ABC008 for Inclusion Body Myositis

Recruiting at44 trial locations

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.

Research Team

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.

Inclusion Criteria

I can walk 3 meters and sit down by myself, using aids if needed but without another person's help.

I have been diagnosed with IBM as per ENMC criteria and have histopathology results.

I am over 40 years old.

Exclusion Criteria

I have a condition that makes it hard to measure my muscle strength or do physical tests.

I have an autoimmune disease but it's not severe and under control.

I do not have any muscle conditions other than IBM.

Treatment Details

Interventions

• ABC008 (Other)

Trial Overview 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).

Participant Groups

Group I: 2.0 mg/kg ABC008 Active Control 1 Intervention

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

Group II: 0.5 mg/kg ABC008 Active Control 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Abcuro, Inc.

Lead Sponsor

Trials

4

Recruited

540+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Costa Panagos

Syneos Health

Chief Executive Officer

Bachelor's degree in a relevant field (specific details not available)

Suma Ramadas

Syneos Health

Chief Medical Officer since 2022

PhD in a relevant field (specific details not available)