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

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ClinicalTrials.gov Identifier: NCT01951326
Recruitment Status : Completed
First Posted : September 26, 2013
Results First Posted : May 1, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited

Study Description
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Brief Summary:
The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: RHB-104 Drug: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2013
Actual Primary Completion Date : May 2018
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Remission at Week 26 [ Time Frame: Week 26 ]
    Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.


Secondary Outcome Measures :
  1. Response at Week 26 [ Time Frame: Week 26 ]
    Reduction of Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points. Lower CDAI scores indicate a better outcome.

  2. Remission at Week 52 [ Time Frame: Week 52 ]
    Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.

  3. Durable Remission Week 26 Through Week 52 [ Time Frame: Week 26 through week 52 ]
    When a subject is in remission with a maximum CDAI score of 149 at every visit from Week 26 through and including Week 52

  4. Remission at Week 16 [ Time Frame: Week 16 ]
    Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.

  5. Steroid Free Remission at Week 52 [ Time Frame: Week 52 ]
    Subjects who are maintained off steroids for a minimum of 3 weeks


Other Outcome Measures:
  1. Duration of Remission [ Time Frame: Baseline through week 52 ]
    Number of weeks that a subject is in a state of remission. Subjects who experienced remission and continued to be in remission at the time of their last CDAI assessment are censored at the date of their last CDAI assessment.

  2. Duration of Response [ Time Frame: Baseline through week 52 ]
    Number of weeks a subject is in a state of response. Subjects who experienced response and continued to be in response at the time of their last CDAI assessment are censored at the date of their last CDAI assessment.

  3. Time to Remission [ Time Frame: Baseline through week 52 ]
    [Date of first observed remission (CDAI score < 150) - Date of first dose or date of randomization if not dosed + 1] / 7 Days. Subjects who never experienced remission during the study are censored at the date of their last CDAI assessment.

  4. Time to Response [ Time Frame: Baseline through week 52 ]
    [Date of first observed response (a reduction from baseline of ≥ 100 in CDAI score) - Date of first dose or date of randomization if not dosed + 1] / 7 Days. Subjects who never experienced response during the study are censored at the date of their last CDAI assessment.

  5. Durable Remission Week 16 Through Week 52 [ Time Frame: Week 16 through week 52 ]
    Remission in a subject from week 16 through week 52.

  6. Response at Week 16 [ Time Frame: Week 16 ]
    Reduction of Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points. Lower CDAI scores indicate a better outcome.

  7. Cardiac Safety [ Time Frame: Week 26 ]
    Change-from-baseline to week 26 in QTcF (based on cardiac safety report)

  8. Cardiac Safety [ Time Frame: Baseline through week 52 ]
    Placebo-corrected change-from-baseline to week 52 in QTcF (based on cardiac safety report)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951326


Locations
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Sponsors and Collaborators
RedHill Biopharma Limited
Investigators
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Study Director: Ira N Kalfus, MD RedHill Biopharma
Principal Investigator: David Y. Graham, MD Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston
  Study Documents (Full-Text)

Documents provided by RedHill Biopharma Limited:
Statistical Analysis Plan  [PDF] April 5, 2018
Study Protocol  [PDF] September 29, 2017

More Information
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Additional Information:

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Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT01951326    
Other Study ID Numbers: RHB-104-01
First Posted: September 26, 2013    Key Record Dates
Results First Posted: May 1, 2020
Last Update Posted: December 8, 2020
Last Verified: June 2020
Keywords provided by RedHill Biopharma Limited:
Crohn's Disease
moderate to severe
remission
MAP
antibiotic
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases