Evaluating efgartigimod for treating Primary Sjögren's Syndrome

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

This study is testing a new treatment called efgartigimod to see if it can help people with moderate-to-severe Primary Sjögren's Syndrome feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 580 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: argenx (Industry-sponsored)
• Drugs / interventions: cyclophosphamide
• Locations: 5 sites (Clearwater, Florida and 4 other locations)
• Trial ID: NCT06684847 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of efgartigimod PH20 SC in patients suffering from moderate-to-severe Primary Sjögren's Disease. It features a double-blinded placebo-controlled treatment phase followed by an open-label treatment phase, with a total duration of approximately 105 weeks for participants. The study will include patients who meet specific criteria related to their condition and will monitor their response to the treatment compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with moderate-to-severe Primary Sjögren's Disease and meet specific clinical criteria.

Not a fit: Patients with secondary Sjögren's disease or those with severe systemic manifestations of the disease that are not well-controlled may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with Primary Sjögren's Syndrome by alleviating symptoms and disease severity.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies targeting autoimmune conditions have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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: ACR/EULAR classification criteria 2016 PSjD; clinESSDAI ≥ 6; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)

Exclusion Criteria:

* Secondary Sjögren's disease where another confirmed autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and inflammatory bowel disease) is the primary diagnosis.
* 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 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 this trial is running

Clearwater, Florida and 4 other locations

• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States (Recruiting)
• Chicago Clinical Research Institute — Chicago, Illinois, United States (Recruiting)
• Accurate Clinical Research Inc. — Lake Charles, Louisiana, United States (Recruiting)
• Accurate Clinical Management — Baytown, Texas, United States (Recruiting)
• Accurate Clinical Research, Inc. — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Sabine Coppieters, MD

Conditions Primary Sjogrens Disease