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    Summary
    EudraCT Number:2020-001239-29
    Sponsor's Protocol Code Number:R2810-ONC-ISA-1981
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-001239-29
    A.3Full title of the trial
    A Phase 2 Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients with Recurrent/Metastatic HPV16 Cervical Cancer who have Experienced Disease Progression after First Line Chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cemiplimab and ISA101b Vaccine in Adult Participants with Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression after First Line Chemotherapy
    A.4.1Sponsor's protocol code numberR2810-ONC-ISA-1981
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04646005
    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 SponsorRegeneron Pharmaceuticals, 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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 Libtayo
    D.2.1.1.2Name of the Marketing Authorisation holderRegeneron Ireland Designated Activity Company
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecemiplimab
    D.3.2Product code REGN2810
    D.3.4Pharmaceutical form 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 INNCEMIPLIMAB
    D.3.9.2Current sponsor codeREGN2810
    D.3.9.4EV Substance CodeSUB189482
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nameHuman Papilloma Virus Type 16 E6/E7 synthetic long peptides vaccine
    D.3.2Product code ISA101b
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-Asp-Lys-Cys-Leu-Lys-Phe-Tyr-Ser-Lys-Ile-Ser-Glu-Tyr-Arg-His-Tyr-Cys-Tyr-Ser-Leu-Tyr-Gly-Thr-Thr-Leu-OH, trifluoroacetate salt
    D.3.9.1CAS number 1218771-50-6
    D.3.9.2Current sponsor codeD-3082-L TFA
    D.3.9.3Other descriptive nameD-3082-L TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124635
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-Leu-Tyr-Cys-Tyr-Glu-Gln-Leu-Asn-Asp-Ser-Ser-Glu-Glu-Glu-Asp-Glu-Ile-Asp-Gly-Pro-Ala-Gly-Gln-Ala-Glu-Pro-Asp-Arg-Ala-His-Tyr-Asn-Ile-Val-Thr-OH, trif
    D.3.9.1CAS number 1218907-64-2
    D.3.9.2Current sponsor codeL-3972-T TFA
    D.3.9.3Other descriptive nameL-3972-T TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124637
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-Met-His-Gly-Asp-Thr-Pro-Thr-Leu-His-Glu-Tyr-Met-Leu-Asp-Leu-Gln-Pro-Glu-Thr-Thr-Asp-Leu-Tyr-Cys-Tyr-Glu-Gln-Leu-Asn-Asp-Ser-Ser-Glu-Glu-Glu-OH, trif
    D.3.9.1CAS number 1218907-32-4
    D.3.9.2Current sponsor codeM-4148-E TFA
    D.3.9.3Other descriptive nameM-4148-E TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124638
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-Arg-Cys-Ile-Asn-Cys-Gln-Lys-Pro-Leu-Cys-Pro-Glu-Glu-Lys-Gln-Arg-His-Leu-Asp-Lys-Lys-Gln-Arg-Phe-His-Asn-Ile-Arg-Gly-Arg-Trp-Thr-OH, trifluoroacetate
    D.3.9.1CAS number 1218907-21-1
    D.3.9.2Current sponsor codeR-4019-T TFA
    D.3.9.3Other descriptive nameR-4019-T TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124639
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-Thr-Leu-Arg-Leu-Cys-Val-Gln-Ser-Thr-His-Val-Asp-Ile-Arg-Thr-Leu-Glu-Asp-Leu-Leu-Met-Gly-Thr-Leu-Gly-Ile-Val-Cys-Pro-Ile-Cys-Ser-Gln-Lys-Pro-NH2, tri
    D.3.9.1CAS number 1218908-02-1
    D.3.9.2Current sponsor codeT-3853-P TFA
    D.3.9.3Other descriptive nameT-3853-P TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124640
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-Asp-Lys-Lys-Gln-Arg-Phe-His-Asn-Ile-Arg-Gly-Arg-Trp-Thr-Gly-Arg-Cys-Met-Ser-Cys-Cys-Arg-Ser-Ser-Arg-Thr-Arg-Arg-Glu-Thr-Gln-Leu-OH, trifluoroacetate
    D.3.9.1CAS number 1218907-24-4
    D.3.9.2Current sponsor codeD-3954-L TFA
    D.3.9.3Other descriptive nameD-3954-L TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124641
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-His-Tyr-Cys-Tyr-Ser-Leu-Tyr-Gly-Thr-Thr-Leu-Glu-Gln-Gln-Tyr-Asn-Lys-Pro-Leu-Cys-Asp-Leu-Leu-Ile-Arg-OH, trifluoroacetate salt
    D.3.9.1CAS number 1218771-56-2
    D.3.9.2Current sponsor codeH-3035-R TFA
    D.3.9.3Other descriptive nameH-3035-R TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124642
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-Lys-Gln-Gln-Leu-Leu-Arg-Arg-Glu-Val-Tyr-Asp-Phe-Ala-Phe-Arg-Asp-Leu-Cys-Ile-Val-Tyr-Arg-Asp-Gly-Asn-OH, trifluoroacetate salt
    D.3.9.1CAS number 1218771-40-4
    D.3.9.2Current sponsor codeK-3118-N TFA
    D.3.9.3Other descriptive nameK-3118-N TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124643
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-Leu-Pro-Gln-Leu-Cys-Thr-Glu-Leu-Gln-Thr-Thr-Ile-His-Asp-Ile-Ile-Leu-Glu-Cys-Val-Tyr-Cys-Lys-Gln-Gln-Leu-Leu-Arg-Arg-Glu-Val-Tyr-OH, trifluoroacetate
    D.3.9.1CAS number 1218907-04-0
    D.3.9.2Current sponsor codeL-3863-Y TFA
    D.3.9.3Other descriptive nameL-3863-Y TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124644
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-Met-His-Gln-Lys-Arg-Thr-Ala-Met-Phe-Gln-Asp-Pro-Gln-Glu-Arg-Pro-Arg-Lys-Leu-Pro-Gln-Leu-Cys-Thr-Glu-Leu-Gln-Thr-Thr-Ile-His-Asp-OH, trifluoroacetate
    D.3.9.1CAS number 1218907-00-6
    D.3.9.2Current sponsor codeM-3878-D TFA
    D.3.9.3Other descriptive nameM-3878-D TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124645
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-Arg-Asp-Leu-Cys-Ile-Val-Tyr-Arg-Asp-Gly-Asn-Pro-Tyr-Ala-Val-Cys-Asp-Lys-Cys-Leu-Lys-Phe-Tyr-Ser-Lys-Ile-OH, trifluoroacetate salt
    D.3.9.1CAS number 1218771-49-3
    D.3.9.2Current sponsor codeR-3083-I TFA
    D.3.9.3Other descriptive nameR-3083-I TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124646
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNH-Tyr-Gly-Thr-Thr-Leu-Glu-Gln-Gln-Tyr-Asn-Lys-Pro-Leu-Cys-Asp-Leu-Leu-Ile-Arg-Cys-Ile-Asn-Cys-Gln-Lys-Pro-Leu-Cys-Pro-Glu-Glu-Lys-OH, trifluoroacetate
    D.3.9.1CAS number 1218907-20-0
    D.3.9.2Current sponsor codeY-3755-K TFA
    D.3.9.3Other descriptive nameY-3755-K TRIFLUOROACETATE
    D.3.9.4EV Substance CodeSUB124647
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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 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
    Recurrent/Metastatic HPV16 Cervical Cancer
    E.1.1.1Medical condition in easily understood language
    Cervical Cancer due to Human Papilloma Virus Type 16 Infection
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008231
    E.1.2Term Cervical cancer recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10063001
    E.1.2Term Human papilloma virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    - To characterize the safety profile of cemiplimab + ISA101b
    - To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Information on the biomedical research and pharmacogenomics optional sub-studies are provided within the protocol.

