Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

An open label extension to the RHB-104-01 Study.

Key facts

Study ID

NCT03009396

Run by

RedHill Biopharma Limited

People needed

54

Starts

2017-03-18

Expected to finish

2019-08-19

Last updated by the study team

2021-02-24

Who can join

Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Digestive Care Associates, Inc., 1000 Laurel Street — San Carlos, California, United States
• Gastrointestinal Specialists of Georgia PC 711 Canton Rd. #300 — Marietta, Georgia, United States
• Cotton-O'Neil Clinical Research Center, 720 SW Lane St. — Topeka, Kansas, United States
• Chevy Chase Clinical Research, 5550 Friendship Blvd. — Chevy Chase, Maryland, United States
• Commonwealth Clinical Studies, 189 Quincy St. — Brockton, Massachusetts, United States
• ClinSearch 6035 Shallowford Road Suite 109 — Chattanooga, Tennessee, United States
• Discovery Clinical Services Ltd., 601 A Discovery St. — Victoria, British Columbia, Canada
• Gastroenterologie s.r.o. Manesova 646 — Hradec Králové, Czechia
• Hepato-Gastroenterologie HK, s.r.o., Hradecka poliklinika III Trida Edvarda Benese 1549/34 — Hradec Králové, Czechia
• Ha'Emek Medical Center, Institute of Gastroenterology and Liver diseases, 21 Yitshak Rabin Boulevard — Afula, Israel
• Gastroenterology Institute, Division of Medicine, Hadassah - Hebrew University Medical Center POB 12000 — Jerusalem, Israel
• Meir Medial Center, 59 Tchemacovsky St. — Kfar Saba, Israel
• Christchurch Hospital, 2 Riccarton Rd. — Christchurch, Canterbury, New Zealand
• Waikato Hospital, Department of Gastroenterology, Level B1, Menzies Building, Pembroke Street — Hamilton, Waikato Region, New Zealand
• NZOZ Specjalistyczne Centrum Gastrologii GASTROMED, Wiejska 81 — Bialystok, Poland
• Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW W Gdańsku Oddział Gastroenterologiczny, Ul. Kartuska 4/6 — Gdansk, Poland
• UNICARDIA Specjalistyczne Centrum Leczenia Chorob Serca i Naczyn & UNIMEDICA. Specjalistyczne Centrum Medyczne Sp. z o.o., Kluczborska 15 — Krakow, Poland
• Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny, Zolnierska 18 — Olsztyn, Poland
• EuroMedis sp. z.o.o., Al. Powstancow Wielkopolskich 33a — Szczecin, Poland
• Centralny Szpital Kliniczny MSW w Warszawie. Klinika Chorob Wewnetrznych i Gastroenterologii, Woloska 137, — Warsaw, Poland
• ARS MEDICA s.c., Powstancow Slaskich 56A/2 — Wroclaw, Poland
• Clinical Department of Gastroenterology and Hepatology Clinic for Internal Diseases Clinical Hospital Center Zvezdara Dimitrija Tucovica 161 — Belgrade, Serbia
• Department of Gastroenterology and Hepatology, Clinical Hospital Center Zemun, Vukova 9 — Belgrade, Serbia
• Center for Gastroenterohepatology, Clinic for Internal Medicine, Clinical Center Kragujevac, Zmaj Jovina 30 — Kragujevac, Serbia

Full record on ClinicalTrials.gov

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