NCT05049525

Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease

Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease Not Responding Adequately to Current Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the response of itraconazole and terbinafine therapy compared to placebo in patients with mild to moderate Crohn's disease (CD).

Detailed description

This multicenter, randomized, double-blind, placebocontrolled, phase II, proof of concept study will randomize 68 subjects at 2 to 5 clinical sites in Canada. Following signature of informed consent, subjects who meet entry criteria will be randomized in a 1:1 ratio to receive either itraconazole and terbinafine, or matching placebos. During the first 4 weeks subjects will receive itraconazole 200 mg twice daily or matching placebo, followed by itraconazole 200 mg twice daily and terbinafine 250 mg twice daily or matching placebos for the remaining 16 weeks. The 2 drugs will be administered orally.

Conditions

• Crohn's Disease
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally.	Itraconazole capsules of 100 mg, antifungal agent. Terbinafine tablets 250 mg (as terbinafine hydrochloride), antifungal agent.
DRUG	Itraconazole's matching placebo 400 mg/day and terbinafine's matching placebo 500 mg/day administered orally.	Matching placebo of itraconazole capsules of 100 mg, antifungal agent. Matching placebo of terbinafine tablets 250 mg, antifungal agent.

Timeline

• Start date: 2022-02-22
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2021-09-20
• Last updated: 2024-05-30

Locations

4 sites across 1 country: Canada