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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
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
Age
18 - 75 years
Sex
FEMALE
Healthy Volunteers
No
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
Start Date
December 1, 2024
Primary Completion Date
December 1, 2026
Completion Date
March 1, 2027
Last Updated
July 18, 2025
106
ESTIMATED participants
RSLV-132
DRUG
Placebo
DRUG
PatientWing https://app.patientwing.com/campaign/clinicaltrials.gov
CONTACT
(213) 459-2979studies@patientwing.comLead Sponsor
Resolve Therapeutics
NCT06528197
NCT04093531
NCT06049368
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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