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    EudraCT Number:2016-005199-90
    Sponsor's Protocol Code Number:RHB-104-04
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-14
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2016-005199-90
    A.3Full title of the trial
    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
    Otvorené klinické skúšanie hodnotiace účinnosť a bezpečnosť fixnej kombinácie liečiv RHB-104 u pacientov s aktívnou Crohnovou chorobou napriek 26 týždňoch účasti v klinickej štúdii MAP US RHB-104-01
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open Label Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease.
    A.3.2Name or abbreviated title of the trial where available
    RHB-104-04 and MAP (US2)
    A.4.1Sponsor's protocol code numberRHB-104-04
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRedHill Biopharma Ltd.
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRedHill Biopharma Ltd.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRedHill Biopharma Ltd.
    B.5.2Functional name of contact pointMedical Director - Ira Kalfus
    B.5.3 Address:
    B.5.3.1Street Address251 Central Park West, Suite 3A
    B.5.3.2Town/ cityNew York, NY
    B.5.3.3Post code10024
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1917817 7517
    B.5.5Fax number+1888685 5218
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code RHB-104
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClarithromycin
    D.3.9.1CAS number 81103-11-9
    D.3.9.3Other descriptive nameCLARITHROMYCIN
    D.3.9.4EV Substance CodeSUB06641MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number95
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRifabutin
    D.3.9.1CAS number 72559-06-9
    D.3.9.3Other descriptive nameRIFABUTIN
    D.3.9.4EV Substance CodeSUB10304MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClofazimine
    D.3.9.1CAS number 2030-63-9
    D.3.9.3Other descriptive nameCLOFAZIMINE
    D.3.9.4EV Substance CodeSUB06694MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to Severely Active Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to estimate the remission rate, defined as a CDAI score of less than 150, at 16 weeks after the initiation of the open-label phase.
    E.2.2Secondary objectives of the trial
    To estimate the
    -response rate of patients, defined by a reduction of CDAI score of ≥100 points at week 16 after the initiation of the open-label phase
    - average duration of remission among participants
    - average time to first response among participants
    - average duration of response among participants
    - the proportion of participants who maintain a state of remission from
    week 16 through week 52.

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Colonoscopy for evaluation of mucosal healing via Crohn’s Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Score for Crohn’s Disease (SES-CD).

    - To estimate the change from baseline in the mean Crohn’s Disease Endoscopic Index of Severity (CDEIS) after 16 and 52 weeks of treatment
    - To estimate the change from baseline in the mean Simple Endoscopic Activity Score (SES-CD) after 16 and 52 weeks of treatment
    - To make a comparison of success rates of (ΔCDEIS and SES-CD) defined by 25% and 50% improvements
    - To estimate the correlation between the change from baseline in the endoscopic index (ΔCDEIS) and the clinical index (ΔCDAI) after 16 and 52 weeks of treatment
    - To make a comparison of success rates of (ΔCDEIS) defined by 25% and 50% improvements and CDAI defined remission
    - To make a comparison of success rates of (ΔCDEIS) defined by 25% and 50% improvements and CDAI defined response
    - To make a comparison of success rates of (ΔSES-CD) defined by 25% and 50% improvements and CDAI defined remission
    - To make a comparison of success rates of (ΔSES-CD) defined by 25% and 50% improvements and CDAI defined response
    E.3Principal inclusion criteria
    1) 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
    2) White blood cell count ≥ 3.5x109 at screening
    3) Subject agrees to use the following effective contraceptive methods
    - diaphragm, cervical cap, contraceptive sponge or condom with spermicidal foam
    - IUD/IUS
    - 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. In regions where local regulatory contraceptive requirements differ, the ICF will reflect local policies
    E.4Principal exclusion criteria
    1) 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, ibutilde, ondansetron or other 5-HT3 receptor antagonists, pimozide, procainamide, quinidine, quinine, quinolones, ranolazine, risperidone, sotalol, terfenadine and tolteridine. QT prolonging drugs may be referenced at the CredibleMeds® web site:
    2) Treatment with the following CYP3A4 interactive medications: alfentanyl,alprazolam, amlodipine, anti-retroviral agents, apixabin, 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.
    3) Positive stool results for C. difficile.
    4) Currently diagnosed or history of uveitis confirmed by either an ophthalmologist or optometrist.
    5) Evidence of any 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.
    6) 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), 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.
    7) QTcF>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.
    8) Females who have a positive pregnancy test or are lactating.
    E.5 End points
    E.5.1Primary end point(s)
    Remission (primary outcome measure) – Remission in a subject is defined as a CDAI score of <150 at 16 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    Response – A response in the individual subject is defined as reduction in CDAI score of ≥100 from baseline where baseline is the measure taken at Screening of this trial (Visit Week 26 of RHB-104-01.)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit Week 26 of RHB-104-01 study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    New Zealand
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subject will return to the physician for follow-up and treatment if necessary after ending the participation in the trial.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-08-19
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