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History of Changes for Study: NCT01951326
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease (MAP US)
Latest version (submitted November 29, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 23, 2013 None (earliest Version on record)
2 September 29, 2013 Recruitment Status, Contacts/Locations and Study Status
3 November 18, 2013 Contacts/Locations, Study Status and Study Identification
4 November 20, 2013 Contacts/Locations and Study Status
5 November 23, 2013 Contacts/Locations and Study Status
6 November 29, 2013 Contacts/Locations and Study Status
7 December 7, 2013 Contacts/Locations and Study Status
8 December 9, 2013 Contacts/Locations and Study Status
9 December 11, 2013 Contacts/Locations and Study Status
10 January 1, 2014 Contacts/Locations and Study Status
11 January 11, 2014 Contacts/Locations and Study Status
12 January 14, 2014 Contacts/Locations and Study Status
13 January 27, 2014 Contacts/Locations and Study Status
14 February 10, 2014 Contacts/Locations and Study Status
15 March 3, 2014 Contacts/Locations and Study Status
16 March 23, 2014 Contacts/Locations and Study Status
17 March 29, 2014 Contacts/Locations and Study Status
18 April 2, 2014 Contacts/Locations and Study Status
19 April 14, 2014 Eligibility, Outcome Measures and Study Status
20 May 7, 2014 Contacts/Locations and Study Status
21 May 14, 2014 Contacts/Locations and Study Status
22 May 22, 2014 Contacts/Locations and Study Status
23 May 26, 2014 Study Status
24 June 2, 2014 Contacts/Locations and Study Status
25 June 4, 2014 Contacts/Locations and Study Status
26 June 9, 2014 Contacts/Locations and Study Status
27 June 24, 2014 Contacts/Locations and Study Status
28 July 10, 2014 Contacts/Locations and Study Status
29 July 22, 2014 Contacts/Locations and Study Status
30 July 24, 2014 Contacts/Locations and Study Status
31 July 27, 2014 Contacts/Locations and Study Status
32 August 6, 2014 Contacts/Locations and Study Status
33 August 12, 2014 Contacts/Locations and Study Status
34 August 20, 2014 Contacts/Locations and Study Status
35 September 2, 2014 Contacts/Locations and Study Status
36 September 16, 2014 Contacts/Locations and Study Status
37 September 19, 2014 Contacts/Locations and Study Status
38 September 25, 2014 Contacts/Locations and Study Status
39 October 4, 2014 Contacts/Locations and Study Status
40 October 7, 2014 Contacts/Locations and Study Status
41 October 9, 2014 Contacts/Locations and Study Status
42 October 10, 2014 Contacts/Locations and Study Status
43 October 23, 2014 Contacts/Locations and Study Status
44 November 10, 2014 Contacts/Locations and Study Status
45 November 18, 2014 Contacts/Locations and Study Status
46 November 19, 2014 Contacts/Locations and Study Status
47 November 24, 2014 Contacts/Locations and Study Status
48 November 25, 2014 Contacts/Locations and Study Status
49 December 3, 2014 Contacts/Locations and Study Status
50 December 23, 2014 Contacts/Locations and Study Status
51 January 5, 2015 Contacts/Locations and Study Status
52 January 18, 2015 Contacts/Locations and Study Status
53 January 22, 2015 Contacts/Locations and Study Status
54 January 26, 2015 Eligibility and Study Status
55 February 18, 2015 Contacts/Locations and Study Status
56 February 23, 2015 Contacts/Locations and Study Status
57 March 3, 2015 Contacts/Locations and Study Status
58 March 5, 2015 Contacts/Locations and Study Status
59 March 15, 2015 Contacts/Locations and Study Status
60 March 18, 2015 Study Status and Contacts/Locations
61 March 19, 2015 Contacts/Locations and Study Status
62 March 24, 2015 Contacts/Locations and Study Status
63 March 28, 2015 Contacts/Locations and Study Status
64 April 8, 2015 Contacts/Locations and Study Status
65 May 2, 2015 Contacts/Locations and Study Status
66 May 11, 2015 Contacts/Locations and Study Status
67 May 14, 2015 Contacts/Locations and Study Status
68 May 20, 2015 Contacts/Locations and Study Status
69 May 22, 2015 Study Design and Study Status
70 June 6, 2015 Contacts/Locations and Study Status
71 June 18, 2015 Contacts/Locations and Study Status
72 June 28, 2015 Contacts/Locations and Study Status
73 July 1, 2015 Contacts/Locations, Eligibility and Study Status
74 July 26, 2015 Contacts/Locations and Study Status
75 August 5, 2015 Contacts/Locations and Study Status
76 August 12, 2015 Contacts/Locations and Study Status
77 August 19, 2015 Contacts/Locations and Study Status
78 August 23, 2015 Contacts/Locations and Study Status
79 September 10, 2015 Contacts/Locations and Study Status
80 September 13, 2015 Contacts/Locations and Study Status
81 September 17, 2015 Contacts/Locations and Study Status
82 September 18, 2015 Contacts/Locations and Study Status
83 September 28, 2015 Contacts/Locations and Study Status
84 October 1, 2015 Contacts/Locations and Study Status
85 October 4, 2015 Study Status
