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    Summary
    EudraCT Number:2015-001341-86
    Sponsor's Protocol Code Number:IFN-K-002
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-02-16
    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 number2015-001341-86
    A.3Full title of the trial
    A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects with Systemic Lupus Erythematosus
    Рандомизирано, двойно сляпо, плацебо-контролирано изпитване от фаза IIb за оценка на неутрализирането на генния модел на интерферон и клиничната ефикасност на IFNα-киноид при възрастни пациенти със системен лупус еритематодес
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIb study of IFN-K in Systemic Lupus Erythematosus
    A.3.2Name or abbreviated title of the trial where available
    Phase IIb study of IFN-K in Systemic Lupus Erythematosus
    A.4.1Sponsor's protocol code numberIFN-K-002
    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 SponsorNeovacs S.A.
    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 supportNeovacs S.A.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeovacs S.A.
    B.5.2Functional name of contact pointNathalie THOMAS-PUJOL
    B.5.3 Address:
    B.5.3.1Street Address3-5 Impasse Reille
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75014
    B.5.3.4CountryFrance
    B.5.4Telephone number3315310 9300
    B.5.5Fax number3315310 9303
    B.5.6E-mailnpujol@neovacs.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 nameIFN-Kinoid
    D.3.2Product code IFN-K
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.2Current sponsor codeIFN-K DS
    D.3.9.3Other descriptive nameIFN-Kinoid Drug Substance
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number380
    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) Yes
    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 placeboEmulsion for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic Lupus Erythematosus
    E.1.1.1Medical condition in easily understood language
    Lupus
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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
    Primary Objective:
    The primary objective of the main study (at week 36) is to evaluate the neutralization of the IFN gene signature following treatment with IFN-K, as measured by the change from baseline of the expression of IFN-induced genes and to evaluate the efficacy of treatment with IFN-K using the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response criteria.
    The study will be considered as positive if a statistically significant better effect of IFN-K compared to placebo is observed on the neutralization of the IFN gene signature and if at least a trend favoring IFN-K is observed on the BICLA response.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    The secondary objectives of this study are:
    •To evaluate the efficacy of treatment with IFN-K using:
    - The SLE Responder Index [(SRI)-4 and above]
    - The SLE Disease Activity Index-2000 (SLEDAI-2K)
    - The BILAG-2004 index
    - The Safety of Estrogen in Lupus Erythematosus National Assessment-SLEDAI (SELENA-SLEDAI) Flare index
    - The Systemic Lupus International Collaborating Clinics/American College of Rheumatology-Damage Index for Systemic Lupus Erythematosus (SLICC/ACR DI)
    - The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in patients with cutaneous lesions at baseline
    •To evaluate the immune response induced by IFN-K
    - Anti-IFNα antibody response
    - Anti-Keyhole Limpet Hemocyanin (KLH) antibody response
    - Anti-IFNα antibody neutralizing capacities
    •To assess the safety of IFN-K emulsified with ISA 51 VG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient meeting all of the following inclusion criteria at screening will be eligible for participation in the study:
    1. Has had a diagnosis of SLE according to current ACR criteria (4 of 11 ACR criteria)
    2. Has SLEDAI-2K ≥ 6
    3. Has at least 1 BILAG A and/or at least 2 BILAG B
    4. Has a positive IFN gene signature by RT-qPCR as assessed on a limited number of genes
    5. Has anti-nuclear antibodies (ANA) ≥ 1:160 and/or anti-dsDNA antibodies ≥ 7.0 IU/mL
    6. Be a male or female, aged between 18 and 65 years, inclusive, at the time of the screening visit
    7. Agrees to receive influenza vaccination during each influenza season of the study period
    8. Currently receiving at least one of the following treatment:
    • Corticosteroids (CS) at a dose of ≤ 20 mg of prednisone equivalent/day
    • Antimalarial drugs (hydroxychloroquine [HCQ] or chloroquine [CQ]); the patient must have been treated since at least 8 weeks and on stable dose for at least 4 weeks prior to first planned administration of the study product
    • Methotrexate (MTX); the patient must have been treated and be on stable dose (≤ 20 mg/week) for at least 12 weeks prior to the first planned administration of the study product
    • Azathioprine (AZA); the patient must have been treated and be on stable dose (≤ 2.5 mg/kg/day) for at least 12 weeks prior to the first planned administration of the study product
    • Mycophenolate mofetil (MMF), the patient must have been treated and be on stable dose (≤ 2 g/day) for at least 12 weeks prior to the first planned administration of the study product
    9. Study patient and his/her partner has to use effective method of contraception for the duration of the study including the Extended Follow-up Period.


    Note: If of child-bearing potential, effective contraception methods include:
    - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks prior to the first planned administration of the study product. In case of oophorectomy alone, the reproductive status of the woman must be confirmed by follow up hormone level assessment.
    - Male sterilization (at least 6 months prior to Screening).
    - Combination of the following:
    • Oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or
    • Placement of an intrauterine device (IUD) or intrauterine system (IUS)
    • And barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
    Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, she is considered not of child bearing potential only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    10. Is able and willing to comply with the requirements of the study protocol (e.g., completion of the diary cards, return for follow-up visits), in the opinion of the Investigator
    11. Has provided written informed consent
    E.4Principal exclusion criteria
    A patient meeting any of the following exclusion criteria at study entry will not be eligible for the study:
    1. Has active, severe lupus nephritis as defined either by the immediate need for cyclophosphamide treatment or by renal BILAG A
    2. Has active, severe, neuropsychiatric SLE, defined as neuropsychiatric BILAG A
    3. During the 4 months prior to the first planned administration of the study product, has been treated with corticosteroids (CS) at a dose of >20 mg of prednisone equivalent/day for > 7 consecutive days
    4. Is currently receiving or has received pulse dose CS (≥ 250 mg prednisone equivalent/day) within 3 months prior to the first planned administration of the study product
    5. Has received potent immunosuppressive drugs such as cyclophosphamide, cyclosporine A, oral tacrolimus within 3 months prior to the first planned administration of the study product
    6. Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, TNF antagonists or another registered or investigational biological therapy within 6 months prior to the first planned administration of the study product
    7. Has received anti-B-cell therapy (e.g., rituximab, epratuzumab) within 12 months prior to the first planned administration of the study product
    8. Has significant electrocardiogram (ECG) abnormalities that are clinically relevant and preclude study eligibility in the Investigator’s opinion
    9. Has inflammatory joint or skin disease other than SLE that may interfere with study assessments
    10. Has any laboratory abnormality that is clinically relevant and precludes study entry in the Investigator’s opinion
    11. Has a history of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
    For US patients only: Has a history of malignant cancer, except the following treated cancer: basal cell carcinoma. Note: only patients with negative screening tests for malignancy according to The American Cancer Society guidelines (see Appendix 12), documented within the 12 months prior screening visit will be enrolled.
    12. Has frequent recurrences of oral or genital herpes simplex lesions
    (≥ 6 occurrences during the 12 months prior to first study product administration)
    13. Has had an episode of shingles during the 12 months prior to the first planned administration of the study product
    14. Has no IgG against herpes simplex virus (HSV-1 and HSV-2), varicella zoster virus (VZV), cytomegalovirus (CMV) or Epstein-Barr virus (EBV)
    15. Is positive for HTLV 1-2 antibodies, HIV antibodies, Hepatitis C (HCV) antibodies, or Hepatitis B surface antigen (HBsAg)
    16. Is at high risk of significant infection and/or has any current signs or symptoms of infection at entry or has received intravenous antibiotics within 2 months prior to the first planned administration of the study product
    17. Has received any live vaccine within 3 months prior to the first planned administration of the study product (e.g. nasal flu vaccine, oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)
    18. Has used any investigational or non-registered product within 30 days or 5 half-lives, whichever is longer, or any investigational or non-registered vaccine within 30 days prior to the first planned administration of the study product
    19. Has a history of chronic alcohol and/or drug abuse within 6 months prior to the first planned administration of the study product
    20. Is breastfeeding, pregnant, or planning to become pregnant during the study period
    21. Has known hypersensitivity to any component of the study product
    22. Is high-risk human papilloma virus (HPV) positive by reverse transcription polymerase chain reaction (RT-qPCR) on a cervical swab at Screening or within 3 months prior to the first planned study product administration
    23. Has cytological abnormalities ≥ HSIL on a cervical swab at Screening or within 3 months prior to the first planned study product administration
    E.5 End points
    E.5.1Primary end point(s)
    Two co-primary endpoints will be evaluated in the trial:
    • Change from baseline in the expression of IFN-induced genes at Week 36.
    • Response to treatment with IFN-K as measured by the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response criteria at Week 36:
    - All BILAG A scores at baseline improve to B/C/D and all BILAG B scores improve to C/D at Week 36
    and
    - No BILAG worsening in other body systems: no new BILAG A or ≥ 2 new BILAG B scores at Week 36
    and
    - No worsening in SLEDAI-2K total score at Week 36 compared with baseline
    and
    - No deterioration in PGA (< 10% worsening) on VAS 100 mm at Week 36 compared with baseline
    and
    - No addition or increased dose level of anti-malarial drugs or immunosuppressive drugs or corticosteroids between Week
    24 and Week 36
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 36
    E.5.2Secondary end point(s)
    Clinical secondary endpoints:
    • Response to treatment with IFN-K, as measured by the SLE Responder Index (SRI)-4 response criteria at Week 36:
    - Reduction ≥ 4 points in SELENA-SLEDAI
    and
    - No new BILAG A
    and
    - No more than 1 new BILAG B
    and
    - No deterioration in PGA (< 10% worsening) on VAS 100 mm compared with baseline
    • Response to treatment with IFN-K, as measured by SLEDAI response, defined as a reduction of the SLEDAI-2K score of at least 4 points at Week 36 compared to baseline
    • Response to treatment with IFN-K, as measured by BILAG grade changes by body system
    • Response to treatment with IFN-K, as measured by incidence of SLE flare (SELENA SLEDAI flare index, BILAG flares)
    • Response to treatment with IFN-K, as measured by SLICC/ACR-DI
    • Response to treatment with IFN-K, as measured by Cutaneous LE Disease Area and Severity Index (CLASI)
    Immunogenicity secondary endpoints:
    At timepoints specified on the flow chart, Geometric Mean Titers (GMT) and seroconversion rates for:
    • Anti-IFNα binding antibody titers
    • Anti-IFNα neutralizing antibody titers
    • Anti-KLH binding antibody titers
    Safety endpoints:
    • Occurrence, intensity and relationship of any solicited local and systemic AEs during a 7-day follow-up period (i.e. day of study product administration and 6 subsequent days) after each IFN-K or placebo dose
    • Occurrence, intensity and relationship of unsolicited local and systemic AEs occurring throughout the study period
    • Occurrence and relationship of all SAEs occurring throughout the study period
    • Occurrence and intensity of solicited injection site reactions 1 hour post study product administration
    • Occurrence and intensity of solicited systemic reactions 1 hour post study product administration
    • Hematological and biochemical levels within or outside the normal ranges and percent change from baseline at each visit
    • Occurrence, intensity and relationship of any abnormality in physical examination, vital signs, 12-lead ECG, clinical laboratory evaluations
    • Rate and severity of viral infections
    Exploratory Endpoints:
    • Evaluation of clinical response by assessing disease activity using: PGA scores, Number of SLE flares, Time to first SLE flare in patients, 28-Tender and Swollen Joint Counts, Joint Pain VAS and incidence of patient requiring change in lupus therapy (intensification and/or addition of drugs)
    • Quality of life using:
    - Changes in the SF-36 score: Physical Component Summary (PCS) and Mental Component Summary (MCS) scores
    - FACIT fatigue score
    • Evaluation of biological response by assessing :
    - Changes in the levels of auto-antibodies (anti-dsDNA, anti-Smith antigen [anti-Sm], anti-RNP, anti-SSA/Ro, anti-SSB/La, anti-cardiolipin, and anti-β2-glycoprotein I antibodies)
    - Changes in the levels of biomarkers (C3, C4, CH50)
    - Neutralizing Anti-IFNα antibodies towards IFNα subtypes
    - Anti-IFNα and anti-KLH antibody isotyping
    - IFNβ cross neutralization
    - Anti-hemagglutinin antibody response
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 36
    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 Yes
    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.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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Belgium
    Bulgaria
    Chile
    Colombia
    Croatia
    France
    Georgia
    Germany
    Italy
    Korea, Republic of
    Mexico
    Moldova, Republic of
    Peru
    Philippines
    Poland
    Russian Federation
    Serbia
    Spain
    Switzerland
    Taiwan
    Thailand
    Tunisia
    Ukraine
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months7
    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: 178
    F.1.3Elderly (>=65 years) No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    F.4.2.2In the whole clinical trial 178
    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)
    Following the 12-week Maintenance Period, patients will enter the 12-week Follow-up Period and subsequently enter in an Extended 240 week Follow-up Period. The visit at Week 276 will be considered as the last planned visit.

    If patients remain positive for anti-IFNa neutralizing antibodies after this Extended Follow up Period, they will be proposed to be enrolled in another 5-year follow up study to confirm the favorable safety profile of IFN-K.
    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 Decision2017-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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