Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

Last updated: April 2, 2025
Sponsor: argenx
Overall Status: Completed

Phase

2

Condition

Sjogren's Syndrome

Dermatomyositis (Connective Tissue Disease)

Treatment

Efgartigimod

Clinical Study ID

NCT06203457
ARGX-113-2211
  • Ages > 18
  • All Genders

Study Summary

Efgartigimod contributes to successfully treat pSS and has the potential to improve disease manifestations by the reduction of IgG autoantibodies in pSS. This open-label extension study will evaluate the long-term safety of efgartigimod in participants with pSS who have completed the treatment period of the qualifying efgartigimod studies (including ARGX-113-2106).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is at least the legal age of consent for clinical trials when signing the ICF

  • Is capable of providing signed informed consent and complying with protocolrequirements

  • Agrees to use contraceptive measures consistent with local regulations and thefollowing: WOCBP must have a negative urine pregnancy test at baseline beforereceiving IMP

  • Has completed the qualifying efgartigimod pSS studies and agrees to continue studydrug treatment without interruption in the extension study

Exclusion

Exclusion Criteria:

  • Clinically significant disease (including newly diagnosed malignancy orcardiovascular disease) or intention to have surgery during the study; or any othermedical condition that, in the investigator's opinion, would confound the results ofthe study or put the participant at undue risk

  • Pregnant or intention to become pregnant during the study

  • Any severe systemic pSS manifestation that may put the participant at undue riskbased on the investigator's opinion

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Efgartigimod
Phase: 2
Study Start date:
August 15, 2023
Estimated Completion Date:
February 03, 2025

Study Description

ARGX-113-2211 is a long-term, single-arm, open-label, multicenter extension study of the pSS-qualifying efgartigimod studies designed to evaluate the long-term safety of efgartigimod in adult patients with pSS. Participants will be enrolled from both active and placebo arms of qualifying efgartigimod studies and receive efgartigimod 10 mg/kg over 48 weeks in the extension study without knowledge of their treatment assignment in the qualifying study. Eligible participants must have completed the treatment period of the qualifying study and must not have permanently discontinued the IMP in that study.

Connect with a study center

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Debreceni Egyetem

    Debrecen, 4032
    Hungary

    Site Not Available

  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • MCBK SC

    Grodzisk Mazowiecki, 05 825
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Krakow, 30 363
    Poland

    Site Not Available

  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.

    Poznan, 60-848
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60 185
    Poland

    Site Not Available

  • Klinika Reuma Park Sp zoo Sp K

    Warsaw, 02 665
    Poland

    Site Not Available

  • MICS Centrum Medyczne Warszawa

    Warszawa, 00 874
    Poland

    Site Not Available

  • Narodowy Instytut Geriatrii

    Warszawa, 02637
    Poland

    Site Not Available

  • FutureMeds sp zoo

    Wroclaw, 50 088
    Poland

    Site Not Available

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