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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
106
Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1)
0.9% sodium chloride solution
Resolve Clinical Site
Chula Vista, California, United States
RECRUITINGResolve Clinical Site
Tustin, California, United States
RECRUITINGResolve Clinical Site
Boca Raton, Florida, United States
RECRUITINGResolve Clinical Site
Boynton Beach, Florida, United States
RECRUITINGEvolution Research Center
Hialeah, Florida, United States
RECRUITINGGNP Research
Hollywood, Florida, United States
RECRUITINGResolve Clinical Site
Miami, Florida, United States
RECRUITINGLife Medical Research
Miami Gardens, Florida, United States
RECRUITINGResolve Clinical Site
Chicago, Illinois, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITING...and 14 more locations
Assessment of cardinal symptoms of Sjogren's
Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument
Time frame: Measured daily from at least 7 days prior to first dose until 169 days after the first dose
Tiredness/fatigue assessment
Change from baseline in the Patient Reported Outcomes Measurement Information System Fatigue Short Form 10a (PROMIS SF10a) on Day 169
Time frame: Measured from before the first dose until Day 169
RSLV-132 pharmacokinetics
Serum concentrations of RSLV-132 using an assay measuring RNAse enzyme activity
Time frame: Measured from before the first dose until Day 211
RSLV-132 immunogenicity
Presence of antibodies to RSLV-132 measured using an immunoassay
Time frame: Measured from before the first dose until Day 211
Adverse events
Incidence of serious and non-serious adverse events
Time frame: From the first dose of Investigational Product until Day 211
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