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A Study of RSLV-132 in Females With Sjögren's Disease
Sponsor: Resolve Therapeutics
Summary
The goal of this clinical study is to learn if RSLV-132 improves the symptoms of SS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are: * Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain? * Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's? * What are the blood levels of RSLV-132 over time? * What is the immune (antibody) response in the body to RSLV-132? * What is the safety profile of RSLV-132? Researchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS. Participants will: Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants With Sjögren's Disease With Moderate to Severe Symptom Burden
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2024-12-01
Completion Date
2027-03-01
Last Updated
2025-07-18
Healthy Volunteers
No
Conditions
Interventions
RSLV-132
Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1)
Placebo
0.9% sodium chloride solution
Locations (24)
Resolve Clinical Site
Chula Vista, California, United States
Resolve Clinical Site
Tustin, California, United States
Resolve Clinical Site
Boca Raton, Florida, United States
Resolve Clinical Site
Boynton Beach, Florida, United States
Evolution Research Center
Hialeah, Florida, United States
GNP Research
Hollywood, Florida, United States
Resolve Clinical Site
Miami, Florida, United States
Life Medical Research
Miami Gardens, Florida, United States
Resolve Clinical Site
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Tufts College
Boston, Massachusetts, United States
Resolve Clinical Site
Albuquerque, New Mexico, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, United States
Onsite Clinical Solutions
Salisbury, North Carolina, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Resolve Clinical Site
Nashville, Tennessee, United States
Resolve Clinical Site
Austin, Texas, United States
Resolve Clinical Site
Katy, Texas, United States
Resolve Clinical Site
McKinney, Texas, United States
Accurate Clinical Research
Richmond, Texas, United States
Resolve Clinical Site
San Antonio, Texas, United States
Metrodora Institute
Salt Lake City, Utah, United States
Arthritis Northwest
Spokane, Washington, United States