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    Summary
    EudraCT Number:2019-003107-35
    Sponsor's Protocol Code Number:ARGX-113-1902
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-003107-35
    A.3Full title of the trial
    Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
    Een open-label uitbreiding van het ARGX-113-1802-onderzoek om de veiligheid, verdraagbaarheid en doeltreffendheid van efgartigimod PH20 SC op lange termijn te onderzoeken bij patiënten met chronische inflammatoire demyeliniserende polyneuropathie (CIDP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder that affects the peripheral nerves)
    Een studie om de veiligheid en doeltreffendheid op lange termijn te ondezoeken van een onderhuidse toediening van efgartigimod bij volwassenen met chronische inflammatoire demyeliniserende polyneuropathie (een autoimmuun ziekte dat de perifere zenuwen aantast)
    A.3.2Name or abbreviated title of the trial where available
    ADHERE+
    CIDP trial 1902 (ADHERE+)
    A.4.1Sponsor's protocol code numberARGX-113-1902
    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 BVBA
    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 BVBA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationargenx BVBA
    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 number00329310 3400
    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 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.3.9.3Other descriptive nameARGX-113
    D.3.9.4EV Substance CodeSUB180001
    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.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
    Chronic Inflammatory Demyelinating Polyneuropathy
    Chronische Inflammatoire Demyelinating Polyneuropathie
    E.1.1.1Medical condition in easily understood language
    Inflammation of peripheral nervous system
    Ontsteking aan het perifere zenuwstelsel
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077384
    E.1.2Term Chronic inflammatory demyelinating polyneuropathy
    E.1.2System Organ Class 100000004852
    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 long-term safety and tolerability of efgartigimod PH20 SC (efgartigimod co-formulated with recombinant human hyaluronidase PH20 [rHuPH20] for subcutaneous [SC] administration)
    •Het beoordelen van de veiligheid en verdraagbaarheid van efgartigimod PH20 SC (efgartigimod gelijktijdig geformuleerd met recombinant humaan hyaluronidase PH20 [rHuPH20] voor subcutane [SC] toediening).
    E.2.2Secondary objectives of the trial
    - To determine the long-term efficacy
    - To evaluate the immunogenicity (anti-drug antibodies [ADA]) of efgartigimod and rHuPH20
    - To evaluate the pharmacokinetics (PK) of efgartigimod PH20 SC
    - To evaluate the pharmacodynamic (PD) effect of efgartigimod PH20 SC (ie, immunoglobulin G [IgG] levels)
    - To evaluate additional patient-reported outcomes (PROs) (including patient-reported quality of life and satisfaction with treatment)
    - To explore self-administration of the treatment
    -Het bepalen van de werkzaamheid op lange termijn.
    -Het beoordelen van de immunogeniciteit (anti-geneesmiddel antilichamen [ADA]) van efgartigimod en rHuPH20.
    -Het beoordelen van de farmacokinetiek (FK) van efgartigimod PH20 SC.
    -Het beoordelen van het farmacodynamisch (FD) effect van efgartigimod PH20 SC (d.w.z. immunoglobuline G [IgG]-waarden).
    -Het beoordelen van aanvullende door de patiënt gemelde resultaten (PRO’s) (waaronder door de patiënt gemelde kwaliteit van leven en tevredenheid met de behandeling).
    -Het verkennen van zelftoediening van de behandeling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand the requirements of the trial, 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) of this trial.

    2. Male or female patient with one of the following options:
    - Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or
    - Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or
    - Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or
    - Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment.

    3. Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.

    4. Women of childbearing potential must use a highly effective method of contraception (failure rate of less than 1% per year) from baseline to 90 days after the last administration of IMP

