A Study of the Efficacy and Safety of Efgartigimod in Patients with Primary Sjogren's Syndrome (PSjD)

JRCT ID: jRCT2031240584

Registered date:26/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Primary Sjogren's Disease
• Date of first enrollment: 26/12/2024
• Target sample size: 30
• Countries of recruitment: U.S.,Japan,EU,Japan,Asian countries,Japan,(about 38 countries),Japan
• Study type: Interventional
• Intervention(s): Eligible patients will be randomized (1:1 ratio) to receive either of efgartigimod PH20 SC or matching placebo in a double-blind fashion for 48 weeks. Participants completing the double-blinded treatment period will receive open-label efgartigimod PH20 SC.

Outcome(s)

• Primary Outcome: Change from baseline in clinESSDAI at week 48

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude criteria

-Secondary Sjogren'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.
diverticular disease associated with colitis, or microscopic colitis.
-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 <= 24 weeks prior to screening
-Anti-CD20 or anti-CD19 antibody received < 6 months before screening

Related Information

• Primary Sponsor: Asahi Yo
• Secondary ID(s): NCT06684847