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   43801   clinical trials with a EudraCT protocol, of which   7272   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:2019-004066-18
    Sponsor's Protocol Code Number:AL001-3
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-10
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-004066-18
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTD followed by An Open-Label Study to Evaluate Long-Term Safety and Tolerability of AL001 in FTD.
    A.4.1Sponsor's protocol code numberAL001-3
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04374136
    A.5.4Other Identifiers
    Name:IND numberNumber:135892
    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 SponsorAlector 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 supportAlector Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlector Inc.
    B.5.2Functional name of contact pointAlector Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address131 Oyster Point Boulevard, Suite 600
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16508262454
    B.5.6E-mailclinicaltrials@alector.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/21/2498 - EMA/OD/0000055853
    D.3 Description of the IMP
    D.3.1Product nameAL001
    D.3.2Product code AL001
    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 INNLatozinemab
    D.3.9.1CAS number 2376132-27-1
    D.3.9.2Current sponsor codeAL001
    D.3.9.3Other descriptive nameAL001
    D.3.9.4EV Substance CodeSUB193428
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Frontotemporal Dementia
    E.1.1.1Medical condition in easily understood language
    A type of dementia that causes problems with behaviour and language
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10068968
    E.1.2Term Frontotemporal dementia
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1: To evaluate the efficacy of AL001 compared with placebo in symptomatic participants as measured by CDR® plus NACC FTLD-SB.
    Part 2: To assess the long-term safety and tolerability of AL001 in participants who have completed Part 1 of the study
    E.2.2Secondary objectives of the trial
    Part 1: Secondary Efficacy:
    To evaluate the efficacy of AL001 compared with placebo in symptomatic participants as measured by CGI-S.
    To evaluate the efficacy of AL001 compared with placebo in symptomatic participants as measured by CGI-I
    To evaluate the efficacy of AL001 compared with placebo in symptomatic participants as measured by RBANS
    Pharmacodynamic and Disease Biomarkers: To evaluate the treatment effect of AL001 compared with placebo as measured by pharmacodynamic and disease pathology biomarkers in the symptomatic population, the at-risk population, and all FTD participants (both symptomatic and at-risk).
    Safety Objective: To evaluate the safety and tolerability of AL001 compared with placebo as measured by safety assessments and antidrug antibodies (ADAs) in the symptomatic population, the at-risk population, and all FTD participants (both symptomatic and at-risk).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1:
    1. Is a known carrier of a heterozygous loss-of-function GRN mutation causative of FTD with a global CDR® plus NACC FTLD score of 0 to 2, and:
    • A CDR® plus NACC FTLD-SB score ≤0.5 with an elevated level of serum NfL, or
    • A CDR® plus NACC FTLD-SB score of >0.5 with 1 or more of the 6 behavioral/cognitive symptoms required for a diagnosis of possible bvFTD
    (Rascovsky 2011), or a diagnosis of PPA
    2. Age 25 to 85 years, inclusive, at Screening
    3. At Screening, women must be nonpregnant and nonlactating, and one of the following conditions must apply:
    a. Not a woman of childbearing potential (WOCBP) (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal [amenorrhea duration of 12 consecutive months with no identified cause other than menopause]).
    b. Is a WOCBP and agrees to use an acceptable contraceptive method from Screening until 10 weeks after the last dose of study treatment. Acceptable contraception is defined as using hormonal contraceptives (e.g. combined oral contraceptive pill) or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. In addition, total abstinence, if in accordance with the lifestyle of the participant, is acceptable.
    c. A WOCBP must have a serum pregnancy test conducted at screening. Additional requirements for pregnancy testing during and after study intervention are described in the Schedules of Assessments.
    4. Men must agree to use acceptable contraception and not donate sperm from Day 0 until 10 weeks after the last dose of study treatment. Acceptable contraception for the male participant when having sexual intercourse with a WOCBP who is not currently pregnant is defined as using a condom. In addition, WOCBP partners must use hormonal contraceptives (e.g. combined oral contraceptive pill) or an intrauterine device.
    5. Agrees not to donate blood or blood products for transfusion for the duration of the study and for 1 year after the final dose of study treatment.
    6. Willing to and can comply with the study protocol requirements, in the opinion of the investigator.
    7. Willing and able to give informed consent. If the patient is not competent, a legally authorized representative must provide informed consent on their behalf, and the patient must provide assent, in accordance with local regulations, guidelines, and IRB or IEC.
    8. Patient has the availability of a person (“study partner”) who has frequent and sufficient contact with the patient (at least 5 hours per week of in-person contact) and who can provide accurate information to the study site regarding the patient's behavior, cognitive, and functional abilities, as well as their health, throughout the study. Requirements for the study partner include:
    a. Willing and able to provide informed consent to participate in the study as a study partner.
    b. The study partner must have sufficient cognitive capacity to accurately report upon the participant’s behavior, cognitive, and functional abilities, in the opinion of the investigator.
    c. The study partner should be in sufficiently good general health to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the study duration.
    d. The same study partner should participate throughout the duration of Part 1 of the study. If a change in study partner is necessary, the medical monitor must be contacted.
    e. Study partner agrees to provide information at investigational site visits that require partner input for COA completion.
    f. Study partner agrees to accompany the participant at COA visits
    Inclusion criteria applicable to those participants participating in the optional Winterlight Labs Speech Assessment (WLA) only:
    1. Has available and willing study partner to administer the WLA.
    2. Has WiFi access in their residence or WiFi access in a private area where the testing can take place.
    3. Participants and study partners must be proficient in English, Spanish, French, Dutch or German in the investigator’s opinion.
    Part 2: Participant must complete Part1, week 97:
    1. Participant is willing and able to give informed consent to continue treatment with AL001. If the study participant is not competent, a legally authorized representative must provide informed consent on his or her behalf, and the participant must provide assent, in accordance with the local regulations, guidelines, and IRB or IEC.
    2. Is willing and has the ability to comply with OLE requirements, in the opinion of the investigator.
    3. Has availability of a person (“study partner”) who can continue to assist with assessments throughout the OLE evaluation period. (For more information please refer to the protocol or as described on PART 1, inclusion criteria number 8)
    E.4Principal exclusion criteria
    Part 1:
    1. Dementia due to a condition other than FTD including, but not limited to, Alzheimer’s disease, Parkinson’s disease, Parkinsonism, REM behavior disorder, dementia with Lewy bodies, Huntington disease, or vascular dementia2.Known mutation causative of neurodegenerative disorder(s) other than heterozygous loss-of-function GRN mutations causative of FTD.3.Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.4.Signs or symptoms of progressive supranuclear palsy or bulbar dysfunction, such as postural instability, eye problems, and swallowing difficulties5. History of moderate or severe substance use disorder within the past 2 years, with the exception of nicotine, as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria6.Clinically significant vitamin B12 or folate deficiency (if treated, must be on a stable regimen for at least 3 months prior to first study treatment administration)7.Untreated hypothyroidism8.Insufficiently controlled diabetes mellitus9.Any surgery (major or emergent) or hospitalization within 30 days prior to first study treatment administration10.History of cancer except if: a.Is considered likely to be cured or in remission for at least 12M,b. Is not being actively treated and, in the opinion of the PI, is not likely to require treatment witin 3 Y, c. Is considered to have low probability of recurrence, d. For prostate cancer, has not had significant progression within the pastY, and is stable and adequately controlled,e. For localized skin basal or squamous cell carcinoma, participants should continue with screening and seek treatment for the skin carcinoma11. Positive for hepatitis B surface antigen, human immunodeficiency virus-1 or -2 antibodies or antigen, or history of spirochetal infection of the CNS. Participants with a positive hepatitis C virus antibody will be allowed if hepatitis C RNA is negative. 12. Significant kidney disease as indicated by either of the following: g. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, according to the re-expressed abbreviated (four-variable) MDRD Study equationb.Creatinine ≥2 mg/dL.13. Impaired hepatic function as indicated by screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 the upper limit of normal (ULN), and total bilirubin ≥1.5 × ULN. Note: Participants with Gilbert's syndrome are eligible to participate if approved by the Medical Monitor. 14. Hematologic abnormalities as indicated by hemoglobin ≤10 g/dL; white blood cells (WBC) ≤3 000/mm3; absolute neutrophil count ≤ 1,000/mm3; or platelet count ≤150,000/mm3.15. Participants with hypertension who are not adequately and stably controlled as per the ACC/AHA 16. History or presence of an abnormal ECG that is clinically significant, or evidence of acute or subacute myocardial infarction or ischemia17. History of or concurrent clinically significant cardiovascular disease such as but not limited to myocardial infarction, angina pectoris, New York Heart Associating Class III or IV cardiac failure ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease If the condition is stable per cardiologist, then the patient can enrol at PI discretion18.Clinically significant electrolyte abnormalities 19. For participants who consent to lumbar puncture, participant has contraindication to lumbar dural puncture, including coagulopathy, concomitant anticoagulation medication (except for a platelet inhibitor such as aspirin), thrombocytopenia, or other factor(s) that precludes safe lumbar puncture. 20. History or presence of clinically evident vascular disease potentially affecting the brain21.History of a clinically significant, persistent neurologic deficit, structural brain damage, or CNS trauma. 22. Resides in a skilled nursing facility, convalescent home, or long-term care facility at screening; or requires continuous nursing care (i.e., >3months)23. Unable to tolerate the required safety portion of MRI procedures (e.g., due to anxiety or claustrophobia) or has a contraindication to MRI. 24. Has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise their ability to comply with the protocol-required testing or procedures, or compromise the participant's well-being, safety, or clinical interpretability
    Part 2:
    Part 1 participants are not eligible for continued treatment with AL001 OLE if any of the following apply:1. Part 1 participant has been admitted to a skilled nursing facility, convalescent home, or long-term care facility at screening and requires continuous nursing care (i.e., >3 months).2. Part 1 participant has a medical condition or extenuating circumstance that, in the opinion of the investigator, continued treatment with AL001 at the conclusion of Part 1 is not beneficial or safe for the participant.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: Primary Efficacy Endpoint:
    Target population: Symptomatic carriers of GRN mutation causative of FTD as defined by the inclusion and exclusion criteria.
    Variable of interest: Change from baseline to Weeks 48, 72, and 96 in the CDR® plus NACC FTLD-SB.
    Intercurrent events and corresponding strategy: Study treatment discontinuation/prohibited concomitant medications (Treatment Policy). All observed values of the variable of interest, regardless of whether or not the participant has discontinued treatment/taken a prohibited medication.
    Population-level summary variable: Percent reduction of the placebo group change from baseline across Weeks 48, 72, and 96
    Part 2: Primary Endpoint:
     Incidence, nature, and severity of AEs and SAEs
     Physical examination abnormalities
     Neurological examination abnormalities
     Changes in vital signs from baseline over time
     Changes in electrocardiograms from baseline over time
     MRI abnormalities
     Changes in clinical laboratory tests from baseline over time
     Sheehan-STS
     Incidence of ADAs to AL001
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: Change in CDR® plus NACC FTLD-SB: Weeks 48, 72, and 96
    Percent reduction of the placebo group values: Weeks 48, 72, and 96
    Part 2: Incidence, nature, and severity of adverse events AEs and SAEs:W100 and every 4Weeks, until week 196
    Physical examination abnormalities:W100 and every 4Weeks until W144; W168, W196
    Neurological examination abnormalities: W100 and every 4Weeks until W144; W168, W196
    Changes in vital signs: W100 and every 4Weeks until week 196
    Changes in ECG:W120,144,168,196
    MRI abnormalities:W144 and W196
    Changes in clinical laboratory tests:W100,112,120,132,144,168,192
    Sheehan-STS:W100 and every 4 weeks until W196
    Incidence of ADAs to AL00:W100,112,120,144,168,196
    E.5.2Secondary end point(s)
    Part 1: Secondary Efficacy Endpoints:
    To evaluate the efficacy of AL001 compared with placebo in symptomatic participants as measured by the CDR® plus NACC FTLD-SB
    Target population: Symptomatic carriers of a GRN mutation causative of FTD as defined by the inclusion and exclusion criteria.
