A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Primary Sjogrens Disease
In brief
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.
Key facts
- Study ID
- NCT06684847
- Run by
- argenx
- People needed
- 631
- Starts
- 2025-01-15
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Arizona Arthritis & Rheumatology Research, PLLC — Sun City, Arizona, United States
- Arizona Arthritis & Rheumatology Research, PLLC — Tucson, Arizona, United States
- Providence Medical Foundation — Fullerton, California, United States
- Stanford University School of Medicine — Stanford, California, United States
- University of Colorado — Aurora, Colorado, United States
- Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
- Centre for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida, United States
- Finlay Medical Research Corp — Greenacres City, Florida, United States
- University of Florida College of Medicine Jacksonville — Jacksonville, Florida, United States
- Life Clinical Trials — Margate, Florida, United States
- Clinical Research of West Florida, Inc. — Tampa, Florida, United States
- Conquest Research — Winter Park, Florida, United States
- Piedmont Healthcare, Inc. — Atlanta, Georgia, United States
- St. Luke's Clinic - Rheumatology — Boise, Idaho, United States
- Chicago Clinical Research Institute — Chicago, Illinois, United States
- Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research — Chicago, Illinois, United States
- Chicago Arthritis & Regenerative Medicine — Chicago, Illinois, United States
- Greater Chicago Specialty Physicians LLC — Orland Park, Illinois, United States
- Arizona Arthritis & Rheumatology Research, PLLC — Willowbrook, Illinois, United States
- Lake Cumberland Rheumatology — New Albany, Indiana, United States
- University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
- Accurate Clinical Research Inc. — Lake Charles, Louisiana, United States
- The Johns Hopkins Hospital — Baltimore, Maryland, United States
- Arthritis and Rheumatism Associates — Rockville, Maryland, United States
- One of a Kind Clinical Research Center LLC — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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