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)

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.

Description

Eligibility

Age range

18–75 years

Sex

All

Healthy volunteers

No

Interventions

• 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.

Locations (29)