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    Summary
    EudraCT Number:2021-006794-37
    Sponsor's Protocol Code Number:VRDN-001-101
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-04-13
    Trial 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 ConcernedGermany - PEI
    A.2EudraCT number2021-006794-37
    A.3Full title of the trial
    A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety, Tolerability and Efficacy Study of VRDN 001
    A.3.2Name or abbreviated title of the trial where available
    A Safety, Tolerability and Efficacy Study of VRDN 001
    A.4.1Sponsor's protocol code numberVRDN-001-101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05176639
    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 SponsorViridian Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportViridian Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationViridian Therapeutics, Inc.
    B.5.2Functional name of contact pointViridian Clinical Trials Desk
    B.5.3 Address:
    B.5.3.1Street Address221 Crescent Street, Suite 401
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02453
    B.5.3.4CountryUnited States
    B.5.6E-mailviridianclinicaltrials@viridiantherapeutics.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 nameVRDN-001
    D.3.2Product code VRDN-001
    D.3.4Pharmaceutical form Concentrate 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 INNn/a
    D.3.9.1CAS number 2728655-31-8
    D.3.9.2Current sponsor codeVRDN-001
    D.3.9.3Other descriptive nameInsulin-like growth factor-1 receptor (IGF-1R) inhibitor
    D.3.9.4EV Substance CodeSUB265864
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 No
    D.IMP: 2
    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 nameVRDN-001
    D.3.2Product code VRDN-001
    D.3.4Pharmaceutical form Concentrate 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 INNn/a
    D.3.9.1CAS number 2728655-31-8
    D.3.9.2Current sponsor codeVRDN-001
    D.3.9.3Other descriptive nameInsulin-like growth factor-1 receptor (IGF-1R) inhibitor
    D.3.9.4EV Substance CodeSUB265864
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 placeboSolution for injection/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
    Thyroid eye disease (TED)
    E.1.1.1Medical condition in easily understood language
    Thyroid eye disease (TED)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084358
    E.1.2Term Thyroid eye disease
    E.1.2System Organ Class 10015919 - Eye 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 establish the safety, tolerability, and efficacy of VRDN-001, and the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of VRDN-001 in NHV and TED patients over a dose range of 3.0 to 20.0 mg/kg.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    Enrollment in the HV and Active TED MAD cohorts has been completed. The inclusion criteria corresponding to the HV and Active and Chronic TED MAD cohorts are now described in Appendices 4 and 5, respectively.
    Active TED Pivotal (THRIVE) participants
    Participants must:
    1. Be able to understand the study procedures and the risks involved and be willing to provide written informed consent before the first study-related activity
    2. Be an adult male or female participant, at least 18 years of age or older
    3. Have had a clinical diagnosis of TED with a CAS of ≥ 3 on the 7-item scale for the study eye
    4. Have moderate to severe (i.e., has an appreciable impact on daily living) active TED associated with proptosis of ≥3 mm above normal values for race and gender in the opinion of the investigator and at least one of the following: lid retraction of ≥2 mm, moderate or severe soft tissue involvement, inconstant or constant diplopia, spontaneous retrobulbar pain or pain on eye movement, swelling of the conjunctiva, eyelids or plica, or redness of the eyelids or plica in the study eye
    5. Have documented evidence of ocular symptoms or signs associated with active TED that began within 15 months prior to study screening
    6. VRDN-001 can be started concomitantly with attempts to achieve euthyroid status. Underlying thyroid status is not an inclusion criterion.
    7. Not require expected immediate surgical ophthalmological or orbital surgery in the study eye for any reason
    8. VRDN-001 can be used with caution in patients with diabetes mellitus. Diabetic participants should be monitored by their endocrinologist or other appropriately trained personnel and have at study entry a glycated hemoglobin (HbA1c) of <8.5%
    9. If female, have a negative serum pregnancy test at screening and further negative urine tests immediately before each dose of study medication following the last dose of study medication as described in Appendix 1C if the participant is a woman of childbearing potential (including those with <2 years since the onset of menopause, amenorrhea for <2 years, or not surgically sterile); such participants must agree to use an acceptable method of contraception such as a condom and a second highly effective method of contraception as described in Section 4.4 from Screening up to and including 100 days after the last dose of study medication. If the participant is initiating hormonal contraception at time of Screening or within one cycle of Day 1, participant agrees to use a double-barrier method of contraception until completing one-full cycle of hormonal contraception. An acceptable double-barrier combination method is a condom with either diaphragm or sponge with spermicide
    10. Be surgically sterile males for at least 6 weeks, or agree to use an acceptable method of contraception such as a condom and a second highly effective method of contraception as described in Section 4.4 from Screening up to and including 100 days after the last dose of study medication
