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    EudraCT Number:2019-001684-77
    Sponsor's Protocol Code Number:1407-0003
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-12-08
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-001684-77
    A.3Full title of the trial
    A 12-weeks Phase II, randomized, double-blind, placebocontrolled, parallel-group, proof-of-concept trial of BI 730357 in patients with active ankylosing spondylitis
    A BI 730357 vizsgálati gyógyszerkészítmény 12 hetes, II. fázisú, randomizált, kettős vak, placebo-kontrollált, párhuzamos csoportos, igazoló („proof-of-concept”) vizsgálata aktív spondyli-tis ankylopoeticában szenvedő betegek körében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to test whether BI 730357 is effective in patients with active ankylosing spondylitis
    A BI 730357 hatékonyságára irányuló vizsgálat aktív Bechterew-kórban szenvedő betegek körében
    A.4.1Sponsor's protocol code number1407-0003
    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 SponsorBoehringer Ingelheim RCV GmbH & Co KG
    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 supportBoehringer Ingelheim RCV GmbH & Co KG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH&Co KG
    B.5.2Functional name of contact pointCT Disclosure & Data Transparency
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.4Telephone number18002430127
    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 BI 730357
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNBI 730357
    D.3.9.2Current sponsor codeBI 730357
    D.3.9.3Other descriptive nameBI 730357
    D.3.9.4EV Substance CodeSUB184416
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated tablet
    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
    axial spondyloarthritis
    E.1.1.1Medical condition in easily understood language
    axial spondyloarthritis
    E.1.1.2Therapeutic area Body processes [G] - Physical Phenomena [G01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10041672
    E.1.2Term Spondylitis ankylosing
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this trial is to evaluate proof-of-clinical-concept (PoCC) by investigating the efficacy, safety and tolerability of BI 730357 compared to placebo in patients with active AS.
    A BI 730357 hatékonyságának, biztonságosságának és tolerálhatóságának vizsgálata placebóval összehasonlítva spondylitis ankylopoeticában szenvedő betegek körében.
    E.2.2Secondary objectives of the trial
    Secondary objectives are, amongst others, achievement of low disease activity or inactive disease status at Week 12.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients.
    2. Age ≥ 18 years and ≤ 75 years at screening visit.
    3. Signed and dated written informed consent in accordance with ICH-GCP and local
    legislation prior to admission to the trial.
    4. Diagnosis of AS according to modified New York criteria (1984).
    5. Documented disease duration ≥ 3 months at screening visit.
    6. Active disease at screening, defined as:
    a. BASDAI score (0-10) ≥ 4, AND
    b. Spinal pain level assessed by the 2nd BASDAI question (0-10) ≥ 4
    7. Have either
    a. an inadequate response for axial symptoms to at least 30 days of optimal daily
    doses of at least two NSAIDs, OR
    b. an intolerance to NSAIDs,
    according to judgement of the investigator.
    8. Women of child-bearing potential must be ready and able to use highly effective methods
    of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year
    when used consistently and correctly. Such methods should be used throughout the trial
    and the patient must agree to periodic pregnancy testing during participation in the trial
    E.4Principal exclusion criteria
    1. Major chronic inflammatory or connective tissue disease other than AS (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, Lyme disease, gout) or fibromyalgia, as assessed by the investigator
    2. Active uveitis or uveitis within 4 weeks prior to randomization
    3. Suspected or diagnosed inflammatory bowel disease
    4. Previous exposure to BI 730357
    5. Prior use of any therapeutic agent directly targeted to IL-17 or TNFα
    6. Evidence of total ankylosis of the spine at any time in judgement of the investigator
    7. Existing contraindications for an MRI examination, according to local medical standards
    8. Use of the treatments:
    - Leflunomide without cholestyramine wash-out within 8 weeks prior to randomisation,
    - non-biologic-targeted synthetic DMARDs (e.g., JAK inhibitors, phosphodiesterase-4 inhibitors or leflunomide with cholestyramine wash-out) within 4 weeks prior to randomization
    - intraarticular injection(s) (including glucocorticoids) and intramuscular or intraveneous corticosteroid treatment within 4 weeks prior to randomization
    - oral glucocorticoids within 2 weeks prior to randomization

    Further criteria apply.
    E.5 End points
    E.5.1Primary end point(s)
    1) Achievement of ASAS 40
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) week 12
    E.5.2Secondary end point(s)
    1) Change from baseline to Week 12 in disease activity assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
    2) Achievement of ASAS 20 at Week 12
    3) Achievement of Low Disease Activity (Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1) at Week 12.
    4) Achievement of Inactive Disease (ASDAS score of < 1.3) at Week 12.
    5) Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12 as compared to baseline
    6) Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 as compared to baseline
    7) Achievement of Major Improvement (ASDAS improvement of >2) at Week 12 as compared to baseline
    8) Achievement of ASAS 5/6 at Week 12
    9) Number of patients discontinued due to drug-related AEs.
    10) AEs
    11) Treatment emergent AEs
    12) SAEs
    13) Intensity (assessed on RCTC criteria)
    14) Safety Laboratory Values (haematology, clinical chemistry and urinanalysis)
    15) Vital Signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) week 12
    2) week 12
    3) week 12
    4) week 12
    5) week 12
    6) week 12
    7) week 12
    8) week 12
    9) week 12
    10) week 12
    11) week 12
    12) week 12
    13) week 12
    14) week 12
    15) week 12

    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    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
    Korea, Republic of
    Moldova, Republic of
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days11
    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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 40
    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)
    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 Decision2020-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-08-18
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