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    Summary
    EudraCT Number:2021-005911-30
    Sponsor's Protocol Code Number:ARGX-113-2106
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-10-24
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-005911-30
    A.3Full title of the trial
    A Phase 2, Randomized, Placebo-controlled, Parallel Group, Double-blind, Proof-of-concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren’s Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the safety and effectiveness of Efgartigimod in Patients with Primary Sjögren’s Syndrome (pSS)
    A.4.1Sponsor's protocol code numberARGX-113-2106
    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 Sponsorargenx BV
    B.1.3.4CountryBelgium
    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 supportargenx BV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationargenx BV
    B.5.2Functional name of contact pointRegulatory
    B.5.3 Address:
    B.5.3.1Street AddressIndustriepark Zwijnaarde 7
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post codeB-9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 9 3103400
    B.5.6E-mailregulatory@argenx.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 nameefgartigimod
    D.3.2Product code ARGX-113
    D.3.4Pharmaceutical form Concentrate for 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 INNEfgartigimod alfa
    D.3.9.1CAS number 1821402-21-4
    D.3.9.2Current sponsor codeARGX-113
    D.3.9.4EV Substance CodeSUB198780
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboConcentrate for solution 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
    Primary Sjögren’s Syndrome
    E.1.1.1Medical condition in easily understood language
    Primary Sjögren’s Syndrome
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10042846
    E.1.2Term Syndrome Sjogren's
    E.1.2System Organ Class 100000004859
    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 effect of efgartigimod IV compared to placebo on CRESS
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of efgartigimod IV compared to placebo on the histology of the parotid gland (selected sites only)
    • To evaluate the safety of efgartigimod IV compared to placebo in participants with pSS
    • To evaluate the effect of efgartigimod IV compared to placebo on clinical efficacy parameters
    • To evaluate the effect of efgartigimod IV compared to placebo on STAR
    • To evaluate the PK of efgartigimod IV
    • To evaluate the PD of efgartigimod IV
    • To evaluate the immunogenicity of efgartigimod IV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    - Is at least the legal age of consent for clinical trials when signing the informed consent form
    - Is capable of providing signed informed consent and complying with protocol requirements
    - Agrees to use contraceptive measures consistent with local regulations and measures described in the protocol
    - Meets the following criteria: ACR/EULAR 2016 pSS who met criteria ≤7 years before screening;
    ESSDAI ≥5; Ro/SS-A positive; Residual salivary flow (UWSF rate >0 and/or SWSF rate >0.10)
    E.4Principal exclusion criteria
    Participants will be excluded from the study if any of the following criteria apply:
    - Known autoimmune disease or any medical condition that, in the investigator’s judgment, would interfere with an accurate assessment of clinical symptoms of pSS or puts the participant at undue risk
    - History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP. Adequately treated participants with the following cancers may be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
    - Clinically significant uncontrolled active acute or chronic bacterial, viral, or fungal infection
    - Positive serum test at screening for an active infection with any of the following: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available; HIV based on test results of a CD4 count of <200 cells/mm3 that are associated with an AIDS-defining condition, HIV based on test results of a CD4 count of >200 cells/mm3 not adequately treated with antiviral therapy
    - Clinically significant disease, recent major surgery (within 3 months of screening), or intention to have surgery during the study; or any other medical condition that, in the investigator’s opinion, would confound the results of the study or put the participant at undue risk
    - Immunoglobulin G (IgG) levels cannot be below a certain threshold ( 4g/L)
    - Positive covid test at study start
    - Some of the medications such as vaccines with live components or medicines that may be prescribed for Sjogren’s syndrome cannot be taken either shortly before or during this study
    - Current participation in another interventional clinical study or previously participation in an efgartigimod clinical study and treatment with ≥1 dose of IMP
    - Known hypersensitivity to IMP or 1 of its excipients
    - History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator
    - Pregnant or lactating state or intention to become pregnant during the study
    - Secondary Sjögren’s syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition is the primary diagnosis
    - Chinese traditional medicine with known immunomodulatory action
    A detailed list is provided in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of CRESS responders on ≥3 of 5 items at week 24. The 5 items are:
    − Systemic disease activity: clinESSDAI
    − Patient-reported symptoms: ESSPRI
    − Tear gland function: Schirmer’s test and OSS
    − Salivary gland function: UWSF rate and SGUS
    − Serology (serum IgG and/or RF)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 24.
    E.5.2Secondary end point(s)
    • Change in the relative counts of lymphocytic infiltrate (stained for CD45) at week 24
    • Change in B/B+T cell ratio at week 24
    • Incidence and severity of TEAEs, AESIs, and SAEs by SOC and PT up to 35 weeks
    • Changes in vital sign measurements, ECG results, and clinical laboratory safety evaluations up to 35 weeks
    • Proportion of participants with minimal clinically important improvement in ESSDAI: improvement of ≥3 points in ESSDAI score at week 24 up to 24 weeks
    • Proportion of participants with low disease activity: ESSDAI score of <5 at week 24 up to 24 weeks
    • Proportion of participants with minimal clinically important improvement in clinESSDAI: improvement of ≥3 points in clinESSDAI score at week 24 up to 24 weeks
    • Proportion of participants with low disease activity: clinESSDAI score of <5 at week 24 up to 24 weeks
    • Proportion of participants with minimal clinically important improvement in ESSPRI: decrease of 1 point or ≥15% at week 24 up to 24 weeks
    • Change in ESSDAI score at week 24
    • Change in clinESSDAI score at week 24
    • Change in ESSPRI score at week 24
    • Proportion of participants with STAR score of ≥5 at week 24
    • Efgartigimod serum concentration-time profile
    • Values, changes from baseline, and percent reduction from baseline in total IgG levels in serum
    • Values, changes from baseline, and percent reduction from baseline in autoantibodies − Anti-Ro/ SS-A − Anti-La/ SS-B in serum
    • Incidence and prevalence of ADA against efgartigimod in serum
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 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 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 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 EEA18
    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 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
    The end-of-study is defined as the date of the last participant’s last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days1
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    patients can roll over to the OLE
    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 Decision2022-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-12
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