    11. Be willing and able to comply with all the requirements of the protocol for the entire duration of the study.
    E.4Principal exclusion criteria
    Exclusion Criteria
    Enrollment in the HV and Active TED MAD cohorts has been completed. The exclusion criteria corresponding to the HV and Active and Chronic TED MAD cohorts are now described in Appendices 4 and 5, respectively.

    Active TED Pivotal (THRIVE) participants
    Participants must not:
    1. Have received prior treatment with another anti-IGF-1R therapy or any investigational agent for TED
    2. Have a compressive optic neuropathy of TED that is expected to require surgical decompression in the immediate future.
    3. Have corneal decompensation in the study eye unresponsive to medical management
    4. Have a decrease in CAS of ≥2 points in the study eye between screening assessment and Day -1
    5. Have a decrease in proptosis of ≥2 mm in the study eye between screening assessment and Day -1
    6. Have had previous orbital irradiation or decompression surgery involving excision of fat for TED to the study eye’s orbit
    7. Have history of or screening audiometry assessment of significant (as determined by the Investigator) ear pathology, relevant ear surgery or hearing loss
    8. Have inflammatory bowel disease (e.g., biopsy proven or clinical evidence of inflammatory bowel disease)
    9. Have used systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to the first dose of study medication (topical steroids or multivitamins that contain selenium are permitted)
    10. Have received other immunosuppressive agents, including rituximab, or tocilizumab, for any condition, including TED, within 8 weeks prior to the first dose of study medication
    11. Have received any other therapy for TED within 8 weeks prior to the first dose of study medication (artificial tears are permitted)
    12. Have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication
    13. Have a pre-existing ophthalmic condition in the study eye which in the opinion of the Investigator, would confound interpretation of the study results
    14. Be a pregnant or lactating woman
    15. Be an active alcoholic or illicit drug user or considered at high risk of relapse by the Investigator
    16. Have a known hypersensitivity to any of the components of VRDN-001 or placebo formulations, or prior hypersensitivity to monoclonal antibodies (mAbs)
    17. Have any condition, which in the opinion of the Investigator, would preclude inclusion in the study
    18. Have a positive test for human immunodeficiency virus (HIV-1 and HIV-2)
    19. Have a positive test for active hepatitis B or hepatitis C infection
    20. Have previously participated in this study or any study of VRDN-001
    21. French participating sites only: In accordance with the provisions of articles L.1121-5 et seq. of the Public Health Code, pregnant or breast-feeding women, persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care without their consent, minors and adults under a legal protection measure must not be included

    Note: Prior thyroidectomy, radioactive iodine (RAI) treatment, or orbital decompression surgery limited to bone only are NOT exclusions.
    E.5 End points
    E.5.1Primary end point(s)
    - SAFETY ENDPOINTS
    Adverse Events (AEs) and Serious Adverse Events (SAEs) will be monitored and recorded throughout the duration of the study. All clinically significant changes in other safety measurements will be recorded as AEs.
    - PRIMARY EFFICACY ENDPOINT IN THE USA, CANADA AND CHINA IN THE PIVOTAL PORTION OF THE STUDY (THRIVE)
    Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥ 2 mm from baseline [without a corresponding increase of ≥ 2 mm in the fellow eye] as measured by exophthalmometer) at 3 weeks post the fifth infusion (i.e., Week 15)
    - PRIMARY EFFICACY ENDPOINT IN AUSTRALIA, EU AND UK IN THE PIVOTAL PORTION OF THE STUDY (THRIVE)
    Overall Response Rate comprised of Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥ 2 mm from baseline [without a corresponding increase of ≥ 2 mm in the fellow eye] as measured by exophthalmometer) at 3 weeks post the fifth infusion (i.e., Week 15) and Clinical Activity Responder Rate in the study eye (i.e., reduction in CAS ≥ 2 points from baseline [without a corresponding increase of ≥ 2 points in the fellow eye]) at 3 weeks post the fifth infusion (i.e., Week 15)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study
    IN THE USA, CANADA AND CHINA IN THE PIVOTAL PORTION OF THE STUDY (THRIVE) at 3 weeks post the fifth infusion (i.e., Week 15).
