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    Summary
    EudraCT Number:2019-000950-78
    Sponsor's Protocol Code Number:CB-03-01/35
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-30
    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 - BfArM
    A.2EudraCT number2019-000950-78
    A.3Full title of the trial
    A Phase 2, multicenter, prospective, randomized, double-blind, Minoxidil and vehicle controlled, dose-ranging study to evaluate the efficacy and safety of CB-03-01 (Cortexolone 17α-propionate) solution for the treatment of androgenetic alopecia in females
    Eine multizentrische, prospektive, randomisierte, doppelblinde, Minoxidil- und vehikelkontrollierte Dosisfindungsstudie der Phase II zur Beurteilung der Wirksamkeit und Sicherheit von CB 03 01 (Cortexolon 17α-Propionat)-Lösung zur Behandlung der weiblichen androgenetischen Alopezie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi center clinical study to evaluate the safety and efficacy of CB-03-01 for the treatment of female pattern hair loss, versus Minoxidil and placebo at different dosage of CB-03-01
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberCB-03-01/35
    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 SponsorCassiopea S.p.A.
    B.1.3.4CountryItaly
    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 supportCassiopea S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationbioskin GmbH
    B.5.2Functional name of contact pointCRO /Clinical Trial Management
    B.5.3 Address:
    B.5.3.1Street AddressMessberg 4
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20095
    B.5.3.4CountryGermany
    B.5.4Telephone number+4940606858
    B.5.5Fax number+4940606830
    B.5.6E-mailjohanna.crone@bioskinCRO.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 nameCortexolone 17α-propionate solution 5%
    D.3.2Product code CB-03-01 solution 5%
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCortexolone 17α-propionate
    D.3.9.1CAS number 19608-29-8
    D.3.9.2Current sponsor codeCB-03-01
    D.3.9.3Other descriptive nameClascoterone
    D.3.9.4EV Substance CodeSUB181067
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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.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 nameCortexolone 17α-propionate solution 7.5%
    D.3.2Product code CB-03-01 solution 7.5%
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCortexolone 17α-propionate
    D.3.9.1CAS number 19608-29-8
    D.3.9.2Current sponsor codeCB-03-01
    D.3.9.3Other descriptive nameClascoterone
    D.3.9.4EV Substance CodeSUB181067
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Regaine® Frauen
    D.2.1.1.2Name of the Marketing Authorisation holderJohnson & Johnson GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMINOXIDIL
    D.3.9.1CAS number 38304-91-5
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB08982MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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 placeboCutaneous solution
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Female Androgenic Alopecia (AGA) is scalp hair loss that occurs due to an underlying susceptibility of hair follicles to androgenic miniaturization. In the hair follicle, testosterone is converted by 5α-reductase into 5α-dihydrotestosterone (DHT). The DHT level is increased in the balding scalp and may be the more relevant androgen for AGA pathogenesis. Thus, blocking or inhibiting the effect of DHT with the local application of Anti-androgens may be an effective treatment for AGA.
    E.1.1.1Medical condition in easily understood language
    Female Androgenetic alopecia (AGA) is scalp hair loss which is due to a change in hormon concentrations which results in reduced hair growth and hair loss.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10068558
    E.1.2Term Androgenic alopecia
    E.1.2System Organ Class 100000004858
    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 study is to evaluate the efficacy and safety of CB-03-01 solution 5%, 7.5% BID dosing compared to the Minoxidil solution 2% (BID) and the vehicle solution (BID) for the treatment of androgenetic alopecia in females.
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject is female, 18-55 years old.
    2.Subject has provided written informed consent.
    3.Negative pregnancy test at screening and baseline for women of childbearing potential (WOCBP)
    4.Exhibits AGA based on a discernable decrease in hair density on the top of the scalp, relative to the sides and back of the scalp, with scalp hair density in involved density area stages n. 3 to n. 6 on the Savin Density Scale.
    5.Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study (implying the same hair coloring interval prior to the approved photos at screening/baseline)
    6.Subject is willing to comply with study instructions and return to the clinic for required visits.
    7.Subject agrees to continue her other general hair care products and regimen for the entire study.
    8.Subject agrees to maintain same dietary and supplement pattern.
    9. If subjects is sexually active with a male partner and is not surgically sterile or postmenopausal she must agree to use an acceptable form of birth control throughout the study and at least for one month after the end of treatment, as described in the informed consent form. An acceptable method (Pearl Index < 1%) would be:
    -Use of hormonal contraceptives a minimum of 6 months prior to visit 2/baseline such as combined oral contraceptives (taking exclusion criterion 18f into account), hormonal implants, vaginal contraceptive ring and hormonal injections;
    -Use of intrauterine devices;
    -Subject is surgically sterile (hysterectomy, bilateral tubal ligation [at least six months prior], or bilateral oophorectomy).
    Or being postmenopausal (defined as amenorrhea greater than 12 consecutive months in women).




