At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 34 enrolled
Drug / intervention
Efgartigimod +1 morebiological
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.
A Phase 2, Randomized, Placebo-controlled, Parallel-group, Double-blinded, proof-of Concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren's Syndrome
In Brief
A Phase 2 clinical trial evaluating Efgartigimod and Placebo for Primary Sjögren's Syndrome. Completed, enrolled 34 participants across 17 sites in 4 countries.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Sjögren's Syndrome
CountriesBelgium, Hungary, Netherlands, Poland
CollaboratorsIQVIA Pty Ltd
Timeline
Phase 2CompletedFinished
202420252026
Enrollment StartApr 2023
First PostedApr 2023
Primary CompletionJan 2024
Study CompletionFeb 2024
TodayJul 2026
First PostedApr 18, 2023
Enrollment StartApr 4, 2023
Primary CompletionJan 29, 2024
Study CompletionFeb 12, 2024
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.2 years ago
Interventions
Efgartigimodbiological
Patients receiving efgartigimod infusions
Placebobiological
Patients receiving placebo infusions