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A Study of RSLV-132 in Females With Sjögren's Disease
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
Who can join
Ages 18 to 75 · Women
Full eligibility criteria
Inclusion Criteria: * Providing written informed consent * Weight at least 45 kg * Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for pSS * Diagnosis in the last 30 years * Positive anti-Ro/SSA antibody test * Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scale and the ESSPRI fatigue scale * Of non childbearing potential or of childbearing potential and using highly effective contraceptive measures Exclusion Criteria: * Diagnosis of any active autoimmune disease other than pSS that could affect the efficacy assessments * Uncontrolled hypothyroidism or severe fibromyalgia * New medications or change in medications in the last 4 weeks for pSS symptoms * Receipt of other prohibited medications * Apheresis or blood donation * Allergic reaction to RSLV-132 or biologic therapy * Clinically significant infection in last 30 days * Participation in another clinical study * Malignancy in last 5 years * Positive test for HIV or hepatitis * Major surgery in last 30 days or anticipated surgery during the study * Pregnancy or breast feeding * Laboratory blood tests outside of specified ranges * Other medical conditions or medications that would make the participant unsuitable
About the study
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
What is being tested
- RSLV-132 (drug)
- Placebo (drug)
Sponsor: Resolve Therapeutics · Participants: 106 · Started: Dec 1, 2024
Contact the study team
- PatientWing https://app.patientwing.com/campaign/clinicaltrials.gov · Phone: (213) 459-2979
Official record on ClinicalTrials.gov — NCT06440525
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.