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Crohn's DiseasePhase 3MAPUSNCT01951326

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

A Phase 3 study testing RHB-104 in people with Crohn's Disease, run by RedHill Biopharma Limited at 103 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
RHB-104
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
331 participants
Where
103 sitesin 10 countries
Study dates
Sep 2013to Aug 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed fully informed consent provided as per this protocol.
  • Diagnosis of Crohn's Disease confirmed by endoscopy or radiography and/or histology at least 6 months prior to randomization into the study.
  • CD involving the ileum and/or colon
  • 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.
  • Current treatment with at least one of the following therapies:
  • Oral 5-acetyl salicylic acid (5-ASA) compounds. Dose must be stable for at least 4 weeks before baseline.
Show all 12Show fewer
  • Corticosteroid therapy. Dose must be stable for at least 2 weeks before baseline.
  • Azathioprine or 6-mercaptopurine (6-MP) or methotrexate. Dose must be stable for at least 8 weeks before baseline.
  • Infliximab or adalimumab. Dose must be stable for at least 14 weeks before baseline.
  • White blood cell count greater than or equal to 3.5 x 109 at screening.
  • 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. .
  • 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.

Who cannot join

  • Crohn's Disease involvement isolated to the mouth, upper gastrointestinal tract, or anus.
  • History of total colectomy with ileorectal anastomosis or a proctocolectomy.
  • Presence of active fistulizing Crohn's Disease or healed fistula within 2 months prior to screening.
  • Subject has postoperative stoma, ostomy, or ileoanal pouch.
  • Subject has short bowel syndrome.
  • Subject is scheduled for surgical bowel resection.
Show all 16Show fewer
  • Subject has known symptomatic obstructive strictures or bowel perforation in the 6 months prior to screening.
  • Change in dose or discontinuation of oral 5-acetyl salicylic acid (5-ASA) compounds less than 4 weeks prior to baseline.
  • Change in dose or discontinuation of corticosteroids less than 2 weeks prior to baseline.
  • Change in dose or discontinuation of azathioprine, 6-mercaptopurine (6-MP) or methotrexate less than 8 weeks prior to baseline.
  • Change in dose or discontinuation of infliximab or adalimumab less than 14 weeks prior to baseline.
  • 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.
  • Previous treatment with rifabutin and/or clofazimine.
  • Oral or parenteral antibiotics in the 4 weeks prior to baseline (topical antibiotics are permitted).
  • Treatment with probiotics (excluding yogurt and yogurt-derived products) in the 4 weeks prior to baseline.
  • Females who have a positive pregnancy test or are lactating.

Trial locations and contacts

103 sites in 10 countries.

103 sites in 10 countries

United States43 sites

  • Associated Gastroenterology Medical Group, 1211 W. La Palmak Ave, Suite 303

    Anaheim, California, 92801

  • Investigative Clinical Research, 612 Ridgely Avenue, Suite 401,

    Annapolis, Maryland, 21401

  • Innovative Medical Research of South Florida, 2999 NE 191 St., Suite 330

    Aventura, Florida, 33180

  • Ehrhardt Clinical Research, LLC, 108 Congress Street

    Belton, Missouri, 64012

  • Commonwealth Clinical Studies, 189 Quincy St.

    Brockton, Massachusetts, 02302-2926

  • University of North Carolina Center for inflammatory Bowel Diseases, CB 7080, 130 Mason Farm Road, 4151 Bioinformatics Bldg.

    Chapel Hill, North Carolina, 27599

  • ClinSearch, 6035 Shallowford Road, Suite 109

    Chattanooga, Tennessee, 37421

  • Chevy Chase Clinical Research, 5550 Friendship Blvd.

    Chevy Chase, Maryland, 20815

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Ohio GI and Liver Institute, 2925 Vernon Place 100

    Cincinnati, Ohio, 45219

  • Ohio GI and Liver Institute

    Cincinnati, Ohio, 45249

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • Atlanta Center for Gastroenterology 2665 North Decatur Road Suite 550

    Decatur, Georgia, 30033

  • AGA Clinical Research Associates, Inc., 3205 Fire Road

    Egg Harbor, New Jersey, 08324

  • Gasteroenterology Associates of Northern Virgina, 3028 Javier Road

    Fairfax, Virginia, 22031

  • Brooke Army Medical Center, 3551 Roger Brooke Drive

    Fort Sam Houston, Texas, 78284

  • North Shore Long Island Jewish Medical Group, 600 Northern Boulevard, Suite 111

    Great Neck, New York, 11021

  • NYU Langone Long Island , 1000 Northern Boulevard, Suite 160

    Great Neck, New York, 11021

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Baylor College of Medicine, 7200 Cambridge Street Suite 180.184, 10th Floor

    Houston, Texas, 77030

  • University of Texas Health Sciences Center at Houston, 6431 Fannin Street, Medical School Bldg 4-234

    Houston, Texas, 77030

  • Spring Gastroenterology Associates, 8901 FM 1960 West

    Humble, Texas, 77036

  • Medvin Clinical Research, 15627 Imperial Highway,

    La Mirada, California, 90638

  • Sunrise Medical Research, Inc. 4700 N. State Road Building A, Suite 111

    Lauderdale Lakes, Florida, 33319

  • Gastrointestinal Specialists of Georgia PC, 711 Canton Rd. Suite 300

    Marietta, Georgia, 30060

  • Gastroenterology Group of Naples, 1064 Goodlette Road

    Naples, Florida, 34102

  • Advanced Research Institute Inc., 7114 Congress Street

    New Port Richey, Florida, 34653

  • Manhattan Medical Research Practice PLLC, 215 Lexington Avenue, 21st Floor

    New York, New York, 10016

  • Endoscopic Research, Inc., 1817 North Mills Avenue

    Orlando, Florida, 32802

  • Advanced Medical Research Center, 1690 Dunlawton Ave., Suite 110

    Port Orange, Florida, 32127

  • DHAT Research Institute / Digestive Health Associates of Texas 3600 Shire Blvd, Suite 106

    Richardson, Texas, 75082

  • McGuire DVAMC, 1201 Broad Rock Boulevard

    Richmond, Virginia, 23249

  • Digestive Disease Center, 621 Camden Street, Suite 202

    San Antonio, Texas, 78215

  • Digestive Care Associates, Inc., 1000 Laurel St.

    San Carlos, California, 94070

  • Holy Name Medical Center, 718 Teaneck Road

    Teaneck, New Jersey, 07666

  • Montefiore Medical Center, 111 East 210th Street

    The Bronx, New York, 10467

  • Cotton-O'Neil Clinical Research Center, 720 SW Lane St.

    Topeka, Kansas, 66606

  • Center For Digestive Health

    Troy, Michigan, 48098

  • Del Sol Research Management, 850 N Knob Road

    Tucson, Arizona, 85710

  • Tyler Research Institute, 1720 S. Beckham

    Tyler, Texas, 75701

  • The Carle Foundation, 611 West Park Street

    Urbana, Illinois, 61801

  • Ventura Clinical Trials, 1835 Knoll Drive

    Ventura, California, 93003

  • West Michigan Clinical Research Center, 2093 Health Dr. SW, Suite 201

    Wyoming, Michigan, 49519

Other trials in United States

Israel10 sites

  • Assaf HaRofeh Medical Center, Gastroenterology Department, Harofeh Medical Center

    Be’er Ya‘aqov, 70300

  • Bnaizion Medical Center, Golomb 47

    Haifa, 31048

  • The E. Wolfson Medical Center, 62 Halohamim Str.

    Holon, 58100

  • Shaare Zedek Medical Center, Beith Street

    Jerusalem, 91031

  • Ein Karem Medical Center, Kiryat Hadassah

    Jerusalem, 91120

  • Meir, 59 Tchemacovsky St

    Kfar Saba, 44281

  • Galilee Medical Center, P.O.B. 21

    Nahariya, 1210001

  • Holy Family Hospital, Namsawi St. POB 8

    Nazareth, 16100

  • RMC Beilinson Hospital, 39 Jabotinsky Street

    Petah Tikva, 49100

  • Sourasky Medical Center, 6 Weizman Street

    Tel Aviv, 64239

Other trials in Israel

Poland10 sites

  • NZOZ Specjalistyczne Centrum Gastrologii GASTROMED Wiejska 81

    Bialystok, 15-351

  • SP ZOZ MSWiA w Gdańsku, Oddział Gastroenterologiczny, ul. Kartuska 4/6

    Gdansk, 80-104

  • UNICARDIA Specjalistyczne Centrum Leczenia Chorob Serca i Naczyn & UNIMEDICA Specjalistyczne Centrum Medyczne Sp. z o.o. Kluczborska 15

