A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The present study will examine the role of circulating RNA complexed with autoantibodies and immune complexes and its role in activation of inflammatory pathways in patients with primary Sjogren's syndrome. The study will be conducted in a subset of Sjogren's patients who have elevated levels of autoantibodies and a pattern of elevated interferon-stimulated gene expression in blood cells. A number of biochemical and clinical parameters will be analyzed to determine the potential therapeutic utility of nuclease therapy in Sjogren's syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Resolve Therapeutics
• Collaborators: Newcastle-upon-Tyne Hospitals NHS Trust; University Hospital Birmingham

Criteria

Inclusion Criteria:

1. Meet 4 of 6 criteria of 2002 American-European Consensus Group (AECG) criteria for Primary Sjogren's Syndrome

2. Presence of anti Ro autoantibodies

3. Presence of interferon signature

Exclusion Criteria:

1. Use fo hydroxychloroquine within 30 days of baseline

2. Use of cyclophosphamide within 180 days of baseline

3. Use of oral corticosteroids greater than 10 mg/day

4. Known IgG4-related disease