A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome (Unity)
A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial With Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients With Primary Sjögren's Disease
Sponsor: argenx
A observational or N/A phase clinical study on Primary Sjogrens Disease, this trial is ongoing. The trial is conducted by argenx and has accumulated 9 data snapshots since 2025. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
9 versions recorded-
Apr 17, 2026 — Present [daily]
Active Not Recruiting
Status: Recruiting → Active Not Recruiting · Phase: PHASE3 → None
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Feb 2026 — Apr 2026 [monthly]
Recruiting PHASE3
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE3
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE3
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Oct 2025 — Dec 2025 [monthly]
Recruiting PHASE3
▶ Show 4 earlier versions
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE3
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Jul 2025 — Sep 2025 [monthly]
Recruiting PHASE3
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Feb 2025 — Jul 2025 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Dec 2024 — Feb 2025 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.
Contact Information
- argenx
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
A Coruña, Spain , Allen, United States , Amman, Jordan , Amman, Jordan , Amman, Jordan , Amman, Jordan , Ankara, Turkey (Türkiye) , Ankara, Turkey (Türkiye) , Anyang-si, South Korea , Ashkelon, Israel and 293 more locations