A Dose Response Study of E6011 in Participants With Rheumatoid Arthritis Inadequately Responding to Methotrexate

Phase 2 Completed 273 enrolled Eisai Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study in rheumatoid arthritis participants inadequately responding to methotrexate.

Timeline

Start: 2016-10-20
Primary completion: 2018-02-28
Completion: 2019-09-17

Outcome

Missed primary endpoint

paper A significant difference from placebo was not found in ACR20 response rates at week 12 PMID 33038062 ↗

paper although the primary end point was not met. PMID 33038062 ↗

Publications

Tanaka Y, Takeuchi T, Yamanaka H, Nanki T, Umehara H, Yasuda N, Tago F, Kitahara Y, Kawakubo M, Torii K, Hojo S, Kawano T, Imai T. Efficacy and Safety of E6011, an Anti-Fractalkine Monoclonal Antibody, in Patients With Active Rheumatoid Arthritis With Inadequate Response to Methotrexate: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Study. Arthritis Rheumatol. 2021 Apr;73(4):587-595. doi: 10.1002/art.41555. Epub 2021 Feb 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	QUETMOLIMAB	Monoclonal antibody	100 mg	Subcutaneous
Subject	QUETMOLIMAB	Monoclonal antibody	200 mg	Subcutaneous