NL-OMON52271
Not yet recruiting
Phase 2
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)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Primary Sjögren's Syndrom
- Sponsor
- Janssen-Cilag
- Enrollment
- 4
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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