    E.5.2Secondary end point(s)
    SECONDARY EFFICACY ENDPOINTS:
    - KEY SECONDARY EFFICACY ENDPOINTS
    - Key Secondary Endpoints in the USA, Canada and China in the Pivotal portion of the Study (THRIVE):
    • Change from baseline in Proptosis in the study eye as measured by exophthalmometer at Week 15
    • Clinical Activity Responder Rate in the study eye at Week 15
    • Change from baseline in CAS in the study eye at Week 15
    • Overall Responder Rate in the study eye at Week 15
    • Diplopia Resolution Rate (i.e., reduction in Gorman Subjective Diplopia Score to 0 from baseline for participants with baseline Gorman Subjective Diplopia Score >0) at Week 15
    • Proportion of participants with a CAS score of zero or one in the study eye at Week 15
    - Key Secondary Endpoints in Australia, EU and UK in the Pivotal portion of the Study (THRIVE):
    • Change from Baseline in proptosis in the study eye as measured by exophthalmometer at Week 15
    • Change from baseline in CAS in the study eye at Week 15
    • Diplopia Resolution Rate at (i.e., reduction in Gorman Subjective Diplopia Score to 0 from baseline for participants with baseline Gorman Subjective Diplopia Score >0) Week 15
    • Proportion of participants with a CAS score of zero or one in the study eye at Week 15
    - EXPLORATORY ENDPOINTS
    - Exploratory Endpoints in Australia, Canada, China, EU, UK and US in the Pivotal portion of the Study (THRIVE):
    • Proptosis Responder Rate in the study eye as measured by exophthalmometer) at Week 24 (12 weeks post fifth infusion), Week 36 (24 weeks post fifth infusion) and Week 52
    • Proptosis Responder Rate in the fellow eye (i.e., reduction of proptosis of ≥ 2 mm from baseline as measured by exophthalmometer) at Weeks 15, 24, 36 and 52
    • Durability of Proptosis Response in the study eye at Weeks 24, 36 and 52
    • Time to First Proptosis Response in the study eye
    • Clinical Activity Responder Rate in the study eye at Weeks 24, 36 and 52
    • Clinical Activity Responder Rate in the fellow eye at Weeks 15, 24, 36 and 52
    • Change from baseline in CAS in the study eye at Weeks 24, 36 and 52
    • Change from baseline in CAS in the fellow eye at Weeks 15, 24, 36 and 52
    • Time to first CAS Response in the study eye
    • Overall Responder Rate in the study eye at Weeks 24, 36 and 52
    • Overall Responder Rate in the fellow eye at Weeks 15, 24, 36 and 52
    • Time to First Overall Response in the study eye
    • Diplopia Resolution Rate at Weeks 24, 36 and 52
    • Proportion of participants with a CAS score of zero or one in the study eye at Weeks 24, 36 and 52
    • Proportion of participants with a CAS score of zero or one in the fellow eye at Weeks 15, 24, 36 and 52
    • Proptosis Response Rate in the study eye as measured by magnetic resonance imaging [MRI] or Computed Tomography [CT – where allowed by local health authorities] at Weeks 15, 24, 36 and 52
    • Change from Baseline in the following parameters at Weeks 15, 24, 36 and 52:
    o Proptosis in the study eye by MRI (or CT – where allowed by local health authorities)
    o Extraocular muscles in the study eye as determined by MRI (or CT – where allowed by local health authorities)
    o Orbital fat in the study eye as measured by MRI (or CT – where allowed by local health authorities)
    o Manual measurement of lid retraction in the study eye
    o Graves’ Orbitopathy-Quality of Life (GO-QoL) combined score
    o GO-QoL activity subscale
    o GO-QoL appearance subscale
    o EQ-5D-5L QoL questionnaire
    o Visual Acuity (VA)
    o Gorman Subjective Diplopia Score
    • VRDN-001, IGF-1 and ADA at various time points pre- and post-infusions as described in Appendix 1C.
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to the protocol
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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) Yes
    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 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Australia
    Canada
    China
    Israel
    United Kingdom
    United States
    Czechia
    France
    Germany
    Italy
    Netherlands
    Spain
    Türkiye
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 134
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 154
    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)
    None
    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 Decision2022-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-03
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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