Overview
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
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