Evaluating efgartigimod for treating Primary Sjögren's Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Clinicaltrials@argenx.com
• Phone: 857-350-4834

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.