86 October 10, 2015 Contacts/Locations and Study Status
87 October 26, 2015 Contacts/Locations and Study Status
88 November 16, 2015 Contacts/Locations and Study Status
89 November 18, 2015 Contacts/Locations and Study Status
90 November 19, 2015 Contacts/Locations and Study Status
91 November 24, 2015 Contacts/Locations and Study Status
92 November 25, 2015 Contacts/Locations and Study Status
93 December 1, 2015 Contacts/Locations and Study Status
94 December 7, 2015 Contacts/Locations and Study Status
95 December 15, 2015 Contacts/Locations and Study Status
96 January 17, 2016 Contacts/Locations and Study Status
97 January 28, 2016 Contacts/Locations and Study Status
98 March 8, 2016 Contacts/Locations and Study Status
99 March 10, 2016 Contacts/Locations and Study Status
100 March 27, 2016 Contacts/Locations and Study Status
101 April 1, 2016 Contacts/Locations and Study Status
102 April 9, 2016 Contacts/Locations and Study Status
103 May 8, 2016 Contacts/Locations and Study Status
104 May 10, 2016 Contacts/Locations and Study Status
105 May 13, 2016 Contacts/Locations and Study Status
106 May 17, 2016 Contacts/Locations and Study Status
107 May 28, 2016 Contacts/Locations and Study Status
108 June 19, 2016 Contacts/Locations and Study Status
109 July 5, 2016 Contacts/Locations and Study Status
110 July 10, 2016 Contacts/Locations and Study Status
111 July 11, 2016 Contacts/Locations and Study Status
112 July 13, 2016 Contacts/Locations and Study Status
113 July 14, 2016 Study Status
114 July 25, 2016 Study Status
115 August 1, 2016 Contacts/Locations and Study Status
116 August 4, 2016 Contacts/Locations and Study Status
117 August 12, 2016 Contacts/Locations and Study Status
118 September 3, 2016 Contacts/Locations and Study Status
119 October 6, 2016 Contacts/Locations and Study Status
120 October 9, 2016 Contacts/Locations and Study Status
121 October 16, 2016 Eligibility, Study Design and Study Status
122 November 17, 2016 Contacts/Locations and Study Status
123 November 23, 2016 Contacts/Locations and Study Status
124 December 14, 2016 Contacts/Locations and Study Status
125 February 6, 2017 Contacts/Locations and Study Status
126 February 8, 2017 Contacts/Locations and Study Status
127 February 9, 2017 Study Status and Contacts/Locations
128 March 17, 2017 Contacts/Locations and Study Status
129 March 22, 2017 Contacts/Locations and Study Status
130 April 7, 2017 Contacts/Locations and Study Status
131 April 10, 2017 Contacts/Locations and Study Status
132 April 12, 2017 Contacts/Locations and Study Status
133 May 22, 2017 Contacts/Locations and Study Status
134 May 28, 2017 Contacts/Locations and Study Status
135 June 6, 2017 Contacts/Locations and Study Status
136 June 8, 2017 Contacts/Locations and Study Status
137 June 14, 2017 Contacts/Locations and Study Status
138 June 19, 2017 Contacts/Locations and Study Status
139 August 1, 2017 Eligibility and Study Status
140 August 7, 2017 Contacts/Locations and Study Status
141 August 8, 2017 Contacts/Locations and Study Status
142 August 29, 2017 Contacts/Locations and Study Status
143 September 1, 2017 Contacts/Locations and Study Status
144 October 17, 2017 Recruitment Status, Contacts/Locations, Study Status and Study Design
145 November 3, 2017 Contacts/Locations and Study Status
146 April 12, 2018 Study Status and Contacts/Locations
147 April 12, 2018 Study Status
148 October 4, 2018 Study Status
149 October 28, 2018 Study Status
150 February 27, 2019 Study Status
151 December 29, 2019 Recruitment Status, Study Status, Study Design
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Results Submission Events
152 April 21, 2020 Outcome Measures, Study Status, Document Section and Results
153 June 3, 2020 Study Status
154 June 25, 2020 Study Status
155 July 8, 2020 Study Status
156 October 3, 2020 Study Status
157 November 29, 2020 Study Status
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Study NCT01951326
Submitted Date:  September 23, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: RHB-104-01
Brief Title: Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease (MAP US)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2013
Overall Status: Not yet recruiting
Study Start: September 2013
Primary Completion: March 2015 [Anticipated]
Study Completion: October 2015 [Anticipated]
First Submitted: September 19, 2013
First Submitted that
Met QC Criteria:
September 23, 2013
First Posted: September 26, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 23, 2013
Last Update Posted: September 26, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: RedHill Biopharma Limited
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Crohn's Disease
Keywords: Crohn's Disease
moderate to severe
remission
MAP
antibiotic
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 240 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. Response at week 26
[ Time Frame: Baseline to week 26 ]

