Long-term Extension Study of Ulviprubart (ABC008) in Subjects with Inclusion Body Myositis
Research type
Research Study
Full title
An Open-label, Multicenter Study to Evaluate the Long-term Safety and Efficacy of Ulviprubart (ABC008) in Subjects Who Have Completed a Trial of Ulviprubart for the Treatment of Inclusion Body Myositis
IRAS ID
1011438
Contact name
Janaki Subramanyam
Contact email
Sponsor organisation
Abcuro, Inc.
Eudract number
2024-517623-39
Research summary
Inclusion Body Myositis or IBM is an inflammatory autoimmune disorder of skeletal muscle resulting in limb weakness and loss of function that gets worse over time. This means harmful immune cells attack muscle, resulting in muscle weakness. These harmful immune cells have a molecule on their surface called KLRG1. The study drug ulviprubart (ABC008) has been designed to attach to KLRG1 and then to reduce the number of these harmful immune cells present in people with IBM.
ABC008-IBM-202 is an open-label, multicentre study for participants who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201. The purpose of this study is to see if long-term treatment with ulviprubart (ABC008) is safe and possibly effective in treating people with IBM. There are no approved treatments for IBM.
There are expected to be about 270 participants in this study. The study will take place at about 40 sites in the United States, Canada, Australia, Belgium, France, Germany, and the United Kingdom.
Participants will take part in this study for up to 3 years, or until drug approval.
Participants will be required to have up to 21 hospital visits to assess their health, disease, and for study treatment. Some of these visits may be able to be a telephone call, if home administration of study drug is available later in the study. The study drug is given through an injection into the body.REC name
Wales REC 3
REC reference
25/WA/0048
Date of REC Opinion
28 Mar 2025
REC opinion
Further Information Favourable Opinion