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    Summary
    EudraCT Number:2021-006820-41
    Sponsor's Protocol Code Number:LYT-100-2022-204
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-16
    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 ConcernedGreece - EOF
    A.2EudraCT number2021-006820-41
    A.3Full title of the trial
    A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis (IPF).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized Double-blind Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis
    A.4.1Sponsor's protocol code numberLYT-100-2022-204
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05321420
    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 SponsorPureTech LYT 100, 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 supportPureTech LYT 100, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPureTech LYT 100, Inc.
    B.5.2Functional name of contact pointSarah Santipadri
    B.5.3 Address:
    B.5.3.1Street Address6 Tide Street, Suite 400
    B.5.3.2Town/ cityBoston
    B.5.3.3Post codeMA 02210
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@puretechhealth.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedeupirfenidone
    D.3.2Product code LYT-100
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdeupirfenidone
    D.3.9.2Current sponsor codeLYT-100
    D.3.9.3Other descriptive namePirfenidone, deuterated
    D.3.9.4EV Substance CodeSUB217017
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number275
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 namepirfenidone
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPirfenidone
    D.3.9.3Other descriptive namePirfenidone
    D.3.9.4EV Substance CodeSUB09907MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number267
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    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 namedeupirfenidone
    D.3.2Product code LYT-100
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdeupirfenidone
    D.3.9.2Current sponsor codeLYT-100
    D.3.9.3Other descriptive namePirfenidone, deuterated
    D.3.9.4EV Substance CodeSUB217017
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number275
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Pulmonary Fibrosis (IPF)
    E.1.1.1Medical condition in easily understood language
    Lung scarring of the unknown cause
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 obtain clinical data establishing the efficacy, tolerability, safety, and dosing regimen of LYT-100 in patients with IPF.
    E.2.2Secondary objectives of the trial
    Part B Objectives:
    • Assess the safety and tolerability of long-term treatment with LYT-100
    in the IPF population
    • Compare the rate of change in FVC through the end of Part B Period 1
    to that observed during Part A, by Part A treatment group assignment
    and by Part B LYT-100 target dose
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Intensive PK Sub-study:
    Intensive PK samIntensive PK Sub-study:
    An optional, intensive PK sub-study will be conducted at a subset of sites
    in approximately 8 completed patients per treatment arm in which each
    patient will provide up to 16 blood samples for PK over a 24-hour period
    at Study Visits 3, 5 and 8.pling over a 24-hour time period at steady-state will be collected in a subset of 8 patients per treatment group (up to 32 patients total) in which each patient will provide up to 16 blood samples for PK over a 24-hour period at Study Visits 3, 5 and 8.
    E.3Principal inclusion criteria
    1. Written or electronic informed consent from the participant prior to
    any study procedures in a manner approved by an IRB, IEC, or HREC
    2. Male or female, age of ≥40 years at the time of informed consent
    3. Able to perform and willing to comply with all study procedures and
    requirements
    4. Treatment-naïve patients or those with <6 months of exposure to
    nintedanib with physician-diagnosed IPF based on ATS/ ERS/JRS/ALAT
    2018 guidelines
    5. IPF on high-resolution computed tomography (HRCT), performed
    within 12 months of Visit 1 as confirmed by central readers
    6. The extent of fibrotic changes is greater than the extent of
    emphysema on the most recent HRCT scan as determined by the investigator and the central reader
    7. Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected
    for hemoglobin (Hb) [Visit 1] ≥30% and ≤90% of predicted normal
    where available at the study site.
