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    Summary
    EudraCT Number:2020-000511-77
    Sponsor's Protocol Code Number:ACT16618
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-24
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-000511-77
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of
    SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS)
    A.3.2Name or abbreviated title of the trial where available
    phaethuSA
    A.4.1Sponsor's protocol code numberACT16618
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1244-2266
    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 & Développement
    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.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Deutschland GmbH
    B.5.2Functional name of contact point
    B.5.3.4CountryGermany
    B.5.6E-mailmedinfo.de@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 nameSAR441344
    D.3.2Product code SAR441344
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSAR441344
    D.3.9.2Current sponsor codeSAR441344
    D.3.9.3Other descriptive nameSAR441344
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sjögren’s syndrome
    E.1.1.1Medical condition in easily understood language
    Sjögren’s syndrome
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with primary Sjögren’s syndrome (pSjS), assessed by the change of the European League Against Rheumatism (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI)
    E.2.2Secondary objectives of the trial
    - To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
    - To evaluate the therapeutic efficacy on fatigue of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
    - To evaluate the pharmacokinetic (PK) exposure of one dose level of SAR441344 over 12 weeks in adult patients with pSjS
    - To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo in adult patients with pSjS as determined by adverse events (AEs)
    - To evaluate the local tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
    - To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS determined by electrocardiogram, vital signs, and laboratory evaluations
    - To measure the immunogenicity of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
    -Diagnosis of pSjS according to the American College of Rheumatology/EULAR 2016 criteria at Screening.
    -Disease duration since first diagnosis of pSjS ≤15 years based on medical history.
    -Participants with moderate to severe disease activity set with ESSDAI total score ≥5, based on the following domains at Screening: glandular, articular, muscular, hematological, biological, and constitutional, lymphadenopathy.
    -Seropositive for anti-Ro/SSA antibodies.
    - IgG > lower limit of normal at Screening.
    -Stimulated salivary flow rate of ≥0.1 mL/min at Screening or Baseline.
    -Body weight within 45 to 120 kg (inclusive) and body mass index within the range of 18.0 to 35.0 kg/m2 (inclusive) at Screening.
    -Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    -Capable of giving signed informed consent
    E.4Principal exclusion criteria
    -Any autoimmune disease (except pSjS and Hashimoto thyroiditis) with or without secondary SjS.
    -History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment.
    -Active life threatening or organ threatening complications of SjS disease at the time of Screening based on treating physician evaluation including but not restricted to:
    -Vasculitis with renal, digestive, cardiac, pulmonary, or CNS involvement characterized as severe,
    -Active central nervous system (CNS) or peripheral nervous system (PNS) involvement requiring high dose steroids,
    -Severe renal involvement defined by objective measures,
    -Lymphoma.
    -Cardiac heart failure Stage III or IV according to the New York Heart Association.
    -Severe pulmonary impairment documented by an abnormal pulmonary function test.
    -Serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis), infection requiring hospitalization or IV antibiotics or significant chronic viral (including history of recurrent or active herpes zoster), bacterial, or fungal infection (eg, osteomyelitis) 30 days before and during Screening.
    -Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution.
    -Evidence of active or latent tuberculosis (TB) as documented by medical history (eg, chest X rays) and examination, and TB testing: A positive or 2 indeterminate QuantiFERON® TB Gold tests at Screening (regardless of prior treatment status).
    -Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection or medical condition (eg, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal, neurologic, or any known immune deficiency) or previous, active or pending surgical disorder, or any condition that may affect participant safety in the judgment of the Investigator (including vaccinations which are not updated based on local regulation).
    -History or presence of diseases which exclude diagnosis of SjS as per the American College of Rheumatology/EULAR 2016 criteria including, but not limited to, sarcoidosis, amyloidosis, graft-versus-host disease, IgG4 related disease, and history of head and neck radiation treatment.
    -History of a systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to humanized monoclonal antibody.
    -Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
    -Any prior history of malignancy or active malignancy, including lymphoproliferative diseases and lymphoma (except successfully treated carcinoma in situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin) within 5 years prior to Baseline.
    -Unstable dose of nonsteroidal anti inflammatory drugs (NSAIDs) and/or unstable use of topical and/or pharmacological stimulant treatment for salivary and lacrimal glands 4 weeks before Screening.
    -High dose steroids, or a change in steroid dose within 4 weeks prior to Day 1/Randomization or expected changes during the course of the study.
    -High dose of hydroxychloroquine or chloroquine, or methotrexate or change in hydroxychloroquine, chloroquine or methotrexate dose within 12 weeks prior to Day 1/Randomization or expected changes during the course of the study.
    -Participants treated with the following medications/procedures prior to Screening within the given timeframe:
    -Previous treatment with azathioprine and other thiopurines, mycophenolate mofetil, sulfasalazine, or cyclosporine A within 3 months
    -Previous treatment with cyclophosphamide, leflunomide, or belimumab within 6 months.
    -Previous treatment with rituximab within 12 months.
    -Previous bone marrow transplantation, total lymphoid irradiation or ablative ultra high dose cyclophosphamide or IV Ig.
    -Previous treatment with any other biologic drug within 5 times the half life of the drug.
    -Received administration of any live (attenuated) vaccine within 3 months prior to Day 1/Randomization (eg, varicella zoster vaccine, oral polio, rabies).
    -Clinically significant abnormal ECG or vital signs at Screening.
    -Abnormal laboratory test(s) at Screening.
    -Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.
    -Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), anti hepatitis B core antibodies (anti HBc Ab), anti hepatitis C virus antibodies (HCV-Ab)
    -If female, pregnant and/or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Change in ESSDAI: The ESSDAI is a validated and established outcome measurement for therapeutic efficacy in SjS, evaluating disease activity mainly on extra glandular manifestations. This score consists of 12 organ specific domains, which are scored based on organ specific items in 3 to 4 different severity grades. This score is summed up over all 12 domains in a weighted way to in a weighted way to summarize into a total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    E.5.2Secondary end point(s)
    1/ Change in ESSPRI: The ESSPRI is a validated and established outcome measurement, reported by patients, which rates the key disease manifestations fatigue, dryness, and pain based on a numeric scale ranging from 0 to 10, where 0 is defined as no symptoms and 10 as maximum imaginable complaints.

