NCT06440525 · Resolve Therapeutics
A Study of RSLV-132 in Females With Sjögren's Disease
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
RSLV-132
Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1)
DRUG
Placebo
0.9% sodium chloride solution
Primary outcome measures
Assessment of cardinal symptoms of Sjogren's
Time frame: Measured daily from at least 7 days prior to first dose until 169 days after the first dose
Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chula Vista, California
- Tustin, California
- Boca Raton, Florida
- Boynton Beach, Florida
- Hialeah, Florida
- Hollywood, Florida
- Miami, Florida
- Miami Gardens, Florida
- Chicago, Illinois
- Iowa City, Iowa
- Boston, Massachusetts
- Albuquerque, New Mexico
And 11 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 18, 2025 · Source of record for eligibility and locations