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    Summary
    EudraCT Number:2015-005008-27
    Sponsor's Protocol Code Number:KTE-C19-102
    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:2016-05-23
    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 number2015-005008-27
    A.3Full title of the trial
    A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) (ZUMA-2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating the Efficacy of KTE-X19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL)
    A.3.2Name or abbreviated title of the trial where available
    ZUMA-2
    A.4.1Sponsor's protocol code numberKTE-C19-102
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02601313
    A.5.4Other Identifiers
    Name:IND NumberNumber:016675
    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 SponsorKite Pharma, 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 supportKite Pharma, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKite Pharma, Inc.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address2400 Broadway
    B.5.3.2Town/ citySanta Monica
    B.5.3.3Post codeCA 90404
    B.5.3.4CountryUnited States
    B.5.6E-mailregulatory@kitepharma.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 Yes
    D.2.1.1.1Trade name Tecartus
    D.2.1.1.2Name of the Marketing Authorisation holderKite Pharma EU BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1552; EU/3/15/1553;EU/3/14/1393
    D.3 Description of the IMP
    D.3.1Product nameKTE-X19
    D.3.2Product code KTE-X19
    D.3.4Pharmaceutical form Dispersion 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 INNKTE-X19
    D.3.9.2Current sponsor codeKTE-X19
    D.3.9.3Other descriptive nameAutologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor.
    D.3.9.4EV Substance CodeSUB193905
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberGene therapy medicinal product. Doc. Ref. EMA/CAT/360525/2015
    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 Yes
    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 Yes
    D.2.1.1.1Trade name Tecartus
    D.2.1.1.2Name of the Marketing Authorisation holderKite Pharma EU BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1552; EU/3/15/1553;EU/3/14/1393
    D.3 Description of the IMP
    D.3.1Product nameKTE-X19
    D.3.2Product code KTE-X19
    D.3.4Pharmaceutical form Dispersion 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 INNKTE-X19
    D.3.9.2Current sponsor codeKTE-X19
    D.3.9.3Other descriptive nameAutologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor.
    D.3.9.4EV Substance CodeSUB193905
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberGene therapy medicinal product. Doc. Ref. EMA/CAT/360525/2015
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed/Refractory Mantle Cell Lymphoma (MCL)
    E.1.1.1Medical condition in easily understood language
    Cancers of white blood cells, collectively known as B-cell non-Hodgkin lymphoma.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061275
    E.1.2Term Mantle cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10026801
    E.1.2Term Mantle cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of KTE-X19, as measured by objective response rate, in subjects with r/r MCL.
    E.2.2Secondary objectives of the trial
    Secondary objectives will include assessing the safety and tolerability of KTE-X19, and additional efficacy endpoints, including duration of response (DOR).

    Secondary objectives related to patient-reported outcomes (PROs) in Cohort 1 and Cohort 2 will include change in the European Quality of Life-5 Dimensions (EQ-5D) scores from baseline to Month 6. Secondary objectives related to PROs in Cohort 3 will include change in EQ-5D and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) scores from baseline over time.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    101. Pathologically confirmed MCL, with documentation of either overexpression of cyclin D1 or presence of t(11;14)

    102. Up to 5 prior regimens for MCL.

    Cohort 1 and Cohort 2: Prior therapy must have included:
    - Anthracycline or bendamustine-containing chemotherapy and
    - Anti-CD20 monoclonal antibody therapy and
    - Ibrutinib or acalabrutinib

    Cohort 3: Prior therapy must have included anthracycline- or bendamustine or high-dose cytarabine containing chemotherapy and anti-CD20 monoclonal antibody therapy. Subjects in
    Cohort 3 must not have received prior therapy with a BTKi.

    103. Relapsed or refractory disease, as defined by the following:
    - Disease progression after last regimen, or
    - Failure to achieve a PR or CR to the last regimen

    104. At least 1 measurable lesion. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. If the only measurable disease is lymph node disease, at least one lymph node should be ≥ 2 cm

    105. For subjects in Cohort 1 and Cohort 2 only: MRI of the brain showing no evidence of CNS lymphoma

    106. At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy or BTKi (ibrutinib or acalabrutinib; as applicable for subjects in Cohort 1 and Cohort 2) at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists etc).

    107. Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia)

    108. Age 18 years or older

    109. Eastern cooperative oncology group (ECOG) performance status of 0 or 1

    110. ANC ≥ 1000/uL

    111. Platelet count ≥ 75,000/μL. For subjects in Cohort 3 with bone marrow involvement, platelet count ≥ 50,000/μL is acceptable.

