NCT05928039 PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
| NCT ID | NCT05928039 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Calgary |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 297 participants |
| Start Date | 2023-10-25 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 297 participants in total. It began in 2023-10-25 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There are currently three classes of biologic treatments approved in Canada for the management of moderate-to-severe Crohn's disease: anti-tumor necrosis factor \[TNF\] alpha, anti-integrin, and anti-interleukin \[IL\]-23 targeted agents. The purpose of this trial is to determine which of these three classes of biologics results in the highest percentage of patients with small bowel (ileal) Crohn's disease entering into endoscopic remission without needing corticosteroids at 1 year. Endoscopic remission means that the ulcers in the small bowel from Crohn's disease have healed. All treatments in this trial are approved by Health Canada. No experimental drugs will be included.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05928039 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05928039 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05928039 currently recruiting?
Yes, NCT05928039 is actively recruiting participants. Contact the research team at harsha.ashton@alimentiv.com for enrollment information.
Where is the NCT05928039 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Vancouver, Canada, Vancouver, Canada and 11 additional locations.
Who is sponsoring the NCT05928039 clinical trial?
NCT05928039 is sponsored by University of Calgary. The trial plans to enroll 297 participants.