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    Summary
    EudraCT Number:2021-000553-40
    Sponsor's Protocol Code Number:CNIS793E12201
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-000553-40
    A.3Full title of the trial
    daNIS-3: An open-label, multi-center, phase II platform study evaluating the efficacy and safety of NIS793 and other new investigational drug combinations with standard of care (SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer (mCRC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of NIS793 and other novel investigational combinations with SOC anti-cancer therapy for the second line treatment of mCRC
    A.4.1Sponsor's protocol code numberCNIS793E12201
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice (MCC)
    B.5.3 Address:
    B.5.3.1Street AddressRoonstrasse 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 911 273-12100
    B.5.5Fax number+49 911 27312160
    B.5.6E-mailinfoservice.novartis@novartis.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.3.2Product code NIS793
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet available
    D.3.9.2Current sponsor codeNIS793
    D.3.9.3Other descriptive nameNIS793
    D.3.9.4EV Substance CodeSUB184323
    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 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 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 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.2.1.1.2Name of the Marketing Authorisation holderBeiGene
    D.2.1.2Country which granted the Marketing AuthorisationChina
    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 nametislelizumab
    D.3.2Product code VDT482
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTislelizumab
    D.3.9.2Current sponsor codeVDT482
    D.3.9.4EV Substance CodeSUB193656
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 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
    metastatic colorectal cancer (mCRC)
    E.1.1.1Medical condition in easily understood language
    colorectal cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    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 PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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
    Safety run-in: To confirm the recommended phase 2 dose (RP2D) of each investigational arm (NIS793 or NIS793 plus tislelizumab or any investigational drug(s) in combination with SOC) (SOC: either modified FOLFOX6 + bevacizumab or FOLFIRI+ bevacizumab chemotherapy regimen)
    Expansion part: To evaluate preliminary efficacy of each investigational arm (NIS793 or NIS793+tislelizumab or any investigational drug(s) in combination with SOC anti-cancer therapy) versus control arm(SOC anti-cancer therapy) in terms of progression-free survival (PFS) by Investigator's assessment per RECIST 1.1
    E.2.2Secondary objectives of the trial
    Safety run-in:
    1. To characterize the safety and tolerability of each investigational arm (NIS793 or NIS793+tislelizumab or any investigational drug(s) in combination with SOC)
    2. Preliminary anti-tumor activity of each investigational arm
    3. To characterize the pharmacokinetics (PK) of each investigational arm (NIS793 or NIS793+tislelizumab or any investigational drug(s) in combination with SOC)
    4. To characterize the immunogenicity of components of each investigational arm
    Expansion part:
    1. To evaluate and compare efficacy of each investigational arm and control arm in terms of ORR, DCR, DOR, TTR by Investigator's assessment per RECIST 1.1
    2. To evaluate and compare the overall survival (OS) of each investigational arm and control arm
    3. Safety and tolerability
    4. To characterize the PK of each investigational arm, control arm
    5. To characterize the immunogenicity of components of each investigational arm, control arm
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent must be obtained prior to participation in the study.
    2. Age 18 years (or older, if required by local regulations) at the time of informed consent.
    3. Histologically or cytologically confirmed (by local laboratory and local clinical guidelines) metastatic colorectal adenocarcinoma that is not amenable to potentially curative surgery in the opinion of the investigator and progressed on or within 6 months after the last dose of one prior line of systemic anti-cancer therapy administered for metastatic disease.
    4. Presence of at least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
    5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
    6. Adequate organ function as defined by the following laboratory values (assessed by central laboratory for eligibility except where indicated):
    • Absolute neutrophil count ≥ 1.5 × 109/L
    • Platelets count ≥ 100 × 109/L
    • Hemoglobin ≥ 9 g/dL
    • Calculated creatinine clearance ≥ 60 mL/min (e.g. by using Cockcroft-Gault equation)
    • Albumin ≥ 3 g/dL
    • PT/INR and PTT ≤ 1.5 x ULN. Participants requiring therapeutic anticoagulants are eligible if coagulation parameters are within therapeutic range.
