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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 : Active, not recruiting
First Posted : September 26, 2013
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited

September 19, 2013
September 26, 2013
October 30, 2018
September 2013
December 2018   (Final data collection date for primary outcome measure)
Remission at week 26 [ Time Frame: Baseline to week 26 ]
Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150
Same as current
Complete list of historical versions of study NCT01951326 on ClinicalTrials.gov Archive Site
  • Response at week 26 [ Time Frame: Baseline to week 26 ]
    Reduction of CDAI score by a minimum of 100 points
  • Time to remission and response [ Time Frame: Baseline through week 52 ]
    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 ]
    The time that a subject is in a state of remission or response.
  • Maintenance of remission [ Time Frame: 52 weeks ]
    Remission in a subject from week 26 through week 52.
Response at week 26 [ Time Frame: Baseline to week 26 ]
Reduction of CDAI score by a minimum of 100 points
  • Proportion of subjects in remission [ Time Frame: 52 Weeks ]
  • Proportion of subjects who maintained remission [ Time Frame: Baseline to week 52 ]
  • RHB-104 plasma concentration measurements at different time points [ Time Frame: Baseline through week 56 ]
  • Changes in MAP blood status by polymerase chain reaction (PCR) [ Time Frame: Baseline through week 26 ]
  • Change in Crohn's Disease Endoscopic Index of Severity (CDEIS) [ Time Frame: Baseline through week 26 ]
  • Change in Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form 36 (SF-36) [ Time Frame: Baseline through Week 52 ]
  • Change in inflammatory markers [ Time Frame: Baseline through Week 52 ]
  • Proportion of subjects tapered off steroids [ Time Frame: Baseline through Week 52 ]
  • Tissue levels of the active agents of RHB-104 in colon biopsy samples [ Time Frame: Baseline to Week 26 ]
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Baseline through Week 56 ]
  • Time to remission and response [ Time Frame: Baseline through week 52 ]
    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 26 ]
    The number of visits that a subject is in a state of remission or response
  • Proportion of subjects in remission [ Time Frame: 52 Weeks ]
  • Proportion of subjects who maintained remission [ Time Frame: Baseline to week 52 ]
  • RHB-104 plasma concentration measurements at different time points [ Time Frame: Baseline through week 56 ]
  • Changes in MAP blood status by polymerase chain reaction (PCR) [ Time Frame: Baseline through week 26 ]
  • Change in Crohn's Disease Endoscopic Index of Severity (CDEIS) [ Time Frame: Baseline through week 26 ]
  • Change in Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form 36 (SF-36) [ Time Frame: Baseline through Week 52 ]
  • Change in inflammatory markers [ Time Frame: Baseline through Week 52 ]
  • Proportion of subjects tapered off steroids [ Time Frame: Baseline through Week 52 ]
  • Tissue levels of the active agents of RHB-104 in colon biopsy samples [ Time Frame: Baseline to Week 26 ]
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Baseline through Week 56 ]
 
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
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
The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Crohn's Disease
  • Drug: RHB-104
    95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
  • Drug: Placebo
    5 placebo capsules administered orally BID
  • Active Comparator: RHB-104
    5 RHB-104 capsules administered orally BID
    Intervention: Drug: RHB-104
  • Placebo Comparator: Placebo
    5 placebo capsules administered orally BID
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
330
240
April 2019
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Bulgaria,   Canada,   Czechia,   Israel,   New Zealand,   Poland,   Serbia,   Slovakia,   United States
Czech Republic
 
NCT01951326
RHB-104-01
Yes
Not Provided
Not Provided
RedHill Biopharma Limited
RedHill Biopharma Limited
Not Provided
Study Director: Ira N Kalfus, MD RedHill Biopharma
Principal Investigator: David Y. Graham, MD Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston
RedHill Biopharma Limited
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP