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    Summary
    EudraCT Number:2020-002324-36
    Sponsor's Protocol Code Number:MK1026-003
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-10-11
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2020-002324-36
    A.3Full title of the trial
    A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in
    Participants with Hematologic Malignancies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies
    A.4.1Sponsor's protocol code numberMK1026-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04728893
    A.5.4Other Identifiers
    Name:INDNumber:133989
    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 SponsorMerck Sharp & Dohme LLC., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Romania SRL
    B.5.2Functional name of contact pointClinical Research Director
    B.5.3 Address:
    B.5.3.1Street AddressAna Towers, Bulevardul Poligrafiei, Nr. 1A, Etaj 5, Bucuresti, Sectorul 1
    B.5.3.2Town/ cityBucharest
    B.5.3.3Post code013704
    B.5.3.4CountryRomania
    B.5.4Telephone number0040215292900
    B.5.5Fax number0040213185236
    B.5.6E-mailelena.aldea@merck.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 name MK-1026
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINN is not assigned at this time
    D.3.9.1CAS number 2095393-15-8
    D.3.9.2Current sponsor codeMK-1026
    D.3.9.3Other descriptive nameARQ 531
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 name MK-1026
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINN is not assigned at this time
    D.3.9.1CAS number 2095393-15-8
    D.3.9.2Current sponsor codeMK-1026
    D.3.9.3Other descriptive nameARQ 531
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    B cell malignancies: Chronic lymphocytic leukemia/Small lymphocytic lymphoma; Richters transformation; Mantle cell lymphoma, Marginal zone lymphoma; Follicular lymphoma; Waldenstroms macroglobulinemia
    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 10003899
    E.1.2Term B-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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10026798
    E.1.2Term Mantle cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10054693
    E.1.2Term Von Waldenstrom macroglobulinemia
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10076596
    E.1.2Term Marginal zone lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Part 1: To determine the safety and tolerability and to establish the RP2D of MK-1026.
    2. Part 2: Cohorts A to C (CLL/SLL): To evaluate the ORR following
    administration with MK-1026 per iwCLL criteria 2018 as assessed by ICR.
    3. Part 2: Cohorts D to G (RT, MCL, MZL, FL): To evaluate the ORR
    following administration with MK-1026 per the Lugano criteria 2014 as assessed by ICR.
    4. Part 2: Cohort H (WM): To evaluate the ORR following administration
    with MK-1026 per International Workshop on WM (IWWM) 2014 as
    assessed by ICR.
    E.2.2Secondary objectives of the trial
    1. Part 1: To characterize the PK profile of MK-1026.
    2. Part 1: To evaluate the ORR and DOR following administration with MK-1026 for CLL/SLL participants per iwCLL criteria 2018 as assessed by ICR.
    3. Part 2: All Cohorts: To determine the safety and tolerability of MK-1026.
    4. Part 2: Cohorts A to C (CLL/SLL): To evaluate DOR following
    administration with MK-1026 per iwCLL criteria 2018 as assessed by ICR.
    5. Pt 2: Cohorts D to G (RT, MCL, MZL, FL): To evaluate the DOR following
    administration with MK-1026 per the Lugano criteria 2014 as assessed by ICR.
    6. Part 2: Cohort H (WM): To evaluate the DOR of MK-1026 per IWWM 2014 as assessed by ICR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In Part 1 and Part 2 (Cohorts A to C) has a confirmed diagnosis of CLL/SLL with:
    -At least 2 lines of prior therapy (Part 1 only)
    -Part 2 Cohort A: CLL/SLL participants who are relapsed or refractory to prior therapy with a covalent, irreversible BTKi and a BCL2i. CLL participants must have received and failed, been intolerant to, or determined by their treating physician to be a poor PI3Ki candidate or ineligible for a PI3Ki per local (institution) guidelines.
