A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)

NCT03191526 ↗

Phase 3 Terminated 66 enrolled Kyowa Kirin, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to assess the efficacy and safety of KW-0761 after intravenous injections in subjects with HTLV-1 associated myelopathy (HAM) in Japan.

Timeline

Start: 2017-05-22
Primary completion: 2019-06-06
Completion: 2021-08-31

Outcome

Missed primary endpoint

Stopped: “Due to not achieving the primary outcome.”

paper At the end of the double-blind period, no significant difference was found in the OMDS improvement rate PMID 38430272 ↗

Publications

Sato T, Nagai M, Watanabe O, Misu T, Takenouchi N, Ohkubo R, Ishihara S, Tsuboi Y, Katsuno M, Nakagawa M, Matsushita T, Aso Y, Matsuura E, Tokashiki T, Mukaino A, Adachi H, Nakanishi K, Yamaguchi Y, Yamaguchi S, Yamano Y. Multicenter, randomized, double-blind, placebo-controlled phase 3 study of mogamulizumab with open-label extension study in a minimum number of patients with human T-cell leukemia virus type-1-associated myelopathy. J Neurol. 2024 Jun;271(6):3471-3485. doi: 10.1007/s00415-024-12239-x. Epub 2024 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mogamulizumab	Monoclonal antibody	0.3 mg/kg	Intravenous