    • Total bilirubin ≤ 1.5 X ULN
    • Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase /serum glutamic pyruvic transaminase (ALT/SGPT) ≤ 3.0 x ULN (≤5 x ULN in presence of liver metastasis). In participants with elevated ALT or AST, the values must be stable for at least 2 weeks and with no evidence of biliary obstruction by imaging.
    7. Women of child-bearing potential must have negative pregnancy tests during the screening period and before starting study treatment.
    8. Able to adhere to study visit schedule and other protocol requirements.
    9. Participant must have recovered from treatment related toxicities of prior anticancer therapies to grade ≤1 (CTCAE v5.0) at the time of screening, except alopecia.
    E.4Principal exclusion criteria
    1.Previously administered of anticancer immunotherapy or TGF-╬▓targeted therapies.
    2.Microsatellite instability-high(MSI-H)/mismatch repair-deficient (dMMR)&/or BRAFV600 mutation positive colorectal cancer(tests performed by local laboratory & per local guidelines)
    3.Known complete or partial dipyrimidine dehydrogenase (DPD) nzyme deficiency(testing for DPD enzyme deficiency is not mandatory unless required by local regulations &can be conducted at local laboratory)
    4.For participants treated with irinotecan: Known history or clinical evidence of reduced UGT1A1 activity (testing for UGT1A1 status is not mandatory unless required by local regulations &can be conducted at local laboratory).
    5.Presence of symptomatic CNS metastases,or CNS metastases that requires directed therapy (such as focal radiotherapy or surgery)or increasing doses of corticosteroids 2 weeks prior to study entry. Participants with treated symptomatic brain metastases should be neurologically stable for 4 weeks post-treatment &prior to study entry,&at a dose of ≤ 10 mg per day prednisone or equivalent for at least 2 weeks before administration of any study treatment.
    6.Known history of severe allergy or hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes(monoclonal antibodies)or contraindication to any of the study drugs as outlined in the ‘Contraindications’ or‘Warnings and Precautions’ sections of the SOC local prescribing information 7.Participant is currently receiving other anti-cancer therapy (medication or radiotherapy)or received other investigational product within 30 days or 5 half-lives prior to initiation of study treatment whichever is longer.
    8.Participant is currently receiving any of prohibited medications as outlined in protocol or in SOC anti-cancer therapy local prescribing information &these cannot be discontinued ≥ 7 days or 5 half-lives whichever is longer, before first dose of that drug.
    9.Participant has not recovered from a major surgery performed prior to start of study treatment or has had a major surgery within 4 weeks days prior to start of study treatment. 10.Radiation therapy ≤ 4 weeks or brain-radiotherapy ≤ 4 weeks prior to start of study treatment
    11.Impaired cardiac function or clinically significant cardio-vascular disease, such as:
    •Congestive heart failure requiring treatment (NYHA grade ≥2)or clinically significant arrhythmia (including uncontrolled atrial flutter/fibrillation)
    •Acute myocardial infarction, unstable angina pectoris, coronary stenting, or bypass surgery <6 months prior to study entry •LVEF < 50% •Elevated cardiac enzymes troponin I > 2 x ULN •Cardiac valvulopathy≥ grade 2 •Uncontrolled hypertension defined by a systolic blood pressure ≥160 mg and/or diastolic blood pressure ≥100 mg Hg • Medical history or current diagnosis of myocarditis
    12.History of positive test for human immunodeficiency virus (HIV) infection 13.Active or chronic hepatitis B virus (HBV) or hepatitis C virus infections.14.Active untreated or uncontrolled systemic fungal, bacterial or viral infection (including COVID-19), which in opinion of investigator places the study participant at an unacceptable risk.
