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

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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

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