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 Sjogren's Disease

argenx BV0 个研究点目标入组 30 人开始时间: 待定最近更新: 2025年2月12日

试验速览

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•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)

•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

Change from baseline in clinESSDAI at week 48

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发起方