    5. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom and his partner must use a highly effective method of contraception (failure rate of less than 1% per year) from baseline to 90 days after the last administration of IMP. Male patients practicing true sexual abstinence (when this is in line with the preferred and usual life style of the participant) can be included. Sterilized male patients who have had vasectomy with documented aspermia post-procedure can be included. In addition, male patients are not allowed to donate sperm from baseline to 90 days after the last administration of IMP.
    1. Zijn in staat om de vereisten van het onderzoek te begrijpen, schriftelijk geïnformeerde toestemming te geven (waaronder toestemming voor het gebruiken en openbaar maken van onderzoeksgerelateerde gezondheidsinformatie), zijn bereid en in staat om te voldoen aan de procedures van het protocol (inclusief de vereiste onderzoeksbezoeken) van dit onderzoek.
    2. Mannelijke of vrouwelijke patiënt met een van de volgende opties:
    • Heeft het bezoek in week 48 van fase B van onderzoek ARGX-113-1802 voltooid en wordt geschikt geacht voor behandeling met efgartigimod PH20 SC; of
    • Is tijdens fase B van onderzoek ARGX-113-1802 verslechterd en wordt geschikt geacht voor behandeling met efgartigimod PH20 SC; of
    • Kreeg deelname aan het OLE-onderzoek aangeboden als gevolg van voortijdige beëindiging van onderzoek ARGX 113 1802 (omdat er voldoende voorvallen voor analyse van het primaire eindpunt van dat onderzoek bereikt waren en het onderzoek werd gestopt) en wordt geschikt geacht voor behandeling met efgartigimod PH20 SC; of
    • Heeft het bezoek in week 48 van de voorafgaande cyclus van het OLE-onderzoek voltooid en wordt geschikt geacht om door te gaan met efgartigimod PH20 SC.
    3. Vruchtbare vrouwen met een negatieve zwangerschapstest op urine bij de baseline voorafgaand aan toediening van het onderzoeksgeneesmiddel.
    4. Vruchtbare vrouwen moeten een zeer effectieve anticonceptiemethode gebruiken (mislukkingspercentage van minder dan 1% per jaar) vanaf de baseline tot 90 dagen na de laatste toediening van het onderzoeksgeneesmiddel.
    5. Niet-gesteriliseerde mannelijke patiënten die seksueel actief zijn met een vruchtbare vrouwelijke partner moeten een condoom gebruiken en hun partner moet een zeer effectieve anticonceptiemethode gebruiken (mislukkingspercentage van minder dan 1% per jaar) vanaf de baseline tot 90 dagen na de laatste toediening van het onderzoeksgeneesmiddel. Mannelijke patiënten die daadwerkelijke seksuele onthouding toepassen (indien dit overeenkomt met de geprefereerde en gebruikelijke levensstijl van de deelnemer) mogen geïncludeerd worden. Gesteriliseerde mannelijke patiënten die een vasectomie hebben ondergaan met gedocumenteerde aspermie na de ingreep, mogen geïncludeerd worden. Daarnaast mogen mannelijke patiënten geen sperma doneren vanaf de baseline tot 90 dagen na de laatste toediening van het onderzoeksgeneesmiddel.
    E.4Principal exclusion criteria
    1. Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP.

    2. Pregnant and lactating women and those intending to become pregnant during the trial or within 90 days after last IMP administration.

    3. Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or any other reason which could confound the results of the trial or put the patient at undue risk.
    1.Het bezoek in week 48/bij voortijdige stopzetting (ED) in onderzoek ARGX-113-1802 of het bezoek in week 48 van de voorafgaande OLE-deelname vond meer dan 14 dagen voorafgaand aan SD1 van het OLE-onderzoek of het begin van een nieuwe behandelingscyclus in het OLE-onderzoek en meer dan 21 dagen sinds de laatste dosis van het onderzoeksgeneesmiddel plaats.

    2.Zwangere vrouwen, vrouwen die borstvoeding geven en vrouwen die van plan zijn zwanger te worden tijdens het onderzoek of binnen 90 dagen na de laatste toediening van onderzoeksgeneesmiddel.

    3. Patiënten met klinisch bewijs van andere belangrijke ernstige ziekte, patiënten die recent een ingrijpende operatie hebben ondergaan of die een ingrijpende operatie gepland hebben staan of enige andere reden die de resultaten van het onderzoek zou kunnen verstoren of een onnodig risico kan zijn voor de patiënt.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of TEAEs and SAEs by system organ class (SOC) and preferred term (PT).
    - Incidence of clinically significant laboratory abnormalities.
    -de incidentie van tijdens de behandeling optredende bijwerkingen (TEAE’s) en ernstige bijwerkingen (SAE’s) per systeem-/orgaanklasse (SOC) en voorkeursterm (PT);
    -de incidentie van klinisch significante afwijkende laboratoriumwaarden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    TEAEs and SAEs are monitored throughout the entire study duration
    Blood sampling for laboratory analysis is taken at every study visit
    TEAEs and SAEs worden tijdens de helel studie gemonitored.
    Bloed monsters worden bij elke studie visite afgenomen.
    E.5.2Secondary end point(s)
    Efficacy;
    Change from baseline over time in the following scores and measurements:
    − Adjusted INCAT score;
    − MRC Sum score;
    − 24-item I-RODS disability scores;
    − Mean grip strength assessed by Martin vigorimeter;
    − TUG score.
    Percentage of patients without clinical deterioration over time, defined by adjusted INCAT increase ≥1 point compared to baseline.

