Testing IV Tulisokibart against a placebo for Crohn's disease
Official title: A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease
- Phase 3
- 11 groups
- Sites in Calgary, Edmonton and 13 more cities
- Recruiting
Interventions (4)
- Medication
IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
- Medication
SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
- Other intervention
IV Placebo
Placebo matching IV tulisokibart
- Other intervention
SC Placebo
Placebo matching SC tulisokibart
Canadian Sites (17)
15 of 17 recruiting
- Recruiting
Heritage Medical Research Clinic ( Site 0004)
Calgary, Alberta
- Recruiting
Gastroenterology and internal medicine research institute ( Site 0009)
Edmonton, Alberta
- Recruiting
Prairie Institute of Liver and Luminal Advanced Research ( Site 0015)
Lethbridge, Alberta
- Recruiting
Fraser Clinical Trials Inc ( Site 0001)
New Westminster, British Columbia
- Recruiting
G.I.R.I. GI Research Institute Foundation ( Site 0018)
Vancouver, British Columbia
- Recruiting
Private Practice - Dr. Bruce Musgrave ( Site 0014)
Kentville, Nova Scotia
- Recruiting
Barrie GI Associates ( Site 0016)
Barrie, Ontario
- Recruiting
University Hospital - London Health Sciences Centre ( Site 0002)
London, Ontario
- Recruiting
London Health Sciences Centre ( Site 0007)
London, Ontario
- Recruiting
West GTA Research Inc. ( Site 0020)
Mississauga, Ontario
- Recruiting
ABP Research Services Corp. ( Site 0019)
Oakville, Ontario
- Recruiting
Toronto Immune & Digestive Health Institute ( Site 0005)
Toronto, Ontario
- Recruiting
Centre de recherche du CISSS de Chaudière-Appalaches - Hôpital Hôtel Dieu de Levis ( Site 0011)
Lévis, Quebec
- Recruiting
Centre Hospitalier de l'Université de Montréal - Gastroenterology ( Site 0013)
Montreal, Quebec
- Recruiting
Montreal General Hospital ( Site 0003)
Montreal, Quebec
- Not currently recruiting
TDDA Inc. ( Site 0006)
Vaughan, Ontario
- Completed
Diex Recherche Quebec ( Site 0008)
Québec, Quebec
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
- +Has moderately to severely active CD.
- +Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
- +Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.
Exclusion
- −Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- −include but are not limited to the following:
- −Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- −Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
- −Has moderately to severely active CD.
- −Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
- −Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.
- −Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- −Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- −Has current stoma or need for colostomy or ileostomy.
- −Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- −Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
- −Has surgical bowel resection within 3 months of study.
- −Has prior or current gastrointestinal dysplasia.
- −Has chronic infection requiring ongoing antimicrobial treatment.
- −Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years.
- −Has active tuberculosis.
- −Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
- −Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).
- −Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in the study.
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 11 groups in this study.
Group A receives one or more of: IV Tulisokibart and SC Tulisokibart.
Registry label: A: Study 1: High Dose Induction, High Dose Maintenance
Groups B and C receive one or more of: IV Tulisokibart, SC Tulisokibart and SC PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
Registry label: B: Study 1: High Dose Induction, Low Dose Maintenance · C: Study 1: Low Dose Induction, Low Dose Maintenance
Groups D and I, the placebo group, receive one or more of: IV Tulisokibart, IV Placebo and SC Placebo.
Registry label: D: Study 1: Placebo · I: Study 2: Placebo
Groups E, J and K receive SC Tulisokibart.
Registry label: E: Study 1: High Dose Extension · J: Study 2: High Dose Extension · K: Study 2: Low Dose Extension
Group F receives one or more of: SC Tulisokibart and SC Placebo.
Registry label: F: Study 1: Low Dose Extension
Group G receives IV Tulisokibart.
Registry label: G: Study 2: High Dose Induction
Group H receives one or more of: IV Tulisokibart and SC Placebo.
Registry label: H: Study 2: Low Dose Induction
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.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of 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 an age range of 16 years to 80 years.
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.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,200 people.
The study is currently expected to finish around November 2029.
The main measurement is taken over: Week 52.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52 — measured over Week 52.
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52 — measured over Week 52.
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52 — measured over Week 52.
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 — measured over Week 12.
The study lists 5 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06430801 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 IV TulisokibartDrug
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
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 SC TulisokibartDrug
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
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 IV PlaceboOther
Placebo matching IV tulisokibart
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About SC PlaceboOther
Placebo matching SC tulisokibart
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
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: an age range of 16 years to 80 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.maximumAge
- 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?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of 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 an age range of 16 years to 80 years.
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.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 52.
The study as a whole is currently expected to finish around 2029-11-12.
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 1,200 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 25 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Lethbridge, Alberta, Canada; New Westminster, British Columbia, Canada; Vancouver, British Columbia, Canada; Kentville, Nova Scotia, Canada, and 19 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 and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
Other Sites (13)
University of Michigan ( Site 5060)
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan, LLC ( Site 5002)
Clinton Township, Michigan, United States
Mayo Clinic in Rochester, Minnesota ( Site 5024)
Rochester, Minnesota, United States
Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)
Great Neck, New York, United States
Circuit Clinical /Crystal Run Healthcare LLP ( Site 5050)
Middletown, New York, United States
NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)
New York, New York, United States
Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)
New York, New York, United States
New York Gastroenterology Associates ( Site 5013)
New York, New York, United States
Northwell Mather Hospital ( Site 5138)
Port Jefferson, New York, United States
Washington Gastroenterology - Bellevue ( Site 5040)
Bellevue, Washington, United States
Swedish Medical Center ( Site 5112)
Seattle, Washington, United States
University of Washington ( Site 5115)
Seattle, Washington, United States
Washington Gastroenterology - Tacoma ( Site 5004)
Tacoma, Washington, United States
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This 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.