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    Summary
    EudraCT Number:2020-002915-23
    Sponsor's Protocol Code Number:ARGX-113-1904
    National Competent Authority:Bulgarian Drug Agency
    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 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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2020-002915-23
    A.3Full title of the trial
    A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus)
    A.3.2Name or abbreviated title of the trial where available
    ADDRESS
    A.4.1Sponsor's protocol code numberARGX-113-1904
    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 (Ghent)
    B.5.3.3Post codeB-9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number003293103400
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/22/2653
    D.3 Description of the IMP
    D.3.1Product nameEfgartigimod PH20 SC
    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 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 number165
    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.IMP: 2
    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/3/22/2653
    D.3 Description of the IMP
    D.3.1Product nameEfgartigimod PH20 SC
    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 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 number180
    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 placeboSubcutaneous use
    D.8 Placebo: 2
    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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pemphigus Vulgaris or Pemphigus Foliaceus
    E.1.1.1Medical condition in easily understood language
    Blistering autoimmune diseases that affect the skin and mucous membranes
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052802
    E.1.2Term Pemphigus vulgaris
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10057069
    E.1.2Term Pemphigus foliaceus
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of efgartigimod PH20 SC compared to placebo in the treatment of participants with Pemphigus vulgaris
    E.2.2Secondary objectives of the trial
    • To demonstrate the efficacy of efgartigimod PH20 SC in the treatment of participants with pemphigus vulgaris or pemphigus foliaceus
    • To assess the safety of efgartigimod PH20 SC in participants with PV or PF
    • To assess the health impact of glucocorticoid (GC) use in participants with PV or PF
    • To evaluate the effects of efgartigimod PH20 SC on quality of life (QoL) in participants with PV or PF
    • To evaluate the PK of efgartigimod PH20 SC in participants with PV or PF
    • To evaluate the PD of efgartigimod PH20 SC in participants with PV or PF
    • To evaluate the immunogenicity of efgartigimod PH20 SC in participants with PV or PF
    • To evaluate the competency of participants or caregivers to self-administer efgartigimod PH20 SC
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Evaluation of biomarkers of pemphigus pathology from skin biopsis
    E.3Principal inclusion criteria
    1. Ability to understand the requirements of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits).
    2. The participant is male or female, and aged from 18 years at the time of signing the informed consent form (ICF).
    3. The participant has a clinical diagnosis of PV (mucosal, cutaneous, mucocutaneous) or PF that has been confirmed by cutaneous histology, positive direct immunofluorescence (IF), and positive indirect IF and/or ELISA.
    4. The participant meets 1 of the following profiles:
    a. Newly diagnosed disease with PDAI ≥15 at baseline and naïve to treatment.
    b. Newly diagnosed disease with PDAI ≥15 while receiving a first course of oral prednisone (or equivalent). According to clinical judgment, the participant has shown no significant improvement of PV or PF signs for at least 2 weeks before baseline and is considered fit to start prednisone treatment at 0.5 mg/kg qd at baseline.
    c. Experiencing flare with PDAI ≥15, a maximum of 4 years since disease onset, and off prednisone therapy ± a conventional immunosuppressant (eg, azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil) or dapsone. Note: conventional immunosuppressants and dapsone must be discontinued before baseline.
    d. Experiencing flare with PDAI ≥15, a maximum of 4 years since disease onset, and receiving a tapered dose of oral prednisone (or equivalent), provided that prednisone has been given at stable dose ± a conventional immunosuppressant (eg, azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil) or dapsone for at least 2 weeks and participants are fit to start prednisone treatment at 0.5 mg/kg qd at baseline. Note: conventional immunosuppressants and dapsone must be discontinued before baseline.
    5. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating clinical trials and:
    a. Male participants:
    -Male participants must agree to use acceptable method of contraception, from signing the ICF until the last dose of IMP.
    b. Female participants:
    - Women of childbearing potential must:
    --have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before the IMP can be administered.
    -- agree to use a highly effective or acceptable contraception method, which should be maintained at minimum until the last dose of IMP.
    E.4Principal exclusion criteria
    1. Participant has a confirmed diagnosis of paraneoplastic pemphigus, drug-induced pemphigus, pemphigus vegetans, pemphigus erythematosus, or any other non-PV/non-PF autoimmune blistering disease.
    2. Participants with mild disease severity as defined by PDAI <15 at baseline.
    3. Participants who show a significant improvement of PV or PF in the period from screening to baseline according to clinical judgment (eg, the Participant has achieved DC or a substantial reduction in PDAI activity score during screening period).
    4. The Participant has been administered therapy other than oral prednisone, conventional immunosuppressants (eg, azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil) or dapsone within 2 months before the baseline visit and that can affect clinical disease activity. For example, excluded medications are intravenous methylprednisolone, dapsone, sulfasalazine, tetracyclines, nicotinamide at doses above the recommended daily allowance (RDA)/dietary reference intake (DRI), plasmapheresis/ plasma exchange, immunoadsorption, and IVIg. Note: conventional immunosuppressants and dapsone must be discontinued before baseline. Nicotinamide doses at or below RDA/DRI from oral supplements is allowed.
    5. Use of any monoclonal antibody (including rituximab or another anti-CD20 biologic) within 6 months before the baseline visit.
    6. Known hypersensitivity to any of the components of the administered treatments.
    7. The participant has a known contraindication to oral prednisone.
    8. The participant has a history of refractory disease, as defined by a failure to respond to first-line and second-line therapies.
    9. Participants who have a history of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before first IMP administration. Participants with any of the following cancers can be included at any time, provided they are adequately treated prior to their participation in the study:
    a. Basal cell or squamous cell skin cancer
    b. Carcinoma in situ of the cervix
    c. Carcinoma in situ of the breast
    d. Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
    10. Participants with clinical evidence of other significant serious disease or participants who recently underwent or have planned a major surgery during the period of the trial, or any other condition in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk.
    11. Pregnant and lactating women and those intending to become pregnant during the trial.
    12. Current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse.
    13. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of PV or PF or put the participant at undue risk.
    14. The participant has a Karnofsky performance score <60%.
    15. Vaccination with live/attenuated viral vaccines within 28 days prior to randomization.
    16. The participant has clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection.
    17. Positive serum test at screening for an active viral infection with any of the following conditions:
    a. Hepatitis B Virus (HBV)
    b. Hepatitis C Virus (HCV)
    c. HIV based on test results that are associated with and AIDS-defining condition or a CD4 count < ≤200 cells/mm3
    18. The participant has total immunoglobulin G (IgG) <6 g/L at screening.
    19. The participant has previously participated in a trial with efgartigimod and has received at least 1 administration of IMP.
    20. Use of an investigational drug within 3 months or 5 half-lives of the drug (whichever is longer) prior to first IMP administration.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of Pemphigus vulgaris participants who achieve CR min therapy within 30 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 30
    E.5.2Secondary end point(s)
    1. Proportion of PV and PF participants who achieve CR min within 30 weeks
    2. Cumulative prednisone dose over the trial in PV participants
    3. Time to Disease Control (DC) in PV participants
    4. Time to CR in PV participants
    5. Proportion of PF participants who achieve CR min within 30 weeks
    6. Cumulative prednisone dose over the trial in PV and PF participants
    7. Time to CR in PV and PF participants
    8. Time to DC in PV and PF participants
    9. Rate of treatment failure
    10. Rate of flare
    11. PDAI at each visit
    12. Incidence and severity of treatment-emergent adverse events (TEAEs), AESIs, and SAEs by system organ class (SOC) and preferred term (PT).
    13. Composite Glucocorticoid Toxicity Index (C GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS)
    14. EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) scale
    15. Autoimmune Bullous Disease Quality of Life (ABQOL) score
    16. Efgartigimod serum concentrations
    17. Total IgG and subtype (IgG1, IgG2, IgG3, IgG4) serum levels
    18. Anti Dsg-1 and -3 autoantibodies serum levels
    19. Incidence and Prevalence of Anti-drug antibodies (ADAs) to efgartigimod and antibodies produced against recombinant human hyaluronidase (rHuPH20) (plasma levels)
    20. Number and percentage of participants or caregivers completing the self-administration training
    21. Number and percentage of participants or caregivers determined by the site staff to be sufficiently competent to self-administer efgartigimod PH20 SC
    22. Number and percentage of participants or caregivers that self-administer efgartigimod PH20 SC under site staff supervision
    E.5.2.1Timepoint(s) of evaluation of this end point
    endpoints 1 to 10: up to 30 weeks
    endpoints 11 to 12: up to 41 weeks
    endpoints 13 to 15: up to 30 weeks
    endpoint 16: up to 38 weeks
    endpoints 17 to 18: up to 41 weeks
    endpoint 19: up to 38 weeks
    Endpoints 20 to 22: up to 41 weeks
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Tolerability
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Australia
    China
    India
    Israel
    Japan
    United States
    Georgia
    Russian Federation
    Turkey
    Ukraine
    Serbia
    Bulgaria
    Croatia
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Poland
    Portugal
    Romania
    Spain
    United Kingdom
    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
    The end of the study is defined as the date of the last visit of the last participant in the study. A participant is considered to have completed the study if he/she has completed all periods of the study including the EoS/ET visit and any follow-up visits (if applicable).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 149
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 213
    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)
    Under certain conditions described in the protocol, participants may be eligible to roll over to the open-label extension trial ARGX-113-1905. For participants, randomized to the efgartigimod PH20 SC or placebo treatment arm in ARGX-113-1904, trial ARGX-113-1905 provides extended or first treatment and re-treatment options in the respective treatment arms. argenx is currently assessing the appropriateness and possibility of making efgartigimod PH20 SC available for trial participants post-trial.
    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 Decision2020-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-22
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