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    Summary
    EudraCT Number:2016-005096-27
    Sponsor's Protocol Code Number:MBPS205
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-02-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-005096-27
    A.3Full title of the trial
    A Phase 2b, Multicentre, Multinational, Placebo-controlled, Double-blind, Dose-finding Study in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with BPS804.
    Étude de phase 2b, multicentrique, multinationale, contrôlée contre placebo, en double aveugle, de détermination de la dose chez des patients adultes atteints d'ostéogenèse imparfaite de type I, III ou IV traités par BPS804
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of test product BPS804 compared to placebo in adults with brittle bone syndrome
    Étude du produit expérimental BPS804 par rapport à un placebo chez des patients adultes atteints d'ostéogenèse imparfaite
    A.4.1Sponsor's protocol code numberMBPS205
    A.5.4Other Identifiers
    Name:IND NumberNumber:113385
    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 SponsorMereo Biopharma 3 Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportMereo BioPharma Group Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMereo Biopharma 3 Ltd.
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street Address1 Cavendish Place
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1G 0QF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number03330237300
    B.5.5Fax number03330237301
    B.5.6E-mailenquiries@mereobiopharma.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1686
    D.3 Description of the IMP
    D.3.2Product code BPS804
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot established
    D.3.9.3Other descriptive nameANTI-SCLEROSTIN MONOCLONAL ANTIBODY
    D.3.9.4EV Substance CodeSUB32049
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteogenesis imperfecta
    ostéogenèse imparfaite
    E.1.1.1Medical condition in easily understood language
    Brittle bone syndrome
    maladie des os de verre
    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 10031243
    E.1.2Term Osteogenesis imperfecta
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that BPS804 is superior to placebo in increasing radial trabecular volumetric bone mineral density (Tr. vBMD)on high resolution peripheral quantitative computated tomography (HRpQCT) and bone strength on finite element analysis (FEA) in patients with OI Type I, III or IV and to determine the dose-response relationship after 6 months of treatment
    Démontrer que le BPS804 est supérieur au placebo pour augmenter la densité minérale osseuse volumétrique trabéculaire (DMOv Tr.) radiale par tomodensitométrie quantitative périphérique à haute résolution (HRpQCT) et la résistance osseuse par analyse en éléments finis (AEF) chez des patients atteints d'OI de type I, III ou IV et déterminer la relation dose-réponse après 6 mois de traitement
    E.2.2Secondary objectives of the trial
    - To evaluate the maintenance of treatment effect at 12 months
    - To evaluate the effect of BPS804 on fracture rate (peripheral, major [long-bone], and vertebral fractures) in comparison with placebo
    - To evaluate the effect of BPS804 on Bone Mineral Density (BMD)
    - To evaluate the effect of BPS804 on bone quality
    - To evaluate the effect of BPS804 on HRpQCT parameters
    - To evaluate the effect of BPS804 on body composition
    - To evaluate the effect of BPS804 on markers of bone composition
    - To evaluate the effect of BPS804 on Patient-Reported Outcomes (PROs) and Quality of Life (QoL)
    - To evaluate the pharmacokinetics (PK) of BPS804
    - To evaluate potential induction of anti-drug antibodies (ADAs) by BPS804 and their effect on safety and PK
    - To evaluate safety and tolerability of BPS804
    - Évaluer le maintien de l'effet thérapeutique après 12 mois de
    traitement
    - Évaluer l'effet du BPS804 sur le taux de fractures fractures périphériques, majeures [os long] et vertébrales) par rapport au placebo
    - Évaluer l'effet du BPS804 sur la densité minérale osseuse (DMO)
    - Évaluer l'effet du BPS804 sur la qualité osseuse
    - Évaluer l'effet du BPS804 sur les paramètres HRpQCT
    - Évaluer l'effet du BPS804 sur la composition corporelle
    - Évaluer l'effet du BPS804 sur les marqueurs de la composition
    corporelle
    - Évaluer l'effet du BPS804 sur les résultats rapportés par le patient (Patient-Reported Outcomes, PRO) et la qualité de vie (QdV)
    - Évaluer la pharmacocinétique (PK) du BPS804
    - Évaluer l'induction potentielle d'anticorps anti-médicament (AAM) par BPS804 et leur effet sur l'innocuité et la PK
    - Évaluer l'innocuité et la tolérance de BPS804
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional bone biopsy sub-study (included in main study protocol, Section 9.1.2).

    Bone biopsies will be performed at Month 6 in a subset of participants. Informed consent will be obtained using a specific bone biopsy consent form.

    Double labelling of bone, according to the procedure detailed in the MBPS205 Bone Biopsy Manual, will be carried out before the bone biopsy procedure to allow determination of the level of bone turnover, and bone formation and mineralisation rates.

    All biopsies will be analysed at a central laboratory as per the MBPS205 Bone Biopsy Manual.
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Type of Participant and Disease Characteristics
    1. Patients with a clinical diagnosis of OI Type I, III, or IV with a defect in COL1A1/COL1A2, as confirmed by genetic testing
    2. Age ≥ 18 years
    3. One or more non-traumatic long-bone, rib, hand/feet and/or vertebral fracture(s) in past 24 months
    Sex
    4. Male and female
    NOTE: The reliability of sexual abstinence for female enrolment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
    Male participants:
    5. There are no contraception requirements for male participants with female partners who are woman of childbearing potential (WOCBP).
    Female participants:
    6. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    a. Not a WOCBP
    OR
    b. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 70 days,
    Informed Consent
    7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    Les patients ne pourront être inclus dans l'étude que s'ils répondent à tous les critères suivants :
    Type de participant et caractéristiques de la maladie
    1. Patients présentant un diagnostic clinique d'ostéogenèse imparfaite de type I, III ou IV avec un défaut des gènes COL1A1/COL1A2, confirmé
    par analyse génétique
    2. Âge ≥ 18 ans
    3. Au moins une fracture non traumatique d'os long, côte, main/pied et/ou vertèbre au cours des 24 derniers mois
    Sexe
    4. Hommes et femmes
    REMARQUE : la fiabilité de l'abstinence sexuelle dans le cadre de l'éligibilité des femmes à cette étude doit être évaluée en rapport avec la durée de l'étude clinique et du style de vie préféré et habituel de la participante. L'abstinence périodique (par ex. méthodes du calendrier ou de détection de l'ovulation, méthodes sympto-thermique ou postovulation) et le retrait ne constituent pas des méthodes de contraception acceptables.
    Pour les hommes :
    5. Aucune obligation de contraception ne s'applique pour les participants qui ont des partenaires femmes en âge de procréer.
    Pour les femmes :
    6. Une femme peut participer à l'étude si elle n'est pas enceinte, si elle n'allaite pas et si au moins une des conditions suivantes s'applique :
    a. Femme pas en âge de procréer
    OU
    b. Femme en âge de procréer qui accepte de suivre les conseils de contraception pendant la phase de traitement et pendant au moins 70 jours
    Consentement éclairé
    7. Capacité à donner un consentement éclairé signé, ce qui implique le respect des conditions et des restrictions énumérées dans le formulaire de consentement éclairé (FCE) et dans ce protocole.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions
    1. History of skeletal malignancies or bone metastases at any time
    2. History of neural foraminal stenosis (except if due to scoliosis)
    3. History of or concomitant uncontrolled diseases such as hypo-/hyperparathyroidism, hypo-/hyperthyroidism, Paget’s disease, abnormal thyroid function or thyroid disease or other endocrine disorders or conditions that could affect bone metabolism e.g. Stage IV/V renal disease
    4. Rickets or any skeletal condition (other than OI) leading to long-bone deformities and/or increased risk of fractures
    5. Documented alcohol and/or drug abuse within 12 months prior to dosing or evidence of such abuse as indicated by the laboratory results during the screening/baseline assessments
    6. Documented history of significant psychiatric or medical disorder that would prevent the participant complying with the requirements of the protocol or would make it unsafe for the participant to participate in the study as judged by the investigator
    7. Current/previously reported allergy to the study drug or any of its excipients or the class of drug under investigation
    Prior/Concomitant Therapy
    8. History of external radiation or chemotherapy
    9. Treatment with any bisphosphonates 3 months prior to baseline and teriparatide, denosumab or other anabolic and anti-reabsorptive medications within 6 months prior to baseline
    Prior/Concurrent Clinical Study Experience
    10. Participation in any clinical investigation within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initial dosing (or longer if required by local regulations)
    Les patients seront exclus de l'étude s'ils répondent à l'un quelconque des critères suivants :
    Conditions médicales :
    1. Antécédents de tumeurs malignes squelettiques ou de métastases osseuses à tout moment
    2. Antécédents de sténose neuroforaminale (sauf si elle est due à une scoliose)
    3. Antécédents de maladies non contrôlées concomitantes telles que hypo /hyperparathyroïdie, hypo-/hyperthyroïdie, maladie de Paget, fonction thyroïdienne anormale ou maladie thyroïdienne ou autres troubles ou états endocriniens susceptibles d'affecter le métabolisme osseux, par ex une maladie rénale de stade IV/V
    4. Rachitisme ou tout trouble squelettique (autre que l'ostéogénèse imparfaite) entraînant des déformations des os longs et/ou un risque accru de fractures
    5. Alcoolisme et/ou toxicomanie documenté(es) au cours des 12 mois précédant l'administration de la dose ou détection d'alcoolisme et/ou toxicomanie dans les résultats d'analyses biologiques au cours des évaluations de sélection/d'entrée dans l'étude
    6. Antécédents documentés de trouble psychiatrique ou médical important qui empêcherait le participant de respecter les conditions du protocole ou qui rendrait la participation à l'étude dangereuse pour le patient, de l'avis de l'investigateur
    7. Allergie actuelle/antérieurement signalée au médicament de l'étude, à l'un de ses excipients ou à la classe du médicament de l'étude Traitement antérieur/concomitant
    8. Antécédents de radiothérapie externe ou de chimiothérapie
    9. Traitement par bisphosphonates 3 mois avant l'entrée dans l'étude et par tériparatide, denosumab ou autre médicaments anabolisants et antirésorptifs dans les 6 mois précédant l'entrée dans l'étude Participation à une étude clinique antérieure/simultanée
    10. Participation à une étude clinique dans les 4 semaines ou 5 demi-vies du médicament (l'échéance la plus longue prévalant) avant l'administration de la première dose (ou plus longtemps si les réglementations locales l'exigent)
    E.5 End points
    E.5.1Primary end point(s)
    Tr. vBMD (radius) on HRpQCT and bone strength on FEA at 6 months.
    DMOv Tr. (radius) par HRpQCT et résistance osseuse par AEF à 6 mois
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening and 6 month visits
    E.5.2Secondary end point(s)
    - Tr. vBMD (tibia & radius) on HRpQCT and bone strength on FEA at 12 months.
    - Total fracture rate, peripheral fracture rate, vertebral fracture rate, long-bone fracture rate and change in vertebral height from baseline at 6 and 12 months
    - Change in Vertebral Fracture Assessment from baseline at 6 and 12 months
    - Changes in lumbar, whole body, and proximal femur DXA BMD (absolute and T-score) from baseline at Month 6 and Month 12.
    - Changes in bone histomorphometry
    - Changes in Trabecular Bone Score (TBS) from baseline at 6 and 12 months
    - Changes (tibial and radial) in Total vBMD, cortical vBMD, bone volume fraction (BV/TV), peripheral to medullary trabecular bone density ratio (Met/Inn), trabecular thickness (TbTh), trabecular number (TbN), Inhomogeneity, cortical thickness, and cortical porosity from baseline at 6 and 12 months
    - Changes in Tr. vBMD (tibia) from baseline at 6 months
    - Changes in body height, weight and body mass index (BMI) from baseline at 6 and 12 months
    - Changes in bone turnover markers and metabolic biomarkers associated with bone (parathyroid hormone [PTH], P1NP, P1CP, osteocalcin [OC], BSAP, carboxy-terminal telo-peptide [CTX-1], amino-terminal telo-peptide [NTX-1], receptor activator of nuclear factor kappa-B ligand [RANKL], osteoprotegerin, transforming growth factor beta [TGF-β], sclerostin) from baseline and each visit.
    - Change in total scores from baseline to Month 6 and 12 on SF-12, EQ-5D-5L and OIQoL-A.
    - Change in OIQoL-A pain and activity sub-scalescores from baseline to Month 6 and 12.
    - Serum concentrations of BPS804
    - Serum concentrations of anti-BPS804 antibodies
    - Serum concentrations of BPS804 neutralising antibodies
    - Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs)
    - Infusion site reactions
    - Vital signs
    - Physical examinations
    - ECG
    - Clinical laboratory tests
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening, 6 and 12 month visits, except:
    - Tr. vBMD (tibia & radius) and bone strength; changes in Tr. vBMD (tibia) - screening and 6 month visit
    - Changes in bone turnover markers and metabolic biomarkers associated with bone - baseline, 3, 6, 9 and 12 month visits and follow-up visit
    - TEAEs, TESAEs vital signs - all study visits
    - Serum concentrations of BPS804, anti-BPS804 antibodies and BPS804 neutralising antibodies - baseline, 1, 2, 3, 6, 9 and 12 month visits and follow-up visit
    - Infusion site reactions - baseline, 1 - 11 month visits
    - ECG - screening, 6 and 12 month visits and follow-up visit
    - Clinical laboratory tests - screening, baseline, 1, 2, 3, 6, 9 and 12 month visits and follow-up visit
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    Denmark
    France
    United Kingdom
    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
    LVLS
    Dernière visite du dernier patient
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 45
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 140
    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)
    Participants completing treatment in the MBPS205 study will be to able discuss other potential treatments with their investigators or be offered continued treatment with BPS804 in the MBPS206 Dose Maintenance Study, subject to meeting any inclusion/exclusion criteria and restrictions on concomitant medication for this study.
    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 Decision2017-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-12
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