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

Sponsor
argenx
Study ID
NCT06203457
Phase
PHASE2
Status
Completed

Conditions

  • Primary Sjögren's Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod — BIOLOGICAL
    Patients receiving efgartigimod infusions

Study Details

Efgartigimod has the potential to improve disease manifestations by the reduction of IgG autoantibodies in Sjogren's Syndrome (SjD or pSS). This open-label extension study will evaluate the long-term safety of efgartigimod in participants with SjD who have completed the treatment period of the qualifying efgartigimod study (ARGX-113-2106).

Key Dates

Start date
Nov 29, 2023
Status verified
Apr 2025
Primary completion
Feb 3, 2025
Completion
Feb 3, 2025

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod
    All participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study.

Primary Outcome Measure

Number of Participants With TEAEs, TESAEs and TEAESIs [ Time Frame: From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks ]

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