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

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.

Key facts

Study ID

NCT01951326

Run by

RedHill Biopharma Limited

People needed

331

Starts

2013-09-01

Expected to finish

2019-08-01

Last updated by the study team

2020-12-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 greater than or equal to 220 and less than or equal to 450) at baseline.
• 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.
• White blood cell count greater than or equal to 3.5 x 109 at screening.
• 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. .
• 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.

You may not qualify if…

• 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-acetyl salicylic 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.

Where it is running

• Associated Gastroenterology Medical Group, 1211 W. La Palmak Ave, Suite 303 — Anaheim, California, United States
• Medvin Clinical Research, 15627 Imperial Highway, — La Mirada, California, United States
• Digestive Care Associates, Inc., 1000 Laurel St. — San Carlos, California, United States
• Ventura Clinical Trials, 1835 Knoll Drive — Ventura, California, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• Innovative Medical Research of South Florida, 2999 NE 191 St., Suite 330 — Aventura, Florida, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Sunrise Medical Research, Inc. 4700 N. State Road Building A, Suite 111 — Lauderdale Lakes, Florida, United States
• Gastroenterology Group of Naples, 1064 Goodlette Road — Naples, Florida, United States
• Advanced Research Institute Inc., 7114 Congress Street — New Port Richey, Florida, United States
• Endoscopic Research, Inc., 1817 North Mills Avenue — Orlando, Florida, United States
• Advanced Medical Research Center, 1690 Dunlawton Ave., Suite 110 — Port Orange, Florida, United States
• Atlanta Center for Gastroenterology 2665 North Decatur Road Suite 550 — Decatur, Georgia, United States
• Gastrointestinal Specialists of Georgia PC, 711 Canton Rd. Suite 300 — Marietta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• The Carle Foundation, 611 West Park Street — Urbana, Illinois, United States
• Cotton-O'Neil Clinical Research Center, 720 SW Lane St. — Topeka, Kansas, United States
• Investigative Clinical Research, 612 Ridgely Avenue, Suite 401, — Annapolis, Maryland, United States
• Chevy Chase Clinical Research, 5550 Friendship Blvd. — Chevy Chase, Maryland, United States
• Commonwealth Clinical Studies, 189 Quincy St. — Brockton, Massachusetts, United States
• Center For Digestive Health — Troy, Michigan, United States
• West Michigan Clinical Research Center, 2093 Health Dr. SW, Suite 201 — Wyoming, Michigan, United States
• Ehrhardt Clinical Research, LLC, 108 Congress Street — Belton, Missouri, United States
• AGA Clinical Research Associates, Inc., 3205 Fire Road — Egg Harbor, New Jersey, United States
• Del Sol Research Management, 850 N Knob Road — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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