Who is sponsoring NCT05049525?

NCT05049525 is sponsored by Montreal Heart Institute.

What drugs are being tested in NCT05049525?

Interventions in NCT05049525: Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally., Itraconazole's matching placebo 400 mg/day and terbinafine's matching placebo 500 mg/day administered orally..

What condition does NCT05049525 study?

NCT05049525 studies Crohn's Disease, Inflammatory Bowel Diseases.

Is NCT05049525 still recruiting?

NCT05049525 is currently terminated. Last updated 30 May 2024.

Last reviewed 2024-05-30 · How we verify

NCT05049525: CD-IT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Last updated 30 May 2024

What this trial tests

Phase 2 trial testing Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally. in Crohn's Disease in 16 participants. Terminated before completion.

Timeline

22 February 2022

Primary endpoint
28 February 2024

28 February 2024

Quick facts

Lead sponsor	Montreal Heart Institute
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	16
Start date	22 February 2022
Primary completion	28 February 2024
Estimated completion	28 February 2024
Sites	4 locations across Canada

Drugs / interventions tested

Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally. — full drug profile →
Itraconazole's matching placebo 400 mg/day and terbinafine's matching placebo 500 mg/day administered orally.

Conditions studied

Crohn's Disease — all drugs for Crohn's Disease →
Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →

Sponsor

Montreal Heart Institute

Who can join

Adults 18 to 65, any sex, with Crohn's Disease or Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Going Beyond Bacteria: Uncovering the Role of Archaeome and Mycobiome in Inflammatory Bowel Disease.
Houshyar Y, Massimino L, Lamparelli LA, Danese S, et al · · 2021 · cited 26× · PMID 34938203 · DOI 10.3389/fphys.2021.783295
The Role of Gut Microbiota in Gastrointestinal Immune Homeostasis and Inflammation: Implications for Inflammatory Bowel Disease.
Bretto E, Urpì-Ferreruela M, Casanova GR, González-Suárez B. · · 2025 · cited 13× · PMID 40868062 · DOI 10.3390/biomedicines13081807

Verify or expand the search:

Other recruiting trials for Crohn's Disease

Currently open trials in the same condition.

NCT07273188 — 68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease · EARLY_PHASE1 · recruiting
NCT07184944 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184931 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting

Other Montreal Heart Institute trials

Trials by the same sponsor.

NCT07524335 — Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial · Phase 3 · not yet recruiting
NCT07257198 — Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone · Phase 3 · recruiting
NCT07391358 — DAPT Strategy in HBR Patients Undergoing Complex PCI Following ACS: Second-Phase Beta Testing of a Patients Decision Aid · NA · not yet recruiting
NCT05450328 — Inhaled Milrinone and Epoprostenol for the Prevention of Difficult Cardiac Pulmonary Bypass Separation · Phase 2 · not yet recruiting
NCT07144722 — Prehabilitation Program for Patients Awaiting Elective Heart Surgery at Increased Risk of Postoperative Complications: F · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05049525 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Montreal Heart Institute
Last refreshed: 30 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05049525.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing