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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41188   clinical trials with a EudraCT protocol, of which   6742   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2018-001238-16
    Sponsor's Protocol Code Number:CNTO1959PSO3012
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-001238-16
    A.3Full title of the trial
    A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis
    A.3.2Name or abbreviated title of the trial where available
    GUIDE
    A.4.1Sponsor's protocol code numberCNTO1959PSO3012
    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 SponsorJanssen-Cilag International N.V.
    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 supportJanssen Pharmaceutica NV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Biologics B.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 71 5242166
    B.5.5Fax number+31 71 5242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameGuselkumab
    D.3.2Product code CNTO1959
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGuselkumab
    D.3.9.2Current sponsor codeCNTO1959
    D.3.9.3Other descriptive nameGUSELKUMAB
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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 Yes
    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 injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Plaque Type Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    The primary objective of the study is to demonstrate that Super-Responders (SRe; defined as psoriasis subjects who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index [PASI] score = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (100 mg q16w).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate
    • whether subjects with short disease duration (≤2 years) show a more rapid and better guselkumab response compared to subjects with longer disease duration and whether subjects with shorter disease are more likely to maintain drug-free control of disease after guselkumab withdrawal. To be evaluated in Study Parts 1, 2 and 3.
    • whether different treatment intervals (weeks 28 to 60: guselkumab 100 mg q8w vs. guselkumab 100 mg q16w) affect the maintenance of drug-free control of disease after 68 weeks of guselkumab treatment. To be evaluated in Study Part 3.
    • the safety and tolerability of guselkumab in subjects with moderate-to-severe plaque-type psoriasis.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudies (part of the final protocol dated 05-Jul-2018):
    Four substudies are planned to further evaluate pharmacologic effects of guselkumab and evaluate various pharmacologic/clinical response relationships allowing assessment of inter-individual variability in clinical outcomes and possible identification of subject population groups that may respond differently to guselkumab. The substudies will also aim to further define the mechanism of action (MoA) of guselkumab at the molecular and cellular levels during and after treatment. Changes in gene expression as well as quantitative and qualitative changes in different types of immune cells will be evaluated in skin biopsies and blood.

    - Substudy 1 (Cellular MoA substudy)
    - Substudy 2 (Gene expression substudy)
    - Substudy 3 (Serum analysis)
    - Substudy 4 (Genetic analyses)


    Exploratory objectives
    The following objectives are to be explored in the mechanistic biomarker substudies:
    • characterization of the immune cellular and molecular composition at baseline (week 0) and changes (quantitative and qualitative characterization) in the lesional skin of subjects during treatment with guselkumab as determined by fluorescence activated cell sorting (FACS)-based analysis. To be explored in substudy 1
    • characterization of the immune cellular changes (quantitative and qualitative characterization) in the blood of subjects at baseline (week 0), during and after treatment with guselkumab as determined by FACS-based analysis. To be explored in substudy 1
    • characterization of molecular (gene expression) changes during treatment with guselkumab in the skin of subjects treated with guselkumab as determined by RNA sequencing (RNAseq) and quantitative polymerase chain reaction (qPCR). To be explored in substudy 2
    • characterization of the tissue immunopathological changes in the skin of subjects during and after treatment with guselkumab as determined by immunohistochemistry (IHC)/ immunofluorescence (IF)/ in situ hybridization (ISH). To be explored in substudy 2
    • characterization of the effects of guselkumab treatment on serum biomarkers as determined by immunoassays. To be explored in substudy 3
    • characterization of the association between changes in the various exploratory biomarker endpoints and 1) efficacy of guselkumab, 2) duration of psoriasis, 3) maintenance of response after stopping guselkumab treatment, and 4) ability to achieve a PASI 100 response at weeks 20 and 28 (super responder status). To be explored in all substudies
    E.3Principal inclusion criteria
    1. Male or female with at least 18 years of age.
    2. Has a disease duration of plaque psoriasis of either ≤2 years or >2 years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40% subjects must have a disease duration ≤2 years.
    3. Has moderate-to-severe plaque-psoriasis defined by a) a PASI score >10 or affected BSA >10% and b) additionally a DLQI score >10 at baseline (week 0).
    4. Is a candidate for systemic treatment for psoriasis.
    5. Before first administration of study drug, a woman must be:
    a. Not of childbearing potential
    b. Of childbearing potential and practicing a highly effective method of contraception
    6. A woman of childbearing potential must have a negative urine pregnancy test at baseline and agree to urine pregnancy testing before receiving injections and at safety follow-up.
    7. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 12 weeks after receiving the last administration of guselkumab.
    8. A male subject must wear a condom when engaging in any activity that allows for passage of ejaculate to another person.
    9. A male subject must agree not to donate sperm for the purpose of reproduction
    10. TB-related inclusion criteria:
    Subjects are considered eligible according to the following TB screening criteria:
    a. Have no history of latent or active TB before screening.
    b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before the first administration of study drug.
    d. Within 2 months before baseline, have a negative QuantiFERON®-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result) in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before baseline.
    e. Have a chest radiograph (posterior-anterior and lateral views, or per country regulations where applicable), taken within 3 months before the first administration of study drug and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
    11. Agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug.
    12. Agrees not to receive a BCG vaccination during the study, or within 12 months after the last administration of study drug.
    13. Clinical laboratory-related inclusion criteria:
    Has screening laboratory test results within the following parameters, if one or more of the laboratory parameters is out of range, a single retest of laboratory values is permitted:
    a. Hemoglobin ≥10 g/dL (SI: ≥100 g/L)
    b. White blood cells ≥3.5 x 103/μL (SI: ≥3.5 GI/L)
    c. Neutrophils ≥1.5 x 103/μL (SI: ≥1.5 GI/L)
    d. Platelets ≥100 x 103/μL (SI: ≥100 GI/L)
    e. Serum creatinine ≤1.5 mg/dL (SI: ≤137 μmol/L)
    f. Aspartate aminotransferase ≤2 × upper limit of normal (ULN)
    g. Alanine aminotransferase ≤2 × ULN
    h. Alkaline phosphatase ≤2 × ULN
    14. Agrees to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet (UV) light sources during study.
    15. Be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
    16. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    17. Must sign a separate ICF if he or she agrees to provide an optional DNA sample or skin biopsy samples for research (where local regulations permit). Refusal to give consent for the optional substudies does not exclude a subject from participation in the main study.
    E.4Principal exclusion criteria
    1 clinically active psoriasis arthritis which needs systemic therapy beyond NSAIDs
    2 diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, which are detected at screening assessments
    3 unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months, diagnosed or reported by the subject
    4 transplanted organ
    5 history of an infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
    6 pregnant, nursing, or planning a pregnancy while enrolled in this study and within 16 weeks following the last administration of study drug
    7 non-plaque form of psoriasis
    8 current drug-induced psoriasis
    9 major surgery, within 8 weeks before screening, or will not have fully recovered from surgery at baseline, or has surgery planned during the time the subject is expected to participate in the study
    10 substance abuse problem within the previous 12 months
    11 known allergy or sensitivity to products containing latex
    12 previously received any therapeutic agent directly targeted to IL-23
    13 received any anti-TNF-α biologic therapy within 3 months before the first administration of study drug
    14 received any therapeutic agent directly targeted to IL-12/23, IL-17A or IL-17R within 3 months of the first administration of study drug
    15 received natalizumab, belimumab, or agents that modulate B cells or T cellswithin 12 months of the first administration of study drug
    16 received any systemic immunosuppressant or anakinra within 4 weeks of the first administration of study drug
    17 received phototherapy or any systemic medications/treatments that could affect psoriasis or IGA evaluations within 4 weeks of the first administration of study drug
    18 used topical treatments that could affect psoriasis or IGA evaluations within 2 weeks of the first administration of study drug
    19 currently receiving lithium, antimalarials, or intramuscular gold, or has received lithium, antimalarials, or IM gold within 4 weeks of the first study drug administration
    20 received an experimental antibody or biologic therapy within the previous 6 months or received any other experimental therapy or new investigational agent within 30 days or 5 half-lives of first study drug administration or is currently enrolled in another study using an investigational agent or procedure
    21 received, or is expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study drug
    22 had a BCG vaccination within 12 months of screening
    23 known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, mAbs, or antibody fragments
    24 known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
