Last updated: December 1, 2023
Sponsor: University of Calgary
Overall Status: Active - Recruiting
Phase
4
Condition
N/ATreatment
Anti-IL12/23 or anti-IL23 - Ustekinumab
TNFa Antagonist - Adalimumab
TNFa Antagonist - Infliximab
Clinical Study ID
NCT05928039
REB22-1641/RCT-01741
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or nonpregnant, nonlactating females, 18 years of age or older. Females ofchildbearing potential must have a negative serum or urine pregnancy test prior torandomization
- Established CD diagnosis by conventional criteria
- Baseline colonoscopy within 3 months of the first day of the screening period, withphoto or video documentation of at least one large ileal ulcer >5 mm and ileal segmentSES-CD ≥4 (eligibility will be determined by local endoscopist, with subsequentconfirmation by a CR at a later time, post enrolment)
- HBI ≥5
- Biologic-treatment naïve for CD-related therapies
- Would otherwise have been eligible to start a biologic for moderate-to-severely activeCD as part of their routine clinical care and for whom there is equipoise around whichbiologic class to start
- Willing and able to participate fully in all aspects of this clinical trial, includingadherence to study protocol and treatment algorithm
- Written informed consent must be obtained and documented
Exclusion
Exclusion Criteria:
- Condition(s) for which the biologics included in this study is contraindicated
- CD-related complications such as symptomatic, endoscopically impassable strictures orabscesses that require imminent surgery (at investigator's discretion)
- Participants with current or history of colonic dysplasia or neoplasia, toxicmegacolon, or fulminant colitis
- Recent bowel resection <3 months before screening
- Active enteric infection (positive stool culture), including but not limited tobacterial (including C. difficile), viral, or parasitic enteric infections
- Known active hepatitis B, hepatitis C, or human immunodeficiency virus infection
- Active COVID-19 infection during the screening period
- Tested positive as part of SOC for tuberculosis (TB) at screening by QuantiFERON® TBGold Test, tuberculin skin test, or history of untreated latent or active TB
- History of malignancy within 5 years of screening, except fully treated carcinomain-situ of the cervix, fully treated and resolved nonmetastatic squamous or basal cellcarcinoma of the skin
- Active chronic or acute infections requiring treatment with systemic antibiotics,antivirals, antifungals, antiparasitics, or antiprotozoals during the screening period
- Serious underlying disease other than CD that, in the opinion of the investigator, mayinterfere with the participant's ability to participate fully in the study
- Not willing to withhold protocol-prohibited medications during the trial, or plannedor anticipated use of any prohibited medications during screening
- Received previously or currently receiving a TNF antagonist, anti-integrin, monoclonalantibody targeting IL-12/23 or IL-23, Janus kinase (JAK) inhibitors, or sphingosine 1phosphate (S1P) receptor modulators (irrespective of indication)
- History of alcohol or drug abuse that, in the opinion of the investigator, mayinterfere with the participant's ability to comply with the study procedures
Study Design
Total Participants: 297
Treatment Group(s): 6
Primary Treatment: Anti-IL12/23 or anti-IL23 - Ustekinumab
Phase: 4
Study Start date:
October 25, 2023
Estimated Completion Date:
December 31, 2028
Study Description
Connect with a study center
University of Calgary
Calgary, Alberta
CanadaActive - Recruiting


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