A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) - A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)

Janssen-Cilag0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•Meets classification criteria for primary Sjogren's syndrome (pSS) by the 2016
•American College of Rheumatology (ACR) / European League Against Rheumatism
•(EULAR) at the time of screening and was diagnosed with pSS no less than 26
•weeks prior to screening
•- At screening is seropositive for antibodies to pSS-associated antigen A
•Ro/sjogren's syndrome-related antigen [SSA])
•- Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease
•Activity Index (clinESSDAI) score greater than or equal to (>=) 6
•- At least one abnormal laboratory marker of pSS-related inflammatory disease
•activity, and at least low activity in one or more specified European League
•Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) domains
•- It is recommended that participants are up to date on all age-appropriate
•vaccinations prior to screening as per routine local medical guidelines. For
•study participants who received locally-approved (and including emergency
•use-authorized) coronavirus disease 2019 (COVID-19) vaccines recently prior to
•study entry, applicable local vaccine labelling, guidelines, and
•standards-of-care for participants receiving immune-targeted therapy will be
•followed when determining an appropriate interval between vaccination and study
•enrollment.

•Has any confirmed or suspected clinical immunodeficiency syndrome not related
•to treatment of his/her pSS or has a family history of congenital or hereditary
•immunodeficiency unless confirmed absent in the participant
•- Comorbidities (for example, asthma, chronic obstructive pulmonary disease)
•which have required 3 or more courses of systemic glucocorticoids within the
•previous 12 months
•- Has any unstable or progressive manifestation of pSS that is likely to
•warrant escalation in therapy beyond permitted background medications
•and/or has severely active pSS
•- Has received oral cyclophosphamide within 3 months or intravenous (IV)
•cyclophosphamide within 6 months prior to first administration of study
•intervention
•- Has Sjogren's syndrome overlap syndromes where another confirmed autoimmune
•rheumatic or systemic inflammatory condition (for example, rheumatoid arthritis
•[RA], systemic lupus erythematosus [SLE], scleroderma, inflammatory bowel
•disease [IBD]) is the primary diagnosis or has clinical manifestations that, in
•the opinion of the investigator, or the sponsor or the sponsor's representative
•are likely to interfere with the investigator's ability to assess pSS
•manifestations

发起方