    Krakow, 31-271

  • Centrum Medyczne Szpital Sw. Rodziny Sp. z o.o. Wigury 19

    Lodz, 90-302

  • Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny Żołnierska 18

    Olsztyn, 10-561

  • ENDOSKOPIA sp. z o.o. B. Chrobrego 6/8

    Sopot, 81-756

  • EuroMedis sp. z.o.o., ul. Powstanców Wielkopolskich 33a

    Szczecin, 70-111

  • "GASTROMED" Kopon, Zmudzinski i wspolnicy sp. j., Specjalistyczne Centrum Gastroskopii i Endoskopii, Specjalistyczne Gabinety Lekarskie Grudziadzka 11

    Torun, 87-100

  • Centralny Szpital Kliniczny MSW w Warszawie Klinika Chorob Wewnetrznych i Gastroenterologii Woloska 137

    Warsaw, 02-507

  • ARS MEDICA s.c. Rybak Maria, Rybak Zbigniew, Powstancow Slaskich 56A/2

    Wroclaw, 53-333

Other trials in Poland

Australia9 sites

  • Ballarat Health Services, Drummond St North

    Ballarat, Victoria, 3350

  • Bankstown Hospital, Level 3, Department of Gastroenterology, Eldridge Road

    Bankstown, New South Wales, 2200

  • Department of Gastroenterology, Eastern Health, ECRU, Level 2, 5 Arnold Street

    Box Hill, Victoria, 3128

  • Department of Gastroenterology and Hepatology, Concord Hospital, Hospital Road

    Concord, New South Wales, 2139

  • 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, 4029

  • Nepean Hospital, Derby Street

    Kingswood, New South Wales, 2747

  • Department of Gastroenterology, Level 1, Clinic 123, New Clinical Building, Liverpool Hospital, Elizabeth St.

    Liverpool, New South Wales, 2170

  • Department of Gastroenterology and Hepatology, Cabrini Medical Centre, 183 Wattletree Road

    Malvern, Victoria, 3144

  • Mater Hospital Brisbane, Department of Gastroenterology, Raymond Terrace

    South Brisbane, Queensland, 4101

Other trials in Australia

Czechia7 sites

  • Nemocnice Horovice, NH Hospital, a.s., Chirurgicke oddeleni, K Nemocnici 1106

    Hořovice, 268 31

  • Gastroenterologie s.r.o., Manesova 646,

    Hradec Králové, 500 02

  • HEPATO-GASTROENTEROLOGIE HK, s.r.o., Trida Edvarda Benese 1549/34

    Hradec Králové, 50012

  • EGK s.r.o., Sanatorium sv. Anny, Gastroenterologicke oddeleni, Lucni 7a/2776,

    Prague, 13000

  • IBD centrum / ISCARE IVF a.s., Jankovcova 1569/2c

    Prague, 17000

  • ARTROSCAN, s.r.o., Gastroenterologicka ambulance, 5114 Trebovicka, Ostrava

    Třebovice, 722 00

  • Krajska zdravotni, a.s., Masarykova nemocnice o.z. Gastroenterologie, Socialni pece 3316/12A

    Ústí nad Labem, 401 13

Other trials in Czechia

Bulgaria5 sites

  • MHAT "Sv. Karidad" EAD, Department of Internal Medicine / Gastroenterology, endocrinology and metabolic disorders, 23А, Nikola Vaptsarov Blvd

    Plovdiv, 4002

  • MHAT "Hadzhi Dimitar" OOD, Department of Internal Medicine / Gastroenterology and Endocrinology, 5, Dimitar Pehlivanov str.

    Sliven, 8800

  • UMHAT "Sv. Ivan Rilski" EAD; Clinic of Gastroenterology, 15, Akad. Ivan Geshov Blvd.,

    Sofia, 1432

  • ACIBADEM CITY CLINIC UNIVERSITY HOSPITAL EOOD, Oncology Center, Clinic of Gastroenterology, 66 A, Tsarigradsko shosse Blvd

    Sofia, 1784

  • DCC "Mladost-M Varna" OOD, office 528 V, 15, Republika Blvd.

