Crohn DiseasePhase 3MAPUS2NCT03009396
Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease
A Phase 3 study testing RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine) in people with Crohn Disease, run by RedHill Biopharma Limited at 24 sites in 7 countries.
Trial summary
An open label extension to the RHB-104-01 Study. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 18 Mar 2017to 19 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 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed fully informed consent (ICF) provided as per this protocol.
- Participation in RHB-104-01 for 26 weeks, and a Crohn's Disease Activity Index (CDAI) score of ≥ 150 at Visit Week 26.
- OR
- More than 26 weeks, with a CDAI ≥150 at Visit Week 26 and all subsequent visits, and subject is between Week 26 and 52 within 4 weeks (28 days) of site activation (e.g. Subject with CDAI = 249 at week 26 and who is at week 38 at the time of site's activation for RHB-104-04 has a 4-week window to be enrolled in the open label study via the Optional Screening Visit)
- Current treatment with at least one of the following therapies which may be discontinued by the investigator as clinically indicated after 8 weeks of open label RHB-104 treatment:
- Oral 5-acetyl salicylic acid (5-ASA) compounds
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- Azathioprine or 6-mercaptopurine (6-MP) or methotrexate
- Infliximab or adalimumab OR Current treatment with corticosteroid therapy which must begin tapering after 4 weeks of treatment with open label RHB-104 (Refer to Appendix 13)
- White blood cell count ≥ 3.5x109 at screening (RHB-104-01 Visit Week 26 visit or Optional Screening visit)
- Subject agrees to use the following effective contraceptive methods
- diaphragm, cervical cap, contraceptive sponge or condom) with spermicidal foam/gel/cream/suppository
- IUD (intrauterine device) /IUS (intrauterine system)
- progestogen injection (Depo-Provera®) throughout the study and for at least 6 weeks after last study drug administration, unless subject or partner of subject is post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation, or has had a vasectomy. Post-menopausal is defined as having experienced 12 consecutive months without menstruation.
- In regions where local regulatory contraceptive requirements differ, the ICF (Informed Consent Form) will reflect local policies.
Who cannot join
- Positive stool results for C. difficile.
- Currently diagnosed or history of uveitis confirmed by either an ophthalmologist or optometrist.
- Treatment with any medication that causes QT prolongation or Torsades de Pointes, including but not limited to: amiodarone, amitriptyline, astemizole, cisapride, citalopram dose greater than 20 mg/day, dihydroergotamine, disopyramide, dofetilide, dronedarone, ergotamine, ibutilide, ondansetron or other 5-HT3 (5-hydroxytryptamine three) receptor antagonists, pimozide, procainamide, quinidine, quinine, quinolones, ranolazine, risperidone, sotalol, terfenadine and tolterodine. QT prolonging drugs may be referenced at the CredibleMeds® web site: https://crediblemeds.org/index.php/drugsearch/
- Treatment with the following CYP3A4 interactive medications: alfentanyl, alprazolam, amlodipine, anti-retroviral agents, apixaban, aprepitant, aripiprazole, atorvastatin, boceprevir, buspirone, carbamazepine, carvedilol, colchicine, cyclosporine, digoxin, diltiazem, estrogens, felodipine, fluconazole, fluvoxamine, grapefruit juice, haloperidol, ketoconazole, lovastatin, lurasidone, metoprolol, nefazodone, nifedipine, nisoldipine, nitrendipine, propranol, roflumilast, simvastatin, St. John's wort, and voriconazole.
- Any evidence of any newly diagnosed significant hematological, hepatic, renal, cardiac, pulmonary, metabolic, neurological, psychiatric or other disease (e.g. porphyria) that might interfere with subject's ability to safely enter and or complete the study requirements.
- Females who have a positive pregnancy test or are lactating.
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- Refusal to sign the study informed consent form.
- Inability to be able to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study.
- Clinically significant abnormalities of hematology or biochemistry as confirmed by repeat testing based on investigator's discretion, including but not limited to, elevations greater than 2 times the upper limit of normal of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) or creatinine clearance less than 60 ml/min at screening via estimated Cockcroft-Gault formula:
- Creatinine Clearance = [140 - age in years] weight (kg) / 72 Serum Creatinine (mg/dl) [multiply estimated rate by 0.85 for women], using actual body weight.
- QTcF (shortening of the QT interval in the heart rate) >450ms in males and QTcF>460ms in females, bundle branch block, or major ST or T wave abnormalities that make the assessment of the QT impossible.
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
Poland7 sites
NZOZ Specjalistyczne Centrum Gastrologii GASTROMED, Wiejska 81
Bialystok, 15-351
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW 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
Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny, Zolnierska 18
Olsztyn, 10-561
EuroMedis sp. z.o.o., Al. Powstancow Wielkopolskich 33a
Szczecin, 70-111
Centralny Szpital Kliniczny MSW w Warszawie. Klinika Chorob Wewnetrznych i Gastroenterologii, Woloska 137,
Warsaw, 02-507
ARS MEDICA s.c., Powstancow Slaskich 56A/2
Wroclaw, 53-333
United States6 sites
Commonwealth Clinical Studies, 189 Quincy St.
Brockton, Massachusetts, 02302-2926
ClinSearch 6035 Shallowford Road Suite 109
Chattanooga, Tennessee, 37421
Chevy Chase Clinical Research, 5550 Friendship Blvd.
Chevy Chase, Maryland, 20815
Gastrointestinal Specialists of Georgia PC 711 Canton Rd. #300
Marietta, Georgia, 30060
Digestive Care Associates, Inc., 1000 Laurel Street
San Carlos, California, 94070
Cotton-O'Neil Clinical Research Center, 720 SW Lane St.
Topeka, Kansas, 66606
Israel3 sites
Ha'Emek Medical Center, Institute of Gastroenterology and Liver diseases, 21 Yitshak Rabin Boulevard
Afula, 1834111
Gastroenterology Institute, Division of Medicine, Hadassah - Hebrew University Medical Center POB 12000
Jerusalem, 91120
Meir Medial Center, 59 Tchemacovsky St.
Kfar Saba, 44281
Serbia3 sites
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 Kragujevac, Zmaj Jovina 30
Kragujevac, 34000
Czechia2 sites
Gastroenterologie s.r.o. Manesova 646
Hradec Králové, 500 02
Hepato-Gastroenterologie HK, s.r.o., Hradecka poliklinika III Trida Edvarda Benese 1549/34
Hradec Králové, 500 12
New Zealand2 sites
Christchurch Hospital, 2 Riccarton Rd.
Christchurch, Canterbury, 80011
Waikato Hospital, Department of Gastroenterology, Level B1, Menzies Building, Pembroke Street
Hamilton, Waikato Region, 3240
Canada1 site
Discovery Clinical Services Ltd., 601 A Discovery St.
Victoria, British Columbia, V8T 5G4
About this study
Official title: An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study
An open label extension to the RHB-104-01 Study.
Read the detailed description
An Open Label Phase III Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study.
- Conditions
- Crohn Disease
- Being tested
- RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)
- Keywords
- Crohn's Disease,, moderate to severe, remission, Mycobacterium avium paratuberculosis, 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-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)Drug
Also called RHB-104
For patients on ACTIVE or PLACEBO in the parent study (RHB-104-01), who were not in remission after 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| RHB-104 - patients on ACTIVE therapy in RHB-104-01 study | Experimental | Subjects who were on the active therapy arm in the RHB-104-01 clinical study will continue to receive RHB-104 at 5 capsules twice a day in addition to the standard of care they received in the RHB-104-01 clinical study Receives: Drug: RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine) |
| RHB-104 - patients on PLACEBO therapy in RHB-104-01 study | Experimental | Subjects who were on the active therapy arm in the RHB-104-01 clinical study will receive RHB-104 at 5 capsules twice a day in addition to the standard of care they received in the RHB-104-01 clinical study. The RHB-104 will be ramped up beginning at 1 capsule twice per day in week 1 increasing to 2 capsules twice per day in week 2, 3 capsules twice per day in week 3, 4 capsules per day in week 4 and achieving 5 capsules per day for the remainder of the study. Receives: Drug: RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Remission at Week 16
The number of patients who achieved a reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150 points.