Reduction of CDAI score by a minimum of 100 points
Other Outcome Measures:
1. 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
2. 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
3. Proportion of subjects in remission
[ Time Frame: 52 Weeks ]

4. Proportion of subjects who maintained remission
[ Time Frame: Baseline to week 52 ]

5. RHB-104 plasma concentration measurements at different time points
[ Time Frame: Baseline through week 56 ]

6. Changes in MAP blood status by polymerase chain reaction (PCR)
[ Time Frame: Baseline through week 26 ]

7. Change in Crohn's Disease Endoscopic Index of Severity (CDEIS)
[ Time Frame: Baseline through week 26 ]

8. Change in Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form 36 (SF-36)
[ Time Frame: Baseline through Week 52 ]

9. Change in inflammatory markers
[ Time Frame: Baseline through Week 52 ]

10. Proportion of subjects tapered off steroids
[ Time Frame: Baseline through Week 52 ]

11. Tissue levels of the active agents of RHB-104 in colon biopsy samples
[ Time Frame: Baseline to Week 26 ]

12. Number of subjects with adverse events as a measure of safety and tolerability
[ Time Frame: Baseline through Week 56 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Males and females 18 to 65 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. C-reactive protein > Upper Limit of Normal (ULN)
  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
Open or close this module Contacts/Locations
Central Contact Person: RedHill Biopharma
Telephone: +972-(0)3-541-3131
Email: info@redhillbio.com
Central Contact Backup: Ira N Kalfus, MD
Telephone: +1-917-817-7517
Email: ira@redhillbio.com
Study Officials: Ira N Kalfus, MD
Study Director
RedHill Biopharma
David Y. Graham, MD
Principal Investigator
Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston
Locations: United States, California
Digestive Care Associats, Inc., 1000 Laurel St.
San Carlos, California, United States, 94070
United States, Georgia
Agile Clinical Research Trials, 10945 State Bridge Road, Suite 401-403
Alpharetta, Georgia, United States, 30022
Dr. Aasim Sheikh - Gastrointestinal Specialists of Georgia PC, 711 Canton Rd. Suite 300
Marietta, Georgia, United States, 30060
United States, Maryland
Investigative Clinical Research, 612 Ridgely Avenue, Suite 401,
Annapolis, Maryland, United States, 21401
United States, Montana
Billings Clinic, Research Center, 1045 No. 30th St.
Billings, Montana, United States, 59101
United States, New Jersey
AGA Clinical Research Associates, Inc., 3205 Fire Road
Egg Harbor Township, New Jersey, United States, 08324
United States, North Carolina
PMG Research of Winstom-Salem, LLC, 1901 S. Hawthorne Rd. Suite 306
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Ohio GI and Liver Institute, 2925 Vernon Place 100
Cincinnati, Ohio, United States, 45219
United States, Texas
Gastroenterology and Associates, 8901 FM 1960 West
Humble, Texas, United States, 77036
United States, Wisconsin
University of Wisconsin Hospital and Clinics, H6/517 CSC-MC5124, 600 Highland Ave.
Madison, Wisconsin, United States, 53792
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