PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease

Launched by UNIVERSITY OF CALGARY · Jun 22, 2023

Keywords

ClinConnect Summary

The PATHFINDER trial is studying the best first-line treatment for adults with moderate-to-severe Crohn's disease that mainly affects the small intestine, known as ileal-dominant Crohn's disease. The goal is to find out which of three approved biologic treatments helps the most patients heal their intestinal ulcers and avoid the use of corticosteroids after one year. All treatments being tested are already approved in Canada, so participants will not be receiving any experimental drugs.

To be eligible for this trial, participants must be 18 years or older and have a confirmed diagnosis of Crohn's disease with specific characteristics, such as having large ulcers in the ileum. They should not have previously received biologic treatments for Crohn's disease and must be willing to follow the study's guidelines. If you join the trial, you can expect regular check-ins and assessments to monitor your progress and overall health. It's important to know that certain medical conditions, recent surgeries, or infections could prevent someone from participating, so discussing any concerns with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• 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. HBI ≥5
• • 5. Biologic-treatment naïve for CD-related therapies
• • 6. 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
• • 7. 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. Not willing to withhold protocol-prohibited medications during the trial, or planned or anticipated use of any prohibited medications during screening
• • 13. 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)
• • 14. 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