NCT07409103

A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ELV001 as Add-on Therapy in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Elevara Medicines Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 randomized, double-blind, placebo-controlled study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit. Approximately 180 participants are planned to be enrolled. The number of participants can be extended to maximally 220 to account for dropouts during the study.

Detailed description

The study has 4 study arms: placebo, 25mg, 75mg and 125mg. The study includes a 4 weeks screening period, a double blind placebo controlled period (weeks 0 to 12), a treatment extension (weeks 12 to 24) and a 4 week safety follow-up.

Conditions

• Active Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	ELV001 25 mg	25mg from week 0 to week 12 then ELV001 75mg or 125mg per day from week 12 to week 24
DRUG	ELV001 75 mg	75mg from week 0 to week 24
DRUG	ELV001 125 mg	125mg from week 0 to week 24
DRUG	Placebo	Placebo from week 0 to week 12, then ELV001 75mg or 125mg per day from week 12 to week 24.

Timeline

• Start date: 2026-01-31
• Primary completion: 2027-04-15
• Completion: 2028-03-31
• First posted: 2026-02-13
• Last updated: 2026-02-13