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

Research Study on Investigational Medication for Primary Sjogren's Syndrome

Recruiting
18 years - 75 years
All
Phase 2
163 participants needed
1 Location

Brief description of study

The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Sjogren's Syndrome
  • Age: 18 years - 75 years
  • Gender: All

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 (results either obtained during screening or documented in the participant's medical history are acceptable to fulfill these criteria for Schirmer's test, unstimulated salivary flow test, ocular staining score, or labial salivary gland biopsy), 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 A [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 to be up to date on all age-appropriate vaccinations prior to screening per routine local medical guidelines. It is strongly recommended that participants will have completed a locally-approved (or emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccination regimen at least 2 weeks prior to study related visits or procedures. Study participants should, follow 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

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) 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 sponsor's representative, are likely to interfere with the investigator's ability to assess pSS manifestations

The purpose of this study is to investigate the safety and usefulness of an investigational medication for treating adults with Primary Sjogren's Syndrome (pSS). This study evaluates how the investigational medication affects people with pSS in terms of safety and effectiveness. Researchers aim to gather information on how well the medication works in managing the symptoms of pSS.

  • Who can participate: Adults diagnosed with Primary Sjogren's Syndrome for at least 26 weeks and who have positive Anti-SSA antibodies may be eligible to participate.
  • Study details: Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study timelines and visits: The study will last 36 weeks. The study requires 15 visits.
Updated on 31 May 2026. Study ID: 851616

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