    25 a history of chronic or recurrent infectious disease
    26 history of active granulomatous infection before study start, including histoplasmosis or coccidioidomycosis. Refer to Inclusion Criterion 10 for information regarding eligibility with a history of latent TB
    27 chest radiograph within 3 months before the first administration of study drug that shows an abnormality suggestive of a malignancy or current active infection, including TB
    28 nontuberculous mycobacterial infection or opportunistic infection. Subjects with a history of esophageal candidiasis or thrush would also be exceptions to this criterion
    29 persistently indeterminate QuantiFERON-TB® Gold test results
    30 infected with HIV
    31 Tests positive for hep B virus infection or who are seropositive for antibodies to hep C virus
    32 serious infection, was hospitalized or received intravenous antibiotics for an infection during 2 months before baseline
    33 herpes zoster within the 2 months before baseline
    34 known malignance or has a history of malignancy within 5 years before study start
    35 history of lymphoproliferative disease; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease
    36 unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
    37 Lives in an institution on court or authority order
    38 condition that, in the opinion of the investigator, would participation not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments
    39 Is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the main study is the proportion of subjects in study groups 2a and 2b who achieve an absolute PASI score <3 at week 68.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 68
    E.5.2Secondary end point(s)
    Major secondary endpoints of this study are:
    • Time to improvement from baseline (week 0) in PASI (PASI 75/90/100 response and absolute PASI score = 0) for subjects with short (≤ 2 years) and longer (>2 years) disease duration per study group (1, 2a 2b, and 2c)
    • Proportion of subjects with short (≤2 years) and longer (>2 years) disease duration who achieve an absolute PASI score of 0, ≤1 and <3 at weeks 20, 28, 68 and 116 per study group (1, 2a, 2b, 2c, 3a and 3b)
    • Proportion of subjects who retain disease control (ie, absolute PASI score <3 at all visits) from week 68 through week 116 for subjects with short (≤ 2 years) and longer (>2 years) disease duration per study group (3a and 3b).

    Other secondary endpoints of this study are:
    • Proportion of subjects who achieve a PASI 75/90/100 response at weeks 20, 28, 68 and 116 per study group (1, 2a, 2b, 2c, 3a and 3b)
    • Time to loss of disease control (absolute PASI score >5 at any visit) after treatment withdrawal beyond week 68 per study group (3a and 3b)
    • Proportion of subjects with an absolute PASI score = 0 at all of the following visits: weeks 12, 16, 20 and 28 (study group 1)
    • The change from baseline (week 0) in Dermatology Life Quality Index (DLQI) score at weeks 28 and 68 per study group (1, 2a, 2b, and 2c)
    • Proportion of subjects who achieve a DLQI score 0/1 and <5 at weeks 28 and 68 per study group (1, 2a, 2b, and 2c)
    • The change from baseline (week 0) in affected Body Surface Area (BSA) at weeks 12, 28, 52, 68, 80, and 104 (all study groups)
    • The change from baseline (week 0) in the Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) score at weeks 28, 68 and 116 among subjects with nail psoriasis at baseline (week 0) (1, 2a, 2b, 2c, 3a and 3b).
    • The change from baseline (week 0) in the signs and symptoms aggregate scores of the Psoriasis Symptoms and Signs Diary (PSSD) at weeks 28, 68 and 116 (1, 2a, 2b, 2c, 3a and 3b)
    • The proportion of subjects who achieve a PSSD sign score = 0 at week 68 among subjects with a PSSD sign score ≥1 at week 28 per study group (2a, 2b and 2c).
    • The association between trough serum concentration and efficacy or serum biomarker level
    • The association between trough serum guselkumab levels at weeks 20, 28, 36 and 68 and achieving a PASI score <3 at week 68 per study group (2a and 2b)
    • Proportion of subjects who were re-treated due to loss of disease control (PASI >5) and regain control of disease (PASI <3) 24 weeks after start of re-treatment (study groups 2d and 3c)
    • Safety and tolerability with regard to adverse events (AEs) and abnormal laboratory results (all study groups).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 12, 16, 20, 28, 36, 52, 68 & 116
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    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 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 trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA93
    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 years4
    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 years5
    E.8.9.2In all countries concerned by the trial months0
    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: 818
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 950
    F.4.2.2In the whole clinical trial 950
    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)
    There are no plans for additional treatment or care after the subject ends (or has ended) participation in the trial.
    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 Decision2019-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-01
    P. End of Trial
    P.End of Trial StatusOngoing
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