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    Summary
    EudraCT Number:2021-003875-32
    Sponsor's Protocol Code Number:P288ALS
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-003875-32
    A.3Full title of the trial
    A double-blind, placebo-controlled, exploratory randomised clinical trial to assess the safety and efficacy of IFB-088 plus riluzole 100 mg vs placebo plus riluzole 100 mg in patients with bulbar-onset amyotrophic lateral sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess the safety and efficacy of IFB-088 plus riluzole 100 mg vs placebo plus riluzole 100 mg in patients with bulbar-onset amyotrophic lateral sclerosis
    A.3.2Name or abbreviated title of the trial where available
    TRIALS study
    A.4.1Sponsor's protocol code numberP288ALS
    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 SponsorInFlectis BioScience
    B.1.3.4CountryFrance
    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 supportInFlectis BioScience
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInFlectis BioScience
    B.5.2Functional name of contact pointAnne Visbecq
    B.5.3 Address:
    B.5.3.1Street Address21 Rue La Noue Bras de Fer
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44200
    B.5.3.4CountryFrance
    B.5.4Telephone number33630632020
    B.5.6E-mailannevisbecq@inflectisbioscience.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 nameIcerguastat
    D.3.2Product code IFB-088
    D.3.4Pharmaceutical form 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 INNIcerguastat
    D.3.9.1CAS number 469866-31-7
    D.3.9.2Current sponsor codeIFB-088
    D.3.9.3Other descriptive nameIFB-088
    D.3.9.4EV Substance CodeSUB192704
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboTablet
    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
    Amyotrophic lateral sclerosis (bulbar-onset)
    E.1.1.1Medical condition in easily understood language
    Amyotrophic lateral sclerosis
    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 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    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
    To assess the safety of IFB-088 50 mg/day in patients with bulbar-onset ALS.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of IFB-088 50 mg/day plus riluzole 100 mg/day
    versus placebo plus riluzole 100 mg/day over a 6-month period in patients
    with bulbar-onset ALS,
    • To determine pharmacokinetics (PK) parameters of IFB-088,
    • To investigate the effects of IFB-088 on ALS potential biomarkers,
    • To investigate quality of life (QoL).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of probable or definite ALS according to the revised El Escorial criteria, with bulbar onset of disease, familial or sporadic form,
    2. Onset of symptoms ≤ 18 months prior to screening, as reported by the patient,
    3. Adult males or females, aged at least 18 years old,
    4. SVC > 60% of predicted value for age and sex,
    5. ALSFRS-R score ≥ 36, with score 3 or 4 for item 3 (swallowing),
    6. Treatment with riluzole 100 mg/day, at stable dose since at least one month and well tolerated,
    7. Male or female patient of childbearing potential who agrees to use highly effective mechanical contraception methods (condom, sexual abstinence, intrauterine device, bilateral tubal occlusion, vasectomised partner) throughout the study, and for 3 months after the end of the treatment,
    8. Patient who read, understood and signed the informed consent form (ICF),
    9. Patient who is willing to adhere to the study visit schedule and is capable to understand and comply with protocol requirements.
    E.4Principal exclusion criteria
    1. Known other significant neurological disease(s),
    2. Serious illness(es) or medical condition(s) (e.g. unstable cardiac disease, cancer, hematologic disease, hepatitis or liver failure, renal failure) that is not stabilised or that could require hospitalisation and may jeopardise the participation in the study,
    3. Other causes of neuromuscular weakness,
    4. Non progressive or very rapidly progressing ALS (ALSFRS-R decline
    from disease onset to randomisation ≤ 0.1 / month or ≥ 1.2 / month),
    5. Percutaneous endoscopic gastrostomy or parenteral nutrition,
    6. Non-invasive ventilation,
    7. Tracheotomy,
    8. Weight loss ≥ 10% compared to weight at symptoms onset as declared by the patient or BMI <18 kg/m2 at screening,
    9. Dementia or other severe active psychiatric illness,
    10. Patient with a significant pulmonary disorder not attributed to ALS or who require treatments that might complicate the evaluation of the effect of ALS on respiratory function,
    11. Patient using unauthorised concomitant treatments, namely moderate or strong inhibitors or inducers of cytochrome P450 family 1 subfamily A member 2 (CYP1A2). Combined oral contraceptives containing ethinylestradiol are forbidden concomitant medications,
    12. Smoker of > 10 cigarettes per day (e-cigarettes and nicotine patches are permitted),
    13. Known hypersensitivity to any of the ingredients or excipients of the
    investigational medicinal products (IMPs),
    14. Pregnant, lactating women,
    15. Patient who participated in another trial of investigational drug(s) within 30 days prior to randomisation,
    16. Patient who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints include:
    • Incidence, grade and relationship to IFB-088 for treatment emergent AEs, SAEs, and AESIs,
    • AEs leading to dose interruption or premature discontinuation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety assessments will be performed in a continuous manner during the 6 months treatment period, and at the follow-up visit.
    E.5.2Secondary end point(s)
    Efficacy:
    • Change in Revised ALS functional rating scale (ALSFRS-R) score from
    baseline to month 3 and to month 6,
    • Worsening according to ALS-Milano-Torino staging system (MITOS) score, i.e. progression to a higher stage at 3 and at 6 months compared to the baseline,
    • Change in King’s College score from baseline to month 3 and to month 6,
    • Assessment of respiratory function (slow vital capacity [SVC], sniff test [optional], arterial blood gases [ABG]): exploratory endpoint.
    PK parameters:
    • Plasma concentration of IFB-088 and IFB-139,
    • AUC of IFB-088 and IFB-139,
    • Maximum observed plasma concentration (Cmax), with associated Tmax,
    • Terminal or apparent terminal half-life (t1/2),
    • Apparent systemic clearance, apparent volume of distribution.
    Biomarkers:
    • Change in TDP-43 plasmatic concentration from baseline to 6 months,
    compared to placebo,
    • Change in neurofilament (NfL) light chain plasmatic concentration from baseline to 6 months, compared to placebo,
    • Change in plasmatic (neuro)inflammatory biomarkers from baseline to 3 months, and from baseline to 6 months, compared to placebo,
    • Change in plasmatic oxidative stress biomarkers from baseline to 3 months and from baseline to 6 months, compared to placebo.
    QoL:
    • Change in ALS assessment questionnaire (ALSAQ-40) from baseline to 6 months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:
    •Change in Revised ALS functional rating scale (ALSFRS-R) score from baseline to month 3 and to month 6,
    •Worsening according to ALS-Milano-Torino staging system (MITOS) score, i.e. progression to a higher stage at 3 and at 6 months compared to the baseline,
    •Change in King’s College score from baseline to month 3 and to month 6,
    •Assessment of respiratory function (slow vital capacity [SVC], sniff test [optional], arterial blood gases [ABG]). At screening, V2 and V3.

    PK parameters at V1.

    Biomarkers changes from baseline to 3 and/or 6 months compared to placebo.

    QoL change in ALS assessment questionnaire (ALSAQ-40) from baseline to 6 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 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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 months6
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    The medication management of the patients will be re-evaluated by the doctor who follows them.
    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 Decision2021-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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