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A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome

Study acronym: Unity
StatusActive, Not Recruiting
PhasePhase 3
Sponsorargenx
Started2025-01-15
View on ClinicalTrials.gov ↗

Amendment history

2026-04-15
Study Status, Study Design, Contacts/Locations v12
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment targetestimated 580→confirmed 631
Study sites304→303
2026-03-16
Study Status, Contacts/Locations v11
Study sites300→304
2026-02-25
Study Status, Contacts/Locations v10
Study sites276→300
2025-12-10
Study Status, Contacts/Locations v9
Study sites262→276
2025-11-19
Study Status, Oversight, Contacts/Locations v8
Study sites220→262
Show 7 earlier versions
2025-09-19
Study Status, Contacts/Locations v7
Study sites179→220
2025-09-17
Study Status, Contacts/Locations v6
Study sites123→179
2025-07-31
Study Status, Eligibility, Contacts/Locations v5
Study sites104→123
Eligibility criteria+82 characters
[...] signing the ICF. Meets the following criteria at screening: fulfilled ACR/EULAR classification criteria 2016 PSjD criteria before screening; clinESSDAI ≥ 6 at screening; Anti-Ro/SS-A positive at central laboratory; Unstimulated [...] salivary flow (≥ 0.01 mL/min) Exclusion Criteria: Secondary (also referred to as associated) Sjögren's disease, wheredefined as overlap with another confirmed autoimmune rheumatic or systemic inflammatory condition (eg [...] atoid arthritis, systemic lupus erythematosus, scleroderma, andor idiopathic inflammatory bowel disease) is the primary diagnosis.myopathy Active fibromy [...] [...]
2025-06-11
Study Identification, Study Status, Contacts/Locations v4
Start date2024-12-04→2025-01-15
Study sites5→104
Study titlerevised
A Study of the Efficacy and Safety of Efgartigimod in Patients withWith Primary Sjögren's Syndrome
2025-01-27
Study Status v3
Re-verified, no change to tracked fields
2025-01-16
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-12→confirmed 2024-12-04
Study sites0→5
Study titlerevised
A Study of the Efficacy and Safety of Efgartigimod in Patients Withwith Primary Sjögren's Syndrome
2024-11-15
Study Identification, Study Status, Oversight, Conditions v1
Study titlerevised
A Study of the Efficacy and Safety of Efgartigimod in Patients withWith Primary Sjögren's Syndrome
2024-11-10
Original filing
Argenx
56 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT06684847
Lead Sponsor argenx
Conditions Primary Sjogrens Disease
Enrollment 631 participants
Start Date 2025-01-15
Primary Completion 2027-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-16