NCT06440525PHASE2Recruiting

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

Resolve Therapeutics

Start Date

12/1/2024

Completion Date

3/1/2027

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

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

United States

Arthritis Northwest

Spokane, Washington 99204

United States