Status:
RECRUITING
A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
Lead Sponsor:
argenx
Conditions:
Primary Sjogrens Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Is at least 18 years of age and the local legal age of consent for clinical studies when 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 residual salivary flow (≥ 0.01 mL/min)
Exclusion
- Secondary (also referred to as associated) Sjögren's disease, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy
- Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
- Any severe systemic pSjD manifestation that is not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator's opinion.
- Use of cyclophosphamide ≤ 24 weeks prior to screening
- Anti-CD20 or anti-CD19 antibody received \< 6 months before screening
Key Trial Info
Start Date :
January 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT06684847
Start Date
January 15 2025
End Date
July 1 2028
Last Update
February 27 2026
Active Locations (300)
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1
One of a Kind Clinical Research Center LLC
Scottsdale, Arizona, United States, 85258
2
Arizona Arthritis & Rheumatology Research, PLLC
Sun City, Arizona, United States, 85351
3
Arizona Arthritis & Rheumatology Research, PLLC
Tucson, Arizona, United States, 85748
4
Providence Medical Foundation
Fullerton, California, United States, 92835