Clinical Trial

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.

Study acronym: PROXIMA
Completed Phase 2
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07335952
Lead Sponsor Peking University People's Hospital
Conditions Rheumatoid Arthritis
Enrollment 179 participants
Start Date 2024-09-02
Primary Completion 2025-10-09 (estimated)
Study Completion 2025-10-09 (estimated)
Updated on ClinicalTrials.gov 2026-01-13