    Variable of Interest: Change from baseline to Weeks 48, 72, and 96 on the CGI-S
    Intercurrent events and corresponding strategy: Study treatment discontinuation/prohibited concomitant medications (Treatment Policy). All observed values of the variable of interest, regardless of whether or not the participant has discontinued treatment/taken a prohibited medication.
    Population level summary variable: Percent reduction of the placebo group change from baseline across Weeks 48, 72, and 96

    To evaluate the efficacy of AL001 compared with placebo in symptomatic participants as measured by CGI-S
    Target population: Target population: Symptomatic carriers of a GRN mutation causative of FTD as defined by the inclusion and exclusion criteria.
    Variable of interest: Actual values at Weeks 48, 72, and 96 on the CGI-S
    Intercurrent events and corresponding strategy: Study treatment discontinuation/prohibited concomitant medications (Treatment Policy). All observed values of the variable of interest, regardless of whether or not the participant has discontinued treatment/taken a prohibited medication.
    Population-level summary variable: Percent reduction of the placebo group values at Weeks 48, 72, and 96

    To evaluate the efficacy of AL001 compared with placebo as measured by RBANS
    Target population: Symptomatic carriers of a GRN mutation causative of FTD as defined by the inclusion and exclusion criteria
    Variable of interest: Change from baseline to Weeks 48, 72, and 96 on the RBANS
    Intercurrent events and corresponding strategy: Study treatment discontinuation/prohibited concomitant medications (Treatment Policy). All observed values of the variable of interest, regardless of whether or not the participant has discontinued treatment/taken a prohibited medication.
    Population-level summary variable: Percent reduction of the placebo group change from baseline across Weeks 48, 72, and 96

    Pharmacodynamic:
    PGRN concentrations in plasma and optional CSF
    Neurofilament light chain (NfL) concentrations in serum and optional CSF
    Structural volumetric MRI whole and regional brain volume

    Safety Endpoints:
    Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs)
    Physical examination abnormalities
    Neurological examination abnormalities
    Changes in vital signs from baseline over time
    Changes in electrocardiograms from baseline over time
    MRI abnormalities
    Changes in clinical laboratory tests from baseline over time
    Sheehan-STS
    Incidence of ADAs to AL001
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1: Secondary Efficacy:
    To evaluate the efficacy of AL001 compared with placebo as measured by
    CGI-S: Change from baseline to Weeks 48, 72, and 96
    CGI-I: at Weeks 48, 72, and 96
    RBANS: Change from baseline to Weeks 48, 72, and 96
    PD
    MRI every 24W
    PGRN:0,8,12,16,24,32,40,48,72,96
    NfL: pre-screening, Screening, every 8 weeks until week 48,72,96
    Safety:
    Incidence, nature, and severity of AEs and SAEs: screening and every next 4 Week, until week 96
    Physical examination: every 4weeks
    Neurological examination: every 4 weeks
    Changes in vital signs: screening and every 4W
    Changes in ECG: every 24W
    MRI: Screening,W48 and 96
    Changes in clinical laboratory tests: screening, every 8W and 12W after week 48
    Sheehan-STS: Screening and every 4W
    ADAs: Week 0, 12,24,48,72,96
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Switzerland
    Australia
    Canada
    Turkey
    United Kingdom
    United States
    Belgium
    France
    Germany
    Greece
    Italy
    Netherlands
    Portugal
    Spain
    Sweden
    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 years7
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days22
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If the study participant is not competent, a legally authorised representative must provide informed consent on their behalf, and the participant must provide assent, in accordance with the local regulations, guidelines, and ethics committees.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 110
    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)
    Upon completion of the double blind study treatment period, participants who qualify are planned to be offered an open label extension (OLE) study with AL001
    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 Decision2020-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-06
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA