Evaluating RSLV-132 for treating symptoms of Sjögren's Syndrome in women
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
This study is testing if a new treatment called RSLV-132 can help women with Sjögren's Syndrome feel better by reducing symptoms like fatigue, dryness, and pain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Resolve Therapeutics Industry-sponsored |
| Locations | 24 sites (Chula Vista, California and 23 other locations) |
| Trial ID | NCT06440525 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to determine the effectiveness of RSLV-132 in alleviating symptoms associated with Primary Sjögren Syndrome (pSS) in adult females. Participants will receive either RSLV-132 or a placebo over a 22-week period, with weekly clinic visits for the first two weeks and bi-weekly visits thereafter. The study will assess improvements in symptoms such as fatigue, dryness, and pain, as well as monitor the safety and immune response to the treatment. Daily symptom recording will also be conducted using an electronic device.
Who should consider this trial
Good fit: Ideal candidates for this study are adult females diagnosed with Primary Sjögren Syndrome who meet specific inclusion criteria.
Not a fit: Patients with active autoimmune diseases other than Sjögren's Syndrome or those with uncontrolled hypothyroidism may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from Sjögren's Syndrome by reducing debilitating symptoms.
How similar studies have performed: While this approach is focused on RSLV-132, similar studies targeting symptom relief in Sjögren's Syndrome have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chula Vista, California and 23 other locations
- Resolve Clinical Site — Chula Vista, California, United States (Recruiting)
- Resolve Clinical Site — Tustin, California, United States (Recruiting)
- Resolve Clinical Site — Boca Raton, Florida, United States (Recruiting)
- Resolve Clinical Site — Boynton Beach, Florida, United States (Recruiting)
- Evolution Research Center — Hialeah, Florida, United States (Recruiting)
- GNP Research — Hollywood, Florida, United States (Recruiting)
- Resolve Clinical Site — Miami, Florida, United States (Recruiting)
- Life Medical Research — Miami Gardens, Florida, United States (Recruiting)
- Resolve Clinical Site — Chicago, Illinois, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Tufts College — Boston, Massachusetts, United States (Recruiting)
- Resolve Clinical Site — Albuquerque, New Mexico, United States (Recruiting)
- Joint and Muscle Research Institute — Charlotte, North Carolina, United States (Recruiting)
- Arthritis and Osteoporosis Consultants of the Carolinas — Charlotte, North Carolina, United States (Recruiting)
- Onsite Clinical Solutions — Salisbury, North Carolina, United States (Recruiting)
- Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States (Recruiting)
- Resolve Clinical Site — Nashville, Tennessee, United States (Recruiting)
- Resolve Clinical Site — Austin, Texas, United States (Recruiting)
- Resolve Clinical Site — Katy, Texas, United States (Recruiting)
- Resolve Clinical Site — McKinney, Texas, United States (Recruiting)
- Accurate Clinical Research — Richmond, Texas, United States (Recruiting)
- Resolve Clinical Site — San Antonio, Texas, United States (Recruiting)
- Metrodora Institute — Salt Lake City, Utah, United States (Recruiting)
- Arthritis Northwest — Spokane, Washington, United States (Recruiting)
Study contacts
- Study coordinator: PatientWing https://app.patientwing.com/campaign/clinicaltrials.gov
- Email: studies@patientwing.com
- Phone: (213) 459-2979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.