A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate

Phase 2 Completed 66 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate (MTX).

Timeline

Start: 2017-09-29
Primary completion: 2018-09-19
Completion: 2018-10-16

Outcome

Missed primary endpoint

paper In the primary efficacy analysis, ACR50-CRP response rates were 6.3% and 18.2% at week 12 in the ASP5094 and placebo groups, respectively; PMID 33087159 ↗

paper a difference of - 11.9, which was not significant (2-sided P value = 0.258). PMID 33087159 ↗

Publications

Takeuchi T, Tanaka Y, Erdman J, Kaneko Y, Saito M, Higashitani C, Smulders R, Lademacher C. ASP5094, a humanized monoclonal antibody against integrin alpha-9, did not show efficacy in patients with rheumatoid arthritis refractory to methotrexate: results from a phase 2a, randomized, double-blind, placebo-controlled trial. Arthritis Res Ther. 2020 Oct 21;22(1):252. doi: 10.1186/s13075-020-02336-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP5094	Monoclonal antibody	10 mg/kg	—