Phase 2/3Completed
A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABC008 in the Treatment of Subjects With Inclusion Body Myositis
- Sponsor
- Abcuro, Inc. (Industry)
- Enrolment
- 272 enrolled
- Conditions
- Inclusion Body Myositis
- Interventions
- ABC008
- Ages
- adults, older adults
- Registry
- NCT05721573
From the registry
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
Primary outcomes
- Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- Part A: Number of Participants With TEAEs by Severity
- Part A: Number of Participants With TEAEs Related to Study Drug
- Part A: Mean Change From Baseline in the Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score at Week 76