    8. FVC ≥45% of predicted normal
    9. Women of childbearing potential (WOCBP) must be non-pregnant and
    non-lactating, and must be abstinent from heterosexual intercourse
    throughout the study and for 30 days following last dose of study
    medication or agree to use 1 of the acceptable, highly effective methods
    of double contraception which is defined as male use of a condom AND 1
    form of the following:
    a. oral, intravaginal, or transdermal combined (estrogen and
    progesterone containing) hormonal contraception associated with
    inhibition of ovulation
    b. oral, injectable, or implantable progestogen-only hormonal
    contraception associated with inhibition of ovulation
    c. intrauterine device (IUD)
    10. Male participants must be surgically sterile (>30 days since
    vasectomy with no viable sperm), abstinent, or, if engaged in
    heterosexual relations, any female partner must be postmenopausal,
    surgically sterile (eg, tubal occlusion, hysterectomy, bilateral
    salpingectomy, bilateral oophorectomy), or using an acceptable, highly
    effective contraceptive method from Screening until study completion,
    including the follow-up period and for no less than 90 days after the last
    dose of study medication along with the use of male condom
    11. Males will not donate sperm for at least 90 days after the last dose of
    study medication
    12. Female partners of male participants and female participants will
    report pregnancy occurring within 90 days from cessation of study
    medication
    Part B:
    1. Signed informed consent for Part B prior to any study-mandated
    procedures
    2. Participant must have completed Part A of the study, through Day 183
    of treatment
    3. In the opinion of the investigator, the participant is a good candidate
    for continued treatment
    E.4Principal exclusion criteria
    1.Participants who, in the judgement of the investigator, are unlikely to
    be able to fulfill study participation requirements
    2.Significant clinical worsening (as per investigator's discretion) of IPF
    between Screening and Baseline Visits
    3.AST or ALT>1.5 × ULN at Visit 1
    4.Total bilirubin>1.5 × ULN at Visit 1. Exceptions may be made on a
    case-by-case basis for participants with Gilbert's syndrome in
    consultation with the medical monitor
    5.Creatinine clearance <30 mL/min calculated by Cockcroft–Gault
    formula at Visit 1
    6.Participants with underlying chronic liver disease (Child-Pugh B or C
    hepatic impairment)
    7.Current or prior treatment with pirfenidone
    8.Other investigational therapy received within 1 month prior to
    randomization visit (Visit 2)
    9.Significant pulmonary hypertension (PH) defined by any of the
    following:
    a.Previous clinical or echocardiographic evidence of significant right
    heart failure
    b.History of right heart catheterization showing a cardiac index ≤2 L/min/m²
    c.PH inhaled requiring subcutaneous or intravenous therapy with
    epoprostenol/treprostinil
    d.In the principal investigator's opinion, the study participant's
    symptoms are more related to their PH than to their IPF
    10.Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC
    <0.7 at Visit 1)
    11.Known explanation for interstitial lung disease, including but not
    limited to radiation, sarcoidosis, hypersensitivity pneumonitis,
    bronchiolitis obliterans organizing pneumonia, HIV, viral hepatitis, and
    cancer
    12.Diagnosis of any connective tissue disease, including but not limited
    to scleroderma/systemic sclerosis, Sjogren's disease, mixed connective
    tissue diseases, polymyositis/dermatomyositis, systemic lupus
    erythematosus, and rheumatoid arthritis
    13.In the opinion of the investigator, other clinically significant
    pulmonary abnormalities, including prior or current lung cancer (treated
    within the past 5 years)
    14.Major extrapulmonary physiological restriction (eg, chest wall abnormality, large pleural effusion)
    15.Cardiovascular diseases, any of the following:
    a.Uncontrolled hypertension, within 3 months of Visit 1
    b.Myocardial infarction within 6 months of Visit 1
    c.Unstable cardiac angina within 6 months of Visit 1
    16.Prior hospitalization within 3 months prior to Visit 1 for
    confirmed COVID-19, acute exacerbation of IPF, or any lower
    respiratory tract infection
    17.Known symptoms of dysphagia or known difficulty in swallowing
    capsules or tablets and/or total gastrectomy
    18.Use of any of the following drugs within 2 weeks prior to Visit 2/
    baseline or planned during the duration of the study:
    a.Strong and moderate CYP1A2 inhibitors (ie, ciprofloxacin, fluvoxamine,
    enoxacin, methoxsalen, mexiletine, vemurafenib) and phenytoin,
    rifampin, and teriflunomide (inducers of CYP1A2)
    b.Medications associated with substantial risk for prolongation of the
    QTc interval (including but not limited to moxifloxacin, quinidine,
    procainamide, amiodarone, sotalol)
    c.Immunosuppressant medications such as azathioprine,
    cyclophosphamide, cyclosporin A, methotrexate, prednisone at a steady
    dose >10mg/day or equivalent
    d.Medications used to treat PH such as endothelin receptor antagonists
    (eg, ambrisentan, bosentan, and macitentan), phosphodiesterase-5
    inhibitors (sildenafil and tadalafil used to treat erectile dysfunction are
    allowed), guanylate cyclase stimulators (eg, riociguat), prostacyclin
    analogs (eg, epoprostenol, treprostnil, iloprost), or prostacyclin receptor
    agonists (eg, selexipag)
    e.Warfarin, as it may worsen IPF
    f.Vaccination with a live vaccine is not permitted during the period from
    4 weeks prior to Screening to 4 weeks after the last dose.
