Crohn's DiseasePhase 2CD-ITNCT05049525
Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease
A Phase 2 study testing Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally. in people with Crohn's Disease and Inflammatory Bowel Diseases, run by Montreal Heart Institute at 4 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease, Inflammatory Bowel Diseases
- What is being tested?
- Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 4 sitesCanada
- Study dates
- 22 Feb 2022to 28 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
CIUSSS de l'Est-de-l'Île-de-Montréal, Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T2M4
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, H2X0A9
McGill University Health Center
Montreal, Quebec, H3G1A4
Centre intégré universitaire de santé et de services sociaux de l'Estrie - CHUS
Sherbrooke, Quebec, J1G 2E8
About this study
Official title: Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease Not Responding Adequately to Current Therapy
This study will evaluate the response of itraconazole and terbinafine therapy compared to placebo in patients with mild to moderate Crohn's disease (CD).
Read the 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
- Being tested
- 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.
- Keywords
- Endoscopy, Radiology, Itraconazole, Terbinafine, Chronic Inflammatory Disorder, Malassezia Restricta
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally.Drug
Itraconazole capsules of 100 mg, antifungal agent. Terbinafine tablets 250 mg (as terbinafine hydrochloride), antifungal agent.
Itraconazole's matching placebo 400 mg/day and terbinafine's matching placebo 500 mg/day administered orally.Drug
Matching placebo of itraconazole capsules of 100 mg, antifungal agent. Matching placebo of terbinafine tablets 250 mg, antifungal agent.
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole and Terbinafine | Active comparator | During the first 4 weeks itraconazole will be administered alone at 200 mg twice daily, followed by itraconazole 200 mg twice daily and terbinafine 250 mg twice daily for the remaining 16 weeks. Both drugs will be administered orally. Receives: Drug: Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally. |
| Placebo | Placebo comparator | During the first 4 weeks a placebo will be administered alone at 200 mg twice daily, followed by placebo 200 mg twice daily and another placebo 250 mg twice daily for the remaining 16 weeks. Both placebos will be administered orally. Receives: Drug: Itraconazole's matching placebo 400 mg/day and terbinafine's matching placebo 500 mg/day administered orally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the response of itraconazole and terbinafine therapy compared to placebo in subjects with CD, assessed by the Modified Harvey Bradshaw Index (HBI).
Clinical response defined as a decrease from baseline to end of treatment in HBI ≥ 3 points
Measured: 20 Weeks
Secondary outcomes (4)
To evaluate the response of the itraconazole and terbinafine therapy compared to placebo in subjects with CD on clinical remission assessed by the HBI.
- Persistence of clinical response defined as a decrease from baseline to 8 weeks post end of treatment in HBI ≥ 3 points
- Clinical remission defined as an HBI at end of treatment ≤ 4 points
- Persistence of clinical remission defined as an HBI at 8 weeks post end of treatment ≤ 4 points
- Change from baseline to end of treatment in HBI
Measured: 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).
- Endoscopic response defined a decrease from baseline to end of treatment in SES-CD ≥ 50% of the baseline SES-CD
- Change from baseline to end of treatment in SES-CD
Measured: 20 Weeks
To evaluate the response of the itraconazole and terbinafine therapy compared to placebo in subjects with CD on fecal and serologic markers.
- Change from baseline to end of treatment in FC levels
- Change from baseline to end of treatment in CRP levels
Measured: 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).
- Change from baseline to end of treatment in ASCA levels
- Change from baseline to 8 weeks post end of treatment in ASCA levels
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start22 Feb 2022
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Why it stopped: Insufficient patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Claude Tardif, MD, Principal investigator, Montreal Heart Institute (MHI)Edmond-Jean Bernard, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049525
- Sponsor's protocol ID
- MHICC-2019-001
- Acronym
- CD-IT
- Status last verified
- May 2024
- First submitted
- 25 Aug 2021
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease Not Responding Adequately to Current Therapy
- ClinicalTrials.gov ID
- NCT05049525
- Acronym / sponsor ID
- CD-IT / MHICC-2019-001
- Conditions
- Crohn's Disease, Inflammatory Bowel Diseases
- Keywords
- Endoscopy, Radiology, Itraconazole, Terbinafine, Chronic Inflammatory Disorder, Malassezia Restricta
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient patient enrollment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itraconazole and Terbinafine | Active comparator | Drug: Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally.During the first 4 weeks itraconazole will be administered alone at 200 mg twice daily, followed by itraconazole 200 mg twice daily and terbinafine 250 mg twice daily for the remaining 16 weeks. Both drugs will be administered orally. |
| Placebo | Placebo comparator | Drug: Itraconazole's matching placebo 400 mg/day and terbinafine's matching placebo 500 mg/day administered orally.During the first 4 weeks a placebo will be administered alone at 200 mg twice daily, followed by placebo 200 mg twice daily and another placebo 250 mg twice daily for the remaining 16 weeks. Both placebos will be administered orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 and Terbinafine |
| 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. | Drug | Placebo |
Primary outcome
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
Clinical response defined as a decrease from baseline to end of treatment in HBI ≥ 3 points
4 secondary outcomes
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 endoscopic response assessed by the Simplified Endoscopic Score for Crohn's disease (SES-CD).
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
Results and safety
The study was stopped early (reason given: Insufficient patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Claude Tardif, MD principal investigator
Montreal Heart Institute (MHI)
Edmond-Jean Bernard, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally. in people with Crohn's Disease and Inflammatory Bowel Diseases, run by Montreal Heart Institute at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient patient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.