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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
4 participants needed
1 Location

Brief description of study

The research study is being conducted in about 150 adults with Primary Sjogren’s Syndrome(pSS). The purpose of this study is to see if the study drug nipocalimab is safe and useful for treating patients with pSS. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) for treating pSS.

Detailed description of study

There are many factors that determine if you are eligible. Some requirements include:
- Diagnosis o Primary Sjogren's Syndrome for at least 26 weeks prior to screening visit. 
- Positive Anti-SSA antibodies (this can be tested for at screening)

You would be in the study for about 36 weeks and visit the study site 15 times for tests and assessments. 

You would be randomly assigned to receive either nipocalimab or placebo (saline) which will be administered through an IV into a vein. This is a double-blind study, which means that you and the study team will not know which group you are in.

We will use your personal health information, information from the tests and procedures done for the study, and information about how the study drug affects you to help determine if the study drug nipocalimab is safe and effective in treating pSS.



Eligibility of study

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

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


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 09 Apr 2026. Study ID: 851616

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