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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by RedHill Biopharma Limited
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited
ClinicalTrials.gov Identifier:
NCT01951326
First received: September 19, 2013
Last updated: August 20, 2014
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Crohn's Disease
Drug: RHB-104
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by RedHill Biopharma Limited:

Primary Outcome Measures:
  • Remission at week 26 [ Time Frame: Baseline to week 26 ] [ Designated as safety issue: No ]
    Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150


Secondary Outcome Measures:
  • Response at week 26 [ Time Frame: Baseline to week 26 ] [ Designated as safety issue: No ]
    Reduction of CDAI score by a minimum of 100 points

  • Time to remission and response [ Time Frame: Baseline through week 52 ] [ Designated as safety issue: No ]
    The time (weeks after randomization) that a subject first records a state of remission or response.

  • Duration of remission and response [ Time Frame: Baseline through week 52 ] [ Designated as safety issue: No ]
    The time that a subject is in a state of remission or response.

  • Maintenance of remission [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Remission in a subject from week 26 through week 52.


Other Outcome Measures:
  • Proportion of subjects in remission [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who maintained remission [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • RHB-104 plasma concentration measurements at different time points [ Time Frame: Baseline through week 56 ] [ Designated as safety issue: No ]
  • Changes in MAP blood status by polymerase chain reaction (PCR) [ Time Frame: Baseline through week 26 ] [ Designated as safety issue: No ]
  • Change in Crohn's Disease Endoscopic Index of Severity (CDEIS) [ Time Frame: Baseline through week 26 ] [ Designated as safety issue: No ]
  • Change in Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form 36 (SF-36) [ Time Frame: Baseline through Week 52 ] [ Designated as safety issue: No ]
  • Change in inflammatory markers [ Time Frame: Baseline through Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects tapered off steroids [ Time Frame: Baseline through Week 52 ] [ Designated as safety issue: No ]
  • Tissue levels of the active agents of RHB-104 in colon biopsy samples [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Baseline through Week 56 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: September 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RHB-104
5 RHB-104 capsules administered orally BID
Drug: RHB-104
95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
Placebo Comparator: Placebo
5 placebo capsules administered orally BID
Drug: Placebo
5 placebo capsules administered orally BID

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females 18 to 75 years of age
  2. Signed fully informed consent provided as per this protocol
  3. Diagnosis of Crohn's Disease confirmed by endoscopy or radiography and/or histology at least 6 months prior to randomization into the study
  4. CD involving the ileum and/or colon
  5. Moderately to severely active CD (Crohn's Disease Activity Index (CDAI) score of ≥ 220 and ≤450) at baseline
  6. Subject must be intolerant or have insufficient response to conventional therapy
  7. Subjects must meet concomitant medication criteria described below:

    Oral 5-acetyl salicylic acid (5-ASA) compounds

    • If currently being taken, dose must be stable for at least 4 weeks
    • If discontinued due to lack of response or lack of tolerance, the stop-date must have been at least 4 weeks prior to baseline

    Corticosteroid therapy

    • If currently being taken, dose must be stable for at least 2 weeks
    • If discontinued due to lack of a response or lack of tolerance, stop date must have been at least 2 weeks prior to baseline

    Azathioprine or 6-mercaptopurine (6-MP) or methotrexate

    • If currently being used, dose must be stable for at least 8 weeks
    • If discontinued due to a lack of response or lack of tolerance, stop date must have been at least 4 weeks prior to baseline
  8. White blood cell count ≥ 3.5x109 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 photographic confirmation of the presence of active CD within 4 weeks of 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 intrauterine device (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.

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. History of fistulizing Crohn's Disease
  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. Treatment with anti-Tumor Necrosis Factor (TNF) biologic agents (e.g. monoclonal antibody therapies), other agents intended to reduce TNF, or other biological therapies < 8 weeks prior to baseline or within 5 half-lives of agent prior to baseline, whichever is longer
  9. Previous treatment with rifabutin and/or clofazimine
  10. Oral or parenteral antibiotics in the 4 weeks prior to baseline (topical antibiotics are permitted)
  11. Treatment with probiotics (excluding yogurt and yogurt-derived products) in the 4 weeks prior to screening
  12. Females who have a positive pregnancy test or are lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951326

Contacts
Contact: Ira Kalfus, MD ira@redhillbio.com
Contact: Barb Evans bevans@cssienroll.com

  Show 47 Study Locations
Sponsors and Collaborators
RedHill Biopharma Limited
Investigators
Study Director: Ira N Kalfus, MD RedHill Biopharma
Principal Investigator: David Y. Graham, MD Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston
  More Information

Additional Information:
No publications provided

Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT01951326     History of Changes
Other Study ID Numbers: RHB-104-01
Study First Received: September 19, 2013
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Israel: Ministry of Health

Keywords provided by RedHill Biopharma Limited:
Crohn's Disease
moderate to severe
remission
MAP
antibiotic

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 26, 2014