Evaluating the best first-line treatment for moderate-to-severe Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to compare the effectiveness of three classes of biologic treatments for patients with moderate-to-severe ileal-dominant Crohn's disease. Participants will be randomly assigned to receive either a TNF antagonist, anti-integrin, or anti-IL23 targeted therapy, all of which are approved treatments. The primary goal is to determine which treatment leads to the highest rate of endoscopic remission without the need for corticosteroids after one year. Participants will be monitored and assessed through standard care protocols, including various clinical evaluations and a video-recorded ileocolonoscopy at the end of the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or nonpregnant, nonlactating females, 18 years of age or older. Females of childbearing potential must have a negative serum or urine pregnancy test prior to randomization
2. Established CD diagnosis by conventional criteria
3. Baseline colonoscopy within 3 months of the first day of the screening period, with photo or video documentation of at least one large ileal ulcer \>5 mm and ileal segment SES-CD ≥4 (eligibility will be determined by local endoscopist, with subsequent confirmation by a CR at a later time, post enrolment)
4. Biologic-treatment naïve for CD-related therapies
5. Would otherwise have been eligible to start a biologic for moderate-to-severely active CD as part of their routine clinical care and for whom there is equipoise around which biologic class to start
6. Willing and able to participate fully in all aspects of this clinical trial, including adherence to study protocol and treatment algorithm

8\. Written informed consent must be obtained and documented

Exclusion Criteria:

1. Condition(s) for which the biologics included in this study is contraindicated
2. CD-related complications such as symptomatic, endoscopically impassable strictures or abscesses that require imminent surgery (at investigator's discretion)
3. Participants with current or history of colonic dysplasia or neoplasia, toxic megacolon, or fulminant colitis
4. Recent bowel resection \<3 months before screening
5. Active enteric infection (positive stool culture), including but not limited to bacterial (including C. difficile), viral, or parasitic enteric infections
6. Known active hepatitis B, hepatitis C, or human immunodeficiency virus infection
7. Active COVID-19 infection during the screening period
8. Tested positive as part of SOC for tuberculosis (TB) at screening by QuantiFERON® TB Gold Test, tuberculin skin test, or history of untreated latent or active TB
9. History of malignancy within 5 years of screening, except fully treated carcinoma in-situ of the cervix, fully treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin
10. Active chronic or acute infections requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics, or antiprotozoals during the screening period
11. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant's ability to participate fully in the study
12. Pregnancy or breastfeeding
13. Not willing to withhold protocol-prohibited medications during the trial, or planned or anticipated use of any prohibited medications during screening
14. Received previously or currently receiving a TNF antagonist, anti-integrin, monoclonal antibody targeting IL-12/23 or IL-23, Janus kinase (JAK) inhibitors, or sphingosine 1 phosphate (S1P) receptor modulators (irrespective of indication)
15. History of alcohol or drug abuse that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures

Where it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting
• University of Alberta IBD Clinic
  Edmonton, Alberta, Canada Recruiting
• GI Research Institute (G.I.R.I)
  Vancouver, British Columbia, Canada Recruiting
• West Coast Gastroenterology
  Vancouver, British Columbia, Canada Recruiting
• Nova Scotia Health Victoria
  Halifax, Nova Scotia, Canada Recruiting
• GNRR Digestive Clinics and Research Center Inc
  Brampton, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Harsha Ashton
• Email: harsha.ashton@alimentiv.com
• Phone: 226-919-6959

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.