    15.Use of hematopoietic growth factors or transfusion support ≤ 2 weeks prior to start of study treatment.
    16.Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding. 17.Serious non-healing wounds.
    18.Stroke or transient ischemic attack, or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before start of study treatment.19.Concurrent malignancy other than disease under investigation with exception of malignancy that was treated curatively&has not recurred within 2 years prior to date of screening. Fully resected basal or squamous cell skin cancers and any carcinoma in situ are eligible.
    20.Any significant medical condition, laboratory abnormality or psychiatric or social condition that would constitute unacceptable safety risks to the participants, contraindicate participant participation in the clinical study, limit participant’s ability to comply with study requirements or compromise participants compliance with protocol& all requirements of study as stated in ICF.
    21.Women of child-bearing potential,unless they are willing to use highly effective methods of contraception during treatment with study drugs and for for at least 120 days after stopping treatment with tislelizumab.
    22.Pregnant or breast-feeding women.
    23.Use of live/attenuated vaccines within 4 weeks of initiation of study treatment 24.Active, known or suspected autoimmune disease or history thereof
    25.Systemic chronic steroid therapy (>10 mg/day prednisone/
    equivalent) or any immunosuppressive therapy
    26.History of allogeneic bone marrow or solid organ transplant
    E.5 End points
    E.5.1Primary end point(s)
    Safety run-in: Incidence of DLTs during the first treatment cycle (4 weeks) of treatment
    Expansion part: Progression-free survival (PFS) by Investigator’s assessment per RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    safety run-in: 4 weeks of treatment
    expansion part: until progression of the disease
    E.5.2Secondary end point(s)
    Safety run-in:
    1. Safety: Incidence and severity of AEs including changes in laboratory parameters, vital signs and ECG parameters
    2. Tolerability: Dose interruptions, reductions and dose intensity
    3. PFS, overall response rate (ORR), disease control rate (DCR), duration of response (DOR) and time to response (TTR)by Investigator's assessment per RECIST 1.1 and Overall survival (OS)
    4. Drug concentrations in serum or plasma of each investigational treatment and components of SOC therapy (bevacizumab, irinotecan, SN-38) over time and derived PK parameters (e.g. Ctrough, Cmax)
    5. Incidence of antidrug antibodies (ADA), prevalence at baseline and ADA incidence during the treatment for investigational treatment(s) and bevacizumab.
    expansion part:
    1. ORR, DCR, DOR, TTR by investigator's assessment by RECIST 1.1
    2. OS
    3. Incidence and severity of AEs, changes in laboratory parameters, vital signs and ECG parameters; dose interruptions, reductions and dose intensity
    4. Drug concentrations in serum or plasma of each investigational treatment and components of SOC therapy (bevacizumab, irinotecan, SN-38) over time and derived PK parameters (e.g. Ctrough, Cmax)
    5. Incidence of antidrug antibodies (ADA), prevalence at baseline and ADA incidence during the treatment for investigational treatment(s) and bevacizumab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    safety run-in:
    1,2 - 4 weeks of treatment
    3 - end of treatment
    4,5 - at protocol defined timepoints
    expansion part:
    1, 2, 3 - at the end of treatment
    4,5 - at protocol defined timepoints
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    platform study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    SoC chemotherapy
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Singapore
    Switzerland
    Taiwan
    Australia
    Belgium
    Canada
    Czechia
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Spain
    United Kingdom
    United States
    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
    When all participants
    • have completed 2 years of potential survival follow-up or 80% OS events for each treatment arm have occurred
    • until death or lost to follow-up, or withdrawal of consent
    • another clinical study with NIS793 or any other new investigational drug becomes available in this participant population and all participants ongoing are eligible to be transferred to that clinical study, in the event of an early study termination decision, the date of that decision.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days10
    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: 164
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 102
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 266
    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)
    n/a
    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 Decision2021-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-30
    P. End of Trial
    P.End of Trial StatusOngoing
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