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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 June 2024
• Main ID: NCT05049525
• Date of registration: 25/08/2021
• Prospective Registration: Yes
• Primary sponsor: Montreal Heart Institute
• Public title: Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease CD-IT
• Scientific title: Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease Not Responding Adequately to Current Therapy
• Date of first enrolment: February 22, 2022
• Target sample size: 16
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT05049525
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Jean-Claude Tardif, MD
• Affiliation: Montreal Heart Institute (MHI)

• Name: Edmond-Jean Bernard, MD
• Affiliation: Centre hospitalier de l'Université de Montréal (CHUM)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with endoscopy/radiology confirmation of active disease within 6 months
prior to enrolment;

- Mild to moderate active CD defined by the HBI score of = 5 to = 16 at baseline;

- Female of childbearing potential must have a negative urine pregnancy test at
screening and at randomization baseline Visit 2. Women are considered not of
childbearing potential if they either:

- Have had a hysterectomy or tubal ligation prior to baseline visit or;

- Are postmenopausal defined as no menses for 12 months or a FSH level (if available)
in the menopausal range.

- Women of childbearing potential must agree to use an effective double method of
birth control throughout the study: barrier method (e.g. male or female condoms,
spermicides, sponges, foams, jellies, and diaphragm) in combination with other
methods of contraception including implantable contraceptives, injectable
contraceptives, oral contraceptives, transdermal contraceptives, intrauterine
devices, abstinence, or a sterile sexual partner.

- Subjects with the capacity to provide informed consent.

Exclusion Criteria:

- Subject with a current diagnosis of ulcerative colitis (UC);

- Contraindication to the use of itraconazole including congestive heart failure,
ventricular dysfunction, ventricular arrhythmia, or negative inotropic state;

- Subjects with elevated or abnormal liver enzymes (ALT/AST>3 ULN) or patients with
pre-existing chronic or active liver disease at screening;

- Female subject who is pregnant, planning to become pregnant during the study, or
breastfeeding;

- Subject with renal impairment (creatinine clearance = 50 mL/min using
Cockcroft-Gault equation);

- Subject with a known hypersensitivity to itraconazole, terbinafine, or any of their
excipients;

- Subjects on medications which interact with itraconazole: methadone, pimozide,
quinidine or other CYP3A4 inhibitors;

- Positive C. difficile toxin test at screening;

- Use of steroid greater than 20 mg/day;

- Change of steroid dosage in the 2 weeks prior to enrolment;

- Change in CD therapy:

- The Anti-TNFs, anti-integrins, anti-IL12/23 in the 4 months prior to enrolment;

- Thiopurines or methotrexate (MTX), in the 2 months prior to enrolment;

- Participation in other clinical trial within 30 days of signing the Information and
Consent Form (ICF).


Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Diseases

Crohn's Disease

Intervention(s)

Drug: Itraconazole's matching placebo 400 mg/day and terbinafine's matching placebo 500 mg/day administered orally.

Drug: Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally.

Primary Outcome(s)

To evaluate the response of itraconazole and terbinafine therapy compared to placebo in subjects with CD, assessed by the Modified Harvey Bradshaw Index (HBI). [Time Frame: 20 Weeks]

Secondary Outcome(s)

To evaluate the response of the itraconazole and terbinafine therapy compared to placebo in subjects with CD on clinical remission assessed by the HBI. [Time Frame: 20 Weeks]

To evaluate the response of the itraconazole and terbinafine therapy compared to placebo in subjects with CD on fecal and serologic markers. [Time Frame: 20 Weeks]

To evaluate the effect of study treatment on the primary endpoint in the subgroup of patients with positive ASCA (as measured on frozen plasma samples at end of the study). [Time Frame: 20 weeks]

To evaluate the response of the itraconazole and terbinafine therapy compared to placebo in subjects with CD on endoscopic response assessed by the Simplified Endoscopic Score for Crohn's disease (SES-CD). [Time Frame: 20 Weeks]

Secondary ID(s)

MHICC-2019-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors