What side effects are associated with this type of intervention?

Common treatments for Inclusion Body Myositis (IBM) include immunosuppressive therapies and intravenous immune globulin (IVIG). Immunosuppressive therapies can lead to side effects such as increased susceptibility to infections, liver toxicity, and gastrointestinal issues. IVIG treatment is generally well-tolerated but can cause headaches, fever, chills, and, in rare cases, more severe reactions like aseptic meningitis or thromboembolic events. Experimental treatments, like those being studied in the ABC008 trial, may have unique side effects that are not yet fully understood.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Inclusion Body Myositis (IBM). The management of IBM typically involves supportive care and physical therapy to maintain muscle function. Some off-label treatments, such as immunosuppressive drugs and intravenous immunoglobulin (IVIG), have been explored, but their efficacy is limited. The trial of ABC008 represents ongoing research efforts to find effective therapies for IBM.

What other types of research exist?

Based on the provided context, there are no specific alternatives to ABC008 mentioned for Inclusion Body Myositis. However, exploring treatments targeting similar pathways or mechanisms in related muscle or neurodegenerative diseases, such as HDAC6 inhibitors (e.g., ACY-738, ACY-775, ACY-1215) used in Charcot-Marie-Tooth Disease, might offer potential. Consulting with a healthcare provider for the latest clinical trials and research specific to IBM is recommended.

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ABC008 for Inclusion Body Myositis

Phase 2 & 3

Waitlist Available

Research Sponsored by Abcuro, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day 1) through study completion, an average of 80 weeks.

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Potential side effects of ABC008 aren't specified here but typically include reactions at the injection site, general discomfort, possible immune system responses, or other drug-specific effects that would be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) through study completion, an average of 80 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day 1) through study completion, an average of 80 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) through study completion, an average of 80 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A - To determine the safety and tolerability of recurrent dosing of ABC008 in subjects with IBM at 2 SC dose levels.

Part B - To determine the efficacy of ABC008 in IBM at two SC dose levels as measured by IBM Functional Rating Scale (IBMFRS) at Week (W)76

Secondary study objectives

Part A - Adverse Events of Special Interest (AESI)

Part A - Clinically significant changes in standard laboratory parameters, vital signs, and ECGs

Part A - Treatment Emergent Adverse Events (TEAEs) onset within 24 hours of Study Medication Administration.

+6 more

Trial Design

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Inclusion Body Myositis (IBM) is commonly treated with immunosuppressive and immunomodulatory therapies, although their efficacy varies. Treatments like intravenous immunoglobulin (IVIG) and rituximab work by modulating the immune system to reduce inflammation and muscle damage. IVIG provides a broad spectrum of antibodies that can neutralize autoantibodies and modulate immune responses, while rituximab targets B-cells to reduce autoantibody production. These mechanisms are crucial for IBM patients as they aim to slow disease progression and improve muscle strength and function, addressing the autoimmune component of IBM.

ICU-acquired weakness.[Thoracoabdominal muscle involvement in anti-PL-7 myopathy revealed by whole-body magnetic resonance imaging].P2RX7 purinoceptor: a therapeutic target for ameliorating the symptoms of duchenne muscular dystrophy.