    19.A current immunosuppressive condition (eg, HIV)
    20.Major surgical procedures during Screening or study periods, with the
    exception of pre-planned procedures that will not interfere with study
    participation
    21.Active alcohol or drug abuse
    22.Use of smoked (burnt) tobacco products or vaping/e-cigarettes
    23.Other disease (including malignancy) that may interfere with testing
    procedures or in the judgement of the investigator may interfere with
    study participation or may put the participant at risk when participating
    in this study
    24.Participants with a documented hypersensitivity to LYT-100
    25.Participants with a documented lactose or galactose intolerance
    .AST, ALT, or total bilirubin >3 Ч ULN
    .Any known factor or disease that interferes with treatment
    compliance, study conduct, or interpretation of the results, as judged by
    the investigator
    Part B:
    1.Participants must not meet any exclusion criteria listed for Part A
    2.Participants who discontinued study medication and started receiving
    commercially available antifibrotic medication during Part A will not be
    eligible for Part B
    3.Participants whose treatment assignment is unblinded during Part A
    will not be eligible for Part B
    E.5 End points
    E.5.1Primary end point(s)
    Rate of decline in FVC (in mL) over Part A (26 weeks)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 26
    E.5.2Secondary end point(s)
    • Change in FVC % predicted (FVCpp) from baseline to the end of Part A
    (Week 26)
    Secondary Efficacy Endpoints
    • Time to IPF progression through 26 weeks (the end of Part A), as
    defined by a decline from baseline in FVCpp of 5% or greater, or death
    • Time to hospitalization due to respiratory cause (as determined by the
    investigator) or all-cause mortality through 26 weeks
    Secondary Tolerability Endpoints
    • Incidence of dose modifications (dose reductions and interruptions)
    • Time to first dose modification (reductions or interruption)
    • Duration of dose modifications (reductions and interruptions)
    • Number of days on full assigned dose
    • Incidence and duration of AESIs
    • Time to treatment discontinuation due to an AE
    Exploratory Endpoints
    • Time to hospitalization due to respiratory cause (as determined by the
    investigator) through 26 weeks
    • Time to all-cause mortality through 26 weeks
    • Change from baseline to Week 26 in King's Brief Interstitial Lung
    Disease Questionnaire (K-BILD) total score
    • Change from baseline to Week 26 in St. George's Respiratory
    Questionnaire – IPF Version (SGRQ-I)
    • Change from baseline to Week 26 in EuroQol 5-Dimensional Quality of
    Life Questionnaire (EQ-5D)
    • Change in serum biomarkers from baseline through Week 26
    • Number and duration of respiratory hospitalizations or pulmonary
    exacerbations (as determined by the investigator) through 26 weeks
    • Rate of hospitalization due to respiratory cause (as determined by the
    investigator) through 26 weeks
    Part B
    Key Secondary Efficacy Endpoints
    • Change in FVCpp from the end of Part A (Week 26) to the end of Part B
    Period 1 (Week 52)
    • Rate of decline in FVC (in mL) from the end of Part A (Week 26) to the
    end of Part B Period 1 (Week 52) using the values obtained from
    spirometry assessments
    Secondary Efficacy Endpoints
    • Time to IPF progression in Part B, as defined by a decline from the end
    of Part A (Week 26) to the end of Part B Period 1 (Week 52) in FVCpp of
    5% or greater, or death
    Secondary Tolerability Endpoints
    • Incidence of dose modifications (dose reductions and interruptions)
    • Time to first dose modification (reduction or interruption)
    • Duration of dose modifications (reductions and interruptions)
    • Number of days on full assigned dose
    • Incidence and duration of AESIs
    • Time to treatment discontinuation due to an AE
    Exploratory Endpoints
    • Time to hospitalization due to respiratory cause (as determined by the
    investigator) from the start of Part B (Week 26) through the end of Part
    B Period 1 (Week 52)
    • Time to all-cause mortality from the start of Part B (Week 26) through
    the end of Part B Period 1 (Week 52)
    • Time to hospitalization due to respiratory cause (as determined by the
    investigator) or all-cause mortality from the start of Part B (Week 26)
    through the end of Part B Period 1 (Week 52)
    • Total duration on assigned dose from the start of Part B through the
    end of Part B Period 1 (Week 52)
    • Change in EQ-5D from the end of Part A (Week 26) through the end of
    Part B Period 1 (Week 52)
    • Change in serum and plasma biomarkers from the end of Part A (Week
    26) through the end of Part B Period 1 (Week 52)
    • Number and duration of respiratory hospitalizations or pulmonary
    exacerbations (as determined by the investigator) from the start of Part
    B (Week 26) through the end of Part B Period 1 (Week 52)
    • Rate of hospitalization due to respiratory cause (as determined by the
    investigator) from the start of Part B (Week 26) through the end of Part
    B Period 1 (Week 52)
    Pharmacokinetic Endpoints
    A sparse PK sampling strategy will be employed in which all participants
    will provide pre-dose blood samples for determination of plasma
    concentrations of LYT-100/pirfenidone and its metabolite(s). In
    addition, an optional, intensive PK substudy will be conducted at a
    subset of sites in approximately 8 completed participants per treatment
    arm in which each participant will provide up to 16 blood samples for PK
    over a 24-hour period at Study Visits 3, 5 and 8.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at week 26 (Part A)
    at week 52 (Part B)
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double-blind Part A is followed by Part B long-term open-label extension
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Chile
    Colombia
    Malaysia
    Georgia
    India
    Korea, Republic of
    Mexico
    South Africa
    Thailand
    United States
    Greece
    Poland
    Romania
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 240
    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)
    All participants will return for a follow-up visit 28 days following their
    last dose of study medication if they do not enter Part B, in which case
    this visit will be performed 4 weeks after the end of treatment in Part
    B.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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