Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Sjogren's syndrome is a chronic, progressive autoimmune disease of unclear etiology typically originating in exocrine glands and capable of affecting the function of almost any organ system in the body. Nipocalimab is a fully human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal fragment crystallizable receptor (FcRn). Nipocalimab blocks the binding site for IgG on FcRn, leads directly to increased IgG catabolism and a decrease in circulating IgG antibody concentrations, including pathogenic IgG antibody concentrations, and directly inhibits inflammatory cellular responses to these pathogenic IgG. Therefore, Nipocalimab may successfully treat pSS and improve disease manifestations. The study will consist of Screening Period (less than or equal to [<=] 6 Weeks), Double-blind Treatment Period (24 Weeks), and a Follow-up Period (6 Weeks). Key safety assessments will include adverse events (AEs), serious adverse events (SAEs), adverse events of special interests (AESIs), clinical laboratory safety tests (hematology, chemistry, urinalysis, and lipid profile) and vital signs. The total duration of the study is up to 36 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04968912
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Completed
Phase Phase 2
Start date September 21, 2021
Completion date November 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03203382 - Corneal Nerve Structure in Sjogren's
Completed NCT00809003 - Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease N/A
Completed NCT00023491 - Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells N/A
Completed NCT05005806 - Fish Oil (Omega 3 ) in Sjogren's Syndrome Phase 2/Phase 3
Enrolling by invitation NCT03436576 - Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye Phase 3
Terminated NCT04143841 - Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease N/A
Completed NCT03611283 - Topical Management of Xerostomia With Dry Mouth Products N/A
Recruiting NCT06104124 - A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity Phase 3
Recruiting NCT05115487 - Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome
Recruiting NCT06437652 - An AI Algorithm for Lymphocyte Focus Score of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren's Syndrome
Recruiting NCT05383677 - Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome Phase 2
Not yet recruiting NCT03938207 - Dry Eye Syndrome, Healthy Control, Sjögren's Syndrome and Other Inflammation Disease in Taiwan Biobank
Completed NCT04546542 - Hydroxychloroquine Blood Levels in Primary Sjögren Syndrome Patients
Completed NCT04239521 - The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
Recruiting NCT05085431 - A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome Early Phase 1
Completed NCT00565526 - Evaluation of the Role of the Autonomic Nervous System in Sj(SqrRoot)(Delta)Gren s Syndrome
Completed NCT01369589 - An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness Phase 1/Phase 2
Completed NCT00001953 - The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers N/A
Completed NCT00001731 - Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops Phase 2