ABC008-IBM-201
Research type
Research Study
Full title
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
IRAS ID
1007255
Contact name
Janaki Subramanyam
Contact email
Sponsor organisation
Abcuro Inc.
Eudract number
2022-003118-35
Clinicaltrials.gov Identifier
5721573
Research summary
Inclusion Body Myositis (IBM) is an inflammatory autoimmune disorder of skeletal muscle resulting in progressive limb weakness and loss of function. 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 ABC008 has been designed to bind to KLRG1 and then to reduce the number of these harmful immune cells present in people with IBM.
There are no approved treatments for IBM. The purpose of this study is to see if ABC008 is safe and possibly effective in treating people with IBM. The study drug ABC008 may help to improve outcomes for people with IBM.
This is a randomised, double-blind, placebo-controlled, multicenter study. This study will have 3 parts. Part A have completed enrolment of 30 participants who received 3 doses of study treatment at 8-week intervals and were watched for side effects or safety concerns. Part A was only opened to United States. United Kingdom will not be participating in Part A, but only in Part B and C.
Part B will enrol 201 more participants who will receive 10 doses of study treatment once every 8 weeks until the last dose on week 72. Participation in this study will last about 85 weeks with Part C, an extended period of evaluation to monitor and assess the effect of ABC008 on the disease after the study treatment has stopped.REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0731
Date of REC Opinion
12 Oct 2023
REC opinion
Further Information Favourable Opinion