drugset / Trial / NCT05928039

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

NCT05928039

Phase 4 Recruiting 297 enrolled University of Calgary Alimentiv Inc. · collab
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2023-10-25
Primary completion
2027-07-30
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous
Comparator Infliximab Monoclonal antibody 5 mg/kg Intravenous
Comparator Risankizumab Monoclonal antibody 360 mg Intravenous
Comparator Ustekinumab Monoclonal antibody 90 mg Intravenous
Comparator Vedolizumab Monoclonal antibody 108 mg Intravenous
Comparator Vedolizumab Monoclonal antibody 300 mg Intravenous

Indications