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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01951326




Registration number
NCT01951326
Ethics application status
Date submitted
19/09/2013
Date registered
26/09/2013
Date last updated
8/12/2020

Titles & IDs
Public title
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
Scientific 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 ID [1] 0 0
RHB-104-01
Universal Trial Number (UTN)
Trial acronym
MAPUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RHB-104
Treatment: Drugs - Placebo

Active Comparator: RHB-104 - 5 RHB-104 capsules administered orally BID

Placebo Comparator: Placebo - 5 placebo capsules administered orally BID


Treatment: Drugs: RHB-104
95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine

Treatment: Drugs: Placebo
5 placebo capsules administered orally BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Remission at Week 26
Timepoint [1] 0 0
Week 26
Secondary outcome [1] 0 0
Response at Week 26
Timepoint [1] 0 0
Week 26
Secondary outcome [2] 0 0
Remission at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Durable Remission Week 26 Through Week 52
Timepoint [3] 0 0
Week 26 through week 52
Secondary outcome [4] 0 0
Remission at Week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Steroid Free Remission at Week 52
Timepoint [5] 0 0
Week 52

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2019
Sample size
Target
Accrual to date
Final
331
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Bankstown Hospital, Level 3, Department of Gastroenterology, Eldridge Road - Bankstown
Recruitment hospital [2] 0 0
Department of Gastroenterology and Hepatology, Concord Hospital, Hospital Road - Concord
Recruitment hospital [3] 0 0
Nepean Hospital, Derby Street - Kingswood
Recruitment hospital [4] 0 0
Department of Gastroenterology, Level 1, Clinic 123, New Clinical Building, Liverpool Hospital, Elizabeth St. - Liverpool
Recruitment hospital [5] 0 0
Department of Gastroenterology and Hepatology, Level 9, Ned Hanlon Building, Royal Brisbane and Women's Hospital Corner Butterfield Street and Bowen Bridge Street - Herston
Recruitment hospital [6] 0 0
Mater Hospital Brisbane, Department of Gastroenterology, Raymond Terrace - South Brisbane
Recruitment hospital [7] 0 0
Ballarat Health Services, Drummond St North - Ballarat
Recruitment hospital [8] 0 0
Department of Gastroenterology, Eastern Health, ECRU, Level 2, 5 Arnold Street - Box Hill
Recruitment hospital [9] 0 0
Department of Gastroenterology and Hepatology, Cabrini Medical Centre, 183 Wattletree Road - Malvern
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
3350 - Ballarat
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Kansas
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Maryland
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Massachusetts
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Michigan
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Missouri
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New York
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North Carolina
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Ohio
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Tennessee
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Texas
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Virginia
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Bulgaria
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Plovdiv
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Bulgaria
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Sliven
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Sofia
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Varna
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Horovice
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Hradec Kralove
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Praha 3
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Czechia
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Praha
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Czechia
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Trebovice
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Czechia
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Usti nad Labem
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Israel
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Be'er Ya'aqov
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Holon
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Kfar-Saba
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Nahariya
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Israel
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Nazareth
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Petach-Tikva
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Israel
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Tel Aviv
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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New Zealand
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Tauranga
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Poland
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Bialystok
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Gdansk
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Krakow
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Olsztyn
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Sopot
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Szczecin
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Torun
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Warszawa
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Wroclaw
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Lódz
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Novi Sad
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Slovakia
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Bratislava
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Slovakia
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Brezno
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Martin
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Slovakia
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Nitra

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
RedHill Biopharma Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's
disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01951326
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ira N Kalfus, MD
Address 0 0
RedHill Biopharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01951326