Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43233   clinical trials with a EudraCT protocol, of which   7153   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-001087-30
    Sponsor's Protocol Code Number:CT-P13_3.8
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-06
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2019-001087-30
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease
    Randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení fáze 3 k posouzení účinnosti a bezpečnosti subkutánně podávaného přípravku CT-P13 (CT-P13 SC) jako udržovací terapie u pacientů se středně těžkou až těžkou aktivní formou Crohnovy choroby
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease
    A.4.1Sponsor's protocol code numberCT-P13_3.8
    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 SponsorCelltrion, Inc
    B.1.3.4CountryKorea, Republic of
    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 supportCelltrion, Inc
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelltrion, Inc
    B.5.2Functional name of contact pointSung Hyun Kim
    B.5.3 Address:
    B.5.3.1Street Address23, Academy-ro
    B.5.3.2Town/ cityYeonsu-gu, Incheon
    B.5.3.3Post code22014
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number82328505778
    B.5.5Fax number82328371203
    B.5.6E-mailsunghyun.kim@celltrion.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 REMSINA
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft
    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.3.2Product code CT-P13
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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.2.1.1.1Trade name Inflectra
    D.2.1.1.2Name of the Marketing Authorisation holderCELLTRION, Inc., 23, Academyro, Yeonsu-gu, Incheon 22014, Republic of Korea
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 CT-P13
    D.3.4Pharmaceutical form Powder for 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 INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to Severely Active Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Crohn’s Disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of CT-P13 SC over Placebo SC based on clinical remission and endoscopic response at Week 54.
    E.2.2Secondary objectives of the trial
    To evaluate additional efficacy, PK, pharmacodynamics (PD) and overall safety including immunogenicity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is male or female aged 18 to 75 years, inclusive.
    2. Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points at Screening.
    3. Patient with average (of 7 days) daily stool frequency ≥4 points (of Type 6 or Type 7 on the BSFS and/or an average (of 7 days) worst daily abdominal pain of ≥2 points (using 4 point scale) at Screening.
    4. Patient who has a SES CD of ≥6 points for ileal-colonic CD or ≥4 points including ulcer score from at least 1 segment for ileal CD or colonic CD at Screening.
    5. Patient who has CD, confirmed at any time in the past by radiography, histology, or endoscopy, of at least 3 months’ disease duration prior to the first administration of the study drug (Day 0).
    6. Patient who has been treated for active CD but has not responded despite a full and adequate course of therapy with corticosteroids and/or immunosuppressants; or who is intolerant to or has medical contraindications for such therapies.
    7. Patient who is receiving a stable dose of the following CD treatments or currently not receiving CD treatment during the specified time frame:
    • Azathioprine (AZA), 6-mercaptopurine (6-MP) or Methotrexate (MTX) for at least 8 weeks prior to the first administration of the study drug (Day 0)
    • Oral budesonide at a dose of 9 mg/day (if the country specific dosage
    is approved for CD treatment) or 6 mg/day or less for at least 2 weeks
    prior to the first administration of the study drug (Day 0)
    • Oral budesonide at a dose of 6 mg/day or less for at least 4 weeks prior to the first administration of the study drug (Day 0)
    • 5-Aminosalicylates (5-ASA) or antibiotics (i.e., ciprofloxacin, metronidazole) for at least 4 weeks prior to the first administration of the study drug (Day 0)
    8. Patient who has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
    • Serum creatinine <1.5×upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula)
    • Serum alanine aminotransferase <2.5×ULN
    • Serum aspartate aminotransferase <2.5×ULN
    • Serum total bilirubin <2×ULN
    9. Patient who has the following clinical hematology results at Screening:
    • Hemoglobin ≥8.5 g/dL (SI [Système International d'Unités] units: ≥85 g/L or 5.28 mmol/L)
    • White blood cell count ≥3.5×103 cells/µL (SI units: ≥3.5×109 cells/L)
    • Neutrophil count ≥1.5×103 cells/µL (SI units: ≥1.5×109 cells/L)
    • Platelet count ≥100×103 cells/µL (SI units: ≥100×109 cells/L)
    10. Patient (or legal guardian, if applicable) who is informed of the full nature and purpose of the study, including possible risks and side effects, has the ability to cooperate with the investigator and is given ample time and opportunity to read or understand verbal and/or written instructions, and has signed and dated the written informed consent form (ICF) prior to participation in the study.
    11. For both male and female patients, the patient and his or her partner of childbearing potential who agree to use one of the following medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug (excluding women who are not of childbearing potential and men who have been sterilized):
    • Barrier contraceptives (male condom, female condom, or diaphragm with a spermicidal gel)
    • Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings)
    • Intrauterine device
    Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use any of the medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing potential.
