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

Launched by ARGENX · Nov 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called efgartigimod for people with moderate-to-severe Primary Sjögren's Syndrome, which is an autoimmune condition that affects the glands that produce moisture in the body. The trial aims to find out if this treatment is effective and safe. It will involve two phases: a double-blinded phase where some participants receive the treatment and others receive a placebo (a dummy treatment), followed by an open-label phase where everyone will receive the treatment. The entire study will last about 105 weeks for participants.

To be eligible for this trial, participants need to be at least 18 years old and diagnosed with Primary Sjögren's Syndrome based on specific medical criteria. They must also have certain symptoms, like a specific level of disease activity and positive test results for certain antibodies. However, people with other autoimmune diseases or certain severe symptoms may not qualify. If enrolled, participants will have regular check-ups to monitor their health and how well the treatment is working. This study is currently recruiting participants of all genders between the ages of 18 and 74.

Gender

ALL

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: 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 Criteria:
• • 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