    -Part 2 Cohort B: CLL/SLL participants who are relapsed or refractory following at least 1 line of prior therapy and are BTKi treatment-naïve
    -Part 2 Cohort C: CLL/SLL participants with 17p deletion or TP53 mutation (as determined locally) who are relapsed or refractory following at least 1 line of prior therapy
    -Active disease for CLL/SLL clearly documented to initiate therapy
    -For SLL participants in Part 2: Participants with lymphoma must provide a lymph node biopsy for biomarker analysis from an archival or newly obtained lymph node biopsy or bone marrow aspirate at Screening
    2.Part 2 (Cohorts D to G):
    -Has a confirmed diagnosis of and response to previous treatment of one of the following:
    *Cohort D:participants with RT who are relapsed or refractory following at least 1 line of prior therapy
    *Cohort E:participants with pathologically confirmed MCL, documented by either overexpression of cyclin D1 or t(11;14), who are relapsed or are refractory to chemoimmunotherapy and a covalent irreversible BTKi
    *Cohort F: participants with MZL (including splenic, nodal, and
    extranodal MZL) who are relapsed or refractory to chemoimmunotherapy and a covalent irreversible BTKi
    *Cohort G: participants with FL who are relapsed or refractory to chemoimmunotherapy, and immunomodulatory agents (i.e. lenalidomide + rituximab)
    -Have measurable disease defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan
    -Provide lymph node biopsy for biomarker analysis from an archival or newly obtained lymph node biopsy at Screening.
    Cohort D can also submit bone marrow aspirate
    3.Part 2 (Cohort H): confirmed diagnosis of WM; participants who are relapsed or refractory to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi
    -Active disease is defined as 1 of the following:
    *Systemic symptoms – Fever, drenching night sweats, fatigue, weight loss, and/or severe neuropathy
    *Physical findings – Symptomatic or bulky (≥5 cm) lymphadenopathy,
    symptomatic hepatomegaly, and/or symptomatic splenomegaly
    *Laboratory abnormalities – Hemoglobin ≤10 g/dL or platelet count
    <100,000/μL
    *Coexisting disease – Immunoglobulin light chain amyloidosis with organ dysfunction, symptomatic cryoglobulinemia, cold agglutinin anemia, immune hemolytic anemia and/or thrombocytopenia, or nephropathy due to WM
    -Have measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement must be >15 mm in the longest
    diameter or >10 mm in the short axis); IgM ≥450 mg/dL; or bone marrow infiltration of 10%
    -Provide a fresh bone marrow aspirate for biomarker analysis at Screening. A lymph node biopsy from an archival or newly obtained lymph node biopsy at screening is also acceptable
    4.Have an ECOG performance status of 0 to 2 within 7 days before allocation
    5.Have a life expectancy of at least 3 months, based on the investigator
    assessment(all cohorts except D [RT])
    6.Have the ability to swallow and retain oral medication
    7.Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
    8.Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening
    9. Have adequate organ function
    10.Is an individual of any sex/gender, 18 years of age or older at the time of providing documented informed consent
    11.If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate the study intervention after the last dose:
    -Abstains from penile-vaginal intercourse as their preferred and usual lifestyle and agrees to remain abstinent
    OR
    -Uses contraception unless confirmed to be azoospermic
    12.A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and:
    -Is not a POCBP
    OR
    -Is a POCBP and uses a contraceptive method that is highly effective
    13.Documented informed consent granted before initiation of any studyspecific procedures
    14.Participants with HIV are eligible if they meet ALL of the following criteria:
    - The CD4 count is >350 cells/μL at screening
    - The HIV viral load is below the detectable level
    - Are on a stable ART regimen for at least 4 weeks before study entry
    - Are compliant with their ART
    E.4Principal exclusion criteria
    1. Part 1 and Part 2 participants: active HBV/HCV infection. See
    Inclusion Criteria 7 (HBV) and 8 (HCV) for requirements.
    2. Has a history of malignancy ≤3 years before providing documented
    informed consent.