    E.4Principal exclusion criteria
    1.Patient who has previously received 2 or more biologic agents, 2 or more Janus kinase (JAK) inhibitors, or 2 or more of both biologic agents and JAK inhibitors
    2.Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives prior to the first administration of the study drug (Day 0).
    3. Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.
    4. Patient who has previously received infliximab for treatment of CD or other disease.
    5. Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins, or has a hypersensitivity to
    immunoglobulin products.
    6. Patient who has received or has a plan to receive any of following
    prohibited medications or treatments:
    • Parenteral corticosteroids for the treatment of CD within 2 weeks prior to the first administration of the study drug (Day 0), JAK nhibitors including but not limited to tofacitinib and baricitinib within 4 weeks prior to the first administration of the study drug (Day 0), Alkylating agents within 12 months prior to the first administration of the study drug (Day 0), Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to the first dministration of the study drug (Day 0), Live or live-attenuated vaccine within 4 weeks prior to the first administration of the study drug (Day 0), Abdominal surgery for, including but not limited to, active gastrointestinal bleeding, peritonitis, intestinal obstruction, GI resection or intra abdominal or pancreatic abscess requiring surgical drainage within 6 months prior to the first administration of the study drug (Day 0), Nonautologous stem cell therapy (e.g., Prochymal) within 12 months prior to the first administration of the study drug (Day 0), Apheresis for the treatment of CD within 3 weeks prior to the first administration of the study drug (Day 0), Use of total parenteral nutrition within a month prior to the first inistration of the study drug (Day 0), Use of exclusive enteral nutrition for more than 3 consecutive days within a month or any single day of exclusive enteral nutrition within 2 weeks prior to the first administration of the study drug (Day 0)
    7. Patient who has a current or history of any of the following Onfections:Known infection with hepatitis B or hepatitis C (active or carrier state), or infection with HIV. However, a patient who is ithout cirrhosis of liver and recovered from a past hepatitis B or hepatitis C infection can be enrolled. In case of hepatitis C infection, patient who has achieved a SVR for at least 12 weeks after completing the treatment for hepatitis C infection can be enrolled. Acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug (Day 0); Other serious infection, in the investigator's opinion, within 6 months prior to the first administration of the study drug (Day 0); Recurrent herpes zoster or other chronic or recurrent infection, in the investigator's opinion, within 6 weeks prior to the first administration of the study drug (Day 0); Past or current ranulomatous infections or opportunistic infections; Evidence
    of infection with cytomegalovirus within 6 months prior to the first
    administration of the study drug (Day 0); Evidence of Clostridium
    difficile toxin within 3 months prior to the first administration of the
    study drug (Day 0); Positive stool examinations for enteric pathogens,
    pathogenic ova or parasites at Screening
    8.Diagnosed with UC or indeterminate colitis; Extensive colonic resection (subtotal and total colectomy) prior to the first administration of the study drug (Day 0); History of more than 3 small-bowel resection
    procedures prior to the first administration of the study drug (Day 0);
    Diagnosed with short bowel syndrome; Evidence of fixed symptomatic
    stenosis or obstruction of the large or small intestine
    Currently require or are anticipated to require surgical intervention for
    CD during the study; Active entero-vesical, entero-retroperitoneal,
    entero-cutaneous, or entero-vaginal fistulae within 6 months prior to the
    first administration of the study drug (Day 0). Entero-enteral fistulae
    without clinically significant symptoms in the investigator's opinion and
    anal fistulae without draining problems are allowed
    Stoma (e.g., ileostomy or colostomy) within 6 months prior to the first
    administration of the study drug (Day 0); ;Body mass index ≥35 kg/m2;
    Uncontrolled diabetes mellitus, even after insulin treatment;
    Uncontrolled hypertension (as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
    For remaining details about exclusion criteria, please refer to the
    protocol.
    E.5 End points
    E.5.1Primary end point(s)
    • Clinical remission at Week 54, defined as an absolute CDAI score of <150 points
    • Endoscopic response at Week 54, defined as a 50% decrease in SES-CD score from the baseline value
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endopoint evaluation will be conducted at Week 54.
