Status:
COMPLETED
A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
Lead Sponsor:
Resolve Therapeutics
Collaborating Sponsors:
University Hospital Birmingham
Newcastle-upon-Tyne Hospitals NHS Trust
Conditions:
Sjogren's Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 syn...
Detailed Description
This is a multi-center, double-blind, placebo-controlled study to evaluate the impact of 8 intravenous infusions of RSLV-132 in 28 patients with primary Sjogren's syndrome. Each of the subjects will b...
Eligibility Criteria
Inclusion
- Meet 4 of 6 criteria of 2002 American-European Consensus Group (AECG) criteria for Primary Sjogren's Syndrome
- Presence of anti Ro autoantibodies
- Presence of interferon signature
Exclusion
- Use fo hydroxychloroquine within 30 days of baseline
- Use of cyclophosphamide within 180 days of baseline
- Use of oral corticosteroids greater than 10 mg/day
- Known IgG4-related disease
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03247686
Start Date
February 1 2017
End Date
August 1 2019
Last Update
April 2 2021
Active Locations (2)
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1
University Hospitals Birmingham
Birmingham, Edgbaston, United Kingdom, B16 6TT
2
Newcastle upon Tyne Hospitals
Newcastle upon Tyne, Gosforth, United Kingdom, NE3 3HD