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    Summary
    EudraCT Number:2017-004581-10
    Sponsor's Protocol Code Number:CL2-201086-002
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2017-004581-10
    A.3Full title of the trial
    Efficacy and safety of 3 doses of S201086/GLPG1972 administered orally once daily in patients with knee osteoarthritis. A 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled, dose-ranging study.
    ROCCELLA Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of S201086/GLPG1972 in patients with knee osteoarthritis
    A.4.1Sponsor's protocol code numberCL2-201086-002
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1205-0321
    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 SponsorInstitut de Recherches Internationales Servier
    B.1.3.4CountryFrance
    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 supportADIR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherches Internationales Servier
    B.5.2Functional name of contact pointClinical Studies Department
    B.5.3 Address:
    B.5.3.1Street Address50, rue Carnot
    B.5.3.2Town/ citySuresnes Cedex
    B.5.3.3Post code92284
    B.5.3.4CountryFrance
    B.5.4Telephone number+33155 72 43 66
    B.5.5Fax number+33155 72 54 12
    B.5.6E-mailclinicaltrials@servier.com
    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.3.1Product nameS201086
    D.3.2Product code S201086
    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.3.9.2Current sponsor codeS201086
    D.3.9.3Other descriptive nameS201086
    D.3.9.4EV Substance CodeSUB190321
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    Osteoarthritis
    E.1.1.1Medical condition in easily understood language
    Osteoarthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031161
    E.1.2Term Osteoarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of at least one dose (among 3 doses) of S201086 compared to placebo after 52 weeks of treatment in reducing cartilage loss measured by cartilage thickness using quantitative magnetic resonance imaging (qMRI) of the central medial tibiofemoral compartment (cMTFC) of the target knee.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of 3 doses of S201086
    To assess efficacy of 3 doses of S201086 versus placebo after 52 weeks of treatment on:
    - the proportion of structural progressors based on cartilage thickness using qMRI of the cMTFC of the target knee
    - pain, function, and stiffness measured with WOMAC
    - pain measured with a 100-mm VAS
    - patient global assessment (PGA) of disease activity measured with 100-mm VAS
    - reduction of cartilage loss measured by cartilage thickness using qMRI of the total tibiofemoral compartment (tTFC) of the target knee
    - Joint Space Width (JSW) measured by x-ray
    To assess efficacy of 3 doses of S201086 versus placebo after 28 and 52 weeks of treatment on bone area using qMRI of the medial femoral condyle surface of the target knee
    To assess the pharmacokinetics of S201086
    To assess efficacy of 3 doses of S201086 versus placebo after 52 weeks of treatment on analgesic consumption
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male patients or female patients of non-childbearing potential
    Age between 40 to 75 years (both inclusive) for male patients and female surgically sterile patients, and 50 to 75 years (both inclusive) for postmenopausal female patients
    Body weight > 40 kg, body mass index (BMI) < 40 kg/m2
    Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology
    History of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month
    Symptoms severity defined by a pain ≥ 40 mm and ≤ 90 mm on VAS (100 mm)
    Documented need for symptomatic as needed-treatment for OA in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics
    E.4Principal exclusion criteria
    Severe clinical knee malalignment according to the investigator
    Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side)
    Knee prosthesis already foreseen within the study period (whichever side)
    Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side)
    Previous osteotomy on the inferior limbs (whichever side) other than intervention for hallux valgus with full clinical recovery after surgery
    Any surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study
    Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study
    Other pathologies affecting the knee
    Any contraindication to MRI including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil
    E.5 End points
    E.5.1Primary end point(s)
    Cartilage thickness of the central medial tibiofemoral compartment (cMTFC) of the target knee
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline to W052
    E.5.2Secondary end point(s)
    Efficacy endpoints:
    Proportion of structural progressors based on cartilage thickness of the cMTFC of the target knee
    WOMAC total score and subscales scores of the target knee for pain, function and stiffness
    Pain of the target knee
    PGA of disease activity of the target knee
    Proportion of Outcome Measures in Rheumatology (OMERACT)-OARSI responders
    Cartilage thickness of the total tibiofemoral compartment (tTFC) of the target knee
    Bone area of the medial femoral condyle surface of the target knee
    JSW of the target knee
    Analgesic consumption

    Safety endpoints:
    Adverse events
    Physical examination
    Body weight
    Vital signs
    Laboratory examinations
    ECG

    Pharmacokinetic parameters of S201086
    E.5.2.1Timepoint(s) of evaluation of this end point
    Proportion of structural progressors based on cartilage thickness of the cMTFC of the target knee, cartilage thickness of the tTFC of the target knee, bone area of the medial femoral condyle surface of the target knee : W000, W028, W052
    WOMAC total score and subscales scores, PGA of disease activity of the target knee, proportion of OMERACT-OARSI responders: W000, W012, W028, W040, W052
    Pain of the target knee: ASSE, W000, W004, W008, W012, W020, W028, W040, W052
    JSW of the target knee: ASSE, W052
    Analgesic consumption: all over the study
    Adverse events, Physical examination, Vital signs, Laboratory examinations: all over the study
    Body weight: ASSE, W000, W012, W028, W052
    ECG: ASSE, W000, W004, W028, W052
    Pharmacokinetic parameters of S201086: W004, W012, W028, W040, W052
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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.7.1.3.1Other 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 trial4
    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 EEA22
    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
    Argentina
    Brazil
    Bulgaria
    Canada
    Denmark
    Hungary
    Japan
    Korea, Democratic People's Republic of
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    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
    Last visit last patient
    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 months5
    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 months5
    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: 502
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 181
    F.4.2.2In the whole clinical trial 852
    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)
    After the discontinuation of the IMP, the patient's treatment is left to the physician's discretion.
    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 Decision2018-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-14
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