Trials / Completed
CompletedNCT04968912
A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 163 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Placebo | Placebo infusion will be administered intravenously. |
| DRUG | Nipocalimab | Nipocalimab dose 1 and dose 2 infusions will be administered intravenously. |
| DRUG | Standard of Care Treatment | Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally. |
Timeline
- Start date
- 2021-09-21
- Primary completion
- 2023-10-23
- Completion
- 2023-11-30
- First posted
- 2021-07-20
- Last updated
- 2025-11-05
Locations
69 sites across 10 countries: United States, France, Germany, Italy, Japan, Netherlands, Poland, Portugal, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04968912. Inclusion in this directory is not an endorsement.