A Phase 1 Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM)

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, ascending dose study for adult patients with inclusion body myositis (IBM).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abcuro, Inc.

Criteria

Key Inclusion Criteria:

• Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, or probable IBM according to the European Neuromuscular Center (ENMC) IBM 2011

• Able to arise from a chair (with or without armrests) without support from another person or device

• Able to ambulate at least 20 feet / 6 meters with or without assistive device

Exclusion Criteria:

• Taking > 7.5 mg prednisolone (or equivalent) or on intravenous immunoglobulin (IVIg) or other immunosuppressants within the last 3 months. Topical, nasal, and ocular corticosteroids are allowed unless they are being widely applied or the severity of the underlying condition makes them unsuitable in the Investigator's opinion. Local steroid injections are allowed