    E.5.2Secondary end point(s)
    Key Secondary endpoints
    • CDAI-100 response at Week 54, defined as a decrease in CDAI score of 100 points or more from the baseline value
    • Clinical remission at Week 54, defined as an average worst daily abdominal pain score of ≤ 1 (using 4-point scale), and an average loose/watery stool frequency score of ≤ 3 (of Type 6 or Type 7 on BSFS) with no worsening in either score compared to the baseline value
    • Corticosteroid-free remission at Week 54, defined as being in clinical remission (by an absolute CDAI score of <150) in addition to not receiving oral corticosteroid for at least 8 weeks prior to Week 54, among the patients who used oral corticosteroids at baseline
    • Endoscopic remission at Week 54, defined as an absolute SES-CD score of ≤ 4 and at least 2-point reduction from the baseline value with no sub-score of >1
    Other Secondary endpoints:
    • Clinical remission, defined as an absolute CDAI score of <150 points
    • Maintenance of clinical remission at Week 54, defined as being in clinical remission by CDAI score of <150 points, among the patients in clinical remission at Week 10
    • Sustained clinical remission at both Week 22 and Week 54, defined as an average worst daily abdominal pain score of ≤1 (using 4-point scale), and an average loose/watery stool frequency score of ≤3 (of Type 6 or Type 7 on BSFS) at both Week 22 and Week 54 with no worsening in either score compared to the baseline value
    • CDAI-70 response, defined as a decrease in CDAI score of 70 points or more from the baseline value
    • CDAI-100 response, defined as a decrease in CDAI score of 100 points or more from the baseline value
    • Maintenance of clinical response at Week 54, defined as being in CDAI-100 response at Week 54, among the patients in CDAI-100 response at Week 10
    • Sustained clinical response at both Week 22 and Week 54, defined as a reduction from the baseline value in average worst daily abdominal pain score (using 4-point scale), and/or in average daily loose/watery stool frequency (of Type 6 or Type 7 on BSFS) at both Week 22 and Week 54
    • Endoscopic remission, defined as an absolute SES-CD score of ≤4 and at least 2-point reduction from the baseline value with no sub-score of >1
    • Endoscopic response, defined as a 50% decrease in SES-CD score from the baseline value
    • Patient global scale, defined as a question that asks a patient’s position on achieving remission from his or her CD symptoms (Yes or No)
    • Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
    Pharmacokinetic Assessments:
    For all patients, Ctrough will be assessed up to Week 100 and Cmax will be assessed at Week 6. Blood samples for PK analysis will be collected at
    pre-dose of Weeks 0, 2, 6, 10, 14, 22, 30, 38, 46, 54, 62,70, 78, 86, 94, 102 and within 15 minutes after the end of the study drug infusion of Week 6. On the day of initiation of dose adjustment, blood samples for PK analyses will be collected at pre-dose.
    For patients who agreed to collect further blood samples, additional blood samples for further Population PK analysis will be collected at following time points:
    • Any time between 48 hours and 72 hours after study drug administration of Week 22
    • Any time between 120 hours and 168 hours after study drug administration of Week 22
    • Pre-dose of Week 24
    Pharmacodynamic Assessments:
    • Fecal calprotectin
    • C-reactive protein (CRP)
    Safety Assessments:
    Safety assessments will be performed on immunogenicity, hypersensitivity monitoring, vital sign measurements, weight, 12-lead ECGs, monitoring of TB signs and symptoms, monitoring of cardiovascular disease related signs and symptoms, chest X ray, IGRA, hepatitis B and C and HIV-1 and -2 status, NYHA functional classification assessment, diabetes mellitus, stool microbiology, physical examination findings, AEs, AEs of special interest (infusion-related reaction/systemic injection reaction, infection, delayed hypersensitivity, localized injection site reaction, malignancy), monitoring of drug-induced liver injury, pregnancy testing, clinical laboratory analyses, local site pain using 100 mm Visual Analogue Scale, and prior and concomitant medications.
    In case of delayed hypersensitivity including serum sickness-like reactions, the following assessments will be additionally performed to determine serum sickness during the study period:
    • Immunogenicity
    • Clinical laboratory analyses
    • Complement (C3, C4) and total hemolytic complement
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key secondary endopoints evaluations will be conducted at Week 54 and other secondary endopoints evaluations will be conducted at time points described in protocol. PK, PD and safety assessments will be perfored at the time points specificed in the schedule of events (Table 10-1 and 10-2).
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA106
    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
    Belarus
    Bulgaria
    Chile
    Croatia
    Czechia
    Estonia
    France
    Germany
    Greece
    Hungary
    India
    Israel
    Italy
    Japan
    Latvia
    Mexico
    Moldova, Republic of
    Peru
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Turkey
    Ukraine
    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
    LVLS
    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 days2
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days2
    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: 552
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 600
    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 will transition to local standard of care treatment if required in the opinion of the investigator.
    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 Decision2019-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-20
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA