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

NCT03247686 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-04-02

Study results available
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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.

Conditions

  • Sjogren's Syndrome

Interventions

DRUG

RSLV-132

RNase Fc fusion protein

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • University Hospital Birmingham

    collaborator OTHER

  • Newcastle-upon-Tyne Hospitals NHS Trust

    collaborator OTHER

  • Resolve Therapeutics

    lead INDUSTRY

Principal Investigators

  • James Posada, Ph.D. · Resolve Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-07-15
Completion
2019-08-01
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03247686 on ClinicalTrials.gov