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    Summary
    EudraCT Number:2014-003277-42
    Sponsor's Protocol Code Number:MCLA-128-CL01
    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:2019-12-13
    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 number2014-003277-42
    A.3Full title of the trial
    A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors (eNRGY)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the investigational drug MCLA-128 which is an antibody that is
    specific to both HER2 and HER3 receptors that are associated with solid
    tumors
    A.4.1Sponsor's protocol code numberMCLA-128-CL01
    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 SponsorMerus N.V.
    B.1.3.4CountryNetherlands
    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 supportMerus N.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerus N.V
    B.5.2Functional name of contact pointMCLA-128-CL01 Project Physician
    B.5.3 Address:
    B.5.3.1Street AddressUppsalalaan 17, 3rd and 4th floor
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CT
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+1617586 9488
    B.5.6E-mailE.Wasserman@merus.nl
    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 nameZenocutuzumab
    D.3.2Product code MCLA-128
    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 INNZenocutuzumab
    D.3.9.1CAS number 1969309-56-5
    D.3.9.2Current sponsor codeMCLA-128
    D.3.9.3Other descriptive nameA bispecific humanized full length IgG1 antibody with enhanced ADCC
    D.3.9.4EV Substance CodeSUB169257
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    Solid Tumors
    E.1.1.1Medical condition in easily understood language
    Solid tumors
    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 LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1:
    - Determination of MTD/MRD and tolerability
    Part 2: Groups A - E:
    - To characterize the safety and tolerability of MCLA-128
    - To explore the relationships between the anti-tumor activity of MCLA-128 and disease-related biomarkers
    Part 2: Groups F, G, H (NRG1 fusion)
    - To assess the magnitude of anti-tumor activity of MCLA-128 in patients with NRG1 fusions as assessed locally
    - To assess durability of anti-tumor activity of MCLA-128 in patients with NRG1 fusions as assessed locally
    E.2.2Secondary objectives of the trial
    Part1:
    - safety and tolerability of MCLA-128
    - PK profile of MCLA-128
    - Immunogenicity of MCLA-128
    - Evaluation of anti-tumor response and CBR
    Part 2 Groups A - E:
    - PK profile of MCLA-128
    - Immunogenicity of MCLA-128
    - Evaluation of PFS and overall survival, duration of response
    Part 2: Groups F, G, H (NRG1 fusion)
    - To assess the magnitude of anti-tumor activity of MCLA-128 in patients
    with NRG1 fusions as assessed centrally
    - To assess the clinical benefit rate (CBR) of MCLA-128 in patients with
    NRG1 fusions as assessed locally and centrally
    - To assess durability of anti-tumor activity of MCLA-128 in patients with
    NRG1 fusions as assessed centrally
    - To assess time to onset of response in patients with NRG1 fusions as assessed locally and centrally
    - To characterize the safety and tolerability of MCLA-128
    - PK profile of MCLA-128
    - Immunogenicity of MCLA-128
    - Evaluation of progression-free survival and overall survival
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age ≥18 yrs
    2.≥1 measurable lesion, RECIST v1.1 or evaluable disease for a limited number of patients in group H
    3.ECOG 0, 1 or 2
    4.life expectancy ≥12 wks
    5. Toxicities incurred as a result of previous anti-cancer therapy resolved to ≤Grade 1 except for alopecia, Grade 2 sensory neurotoxicity, or any other toxicity that in the opinion of the investigator does not affect the assessment of adverse events related to the study drug
    6.Treatment with anti-cancer or investigational product within set intervals before first dose of IMP:
    a.>14d or >5 half-lives prior to study entry, whichever is shorter.
    b.>14d for radiotherapy. Note: A less than 1-week wash-out period is permitted only for palliative radiation to non-CNS disease with Sponsor approval.
    7.Recovery from prior surgery/other procedure/ complication to ≤ Grade 2 or to baseline condition that in opinion of the investigator does not affect the assessment of adverse events related to the study drug;
    8.Screening Lab values:
    a.Absolute neutrophil count ≥1.5 x 10^9/L without colony stimulating factor support for at least 7 days prior to Screening;
    b.Platelets ≥75 x 10^9/L without transfusion support for at least 7 days prior to Screening;
    c.Hemoglobin ≥8 g/dL or ≥5 mmol/L;
    d.ALT, AST ≤3 x ULN and total bilirubin ≤1.5 x ULN (for exceptions please refer to protocol)
    e.Estimated glomerular filtration rate (GFR) of >30 mL/min based on the Cockroft-Gault formula;
    9.Able to provide at baseline a mandatory tumor biopsy sample, preferably a block. If safe/feasible, a fresh FFPE biopsy sample is preferred; archival tissue is acceptable (preferably not more than 2
    years old
    Note 1: For patients who received afatinib or other HER-targeting agents, a biopsy collected after the last line of treatment is strongly preferred to assess for mechanisms of acquired resistance
    Note 2: For patients with a locally confirmed NRG1 gene fusion, when archival tissue is not available and collection of a fresh biopsy is not safe or feasible during the screening period, these patients will be allowed to enroll in the MCLA128-CL01 trial provided they meet all other inclusion/exclusion criteria.
