Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01951326
• Date of registration: 19/09/2013
• Prospective Registration: No
• Primary sponsor: RedHill Biopharma Limited
• Public title: Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease MAPUS
• Scientific title: A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects With Moderately to Severely Active Crohn's Disease
• Date of first enrolment: September 2013
• Target sample size: 331
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01951326
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Bulgaria, Canada, Czech Republic, Czechia, Israel, New Zealand, Poland, Serbia, Slovakia, United States

Contacts

• Name: Ira N Kalfus, MD
• Affiliation: RedHill Biopharma

• Name: David Y. Graham, MD
• Affiliation: Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston

Key inclusion & exclusion criteria

Inclusion Criteria

1. Signed fully informed consent provided as per this protocol.

2. Diagnosis of Crohn's Disease confirmed by endoscopy or radiography and/or histology at
least 6 months prior to randomization into the study.

3. CD involving the ileum and/or colon

4. Moderately to severely active CD (Crohn's Disease Activity Index (CDAI) score of
greater than or equal to 220 and less than or equal to 450) at baseline.

5. Current treatment with at least one of the following therapies:

A. Oral 5-acetyl salicylic acid (5-ASA) compounds. Dose must be stable for at least 4
weeks before baseline.

B. Corticosteroid therapy. Dose must be stable for at least 2 weeks before baseline.

C. Azathioprine or 6-mercaptopurine (6-MP) or methotrexate. Dose must be stable for at
least 8 weeks before baseline.

D. Infliximab or adalimumab. Dose must be stable for at least 14 weeks before
baseline.

6. White blood cell count greater than or equal to 3.5 x 109 at screening.

7. Active Crohn's disease, defined by at least one of the following: C-reactive protein
greater than Upper Limit of Normal (ULN) at screening, fecal calprotectin greater than
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. .

8. Subject agrees to use barrier contraceptive methods (i.e. diaphragm, cervical cap,
contraceptive sponge or condom) with spermicidal foam/gel/cream/suppository, IUD/IUS
or progestogen injection (Depo-Provera®) 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. In regions where local regulatory contraceptive requirements differ, the
ICF will reflect local policies.

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. Presence of active fistulizing Crohn's Disease or healed fistula within 2 months prior
to screening.

4. Subject has postoperative stoma, ostomy, or ileoanal pouch.

5. Subject has short bowel syndrome.

6. Subject is scheduled for surgical bowel resection.

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 baseline.

9. Change in dose or discontinuation of corticosteroids less than 2 weeks prior to
baseline.

10. Change in dose or discontinuation of azathioprine, 6-mercaptopurine (6-MP) or
methotrexate less than 8 weeks prior to baseline.

11. Change in dose or discontinuation of infliximab or adalimumab less than 14 weeks prior
to baseline.

12. 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.

13. Previous treatment with rifabutin and/or clofazimine.

14. Oral or parenteral antibiotics in the 4 weeks prior to baseline (topical antibiotics
are permitted).

15. Treatment with probiotics (excluding yogurt and yogurt-derived products) in the 4
weeks prior to baseline.

16. Females who have a positive pregnancy test or are lactating.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Placebo

Drug: RHB-104

Primary Outcome(s)

Remission at Week 26 [Time Frame: Week 26]

Secondary Outcome(s)

Response at Week 26 [Time Frame: Week 26]

Steroid Free Remission at Week 52 [Time Frame: Week 52]

Durable Remission Week 26 Through Week 52 [Time Frame: Week 26 through week 52]

Remission at Week 16 [Time Frame: Week 16]

Remission at Week 52 [Time Frame: Week 52]

Secondary ID(s)

RHB-104-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01951326