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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Primary Sjögren Syndrome

In brief

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

Key facts

Study ID

NCT06440525

Run by

Resolve Therapeutics

People needed

106

Starts

2024-12-01

Expected to finish

2027-03-01

Last updated by the study team

2025-07-18

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Resolve Clinical Site — Chula Vista, California, United States (enrolling)
• Resolve Clinical Site — Tustin, California, United States (enrolling)
• Resolve Clinical Site — Boca Raton, Florida, United States (enrolling)
• Resolve Clinical Site — Boynton Beach, Florida, United States (enrolling)
• Evolution Research Center — Hialeah, Florida, United States (enrolling)
• GNP Research — Hollywood, Florida, United States (enrolling)
• Resolve Clinical Site — Miami, Florida, United States (enrolling)
• Life Medical Research — Miami Gardens, Florida, United States (enrolling)
• Resolve Clinical Site — Chicago, Illinois, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Tufts College — Boston, Massachusetts, United States (enrolling)
• Resolve Clinical Site — Albuquerque, New Mexico, United States (enrolling)
• Joint and Muscle Research Institute — Charlotte, North Carolina, United States (enrolling)
• Arthritis and Osteoporosis Consultants of the Carolinas — Charlotte, North Carolina, United States (enrolling)
• Onsite Clinical Solutions — Salisbury, North Carolina, United States (enrolling)
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States (enrolling)
• Resolve Clinical Site — Nashville, Tennessee, United States (enrolling)
• Resolve Clinical Site — Austin, Texas, United States (enrolling)
• Resolve Clinical Site — Katy, Texas, United States (enrolling)
• Resolve Clinical Site — McKinney, Texas, United States (enrolling)
• Accurate Clinical Research — Richmond, Texas, United States (enrolling)
• Resolve Clinical Site — San Antonio, Texas, United States (enrolling)
• Metrodora Institute — Salt Lake City, Utah, United States (enrolling)
• Arthritis Northwest — Spokane, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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