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

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

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