    112. Absolute lymphocyte count ≥ 100/ μL

    113. Adequate renal, hepatic, pulmonary and cardiac function defined as:
    - Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min
    - Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 upper limit of normal (ULN)
    - Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert’s syndrome
    - Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings. For subjects in Cohort 3, a multigated acquisition (MUGA) scan may be used in place of ECHO.
    - No clinically significant pleural effusion for subjects in Cohort 1 and Cohort 2, and no clinically significant pleural effusion, pericardial effusion, or ascites for subjects in Cohort 3
    - Baseline oxygen saturation > 92% on room air

    114. Females of childbearing potential must have a negative serum or urine pregnancy test. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
    E.4Principal exclusion criteria
    201. History of malignancy other than nonmelanomatous skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years.

    202. Autologous stem cell transplant within 6 weeks of planned KTE-X19 or axicabtagene ciloleucel infusion.

    203. History of alloSCT, with the exception of subjects in Cohort 3 with no donor cells detected on chimerism > 100 days after alloSCT

    204. Prior CD19 targeted therapy with the exception of subjects who received KTE-X19 or axicabtagene ciloleucel in this study and are eligible for retreatment.

    205. Prior chimeric antigen receptor therapy or other genetically modified T cell therapy

    206. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides

    207. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite Medical Monitor.

    208. History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection. Subjects with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing. For subjects in Cohort 3 enrolled in France, those with any history of acute or chronic hepatitis B or C infection are excluded.

    209. Presence of any indwelling line or drain (e.g. percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted

    210. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases

    211. History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease,
    cerebral edema, posterior reversible encephalopathy syndrome (PRES), or any autoimmune disease with CNS involvement

    212. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmias, or other clinically significant cardiac disease within 12 months of enrollment

    213. Subjects with cardiac atrial or cardiac ventricular lymphoma involvement

    214. History of deep vein thrombosis or pulmonary embolism requiring therapeutic anticoagulation within 6 months of enrollment

    215. Possible requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, tumor mass effect, tumor lysis
    syndrome)

    216. Primary immunodeficiency

    217. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment

    218. History of severe immediate hypersensitivity reaction to any of the agents used in this study

    219. Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen

    220. Females of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant

    221. Subjects of both genders who are not willing to practice birth control from the time of consent through 6 months after the completion of KTE-X19 or axicabtagene ciloleucel infusion

    222. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.

    223. History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate [ORR] (complete response [CR] + partial response [PR]) per the Lugano Classification (Cheson et al, 2014) per Independent Radiology Review Committee (IRRC) review.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis in Cohort 1 will be performed after 60 KTE-X19 subjects in the mITT set of Cohort 1 have been enrolled and treated with KTE-X19 and have had the opportunity to be evaluated for response 6 months after the Week 4 disease assessment.

    The primary analysis in Cohort 3 will occur after 86 subjects in Cohort 3 have been enrolled and treated with KTE-X19 and have had the opportunity to be assessed for response 6 months after the first objective response or 9 months after the KTE-X19 infusion, whichever is earlier. A follow-up analysis will be performed after 86 subjects in Cohort 3 have had the opportunity to be assessed for response 18 months after the first objective response to further evaluate the risk-benefit profile of KTE-X19, including the durability of response.
    E.5.2Secondary end point(s)
    - Duration of Response
    - Best Objective Response
    - Objective response rate as determined by study investigators
    - Progression Free Survival
    - Overall Survival
    - Incidence of adverse events and clinically significant changes in laboratory values
    -Incidence of anti-CD19 CAR antibodies
    - Levels of anti-CD19 CAR+ T cells in blood
    - Levels of cytokines in serum
    - Changes over time in the EQ-5D scale score and visual analogue scale score
    - Changes over time in the EORTC-QLQ-C30 score (Cohort 3 only)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All enrolled subjects will be followed in the long term follow-up period for survival and disease status if applicable. Subjects will begin the long term follow-up period after they have completed the Month 3 visit of the post treatment assessment period (whether they have responded to treatment or went straight to the month 3 visit due to disease progression)
    - Every 3 months (± 2 weeks) through Month 18 (for Cohort 1 and Cohort 2) or through Month 21 (for Cohort 3)
    - Month 24 (± 1 month)
    - Beginning with Protocol Amendment 8 and after completion of at least 24 months of assessments in KTE-C19-102, subjects who received an infusion of anti-CD19 CAR T cells will be given the opportunity to transition to a separate LTFU study, KT-US-982-5968, after providing signed informed consent.
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    United States
    France
    Netherlands
    Spain
    Germany
    United Kingdom
    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
    Defined as when the last subject is assessed or received an intervention for evaluation in the study, including survival assessments
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years16
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years19
    E.8.9.2In all countries concerned by the trial months0
    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: 150
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 220
    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 Decision2018-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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