    E.4Principal exclusion criteria
    1. Pregnancy or planned pregnancy
    2. Breastfeeding women
    3. Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the
    IMP or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp
    atrophy.
    4. Subject has any skin pathology or condition that, in the investigator’s opinion, could interfere with the evaluation of IMP or requires use of interfering topical, systemic, or surgical therapy.
    5. Subject has a history or any signs of hyperandrogenemia
    6. Subject has current/recent history (within 6 months) of hair weaves, non-breathable wigs, or hair bonding.
    7. Subject had scalp hair transplants at any time
    8. Subject has a history or active hair loss due to diffuse telogen
    effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA
    9. Subject has a current or recent history (within 6 months) of severe dietary or weight changes or has a history of eating disorder(s) any history of bariatric surgery (gastric bypass, gastric sleeve, stomach stapling); macro- or micro-nutrient deficiencies within the last 6 months (i.e.: clinically significant iron deficiency, protein deficiency confirmed by lab testing) and/or any current diagnosis of malabsorptive disease (i.e Celiac, Irritable Bowel disease etc).
    10. Subject has any condition which, in the investigator’s opinion, would make it unsafe for the subject to participate in this study, including clinically significant abnormal laboratory or 12-lead electrocardiogram findings during the screening period
    11. Subject with diagnosed treated or untreated hypertension and/ or with signs of or known clinically significant cardiovascular diseases or cardiac arrhythmia
    12. Subject is currently enrolled in an investigational drug or device study
    13. Subject has used an investigational drug or investigational device treatment within 30 days or 5 half-lives (whichever is longer)prior to Visit 2/Baseline.
    14. Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
    15. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, subjects who are unable to return for scheduled follow-up visits, or subjects who are institutionalized because of legal or regulatory order
    16. Subject has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the IMPs or tattoo ink
    17. Subject has used any of the following topical preparations or procedures on the scalp:
    a) Topical scalp treatments for hair growth or other agents known to affect hair growth within 12weeks of Visit 2/Baseline;
    b) Topical scalp over-the-counter or cosmetic treatments known or reasonably believed to affect hair growth/health or hair growth products with saw palmetto, copper, etc. within 4weeks of Visit 2/Baseline
    c) Topical scalp treatments that may have ancillary effect on hair growth (e.g.corticosteroids, retinoids) within 4weeks of Visit 2/Baseline
    d) Scalp procedures within 6 months of Visit 2/Baseline;
    e) Platelet rich plasma (PRP) procedure on the scalp within 1 year
    18. Subject has used the following systemic medications/procedures:
    a) Beta blockers, cimetidine, diazoxide, or corticosteroids within 12 weeks of Visit 2/Baseline. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable [defined as doses and frequency unchanged for at least 4 weeks prior to Visit 2/Baseline];
    b) Retinoid, isotretinoin, vitamin A intake above 10,000 IU/day, or cyclosporine therapy within 6months of Visit 2/Baseline
    c) Any 5 alpha reductase medications (i.e: Finasteride (Propecia®, etc), Dutasteride or similar products) within 12 months of Visit 2/Baseline
    d) Chemotherapy or cytotoxic agents at any time
    e) Radiation of the scalp at any time point
    f) Anti-Androgens within 6 months Visit 2/Baseline; Anti-Androgens (cyproterone acetate, chlormadinone acetate, etc) together with contraceptive pills are allowed if use is stable [defined as doses and frequency unchanged for at least 3 months prior to Visit 2/Baseline]
    g) Any changes in hormonal treatments for menopause during the 6 months prior to baseline or during the study
    h) Other systemic therapy, which in the opinion of the investigator, may materially affect the subject’s hair or hair growth, including spironolactone, vitamin (including biotin intake >5mg/day) or homeopathy supplement hair growth or hair health products or other steroid hormones (in any form), including anabolic steroids during the 3 months prior to baseline or during the study
    19. Subject has been previously enrolled in any study with CB 03 01
    20. Subject is an employee or direct relative of an employee of the contract research organization (CRO), the study site, or the Sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary efficacy endpoints include:
    1.CB-03-01 Treatment Effects in Change from Baseline in non-vellus TAHC at Month 6 in Comparison to Vehicle.
    2.CB-03-01 Treatment Effects in HGA score at Month 6 in Comparison to Vehicle.
    E.5.1.1Timepoint(s) of evaluation of this end point
    months 6 (both co-primary endpoints)
    E.5.2Secondary end point(s)
    Efficacy:
    1.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHC at Months 3 in Comparison to Vehicle
    2.CB-03-01 Treatment Effects in HGA score at Months 3 in Comparison to vehicle.
    3.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHC at Months 3 and 6 in Comparison to Minoxidil
    4. CB-03-01 Treatment Effects in HGA score at Months 3 and 6 in Comparison to Minoxidil.
    5.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHW at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively.
    6.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHD at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively.
    7. CB-03-01 Treatment Effects in HGI and HGSS scores at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively.
    8. CB-03-01 Treatment Effects in IGA at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively

    Cosmetic Evaluation:
    1.Acceptability score
    2.Easy to use score

    Safety:
    1.Incidence (severity and causality) of any local and systemic AEs
    2.Number of subjects with presence (and severity) of the following reactions in the LTA: erythema, scaling, pruritus, burning/stinging, skin atrophy, telangiectasia, folliculitis, hypopigmentation, and hyperpigmentation at each time point
    3.Number of subjects with presence (and severity) of Facial hypertrichosis
    4.Changes from Baseline in vital signs and weight
    5.Changes from Screening in overall interpretation of the ECG at Month 3, 6 and 7 (if applicable)
    5.Changes from Screening in safety laboratory tests (chemistry, hematology, urinalysis, and morning cortisol)
    6.Changes from Screening in overall interpretation of the ECG

    PK Analysis:
    Trough concentrations of CB-03-01

    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:
    1 Months 3
    2 Month 3
    3 Months 3+6
    4 Months 3+6
    5 Months 3 + 6
    6 Months 3 + 6
    7 Months 3 + 6
    8 Months 3 + 6

    Cosmetic Evaluation:
    1.Acceptability score:Month 1, 3 + 6
    2.Easy to use score:Month 1, 3 + 6

    Safety aspects (others at each timepoint/over the whole study duration):
    Changes from Baseline in vital signs/weight:Months 3, 6 + 7
    Changes from Screening in safety lab tests:Months 3, 6 + 7
    Changes from Screening in overall interpretation of the ECG:Months 3, 6 + 7

    PK:
    Trough concentrations (CB-03-01):Month 3 + 6
    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 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 Yes
    E.8.1.7.1Other trial design description
    dose-ranging
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned 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: 280
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state280
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 280
    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 Decision2019-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-11
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