    Biomedical Research (Optional Sub-Study)
    The unused samples (biomarker, PK and ADA), may be utilized for future biomedical research. Future biomedical research may include assay development and/or validation, and the samples may be used as references or controls in unrelated experiments.

    Pharmacogenomics (Optional Sub-Study)
    The purpose of the pharmacogenomic analyses is to identify genomic associations with clinical (safety or efficacy) or biomarker response to cemiplimab, clinical outcome measures, and possible AEs. In addition, associations between genomic variants and prognosis or progression of cervical cancer or related diseases may also be studied. These data may be used or combined with data collected from other studies to identify and validate genomic markers related to the study drug, target pathway, or cervical cancer and related diseases.
    E.3Principal inclusion criteria
    1. Adult patients ≥18 years of age (or the legal age of adults to consent to participate in a clinical study per country specific regulations).
    2. Has histologically confirmed recurrent or metastatic HPV16 positive squamous cell cervical cancer, who have experienced disease progression after treatment with platinum containing therapy as defined in the protocol
    3. Patient must be determined to be positive for HPV16 genotype, as determined by a specified central reference laboratory.
    4. Patient must have measurable disease as defined by RECIST 1.1.
    5. ECOG performance status of 0 or 1.
    6. Has adequate organ and bone marrow function as defined in the protocol.
    7. Anticipated life expectancy ≥20 weeks.

    Other protocol-defined Inclusion criteria apply
    E.4Principal exclusion criteria
    1. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
    2. Prior treatment with other systemic immune-modulating agents as defined in the protocol
    3. Major surgery or radiation therapy within 14 days of first administration of study drug
    4. Has received treatment with an approved systemic therapy within 4 weeks of first dose of study drug, or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol
    5. Has another malignancy that is progressing or requires active treatment and/or history of malignancy other than cervical cancer within 3 years of date of first planned dose of study drug as defined in the protocol
    6. Has any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 4 weeks prior to the first dose of study drug.
    7. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol

    Other protocol-defined Exclusion criteria apply
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 36 months
    E.5.2Secondary end point(s)
    1. Incidence and severity of treatment emergent adverse events (TEAEs)
    2. Incidence and severity of adverse events of special interest (AESIs)
    3. Incidence and severity of serious adverse events (SAEs)
    4. Incidence and severity of ≥ grade 3 laboratory abnormalities
    5. Duration of response (DOR)
    6. Progression free survival (PFS)
    7. Overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4: Up to 90 days after the last dose of study treatment
    5-7: Up to 36 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Belgium
    Brazil
    Italy
    Korea, Republic of
    Netherlands
    Russian Federation
    Spain
    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
    Date of the last contact of the last patient in the study.
    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 months5
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days19
    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: 93
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 54
    F.4.2.2In the whole clinical trial 103
    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 Decision2021-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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