A Study of RSLV-132 in Females With Sjögren's Disease
Purpose
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
Condition
- Primary Sjögren Syndrome
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RSLV-132 |
Intravenous infusions of 10 mg/kg RSLV-132 solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment |
|
|
Placebo Comparator Placebo |
Intravenous infusions of placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment |
|
Recruiting Locations
Charlotte, North Carolina 28204
Charlotte, North Carolina 28208
Duncansville, Pennsylvania 16635
More Details
- Status
- Recruiting
- Sponsor
- Resolve Therapeutics
Study Contact
PatientWing https://app.patientwing.com/campaign/clinicaltrials.gov(213) 459-2979
studies@patientwing.com