NCT07335952

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	proximod 5mg daily	Patients will take proximod 5mg daily
DRUG	proximod 10mg daily	Patients will take proximod 10mg daily

Timeline

• Start date: 2024-09-02
• Primary completion: 2025-10-09
• Completion: 2025-10-09
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

20 sites across 1 country: China