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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01951326
First Posted: September 26, 2013
Last Update Posted: November 7, 2017
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.
Information provided by (Responsible Party):
RedHill Biopharma Limited
  Purpose
The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.

Condition Intervention Phase
Crohn's Disease Drug: RHB-104 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by RedHill Biopharma Limited:

Primary Outcome Measures:
  • 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:
  • 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.


Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 330
Study Start Date: September 2013
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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


  Hide Study Locations
Locations
United States, Arizona
Del Sol Research Management, 850 N Knob Road
Tucson, Arizona, United States, 85710
United States, California
Associated Gastroenterology Medical Group, 1211 W. La Palmak Ave, Suite 303
Anaheim, California, United States, 92801
Medvin Clinical Research, 15627 Imperial Highway,
La Mirada, California, United States, 90638
Digestive Care Associates, Inc., 1000 Laurel St.
San Carlos, California, United States, 94070
Ventura Clinical Trials, 1835 Knoll Drive
Ventura, California, United States, 93003
United States, Connecticut
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States, 06518
United States, Florida
Innovative Medical Research of South Florida, 2999 NE 191 St., Suite 330
Aventura, Florida, United States, 33180
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Sunrise Medical Research, Inc. 4700 N. State Road Building A, Suite 111
Lauderdale Lakes, Florida, United States, 33319
Gastroenterology Group of Naples, 1064 Goodlette Road
Naples, Florida, United States, 34102
Advanced Research Institute Inc., 7114 Congress Street
New Port Richey, Florida, United States, 34653
Endoscopic Research, Inc., 1817 North Mills Avenue
Orlando, Florida, United States, 32802
Advanced Medical Research Center, 1690 Dunlawton Ave., Suite 110
Port Orange, Florida, United States, 32127
United States, Georgia
Atlanta Center for Gastroenterology 2665 North Decatur Road Suite 550
Decatur, Georgia, United States, 30033
Gastrointestinal Specialists of Georgia PC, 711 Canton Rd. Suite 300
Marietta, Georgia, United States, 30060
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
The Carle Foundation, 611 West Park Street
Urbana, Illinois, United States, 61801
United States, Kansas
Cotton-O'Neil Clinical Research Center, 720 SW Lane St.
Topeka, Kansas, United States, 66606
United States, Maryland
Investigative Clinical Research, 612 Ridgely Avenue, Suite 401,
Annapolis, Maryland, United States, 21401
Chevy Chase Clinical Research, 5550 Friendship Blvd.
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Commonwealth Clinical Studies, 189 Quincy St.
Brockton, Massachusetts, United States, 02302-2926
United States, Michigan
Center For Digestive Health
Troy, Michigan, United States, 48098
West Michigan Clinical Research Center, 2093 Health Dr. SW, Suite 201
Wyoming, Michigan, United States, 49519
United States, Missouri
Ehrhardt Clinical Research, LLC, 108 Congress Street
Belton, Missouri, United States, 64012
United States, New Jersey
AGA Clinical Research Associates, Inc., 3205 Fire Road
Egg Harbor Township, New Jersey, United States, 08324
Holy Name Medical Center, 718 Teaneck Road
Teaneck, New Jersey, United States, 07666
United States, New York
North Shore Long Island Jewish Medical Group, 600 Northern Boulevard, Suite 111
Great Neck, New York, United States, 11021
NYU Langone Long Island , 1000 Northern Boulevard, Suite 160
Great Neck, New York, United States, 11021
Manhattan Medical Research Practice PLLC, 215 Lexington Avenue, 21st Floor
New York, New York, United States, 10016
Montefiore Medical Center, 111 East 210th Street
The Bronx, New York, United States, 10467
United States, North Carolina
University of North Carolina Center for inflammatory Bowel Diseases, CB 7080, 130 Mason Farm Road, 4151 Bioinformatics Bldg.
