At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
Efgartigimodbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome (pSS) Who Complete Qualifying Efgartigimod pSS Studies
In Brief
A Phase 2 clinical trial evaluating Efgartigimod for Primary Sjögren's Syndrome. Completed, enrolled 24 participants across 11 sites in 3 countries.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Sjögren's Syndrome
CountriesBelgium, Hungary, Poland
CollaboratorsIQVIA Pty Ltd
Timeline
Phase 2CompletedFinished
202420252026
Enrollment StartNov 2023
First PostedJan 2024
Primary CompletionFeb 2025
TodayJul 2026
First PostedJan 12, 2024
Enrollment StartNov 29, 2023
Primary CompletionFeb 3, 2025
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 2.5 years ago
Interventions
Efgartigimodbiological
Patients receiving efgartigimod infusions