A Study of RSLV-132 in Females With Sjögren's Disease
ConditionPrimary Sjögren Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorResolve Therapeutics
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RSLV-132
- Placebo
Treatment groups
106 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov