Moderately to Severely Active Crohn's Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
RedHill Biopharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participation in RHB-104-01 for: - 26 weeks, and a Crohn’s Disease Activity Index (CDAI) score of = 150 at Visit Week 26 OR - More than 26 weeks, with a CDAI =150 at Visit Week 26 and all subsequent visits, and subject is between Week 26 and 52 within 4 weeks (28 days) of site activation 2) White blood cell count = 3.5x109 at screening 3) Subject agrees to use the following effective contraceptive methods - diaphragm, cervical cap, contraceptive sponge or condom with spermicidal foam - IUD/IUS - progestogen injection (Depo-Provera®) throughout the study and for at least 6 weeks after last study drug administration, unless subject or partner of subject is post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation, or has had a vasectomy. In regions where local regulatory contraceptive requirements differ, the ICF will reflect local policies Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1) Treatment with any medication that causes QT prolongation or Torsades de Pointes, including but not limited to: amiodarone, amitriptyline, astemizole, cisapride, citalopram dose greater than 20 mg/day, dihydroergotamine, disopyramide, dofetilide, dronedarone, ergotamine, ibutilde, ondansetron or other 5-HT3 receptor antagonists, pimozide, procainamide, quinidine, quinine, quinolones, ranolazine, risperidone, sotalol, terfenadine and tolteridine. QT prolonging drugs may be referenced at the CredibleMeds® web site: https://crediblemeds.org/index.php/drugsearch 2) Treatment with the following CYP3A4 interactive medications: alfentanyl,alprazolam, amlodipine, anti-retroviral agents, apixabin, aprepitant, aripiprazole, atorvastatin, boceprevir, buspirone, carbamazepine, carvedilol, colchicine, cyclosporine, digoxin, diltiazem, estrogens, felodipine, fluconazole, fluvoxamine, grapefruit juice, haloperidol, ketoconazole, lovastatin, lurasidone, metoprolol, nefazodone, nifedipine, nisoldipine, nitrendipine, propranol, roflumilast, simvastatin, St. John’s wort, and voriconazole. 3) Positive stool results for C. difficile. 4) Currently diagnosed or history of uveitis confirmed by either an ophthalmologist or optometrist. 5) Evidence of any significant hematological, hepatic, renal, cardiac, pulmonary, metabolic, neurological, psychiatric or other disease (e.g. porphyria) that might interfere with subject’s ability to safely enter and or complete the study requirements. 6) Clinically significant abnormalities of hematology or biochemistry as confirmed by repeat testing based on investigator’s discretion, including but not limited to, elevations greater than 2 times the upper limit of normal of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), or creatinine clearance less than 60 ml/min at screening via estimated Cockcroft-Gault formula: Creatinine Clearance = [140 - age in years] * weight (kg) / 72 * Serum Creatinine (mg/dl) [multiply estimated rate by 0.85 for women], using actual body weight. 7) QTcF>450ms in males and QTcF>460ms in females, bundle branch block, or major ST or T wave abnormalities that make the assessment of the QT impossible. 8) Females who have a positive pregnancy test or are lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to estimate the remission rate, defined as a CDAI score of less than 150, at 16 weeks after the initiation of the open-label phase.;Secondary Objective: To estimate the -response rate of patients, defined by a reduction of CDAI score of =100 points at week 16 after the initiation of the open-label phase - average duration of remission among participants - average time to first response among participants - average duration of response among participants - the proportion of participants who maintain a state of remission from week 16 through week 52. ;Primary end point(s): Remission (primary outcome measure) – Remission in a subject is defined as a CDAI score of <150 at 16 weeks.;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response – A response in the individual subject is defined as reduction in CDAI score of =100 from baseline where baseline is the measure taken at Screening of this trial (Visit Week 26 of RHB-104-01.);Timepoint(s) of evaluation of this end point: Visit Week 26 of RHB-104-01 study | — |
Countries
Australia, Canada, Czech Republic, Israel, New Zealand, Poland, Serbia, Slovakia, United States
Contacts
Public ContactMedical Director - Ira Kalfus
RedHill Biopharma Ltd.
Outcome results
None listed