Phase 2 Study of Intravenous RSLV-132 to Treat Moderate to Severe Symptoms of Primary Sjgrens Syndrome in Adult Women

What this Trial Is About

Researchers are evaluating the effects of RSLV-132 in adult females with Primary Sjgren Syndrome pSS, a condition characterized by symptoms like fatigue, dryness, and pain. This Phase 2 clinical trial aims to determine if RSLV-132 improves these key symptoms, assess its safety, and study immune responses and blood levels of the drug over time. The study compares RSLV-132 to a placebo to understand its impact on symptom relief and safety in participants with moderate to severe symptom burden. Participants receive intravenous infusions of either 10 mgkg RSLV-132 or a placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155, covering a total of 22 weeks of treatment. This double-blind, randomized study includes regular clinic visits weekly for the first two weeks, then every two weeks until the end of treatment, with a final follow-up visit at Day 211. Each infusion and visit involves monitoring and assessments to track progress and responses. During the study, participants will record their symptoms daily using an electronic device and attend scheduled clinic visits for check-ups, tests, and questionnaires. Researchers will assess fatigue and tiredness, measure drug levels and immune responses in blood samples, and monitor for any adverse events throughout and after treatment. The main outcome focuses on the evaluation of key symptoms of Sjgrens disease, with safety and immune response also closely observed until Day 211.

A Study of RSLV-132 in Females With Sjögren's Disease