Moderately Active Crohn's Disease MedDRA version: 18.0 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. Males and females 18 to 75 years of age. 2. Able to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study. 3. Be willing to provide written informed consent (IC) as evidenced by signature on an informed consent document approved by an institutional review board (IRB) or independent ethics committee (IEC). 4. Diagnosis of Crohn’s disease confirmed by endoscopy or radiography and/or histology at least 6 months prior to randomization into the study. 5. CD involving the ileum and/or colon. 6. Moderately active Crohn’s Disease Activity Index (CDAI) score of =220 and =450 at Visit 1. 7. Treatment with at least one of the following therapies at screening: - Oral 5-acetyl salicylic acid (5-ASA) compounds: Dose must be stable for at least 4 weeks - Corticosteroid therapy: Dose must be stable for at least 2 weeks - Azathioprine or 6-mercaptopurine (6-MP) or methotrexate: Dose must be stable for at least 8 weeks - Infliximab or adalimumab: Dose must be stable for at least 8 weeks 8. White blood cell count = 3.5x10^9 at screening. 9. 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 (CTE or MRE) OR endoscopic with photographic confirmation of the presence of active CD within 4 weeks of screening visit. Upon approval of the medical monitor, screening colonoscopy and baseline visit may be performed up to 6 weeks after the screening visit. 10. Subject agrees to use barrier contraceptive methods (i.e. diaphragm, cervical cap, contraceptive sponge or condom) with spermicidal foam/gel/cream/suppository, or IUD throughout the study and for at least 6 weeks after last study drug administration, unless subject is post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation, or has had a vasectomy. 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 330 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Crohn’s disease involvement isolated to the mouth, upper gastrointestinal tract, or anus. 2. History of total colectomy with ileorectal anastomosis or a proctocolectomy. 3. Subject has postoperative stoma, ostomy, or ileoanal pouch. 4. Any fistulizing Crohn’s Disease other than asymptomatic internal fistulae, simple (non- draining) perianal fistulae without inflammation or healed fistula. 5. Subject has short bowel syndrome. 6. Subject is scheduled for surgical bowel resection or is anticipated to require surgical intervention for CD during the study. 7. Subject has known symptomatic obstructive strictures or bowel perforation in the 6 months prior to screening. 8. Change in dose or discontinuation of oral 5-acetyl salicylic acid (5-ASA) compounds less than 4 weeks prior to screening. 9. Change in dose or discontinuation of corticosteroids less than 2 weeks prior to screening. 10. Change in dose or discontinuation of azathioprine, 6-mercaptopurine (6-MP) or methotrexate less than 4 weeks prior to screening 11. Treatment with vedolizumab < 120 days prior to screening or other biological therapies (infliximab, adalimumab are allowed at a stable dose for at least 8 weeks) < 60 days prior to screening. 12. Treatment with any medication that causes QT prolongation or Torsades de Pointes within 7 days prior to initiation of study drug. 13. Treatment with the outlined medications within 7 days prior to initiation of study drug. 14. Previous treatment with amiodarone. 15. Previous treatment with rifabutin and/or clofazimine. 16. Oral or parenteral antibiotics in the 4 weeks prior to screening (topical antibiotics are permitted). 17. Treatment with probiotics (excluding yogurt and yogurt-derived products) in the 4 weeks prior to screening. 18. Concomitant use of cyclosporine administered within the previous 8 weeks prior to screening. 19. Chronic use of oral or systemic corticosteroid therapy for other disease(s) e.g. pulmonary diseases. Stable inhaled corticosteroids are permitted. 20. Adverse reaction or hypersensitivity to the study drug or any medications related to the study drug. 21. Positive stool results for C. difficile, other pathogens including ova, or parasites. 22. Positive serology for Hepatitis B, Hepatitis C, or HIV. • If positive history of previously treated Hepatitis C, but HCV PCR is undetectable off medications for at least 6 months prior to screening, and treating hepatologist or infectious disease specialist believes the subject is cured – subject may be enrolled 23. History of: • Atypical mycobacterial infections (other than MAP) • Active tuberculosis requiring treatment in the past 3 years 24. Positive or indeterminate QuantiFERON TB Gold test: • In the presence of clinical signs/symptoms of TB or high risk of TB infection 25. Currently diagnosed or history of uveitis confirmed by either an ophthalmologist or optometrist. 26. Evidence of any significant hematological, hepatic, renal, cardiac, pulmonary, metabolic, neurological, psychiatric or other disease that might interfere with subject’s ability to safely enter and or complete the study requirements. 27. History of malignancy within the past five years prior to screening except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been treated with no evidence of recurrence. 28. Current treatment with total parenteral nutrition. 29. Females who have a positive pregnancy test or are lactating. 30. Hi
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 response at 26 weeks 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: 26 weeks and 52 weeks | — |
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 Visit 1 ;Timepoint(s) of evaluation of this end point: Visit 1, 26 weeks and 52 weeks | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Ireland, Netherlands, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom
Contacts
Public ContactMedical Director
RedHill Biopharma Ltd.
Outcome results
None listed