RecruitingPrimary Sjögren Syndrome

A Study of RSLV-132 in Females With Sjögren's Disease

Eligible age

18–75 yrs

Accepts

Women

Locations

12 states

Healthy volunteers

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About this 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

Sponsor: Resolve Therapeutics

You may qualify if…

✓ 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

You may not qualify if…

✕ 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