    3. Has active CNS disease.
    4. Has an active infection requiring systemic therapy.
    5. Exclusion criterion removed.
    6. Has a history or current evidence of any condition, therapy, or
    laboratory abnormality that might confound the results of the study,
    interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
    7. Has QTc prolongation (defined as a QTcF >450 msec) or other
    significant ECG abnormalities including second degree AV block type II, third degree AV block, or bradycardia (ventricular rate less than 50
    beats/min).
    8. Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before allocation.
    9. Currently being treated with the following drugs:
    -P-gp substrates with a narrow therapeutic index (such as digoxin)
    -CYP3A strong inducers (such as rifampin)
    -CYP3A strong inhibitors
    10. Is currently participating in or has participated in a study of an
    investigational agent or has used an investigational device within 4
    weeks before the first dose of study intervention.
    11. Prior exposure to noncovalent, reversible BTK inhibitors.
    12. Has a known psychiatric or substance abuse disorder that would
    interfere with the participant's ability to cooperate with the
    requirements of the study.
    13. Has any clinically significant gastrointestinal abnormalities that
    might alter absorption.
    14. Has a known severe hypersensitivity (≥Grade 3) to nemtabrutinib,
    its active substance and/or any of its excipients. Refer to the IB for a list of excipients.
    15. History of severe bleeding disorders
    E.5 End points
    E.5.1Primary end point(s)
    1. Part 1: Number of participants experiencing dose-limiting toxicities (DLTs)
    2. Part 1: Number of participants experiencing adverse events (AEs)
    3. Part 1: Number of participants discontinuing study treatment due to AEs
    4. Part 2: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by
    independent central review (ICR)
    5. Part 2 (Cohorts D to G): ORR per Lugano criteria 2014 as assessed by ICR
    6. Part 2 (Cohort H): ORR per International Workshop on Waldenström’s Macroglobulinemia (IWWM) criteria 2014 as assessed by ICR
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to ~56 days (Cycles 1-2, cycle = 28 days)
    2. Up to ~78 months
    3. Up to ~ 78 months
    4. Up to ~ 78 months
    5. Up to ~ 78 months
    6. Up to ~ 78 months
    E.5.2Secondary end point(s)
    1. Part. 1: Area Under the Curve (AUC) of MK-1026
    2. Part. 1: Minimum Concentration (Cmin) of MK-1026
    3. Part 1: Maximum Concentration (Cmax) of MK-1026
    4. Part 1: ORR per iwCLL criteria 2018 as assessed by ICR
    5. Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR
    6. Part 2: Number of participants experiencing AEs
    7. Part 2: Number of participants discontinuing study treatment due to AEs
    8. Part. 2: AUC of MK-1026
    9. Part. 2: Cmin of MK-1026
    10. Part 2: Cmax of MK-1026
    11. Part 2: DOR per iwCLL criteria 2018 as assessed by ICR
    12. Part 2: DOR per Lugano criteria 2014 as assessed by ICR
    13. Part 2: DOR per IWWM criteria 2014 as assessed by ICR
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At designated time points (up to ~57 days)
    2. At designated time points (up to ~57 days)
    3. At designated time points (up to ~57 days)
    4. Up to ~78 months
    5. Up to ~78 months
    6. Up to ~78 months
    7. Up to ~78 months
    8. At designated time points (up to ~57 days)
    9. At designated time points (up to ~57 days)
    10. At designated time points (up to ~57 days)
    11. Up to ~78 months
    12. Up to ~78 months
    13. Up to ~78 months
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    parallel groups
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Switzerland
    Ukraine
    Australia
    Brazil
    Canada
    China
    Israel
    Korea, Republic of
    Russian Federation
    United Kingdom
    United States
    Czechia
    Denmark
    France
    Germany
    Hungary
    Ireland
    Italy
    Poland
    Romania
    Spain
    Türkiye
    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
    The overall study ends when the last participant completes the last
    study-related contact, withdraws consent, or is lost to follow-up. For
    purposes of analysis and reporting, the overall study ends when the
    Sponsor receives the last laboratory test result or at the time of final
    contact with the last participant, whichever comes last.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 221
    F.4.2.2In the whole clinical trial 450
    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 Decision2022-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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