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    Summary
    EudraCT Number:2020-003880-24
    Sponsor's Protocol Code Number:ACT16832
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-28
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-003880-24
    A.3Full title of the trial
    A multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia
    Multicentrikus, nyílt, nem randomizált, Ib/II. fázisú vizsgálat a szubkután isatuximab biztonságosságának, farmakokinetikájának és hatásosságának értékelésére meleg antitestes autoimmun hemolitikus anémiában szenvedő felnőtteknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia
    A szubkután (injekcióval bőr alá beadott) isatuximab biztonságossága, farmakokinetikája és hatásossága meleg típusú autoimmun hemolitikus anémiában szenvedő felnőtteknél
    A.4.1Sponsor's protocol code numberACT16832
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1255-5350
    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 SponsorSanofi-Aventis Recherche & Developpement
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Zrt.
    B.5.2Functional name of contact pointNA.
    B.5.3 Address:
    B.5.3.1Street AddressTó utca 1-5.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1045
    B.5.3.4CountryHungary
    B.5.6E-mailkapcsolat@sanofi.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 nameIsatuximab
    D.3.2Product code SAR650984
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIsatuximab
    D.3.9.3Other descriptive nameSAR650984
    D.3.9.4EV Substance CodeSUB119676
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Warm autoimmune hemolytic anemia
    meleg antitestes autoimmun hemolitikus anémia (immuneredetű vérszegénység)
    E.1.1.1Medical condition in easily understood language
    Blood and lymphatic diseases
    Vér- és nyirokbetegségek
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10047822
    E.1.2Term Warm type haemolytic anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic 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 A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults
    with wAIHA
    • Part B: To evaluate the efficacy of the selected dose in adults with wAIHA
    • A. rész: Az isatuximab szubkután injekciók biztonságosságának és tolerálhatóságának értékelése wAIHA-ban szenvedő felnőtteknél.
    • B. rész: A kiválasztott dózis hatásosságának értékelése wAIHA-ban szenvedő felnőtteknél.
    E.2.2Secondary objectives of the trial
    Part A (Cohorts 2 and 3 only)
    -To evaluate the efficacy of isatuximab in adults with wAIHA
    -To evaluate the durability of response to isatuximab and time to response
    -To evaluate the impact of isatuximab treatment on fatigue
    • Part B
    -To evaluate the safety and tolerability of isatuximab in adults with wAIHA
    -To evaluate the durability of response to isatuximab and time to response
    -To evaluate the impact of isatuximab treatment on fatigue
    • Parts A (all Cohorts) and B
    -To evaluate the effect of isatuximab on markers of hemolysis
    -To characterize the pharmacokinetic profile of isatuximab in adults with wAIHA
    -To evaluate the immunogenicity of isatuximab
    A. rész (csak a 2. és 3. csoport)
    - Az isatuximab hatásosságának értékelése wAIHA-ban szenvedő felnőtteknél.
    - Az isatuximabra adott válasz tartósságának és a válaszig eltelt időnek az értékelése.
    - Az isatuximab kezelés kimerültségre gyakorolt hatásának értékelése.
    B. rész:
    - Az isatuximab biztonságosságának és tolerálhatóságának értékelése wAIHA-ban szenvedő felnőtteknél.
    - Az isatuximabra adott válasz tartósságának és a válaszig eltelt időnek az értékelése.
    - Az isatuximab kezelés kimerültségre gyakorolt hatásának értékelése.
    A. rész (összes csoport) és B. rész
    - Az isatuximab hemolízis markerekre gyakorolt hatásának értékelése.
    - Az isatuximab farmakokinetikai profiljának jellemzése wAIHA-ban szenvedő felnőtteknél.
    - Az isatuximab immunogenitásának értékelése.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must be ≥18 to years of age, inclusive, at the time of signing the informed consent.
    - Males and females with a confirmed diagnosis of primary w AIHA or systemic lupus erythematosus (SLE)-associated w AIHA (without other SLE-related manifestations apart from cutaneous and musculoskeletal manifestations) who meet the following criteria:
    a) Hemoglobin level <10 g/dL at screening.
    b) Hemolysis (haptoglobin ≤40 mg/dL and total or indirect/unconjugated bilirubin above the upper limit of normal).
    c) Positive direct antiglobulin test (DAT) (IgG or IgG + complement C3d pattern or IgM warm autoantibodies (positive dual DAT)).
    - Participants who have previously failed to maintain a sustained response after treatment with corticosteroids (corticosteroid-refractory or corticosteroid-dependent primary wAIHA).
    - Part A only: Participants who have previously failed to maintain a sustained response after treatment with rituximab (or other anti-CD20 monoclonal antibodies). The last dose of the anti-CD20 antibody must have been administered at least 12 weeks before enrollment.
