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New treatment option for Primary Sjögren Syndrome
Official title A Study of RSLV-132 in Females With Sjögren's Disease
ClinicalTrials.gov ID: NCT06440525
What this study is testing
What is RSLV-132?
RSLV-132 is an investigational medicine, being studied as a potential treatment for primary sjögren syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 22 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join 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
You likely can't join if
- Diagnosis of any active autoimmune disease other than pSS that could affect the how well it works 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
See the full eligibility 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
- Diagnosis of any active autoimmune disease other than pSS that could affect the how well it works 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
The study team makes the final eligibility decision.
Where it's taking place
- Chula Vista, California, United States
- Tustin, California, United States
- Boca Raton, Florida, United States
- Boynton Beach, Florida, United States
- Hialeah, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Albuquerque, New Mexico, United States
- Charlotte, North Carolina, United States
- Salisbury, North Carolina, United States
- Duncansville, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Katy, Texas, United States
- McKinney, Texas, United States
- Richmond, Texas, United States
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 22 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chula Vista, California, United States; Tustin, California, United States; Boca Raton, Florida, United States; Boynton Beach, Florida, United States; Hialeah, Florida, United States; Hollywood, Florida, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.