A Study of RSLV-132 in Females With Sjögren's Disease (NCT06440525) | Clinical Trial Compass
RecruitingPhase 2
A Study of RSLV-132 in Females With Sjögren's Disease
United States106 participantsStarted 2024-12-01
Plain-language summary
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
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of cardinal symptoms of Sjogren's
Timeframe: Measured daily from at least 7 days prior to first dose until 169 days after the first dose