    2/ Change in MFI general fatigue subscale and other subscales: The MFI is a validated, 20 item self-report instrument to evaluate fatigue by investigating the following components: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity.

    3/ Descriptive statistics of SAR441344 concentrations: Descriptive statistics of SAR441344 concentrations, including mean, median, and standard deviation, over 12 weeks

    4/ Assessment of PK parameter: Cmax: Maximum plasma concentration of SAR441344

    5/ Assessment of PK parameter: tmax: Time to reach Cmax for SAR441344

    6/ Assessment of PK parameter: AUC0-tau : Area under the plasma concentration - time curve over the dosing interval

    7/ Assessment of PK parameter: t1/2z: Terminal half life of SAR441344

    8/ Incidence of treatment emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)

    9/ Incidence of study investigational medicinal product (IMP) discontinuation and withdrawals due to TEAEs

    10/ Change in participant reported local tolerability scale

    11/ Incidence of AEs related to local tolerability findings: Findings at the site of injection following IMP injection such as, but not limited to tenderness, erythema, and swelling will be recorded in the e CRF in 4 different grades (mild/moderate/severe/very severe).

    12/ Participants with medically significant changes in vital signs, electrocardiogram, and/or laboratory evaluations

    13/ Antidrug antibodies: Antidrug antibodies at Baseline, Week 4, Week 8, Week 12, and Week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    From 1/ to 7/ and from 10/ to 12/ : Baseline to 12 weeks
    8/, 9/, 13/: Baseline to Week 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    ImmunogenIcity
    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 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 EEA13
    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
    Canada
    Korea, Republic of
    Mexico
    Taiwan
    United States
    France
    Netherlands
    Spain
    Germany
    Belgium
    Hungary
    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 years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days5
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 180
    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 Decision2020-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-01
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