Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 12 for:    RedHill Biopharma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01951326
Recruitment Status : Active, not recruiting
First Posted : September 26, 2013
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited

Tracking Information
First Submitted Date  ICMJE September 19, 2013
First Posted Date  ICMJE September 26, 2013
Last Update Posted Date March 1, 2019
Study Start Date  ICMJE September 2013
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01951326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
Response at week 26 [ Time Frame: Baseline to week 26 ]
Reduction of CDAI score by a minimum of 100 points
Current Other Pre-specified Outcome Measures
 (submitted: April 14, 2014)
  • 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 ]
Original Other Pre-specified Outcome Measures
 (submitted: September 23, 2013)
  • 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 ]
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
Official Title  ICMJE 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
Brief Summary The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: RHB-104
    95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
  • Drug: Placebo
    5 placebo capsules administered orally BID
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2017)
330
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2013)
240
Estimated Study Completion Date  ICMJE April 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Canada,   Czechia,   Israel,   New Zealand,   Poland,   Serbia,   Slovakia,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01951326
Other Study ID Numbers  ICMJE RHB-104-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RedHill Biopharma Limited
Study Sponsor  ICMJE RedHill Biopharma Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ira N Kalfus, MD RedHill Biopharma
Principal Investigator: David Y. Graham, MD Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston
PRS Account RedHill Biopharma Limited
Verification Date April 2018

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