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Ohio GI and Liver Institute, 2925 Vernon Place 100
Cincinnati, Ohio, United States, 45219
Ohio GI and Liver Institute
Cincinnati, Ohio, United States, 45249
United States, Tennessee
ClinSearch, 6035 Shallowford Road, Suite 109
Chattanooga, Tennessee, United States, 37421
United States, Texas
Brooke Army Medical Center, 3551 Roger Brooke Drive
Fort Sam Houston, Texas, United States, 78284
Baylor College of Medicine, 7200 Cambridge Street Suite 180.184, 10th Floor
Houston, Texas, United States, 77030
University of Texas Health Sciences Center at Houston, 6431 Fannin Street, Medical School Bldg 4-234
Houston, Texas, United States, 77030
Spring Gastroenterology Associates, 8901 FM 1960 West
Humble, Texas, United States, 77036
DHAT Research Institute / Digestive Health Associates of Texas 3600 Shire Blvd, Suite 106
Richardson, Texas, United States, 75082
Digestive Disease Center, 621 Camden Street, Suite 202
San Antonio, Texas, United States, 78215
Tyler Research Institute, 1720 S. Beckham
Tyler, Texas, United States, 75701
United States, Virginia
Gasteroenterology Associates of Northern Virgina, 3028 Javier Road
Fairfax, Virginia, United States, 22031
McGuire DVAMC, 1201 Broad Rock Boulevard
Richmond, Virginia, United States, 23249
Australia, New South Wales
Bankstown Hospital, Level 3, Department of Gastroenterology, Eldridge Road
Bankstown, New South Wales, Australia, 2200
Department of Gastroenterology and Hepatology, Concord Hospital, Hospital Road
Concord, New South Wales, Australia, 2139
Nepean Hospital, Derby Street
Kingswood, New South Wales, Australia, 2747
Department of Gastroenterology, Level 1, Clinic 123, New Clinical Building, Liverpool Hospital, Elizabeth St.
Liverpool, New South Wales, Australia, 2170
Australia, Queensland
Department of Gastroenterology and Hepatology, Level 9, Ned Hanlon Building, Royal Brisbane and Women's Hospital Corner Butterfield Street and Bowen Bridge Street
Herston, Queensland, Australia, 4029
Mater Hospital Brisbane, Department of Gastroenterology, Raymond Terrace
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Ballarat Health Services, Drummond St North
Ballarat, Victoria, Australia, 3350
Department of Gastroenterology, Eastern Health, ECRU, Level 2, 5 Arnold Street
Box Hill, Victoria, Australia, 3128
Department of Gastroenterology and Hepatology, Cabrini Medical Centre, 183 Wattletree Road
Malvern, Victoria, Australia, 3144
Bulgaria
MHAT "Sv. Karidad" EAD, Department of Internal Medicine / Gastroenterology, endocrinology and metabolic disorders, 23А, Nikola Vaptsarov Blvd
Plovdiv, Bulgaria, 4002
MHAT "Hadzhi Dimitar" OOD, Department of Internal Medicine / Gastroenterology and Endocrinology, 5, Dimitar Pehlivanov str.
Sliven, Bulgaria, 8800
UMHAT "Sv. Ivan Rilski" EAD; Clinic of Gastroenterology, 15, Akad. Ivan Geshov Blvd.,
Sofia, Bulgaria, 1432
ACIBADEM CITY CLINIC UNIVERSITY HOSPITAL EOOD, Oncology Center, Clinic of Gastroenterology, 66 A, Tsarigradsko shosse Blvd
Sofia, Bulgaria, 1784
DCC "Mladost-M Varna" OOD, office 528 V, 15, Republika Blvd.
Varna, Bulgaria, 9020
Canada, British Columbia
Discovery Clinical Services Ltd. 601 A Discovery St.
Victoria, British Columbia, Canada, V8T 5G4
Canada, Ontario
Mount Sinai Hospital, 600 University Avenue, Suite 445
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Montreal General Hospital Digestive Lab Research Institute McGill University Health Center, 1650 Cedar Avenue C10.145
Montreal, Quebec, Canada, H3G 1A4
Canada, Saskatchewan
University of Saskatchewan Royal University Hospital, 103 Hospital Drive IBD Clinical Trials Unit Rm 2658
Saskatoon, Saskatchewan, Canada, S7N 0W8
Czechia
Nemocnice Horovice, NH Hospital, a.s., Chirurgicke oddeleni, K Nemocnici 1106
Horovice, Czechia, 268 31
Gastroenterologie s.r.o., Manesova 646,
Hradec Kralove, Czechia, 500 02
HEPATO-GASTROENTEROLOGIE HK, s.r.o., Trida Edvarda Benese 1549/34
Hradec Kralove, Czechia, 50012
EGK s.r.o., Sanatorium sv. Anny, Gastroenterologicke oddeleni, Lucni 7a/2776,
Praha 3, Czechia, 13000
IBD centrum / ISCARE IVF a.s., Jankovcova 1569/2c
Praha, Czechia, 17000
ARTROSCAN, s.r.o., Gastroenterologicka ambulance, 5114 Trebovicka, Ostrava
Trebovice, Czechia, 722 00
Krajska zdravotni, a.s., Masarykova nemocnice o.z. Gastroenterologie, Socialni pece 3316/12A
Usti nad Labem, Czechia, 401 13
Israel
Assaf HaRofeh Medical Center, Gastroenterology Department, Harofeh Medical Center
Be'er Ya'aqov, Israel, 70300
Bnaizion Medical Center, Golomb 47
Haifa, Israel, 31048
The E. Wolfson Medical Center, 62 Halohamim Str.
Holon, Israel, 58100
Shaare Zedek Medical Center, Beith Street
Jerusalem, Israel, 91031
Ein Karem Medical Center, Kiryat Hadassah
Jerusalem, Israel, 91120
Meir, 59 Tchemacovsky St
Kfar-Saba, Israel, 44281
Galilee Medical Center, P.O.B. 21
Nahariya, Israel, 1210001
Holy Family Hospital, Namsawi St. POB 8
Nazareth, Israel, 16100
RMC Beilinson Hospital, 39 Jabotinsky Street
Petach-Tikva, Israel, 49100
Sourasky Medical Center, 6 Weizman Street
Tel Aviv, Israel, 64239
New Zealand
Shakespeare Specialist Group, North Shore, Suite 3, 181 Shakespeare Road, Milford Takapuna
Auckland, New Zealand, 0620
Christchurch Hospital
Christchurch, New Zealand, 4710
Gastroenterology Unit, Southern District Health Board, 201 Great King Street,
Dunedin, New Zealand, 9054
Department of Gastroenterology,Waikato Hospital
Hamilton, New Zealand, 3240
Clinical Trials Unit, Tauranga Hospital,
Tauranga, New Zealand, 3112
Poland
NZOZ Specjalistyczne Centrum Gastrologii GASTROMED Wiejska 81
Bialystok, Poland, 15-351
SP ZOZ MSWiA w Gdańsku, Oddział Gastroenterologiczny, ul. Kartuska 4/6
Gdańsk, Poland, 80-104
UNICARDIA Specjalistyczne Centrum Leczenia Chorob Serca i Naczyn & UNIMEDICA Specjalistyczne Centrum Medyczne Sp. z o.o. Kluczborska 15
Krakow, Poland, 31-271
Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny Żołnierska 18
Olsztyn, Poland, 10-561
ENDOSKOPIA sp. z o.o. B. Chrobrego 6/8
Sopot, Poland, 81-756
EuroMedis sp. z.o.o., ul. Powstanców Wielkopolskich 33a
Szczecin, Poland, 70-111
"GASTROMED" Kopon, Zmudzinski i wspolnicy sp. j., Specjalistyczne Centrum Gastroskopii i Endoskopii, Specjalistyczne Gabinety Lekarskie Grudziadzka 11
Torun, Poland, 87-100
Centralny Szpital Kliniczny MSW w Warszawie Klinika Chorob Wewnetrznych i Gastroenterologii Woloska 137
Warszawa, Poland, 02-507
ARS MEDICA s.c. Rybak Maria, Rybak Zbigniew, Powstancow Slaskich 56A/2
Wroclaw, Poland, 53-333
Centrum Medyczne Szpital Sw. Rodziny Sp. z o.o. Wigury 19
Łódź, Poland, 90-302
Serbia
: Clinic for Gastroenterology and Hepatology, Clinical Center of Serbia Koste Todorovica 2
Belgrade, Serbia, 11000
Clinical Department of Gastroenterology and Hepatology, Clinic for Internal Diseases, Clinical Hospital Center Zvezdara Dimitrija Tucovica 161
Belgrade, Serbia, 11000
Department of Gastroenterology and Hepatology, Clinical Hospital Center Zemun Vukova 9
Belgrade, Serbia, 11080
: Center for Gastroenterohepatology, Clinic for Internal Medicine, Clinical Center of Kragujevac Zmaj Jovina 30
Kragujevac, Serbia, 34000
: Clinic of Gastroenterology and Hepatology, Clinical Center of Vojvodina Hajduk Veljkova 1
Novi Sad, Serbia, 21000
Slovakia
Univerzitna nemocnica Bratislava - Nemocnica Ružinov, V. Interná klinika LFUK a UNB, Gastroenterologické a hepatologické oddelenie, Ruzinovska 6
Bratislava, Slovakia, 82606
Univerzitná nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda Gastroenterologická klinika SZU a UNB Antolská 11
Bratislava, Slovakia, 851 07
Breznianske centrum gastroenterologie, s.r.o. Banisko 1
Brezno, Slovakia, 97701
PIGEAS s.r.Prieložtek 1, o.,
Martin, Slovakia, 036 01
KM Management spol. s.r.o., Gastroenterologické a hepatologické centrum Nitra, Špitálska 13
Nitra, Slovakia, 949 01
Sponsors and Collaborators
RedHill Biopharma Limited
Investigators
Study Director: Ira N Kalfus, MD RedHill Biopharma
Principal Investigator: David Y. Graham, MD Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston
  More Information

Additional Information:
Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT01951326     History of Changes
Other Study ID Numbers: RHB-104-01
First Submitted: September 19, 2013
First Posted: September 26, 2013
Last Update Posted: November 7, 2017
Last Verified: October 2016

Keywords provided by RedHill Biopharma Limited:
Crohn's Disease
moderate to severe
remission
MAP
antibiotic

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases