Efficacy and Safety of SA001 in Patients with Primary Sjogren's Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

ABSTRACT: Background/Objectives: SA001, a mofetil-ester prodrug of rebamipide, was developed to enhance gastrointestinal absorption and systemic exposure, which was confirmed in a prior Phase 1 study. Given the limited efficacy of current symptomatic therapies for primary Sjögren's syndrome (pSS), this trial aimed to assess whether the improved bioavailability of SA001 could translate into clinical benefits. Methods: This multicenter, randomized, double-blind, placebo-controlled Phase 2a study enrolled adults who met the 2016 ACR-EULAR criteria for pSS. The participants were randomly assigned to one of four groups: SA001 at 360, 720, or 1080 mg/day (administered twice daily for 8 weeks) or placebo. Exploratory ocular assessments included tear break-up time, ocular surface staining, the

SUBMITTER: Park J 

PROVIDER: S-EPMC12844686 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature