Proximod, a Selective Sphingosine-1-phosphate Receptor 1 Modulator in Patients With Moderate-to-severe Active Rheumatoid Arthritis: a Double-blind, Randomised, Placebo-controlled, Phase 2 Trial.

Summary

The goal of this multicenter, randomized, double-blind, placebo-controlled phase 2 clinical trial is to evaluate the efficacy and safety of proximod in active rheumatoid arthritis patients with inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). The main questions it aims to answer are: Evaluate the efficacy of different doses of proximod in active RA patients who have inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), and provide a basis for dose selection in the confirmatory phase III clinical study. Explore the changes of S1P and SPHK before and after treatment of proximod. Participants will take proximod 5mg/10mg daily or placebo for three months and will be followed up for 1 month.

Timeline

Start

2024-09-02

Primary completion

2025-10-09

Completion

2025-10-09

Drugs

Indications