ABC008 for Inclusion Body Myositis

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Abcuro, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called ABC008 to help people with Inclusion Body Myositis, a muscle disease with few treatment options. The drug may work by affecting certain immune cells. Researchers will check if it improves muscle strength and quality of life.

Eligibility Criteria

This trial is for adults over 40 with Inclusion Body Myositis who can walk and rise from a chair unassisted. They must weigh between 40-150 kg and meet specific diagnostic criteria. Excluded are those with other myopathies, severe arthritis affecting assessments, or autoimmune diseases like lupus or rheumatoid arthritis.

Treatment Details

The study tests ABC008's effectiveness and safety in treating Inclusion Body Myositis. Participants will be randomly assigned to receive either ABC008 or a placebo without knowing which one they're getting (double-blind).

3Treatment groups

Active Control

Placebo Group

Group I: 2.0 mg/kg ABC008Active Control1 Intervention

Part A - ABC008 N=12 Part B - ABC008 N= 67

Group II: 0.5 mg/kg ABC008Active Control1 Intervention

Part A - ABC008 N=12 Part B - ABC008 N= 67

Group III: PlaceboPlacebo Group1 Intervention

Part A - Placebo N= 6 Part B - Placebo N= 67