    - Part B: Participants who have had an insufficient response to at least 1 prior therapy in addition to corticosteroids (splenectomy is regarded as a prior therapy).
    - Contraceptive use by men and women
    - A résztvevő életkora legalább ≥18 év a tájékoztatás utáni beleegyező nyilatkozat aláírásának időpontjában.
    - Olyan férfiak és nők, akiknél megerősítették az elsődleges meleg antitestek okozta autoimmun hemolitikus anémia (wAIHA) vagy szisztémás lupusz eritematózusszal (SLE) összefüggő wAIHA diagnózisát (más SLE-vel kapcsolatos tünetek nélkül, kivéve a bőr- és váz-izomrendszeri tüneteket), akik megfelelnek az alábbi kritériumoknak:
    a) Hemoglobinszint <10 g/dl a szűréskor.
    b) Hemolízis (haptoglobin ≤40 mg/dl és összbilirubin vagy az indirekt/nem konjugált bilirubin a normál tartomány felső határértéke felett).
    c) Pozitív direkt antiglobulin teszt (DAT) (IgG vagy IgG + komplement C3d minta vagy IgM meleg autoantitestek [pozitív kettős DAT]).
    - Azok a résztvevők, akiknél a kortikoszteroidokkal végzett kezelés után korábban nem sikerült tartós választ fenntartani (kortikoszteroid-refrakter vagy kortikoszteroid-függő elsődleges wAIHA).
    - Kizárólag az A. részben: Azok a résztvevők, akiknél a rituximabbal (vagy más anti-CD20 monoklonális antitestekkel) végzett kezelés után nem sikerült tartós választ fenntartani. Az anti-CD20 antitest utolsó dózisát legalább 12 héttel a bevonás előtt kellett beadni.
    - B. rész: Azok a résztvevők, akik nem reagáltak megfelelően legalább 1 korábbi terápiára kortikoszteroidok mellett (a lépeltávolítás korábbi terápiának minősül).
    - A férfiak és nők által alkalmazott fogamzásgátlás.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    - Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his or her participation in the study as determined by the Investigator.
    - Serious infection that required hospitalization within 3 months prior to enrollment.
    - Secondary wAIHA from any cause including drugs, lymphoproliferative disorders, infectious or autoimmune disease (SLE without other SLE-related manifestations apart from cutaneous and musculoskeletal manifestations is allowed), or active hematologic malignancies. Participants with positive antinuclear antibodies but without a definitive diagnosis of an autoimmune disease are allowed.
    - History of coagulation or bleeding disorders (Evans Syndrome is allowed).
    - Uncontrolled or active HBV or HCV infection
    - HIV infection.
    - Serum gammaglobulin levels <3 g/L.
    - Females who are pregnant, lactating, or considered unreliable with respect to contraceptive practice.
    - Concurrent treatment with corticosteroids, unless the participant has been on a stable daily dose for ≥ 15 days prior to enrollment.
    - Treatment with cyclophosphamide within 4 weeks prior to enrollment.
    - Treatment with cytotoxic drugs (other than cyclophosphamide) within 12 weeks prior to enrollment.
    - Treatment with non-cytotoxic, immunomodulatory drugs (including but
    not limited to Cyclosporine, Sirolimus, Tacrolimus, Idelalisib, Ibrutinib),
    excluding biologic agents, within 4 weeks prior to enrollment.
    - Treatment with any biologic agent within 12 weeks prior to enrollment.
    A résztvevőket kizárják a vizsgálatból, ha az alábbi kritériumok bármelyike érvényes:
    - Klinikailag jelentős kórtörténet vagy krónikus betegség, amely veszélyeztetné a résztvevő biztonságát vagy rontaná a vizsgálatban való részvételéből származó adatok minőségét a vizsgáló orvos megítélése szerint.
    - Súlyos fertőzés, amely kórházi felvételt tett szükségessé a bevonást megelőző 3 hónapon belül.
    - Másodlagos wAIHA bármilyen okból, beleértve a gyógyszereket, limfoproliferatív rendellenességeket, fertőző vagy autoimmun betegséget (az SLE megengedett egyéb SLE-tünetek nélkül, a bőr- és váz-izomrendszeri tünetek kivételével), illetve aktív hematológiai rosszindulatú daganatok. Azok a résztvevők alkalmasak, akiknél pozitív az antinukleáris antitest, de nem állapítottak meg autoimmun betegséget.
    - Koagulációs vagy vérzési rendellenességek a kórtörténetben (Evans-szindróma megengedett).
    - Nem kontrollált vagy aktív hepatitisz B vírus (HBV) vagy hepatitisz C vírus (HCV) fertőzés.
    - HIV-fertőzés
    - Szérum gammaglobulin-szint <3 g/l.
    - Terhes, szoptató vagy a fogamzásgátlás szempontjából megbízhatatlannak ítélt nők.
    - Egyidejűleg alkalmazott kortikoszteroid kezelés, kivéve, ha a résztvevő stabil napi dózisra van állítva a bevonás előtti legalább 15. naptól kezdve.
    - Ciklofoszfamid kezelés a bevonást megelőző 4 héten belül.
    - A (ciklofoszfamidon kívüli egyéb) citotoxikus kezelés a bevonást megelőző 12 héten belül.
    - Nem citotoxikus, immunmoduláló gyógyszerekkel történő kezelés (beleértve többek között: ciklosporin, szirolimusz, takrolimusz, idelalisib, ibrutinib), kivéve a biológiai szereket, a bevonást megelőző 4 héten belül
    - Bármilyen biológiai szerrel történő kezelés a bevonást megelőző 12 héten belül
    E.5 End points
    E.5.1Primary end point(s)
    Part A: To assess safety and tolerability
    Standard clinical and laboratory parameters and adverse events

    Part B : To evaluate overall response rate (R) or complete response (CR) at Day 85
    R is defined as an increase in hemoglobin by ≥2 g/dL from baseline and an absence of transfusion in the last 7 days and absence of rescue medications in the past 4 weeks. Biochemical evidence of hemolysis may still be present.
    CR is defined as hemoglobin ≥11 g/dL (women) or ≥12 g/dL (men), no evidence of hemolysis (normal bilirubin, LDH, haptoglobin, and reticulocytes), absence of transfusion in the last 7 days and absence of rescue medication in the past 4 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A: Through Day 169
    Part B: Through Day 85
    E.5.2Secondary end point(s)
    1 - Part A (Cohorts 2 and 3 Only) : To evaluate overall response rate (R) or complete response (CR) at Day 85 ; R is defined as an increase in hemoglobin by ≥2 g/dL from baseline and an absence of transfusion in the last 7 days and absence of rescue medications in the past 4 weeks. Biochemical evidence of hemolysis may still be present.
    CR is defined as hemoglobin ≥11 g/dL (women) or ≥12 g/dL(men), no evidence of hemolysis (normal bilirubin, LDH, haptoglobin, and reticulocytes), and absence of transfusion in the last 7 days and absence of rescue medication in the past 4 weeks.
    2 - Part A (Cohorts 2 and 3 Only) and Part B : Proportion of participants with durable hemoglobin response by Day 169 ; Durable response is defined as Hb level ≥10 g/dL with an increase from baseline of ≥2 g/dL on three consecutive evaluable visits during the study period; with absence of transfusion and no rescue medication during the period of 3 consecutive visits and for at least 7 days (transfusions) and 4 weeks (rescue medication) prior to the first consecutive visit.
    3 - Part A (Cohorts 2 and 3 Only) and Part B : Overall response rate at Day 169, median time to R or CR, median time to loss of R or CR, proportion of participants requiring rescue therapy (any wAIHA-directed therapy other than prednisone or transfusion) or splenectomy ; Overall response rate at Day 169, median time to R or CR, median time to loss of R or CR (loss of R defined as hemoglobin <10 g/dL at two consecutive visits at least 7 days apart and initiation of new treatment for anemia or increase in steroid dose; loss of CR is defined as hemoglobin <11 g/dL (women) or <12 g/dL (men) at two consecutive visits at least 7 days apart), proportion of participants requiring rescue therapy (any wAIHAdirected therapy other than prednisone or transfusion) or splenectomy
    4 - Part A (Cohorts 2 and 3 Only) and Part B : FACIT-fatigue scale score
    5 - Part B : To assess safety and tolerability ; Standard clinical and laboratory parameters and adverse events.
    6 - Part A (All Cohorts) and B : Change from baseline in LDH
    7 - Part A (All Cohorts) and B: Change from baseline in haptoglobin,
    8 - Part A (All Cohorts) and B : Change from baseline in reticulocytes
    9 - Part A (All Cohorts) and B : Change from baseline in total bilirubin
    10 - Part A (All Cohorts) and B : PK parameters after subcutaneous administrations (Cmax) ; Maximum concentration received after injection (Cmax) and area under the plasma concentration versus time curve calculated over the dosing interval T (336 h) (AUC0-2week)
    11 - Part A (All Cohorts) and B : PK parameters after subcutaneous administrations (AUC0-2week) ; Area under the plasma concentration versus time curve calculated over the dosing interval T (336 h) (AUC0-2week)
    12 - Part A (All Cohorts) and B : Incidence of anti-isatuximab antibodies
    13 - Titer (if relevant) of anti-isatuximab antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 : Through Day 85
    2 to 13 : Through Day 169
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/II study
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Germany
    Hungary
    Italy
    Netherlands
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Subject Last Visit
    Utolsó beteg utolsó vizitje
    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 months3
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days28
    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: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 19
    F.4.2.2In the whole clinical trial 23
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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