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

NCT05928039 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2025-06-11

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

BIOLOGICAL

TNFa Antagonist - Infliximab

• Infliximab 5 mg/kg intravenously \[IV\] at weeks 0, 2, 6, then 5 mg/kg every 8 weeks

BIOLOGICAL

TNFa Antagonist - Adalimumab

• Adalimumab subcutaneously \[SC\] 160 mg at week 0, 80 mg at week 2, then 40 mg every 2 weeks

BIOLOGICAL

Anti-IL12/23 or anti-IL23 - Ustekinumab

• Ustekinumab \~6 mg/kg IV x1, then 90 mg SC every 8 weeks

BIOLOGICAL

Anti-IL12/23 or anti-IL23 - Risankizumab

• Risankizumab 600 mg IV at weeks 0, 4, and 8, then 360 mg SC every 8 weeks

BIOLOGICAL

Anti-integrin - Vedolizumab IV

• Vedolizumab 300 mg IV at weeks 0, 2, and 6, then every 8 weeks

BIOLOGICAL

Anti-integrin - Vedolizumab IV and SC

• Vedolizumab 300 mg IV at weeks 0 and 2, then 108 mg SC every 2 weeks

Sponsors & Collaborators

  • Alimentiv Inc.

    collaborator OTHER

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05928039 on ClinicalTrials.gov