    Varna, 9020

Other trials in Bulgaria

New Zealand5 sites

  • Shakespeare Specialist Group, North Shore, Suite 3, 181 Shakespeare Road, Milford Takapuna

    Auckland, 0620

  • Christchurch Hospital

    Christchurch, 4710

  • Gastroenterology Unit, Southern District Health Board, 201 Great King Street,

    Dunedin, 9054

  • Department of Gastroenterology,Waikato Hospital

    Hamilton, 3240

  • Clinical Trials Unit, Tauranga Hospital,

    Tauranga, 3112

Other trials in New Zealand

Serbia5 sites

  • : Clinic for Gastroenterology and Hepatology, Clinical Center of Serbia Koste Todorovica 2

    Belgrade, 11000

  • Clinical Department of Gastroenterology and Hepatology, Clinic for Internal Diseases, Clinical Hospital Center Zvezdara Dimitrija Tucovica 161

    Belgrade, 11000

  • Department of Gastroenterology and Hepatology, Clinical Hospital Center Zemun Vukova 9

    Belgrade, 11080

  • : Center for Gastroenterohepatology, Clinic for Internal Medicine, Clinical Center of Kragujevac Zmaj Jovina 30

    Kragujevac, 34000

  • : Clinic of Gastroenterology and Hepatology, Clinical Center of Vojvodina Hajduk Veljkova 1

    Novi Sad, 21000

Other trials in Serbia

Slovakia5 sites

  • Univerzitna nemocnica Bratislava - Nemocnica Ružinov, V. Interná klinika LFUK a UNB, Gastroenterologické a hepatologické oddelenie, Ruzinovska 6

    Bratislava, 82606

  • Univerzitná nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda Gastroenterologická klinika SZU a UNB Antolská 11

    Bratislava, 851 07

  • Breznianske centrum gastroenterologie, s.r.o. Banisko 1

    Brezno, 97701

  • PIGEAS s.r.Prieložtek 1, o.,

    Martin, 036 01

  • KM Management spol. s.r.o., Gastroenterologické a hepatologické centrum Nitra, Špitálska 13

    Nitra, 949 01

Other trials in Slovakia

Canada4 sites

  • Montreal General Hospital Digestive Lab Research Institute McGill University Health Center, 1650 Cedar Avenue C10.145

    Montreal, Quebec, H3G 1A4

  • University of Saskatchewan Royal University Hospital, 103 Hospital Drive IBD Clinical Trials Unit Rm 2658

    Saskatoon, Saskatchewan, S7N 0W8

  • Mount Sinai Hospital, 600 University Avenue, Suite 445

    Toronto, Ontario, M5G 1X5

  • Discovery Clinical Services Ltd. 601 A Discovery St.

    Victoria, British Columbia, V8T 5G4

Other trials in Canada

About this study

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

The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.

Read the 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.

Conditions
Crohn's Disease
Being tested
RHB-104, Placebo
Keywords
Crohn's Disease, moderate to severe, remission, MAP, antibiotic
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RHB-104Drug

    95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine

  • PlaceboDrug

    5 placebo capsules administered orally BID

Study groups in NCT01951326
Study groupRoleWhat they receive
RHB-104Active comparator5 RHB-104 capsules administered orally BID
Receives: Drug: RHB-104
PlaceboPlacebo comparator5 placebo capsules administered orally BID
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remission at Week 26

    Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.

    Measured: Week 26

Secondary outcomes (5)

  1. Response at Week 26

    Reduction of Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points. Lower CDAI scores indicate a better outcome.

    Measured: Week 26

  2. Remission at Week 52

    Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.

    Measured: Week 52

  3. Durable Remission Week 26 Through Week 52

    When a subject is in remission with a maximum CDAI score of 149 at every visit from Week 26 through and including Week 52

    Measured: Week 26 through week 52

  4. Remission at Week 16

    Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.

    Measured: Week 16

  5. Steroid Free Remission at Week 52

    Subjects who are maintained off steroids for a minimum of 3 weeks

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionMay 2018
  4. Study completionAug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01951326
Sponsor's protocol ID
RHB-104-01
Acronym
MAPUS
Status last verified
Jun 2020
First submitted
19 Sep 2013
Last updated
8 Dec 2020
Data monitoring committee
Yes

Publications

  • Graham DY, Naser SA, Borody T, Hebzda Z, Sarles H, Levenson S, Hardi R, Arlukowicz T, Svorcan P, Fathi R, Bibliowicz A, Anderson P, McLean P, Fehrmann C, Harris MS, Zhao S, Kalfus IN. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. doi: 10.3390/antibiotics13080694.

    PubMed 39199994

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RHB-104 in people with Crohn's Disease, run by RedHill Biopharma Limited at 103 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Israel, Poland, Australia, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission at Week 26 (time frame: Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01951326, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.

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