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

Inclusion Criteria:

• Subjects with endoscopy/radiology confirmation of active disease within 6 monthsprior 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 atscreening and at randomization baseline Visit 2. Women are considered not ofchildbearing 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 ofbirth control throughout the study: barrier method (e.g. male or female condoms,spermicides, sponges, foams, jellies, and diaphragm) in combination with othermethods of contraception including implantable contraceptives, injectablecontraceptives, oral contraceptives, transdermal contraceptives, intrauterinedevices, 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 withpre-existing chronic or active liver disease at screening;

• Female subject who is pregnant, planning to become pregnant during the study, orbreastfeeding;

• Subject with renal impairment (creatinine clearance ≤ 50 mL/min usingCockcroft-Gault equation);

• Subject with a known hypersensitivity to itraconazole, terbinafine, or any of theirexcipients;

• 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 andConsent Form (ICF).