Lower CDAI scores indicate a better outcome.
Measured: Week 16
Secondary outcomes (6)
Response at Week 16
Reduction of the total Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points Lower CDAI scores indicate a better outcome.
Measured: Week 16
The Number of Weeks for Patients to Achieve Remission
[Date of first observed remission (CDAI less than 150) - date of first dose, or date of randomization if not dosed, plus 1] / 7 days. Subject who never experience remission during the study are censored at the time of their last CDAI assessment.
Measured: Baseline through week 52
Number of Weeks the Patients Are in Remission
Duration of remission is defined as the number of weeks the subject is in remission (CDAI score < 150). It is calculated as the first date following remission at which CDAI is ≥150 minus the date of first remission, plus 1 day, divided by 7. Subjects who experienced remission and continued to be in remission at the time of their last CDAI assessment are censored at the date of their last CDAI assessment.
Measured: Baseline through week 52
Number of Weeks to Achieve Response
[Date of first observed response (a reduction from baseline of ≥ 100 in CDAI score) - Date of first dose or date of randomization if not dosed + 1] / 7 Days. Subjects who never experienced response during the study are censored at the date of their last CDAI assessment.
Measured: Baseline through week 52
Number of Weeks the Patients Are in Response.
Duration of response is defined as the number of weeks the subject is in a state of response (a reduction from baseline of ≥ 100 in CDAI score). It is calculated as the first date following response at which the reduction from baseline in CDAI is <100 minus the date of first response, plus 1 day, divided by 7. Subjects who experienced response and continued to be in response at the time of their last CDAI assessment are censored at the date of their last CDAI assessment.
Measured: Baseline through week 52
Durable Remission Week 16 Through Week 52
When a subject is in remission with a maximum CDAI score of 149 at every visit from week 16 through and including week 52.
Measured: Week 16 through week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start18 Mar 2017
- Primary completion13 Nov 2018
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Active
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedHill Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ira N Kalfus, MD, Study director, RedHill Biopharma LimitedDavid Y Graham, MD, Principal investigator, Department of Medicine / Gastroenterology, Baylor College of Medicine, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009396
- Sponsor's protocol ID
- RHB-104-04
- Acronym
- MAPUS2
- Status last verified
- Feb 2021
- First submitted
- 26 Dec 2016
- Last updated
- 24 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study
- ClinicalTrials.gov ID
- NCT03009396
- Acronym / sponsor ID
- MAPUS2 / RHB-104-04
- Conditions
- Crohn Disease
- Keywords
- Crohn's Disease,, moderate to severe, remission, Mycobacterium avium paratuberculosis, antibiotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- RedHill Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2017 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Posted 24 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label extension to the RHB-104-01 Study.
Detailed description
An Open Label Phase III Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Active
| Arm | Type | Receives |
|---|---|---|
| RHB-104 - patients on ACTIVE therapy in RHB-104-01 study | Experimental | Drug: RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)Subjects who were on the active therapy arm in the RHB-104-01 clinical study will continue to receive RHB-104 at 5 capsules twice a day in addition to the standard of care they received in the RHB-104-01 clinical study |
| RHB-104 - patients on PLACEBO therapy in RHB-104-01 study | Experimental | Drug: RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)Subjects who were on the active therapy arm in the RHB-104-01 clinical study will receive RHB-104 at 5 capsules twice a day in addition to the standard of care they received in the RHB-104-01 clinical study. The RHB-104 will be ramped up beginning at 1 capsule twice per day in week 1 increasing to 2 capsules twice per day in week 2, 3 capsules twice per day in week 3, 4 capsules per day in week 4 and achieving 5 capsules per day for the remainder of the study. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed fully informed consent (ICF) provided as per this protocol.
