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: •Males and females 18 to 75 years of age. •Signed fully informed consent provided as per this protocol. •Diagnosis of Crohn’s Disease confirmed by endoscopy or radiography and/or histology at least 6 months prior to randomization into the study. •CD involving the ileum and/or colon •Moderately to severely active CD (Crohn’s Disease Activity Index (CDAI) score of = 220 and =450) at baseline. •Current treatment with at least one of the following therapies: - Oral 5-aminosalicylic acid (5-ASA) compounds. Dose must be stable for at least 4 weeks before baseline. - Corticosteroid therapy. Dose must be stable for at least 2 weeks before baseline. - Azathioprine or 6-mercaptopurine (6-MP) or methotrexate. Dose must be stable for at least 8 weeks before baseline. - Infliximab or adalimumab. Dose must be stable for at least 14 weeks before baseline. • White blood cell count = 3.5x10 exp 9 at screening. • Active Crohn’s disease, defined by at least one of the following: C-reactive protein > Upper Limit of Normal (ULN) at screening, fecal calprotectin > upper Limit of Normal (ULN) at screening, OR radiographic (MRE or CTE) or endoscopic confirmation of the presence of active CD within 5 weeks of screening visit. •Subject agrees to use the following effective contraceptive methods only - diaphragm, cervical cap, contraceptive sponge or condom with spermicidal foam/gel/cream/suppository - 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 288 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: •Crohn’s Disease involvement isolated to the mouth, upper gastrointestinal tract, or anus. •History of total colectomy with ileorectal anastomosis or a proctocolectomy. •Presence of active fistulizing Crohn’s Disease or healed fistula within 2 months prior to screening. •Subject has postoperative stoma, ostomy, or ileoanal pouch. •Subject has short bowel syndrome. •Subject is scheduled for surgical bowel resection. •Subject has known symptomatic obstructive strictures or bowel perforation in the 6 months prior to screening. •Change in dose or discontinuation of oral 5-aminosalicylic acid (5-ASA) compounds less than 4 weeks prior to baseline. •Change in dose or discontinuation of corticosteroids less than 2 weeks prior to baseline. •Change in dose or discontinuation of azathioprine, 6-mercaptopurine (6-MP) or methotrexate less than 8 weeks prior to baseline. •Change in dose or discontinuation of infliximab or adalimumab less than 14 weeks prior to baseline. •Treatment with vedolizumab less than 120 days prior to baseline or biological therapies (apart from infliximab or adalimumab) less than 60 days prior to baseline. •Previous treatment with rifabutin and/or clofazimine. •Oral or parenteral antibiotics in the 4 weeks prior to baseline (topical antibiotics are permitted). •Treatment with probiotics (excluding yogurt and yogurt-derived products) in the 4 weeks prior to baseline. •Females who have a positive pregnancy test or are lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess whether subjects randomized to receive RHB-104 have a higher probability of being in a state of remission at the 26 week assessment as compared to subjects randomized to receive placebo. ; Secondary Objective: Assess whether subjects randomized to receive RHB-104 have a higher probability of being in a state of 1) response at the 26 week assessment 2) remission at the 52 week assessment 3) remission in assessments from week 26 through week 52 4) remission at the 16 week assessment 5) steroid free remission at the 52 week assessment (subjects must be maintained off steroids for 3 weeks in order to be determined to be in steroid free remission e.g. by week 49.) as compared to subjects randomized to receive placebo. ;Primary end point(s): Remission (primary outcome measure) – Remission in a subject is defined as a CDAI score of <150. ;Timepoint(s) of evaluation of this end point: Week 26 | — |
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;Timepoint(s) of evaluation of this end point: Week 26 | — |
Countries
Australia, Bulgaria, Canada, Czech Republic, Israel, New Zealand, Poland, Romania, Serbia, Slovakia, United States
Contacts
Public ContactMedical Director - Ira Kalfus
RedHill Biopharma Ltd.
Outcome results
None listed