A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)
- Conditions
- Primary Sjögren's Syndromchronicprogressive autoimmune disease10003816
- Registration Number
- NL-OMON52271
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 4
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Measure: Change from Baseline in Clinical European League Against Rheumatism<br /><br>Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24<br /><br><br /><br>TimeFrame: Baseline to Week 24<br /><br><br /><br>Description: The clinESSDAI is a validated tool used in clinical studies to<br /><br>measure the systemic disease activity in participants with primary Sjogren*s<br /><br>syndrome. The clinESSDAI includes 11 domains divided into 3-4 activity levels,<br /><br>where zero represents no activity and low, medium, and high scores can vary in<br /><br>numerical value depending on the domain.</p><br>
- Secondary Outcome Measures
Name Time Method