- Participation in RHB-104-01 for 26 weeks, and a Crohn's Disease Activity Index (CDAI) score of ≥ 150 at Visit Week 26.
- OR
- More than 26 weeks, with a CDAI ≥150 at Visit Week 26 and all subsequent visits, and subject is between Week 26 and 52 within 4 weeks (28 days) of site activation (e.g. Subject with CDAI = 249 at week 26 and who is at week 38 at the time of site's activation for RHB-104-04 has a 4-week window to be enrolled in the open label study via the Optional Screening Visit)
- Current treatment with at least one of the following therapies which may be discontinued by the investigator as clinically indicated after 8 weeks of open label RHB-104 treatment:
Key exclusion criteria (11 listed)
- Positive stool results for C. difficile.
- Currently diagnosed or history of uveitis confirmed by either an ophthalmologist or optometrist.
- Treatment with any medication that causes QT prolongation or Torsades de Pointes, including but not limited to: amiodarone, amitriptyline, astemizole, cisapride, citalopram dose greater than 20 mg/day, dihydroergotamine, disopyramide, dofetilide, dronedarone, ergotamine, ibutilide, ondansetron or other 5-HT3 (5-hydroxytryptamine three) receptor antagonists, pimozide, procainamide, quinidine, quinine, quinolones, ranolazine, risperidone, sotalol, terfenadine and tolterodine. QT prolonging drugs may be referenced at the CredibleMeds® web site: https://crediblemeds.org/index.php/drugsearch/
- Treatment with the following CYP3A4 interactive medications: alfentanyl, alprazolam, amlodipine, anti-retroviral agents, apixaban, aprepitant, aripiprazole, atorvastatin, boceprevir, buspirone, carbamazepine, carvedilol, colchicine, cyclosporine, digoxin, diltiazem, estrogens, felodipine, fluconazole, fluvoxamine, grapefruit juice, haloperidol, ketoconazole, lovastatin, lurasidone, metoprolol, nefazodone, nifedipine, nisoldipine, nitrendipine, propranol, roflumilast, simvastatin, St. John's wort, and voriconazole.
- Any evidence of any newly diagnosed significant hematological, hepatic, renal, cardiac, pulmonary, metabolic, neurological, psychiatric or other disease (e.g. porphyria) that might interfere with subject's ability to safely enter and or complete the study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)Also: RHB-104For patients on ACTIVE or PLACEBO in the parent study (RHB-104-01), who were not in remission after 26 weeks | Drug | RHB-104 - patients on ACTIVE therapy in RHB-104-01 study, RHB-104 - patients on PLACEBO therapy in RHB-104-01 study |
Primary outcome
Number of Patients in Remission at Week 16
Time frame: Week 16
The number of patients who achieved a reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150 points. Lower CDAI scores indicate a better outcome.
6 secondary outcomes
Response at Week 16
Time frame: Week 16
The Number of Weeks for Patients to Achieve Remission
Time frame: Baseline through week 52
Number of Weeks the Patients Are in Remission
Time frame: Baseline through week 52
Number of Weeks to Achieve Response
Time frame: Baseline through week 52
Number of Weeks the Patients Are in Response.
Time frame: Baseline through week 52
Durable Remission Week 16 Through Week 52
Time frame: Week 16 through week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- RedHill home pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira N Kalfus, MD study director
RedHill Biopharma Limited
David Y Graham, MD principal investigator
Department of Medicine / Gastroenterology, Baylor College of Medicine, Houston
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine) in people with Crohn Disease, run by RedHill Biopharma Limited at 24 sites in 7 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 14 inclusion and 11 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Poland, United States, Israel, Serbia, Czechia and 2 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. 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 24 Feb 2021). 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?
Number of Patients in Remission at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2021.