begins.Read more → (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screeningScreeningThe checks done before joining, to see whether a study fits.Read more → video endoscopy
- +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
- +An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopy
- +Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0)
- +Demonstrated an inadequate response to, or failure to tolerate conventional therapy but are naïve to advanced therapies (ADT naïve), or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of UC (ADT-inadequate responder \[IR\]) as defined in the protocolProtocolThe detailed plan a study must follow.Read more →
- +Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
Exclusion
- −Presence of a stoma
- −Presence or history of a fistula
- −History of extensive colonic resection (that is, less than \[\<\] 30 centimeter \[cm\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention
- −Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in the study
- −Colonic resection within 24 weeks before baselineBaselineYour starting measurements, taken before treatment begins.Read more → or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 6 groups in this study.
Groups A, C, E and F receive Icotrokinra.
Registry label: A: Double-blind (DB) Induction Study: Icotrokinra · C: DB Maintenance Study: Icotrokinra · E: Open-label (OL) Induction Phase: Icotrokinra · F: OL Maintenance Phase: Icotrokinra
Groups B and D, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receive Placebo.
Registry label: B: DB Induction Study: Placebo · D: DB Maintenance Study: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 12 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 882 people.
The study is currently expected to finish around January 2032.
The main measurement is taken over: At Week I-12.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Double-blindDouble-blindNeither you nor the study team knows which group you are in.Read more → (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 — measured over At Week I-12.
DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 — measured over At Week M-40.
Open-LabelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more → (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 — measured over At Week M-40.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07196748 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About IcotrokinraDrug
Icotrokinra tablet will be administered orally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Placebo tablet will be administered orally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 12 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 12 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At Week I-12.
The study as a whole is currently expected to finish around 2032-01-13.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 882 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Kentville, Nova Scotia, Canada; Barrie, Ontario, Canada; London, Ontario, Canada; Mississauga, Ontario, Canada, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
Other Sites (8)
Westchester Putnam Gastroenterology
Carmel, New York, United States
Inflammatory Bowel Disease Center at NYU Langone
New York, New York, United States
Manhattan Clinical Research LLC
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
New York Gastroenterology Associates
New York, New York, United States
GI Alliance Tacoma
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.