    10.Negative pregnancy test at Screening and ≤7 days of D1
    Note: Women with amenorrhea associated with prior treatment with antineoplastic medications are still considered as being of child-bearing potential.
    11.Sexually active male and female patients of childbearing potential must agree to use one of the highly effective methods of birth control during entire study and 6 months after final administration of MCLA-128
    12.Give written informed consent
    13.Capable of understanding protocol requirements, is willing and able to comply with study procedures and has signed the main informed consent document. For any optional biopsy sampling (tissue and/or blood) and long-term sample storage, additional consent is required
    14. Patients must have received prior standard therapy appropriate for their tumor type and stage of disease;
    15. Histologic or cytologic diagnosis of locally-advanced unresectable or metastatic solid tumor malignancy with a documented NRG1 gene fusion, identified through molecular assays such as PCR, next generation sequencing-based assays [DNA or RNA], as routinely performed ast CLIA
    or other similarly-certified laboratories. The following tumor types are included:
    o Group F: NSCLC
    o Group G: pancreatic adenocarcinoma
    o Group H: any other solid tumor
    NOTE: Patients harboring fusions that are predicted to be non-functional, i.e.., lack of EGF-domain, will not be included in the study. For equivocal cases, including those with NRG1 as the upstream partner, the Sponsor will manually review genomic results and may request collateral testing, approve, or deny the case.
    E.4Principal exclusion criteria
    1. Pregnant or lactating;
    2. Presence of an active uncontrolled infection or an unexplained fever greater than 38.5°C during Screening up to the first scheduled day of dosing. At the discretion of the Investigator, patients with tumor fever or a clinically insignificant minor infection may be enrolled (i.e. mild upper respiratory infection);
    3. Known hypersensitivity to any of the components of MCLA-128 or history of severe hypersensitivity reactions to human or humanized monoclonal antibodies, including therapeutic antibodies;
    4. Patients with the following infectious diseases are excluded:
    a. known HIV
    b. active Hepatitis B infection (HBsAg positive) without receiving antiviral treatment
    Note:
    • Patients with active hepatitis B (HBsAg positive) must receive antiviral treatment with lamivudine, tenofovir, entecavir, or other antiviral agents, starting at least ≥ 7 days before the initiation of the study
    treatment.
    • Patients with antecedents of Hepatitis B (anti-HBc positive, HBsAg and HBV-DNA negative) are eligible.
    c. positive test for Hepatitis C ribonucleic acid (HCV RNA)
    Note:
    • Patients in whom HCV infection resolved spontaneously (positive HCV antibodies without detectable HCV-RNA) or those that achieved a sustained response after antiviral treatment and show absence of
    detectable HCV RNA ≥ 6 months (with the use of IFN-free regimens) or ≥ 12 months (with the use of IFN-based regimens) after cessation of antiviral treatment are eligible;
    NOTE: Patients without known or suspected HIV, Hepatitis B or Hepatitis C infection do not require specific viral testing during the screening period.
    5. Known symptomatic or unstable brain metastases. Patients with asymptomatic brain metastases are eligible to participate if the metastases have been radiographically and clinically stable for at least
    one month. If on steroids for this indication, the patient must be on a stable dose for at least one month.
    6. Patients with leptomeningeal metastases
    7. Previous or concurrent malignancy (excluding non-basal cell carcinoma of skin or carcinoma in situ of the uterine cervix) unless the tumor was treated with curative or palliative intent and in the opinion of the investigator, with sponsor agreement, the previous or concurrent malignancy condition doesn't affect the assessment of safety and efficacy of the study drug;
    8. Presence of LVEF <50% on the screening echocardiogram; or history or presence of any significant cardiovascular disease, including unstable angina or myocardial infarction within 12 months prior to screening, congestive heart failure (NYHA Class III or IV), or ventricular arrhythmia requiring medication;
    9. Presence of any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate or participate in the study, or interfere with the interpretation of the results.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1:
    • Evaluation of adverse events (AEs) and dose limiting toxicities (DLT).
    Part 2: Groups A - E:
    • Frequency and nature of AEs
    • Overall response rate (ORR), DOR, CBR (defined as the proportion of patients in whom a CR or PR is observed, or SD of a minimum duration of 12 weeks) per RECIST v1.1 as per local Investigator's assessment. The relationship between anti-tumor activity and biomarkers including expression of HER2, HER3, and heregulin will be explored, and serum biomarkers such as CA-125 (ovarian, endometrial) and CA 19-9 (gastric)
    Part 2: Groups F, G, H (NRG1 fusion):
    • Overall response rate (ORR) per RECIST v1.1 as per local Investigator's assessment
    • Duration of response per RECIST v1.1 as per local Investigator's assessment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1:
    - Continuous assessment of AEs
    Part 2 A-E:
    - Continuous assessment of AEs
    - Every 8 weeks until end of treatment (ORR, DOR, CBR)
    - Pre-dose Cycle 1 Day, Cycle 2 D1. Every 2 cycles therafter (biomarkers)
    Part 2 F,G,H:
    - Every 8 weeks until end of treatment
    E.5.2Secondary end point(s)
    Part 1:
    1 Frequency and nature of AEs/serious adverse events (SAEs)
    2 Assessment of PK variables, including total exposure, maximum concentration (Cmax) clearance, volume of distribution (V), volume of distribution at steady state (Vss), half-life (t1/2), AUC0-t (area under the concentration versus time curve from time zero to time t), AUC0-∞
    (area under the concentration versus time curve), tmax (time to reach maximum concentration)
    3 Incidence and serum titers of anti-drug antibodies against MCLA-128
    4 Anti-tumor activity and clinical benefit assessed by RECIST v1.1 determining objective overall response rate (ORR), duration of response (DOR), progression-free survival (PFS) and survival; CBR is defined as the proportion of patients in whom a complete response (CR) or partial
    response (PR) or stable disease (SD) is observed (where SD duration is a minimum of 12 weeks).
    Part 2: Groups A - E:
    5 Assessment of PK variables, including total exposure, Cmax, V, Vss, t1/2, AUC0-t, AUC0-∞, tmax
    6 Population PK analysis
    7 Incidence and serum titers of anti-drug antibodies against MCLA-128
    Part 2: Groups F, G, H (NRG1 fusion):
    8 Overall response rate per RECIST v1.1 as per central review.
    9 CBR (defined as the proportion of patients with a CR or PR, or an SD of a minimum duration of 24 weeks) per RECIST v1.1 as per local Investigator's assessment.
    10 CBR per RECIST v1.1 as per central review.
    11 Duration of response per RECIST v1.1 as per central review.
    12 Time to response per RECIST v1.1. as per local Investigator's assessment.
    13 Time to response per RECIST v1.1 as per central review.
    14 Frequency and nature of AEs
    15 Assessment of PK variables, including total exposure, Cmax, V, Vss, t1/2, AUC0-t, AUC0-∞, tmax
    16 Population PK analysis
    17 Incidence and serum titers of anti-drug antibodies against MCLA-128
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1:
    1 Continuous AEs assessment
    2 Pre-dose C1D1, EOI; 2,4,24h post EOI, pre-dose & EOI on D15.Cycles 2&3:pre-dose & EOI D1,15. C4 & every 2 cycles thereafter pre-dose D1
    3 D1 pre-dose C1,2,3,&4. Every fourth cycle thereafter & EOT & Final visit
    4 Every 8 wks til EOT
    Part 2 A-E:
    5,6 Pre-dose C1D1, EOI; 2,4,24 h post EOI, pre-dose & EOI on D15.C2&3:pre-dose & EOI D1,15. C4 & every2 cycles thereafter pre-dose D1 7 D1 pre-dose for C1,2,3,&4. Every fourth cycle thereafter & EOT & Final visit
    Part 2 F, G, H:
    8-13 Every 8 wks til EoT
    14 Continuous AEs assessment
    15 16 Pre-dose C1D1, EOI; 2,4,24 h post EOI, pre-dose & EOI on D15.Cycles 2&3:pre-dose & EOI D1,15. C4,6,8 pre-dose D1
    17 D1 pre-dose for C1,2,3,4&8
    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 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) Yes
    E.7.1.1First administration to humans Yes
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Part 2 is parallel design, Part 1 is not
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA32
    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
    Taiwan
    Austria
    Belgium
    Canada
    Denmark
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Norway
    Spain
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months10
    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: 172
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 286
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 258
    F.4.2.2In the whole clinical trial 458
    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)
    Patients may remain on treatment until disease progression, death, unacceptable toxicity or discontinuation for any other reason.
    Continuing treatment beyond progression for either arm is only to be considered under special circumstances when it is believed that the
    patient may clinically benefit by continued treatment beyond progression. If it is judged by the Investigator in consultation with the Sponsor to be in the best interest of the patient, patients may continue dosing.
    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 Decision2020-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-18
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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