    Immunogenicity;
    - Percentage of patients with and titers of binding antibodies (BAb) towards efgartigimod and/or rHuPH20; and the presence of neutralizing antibodies (NAb) against efgartigimod and titers of NAb against rHuPH20.

    Pharmacokinetics;
    - Efgartigimod serum concentrations over time during the trial.

    Pharmacodynamics;
    - Changes from baseline over time of serum IgG levels (total and IgG subtypes)

    Additional Patient-reported Outcome;
    Change from baseline over time in:
    − Health-related quality-of-life questionnaire (EQ-5D-5L);
    − Brief Pain Inventory – Short Form (BPI-SF);
    − 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9);
    − Rasch-transformed-Fatigue Severity Scale (RT-FSS);
    − Hospital Anxiety and Depression Scale (HADS).
    Verdraagbaarheid:
    Verandering ten opzichte van de baseline in de loop der tijd van de volgende scores en metingen:
    -aangepaste INCAT-score;
    -totaalscore van MRC;
    -invaliditeitsscores op de 24-item I-RODS;
    -gemiddelde grijpkracht, zoals beoordeeld met de Martin-vigorimeter;
    -score op de Timed Up-and-go (TUG).
    •Percentage patiënten zonder klinische verslechtering in de loop der tijd, gedefinieerd door verslechtering ≥1 punt in aangepaste INCAT ten opzichte van OLE SD1.

    Immunogeniteit:
    •Percentage patiënten met en titers van bindende antilichamen (BAb) voor efgartigimod en/of rHuPH20; en de aanwezigheid van neutraliserende antilichamen (NAb) tegen efgartigimod en titers van NAb tegen rHuPH20.
    Pharmacokinitiek
    •Efgartigimod serumconcentraties in de loop der tijd gedurende het onderzoek.
    Pharmacodynamiek:
    Veranderingen in IgG-waarden in serum (totaal en IgG-subtypes) ten opzichte van de baseline in de loop der tijd.

    Extra uitkomsten:
    •Verandering ten opzichte van de baseline in de loop van de tijd van:
    -Vragenlijst EuroQol 5 dimensies en 5 niveaus gezondheidsgerelateerde kwaliteit van leven (EQ-5D-5L);
    -Brief Pain Inventory – Short Form (BPI SF);
    -9 item Treatment Satisfaction Questionnaire for Medication (TSQM-9);
    -Rasch-transformed Fatigue Severity Scale (RT-FSS);
    -Hospital Anxiety and Depression Scale (HADS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy, immunogenicity, pharmacokinetic and pharmacodynamic endpoints are assessed at every study visit
    Patient report outcomes are assessed at every study visit with the exception of visit 2 (week 4)
    Verdraagbaarheid, immunogeniteit, pharmacokinetiek en pharmacodynamiek zijn eindpunten die bij elke visite onderzocht worden.
    Patient report outcomes worden bij elke visite onderzocht, behalve visite 2 (week4)
    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
    immunogeniteit
    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 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 trial1
    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 EEA61
    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
    Bulgaria
    Canada
    Czechia
    Denmark
    France
    Georgia
    Germany
    Hungary
    Israel
    Italy
    Japan
    Latvia
    Netherlands
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Ukraine
    United Kingdom
    United States
    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
    laatste visite laatste patient
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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: 216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 155
    F.4.2.2In the whole clinical trial 360
    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)
    After the end of the trial, patients will no longer receive IMP and will be treated as considered appropriate by the investigator
    Na einde studie, ontvangen patienten niet langer IMP en zullen ze door de arts zo goed mogelijk behandeld worden.
    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 Decision2020-05-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-25
    P. End of Trial
    P.End of Trial StatusOngoing
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