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COMPLETED
NCT05721573
PHASE2/PHASE3

A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis

Sponsor: Abcuro, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

272

Start Date

2023-02-28

Completion Date

2025-11-27

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DRUG

ABC008

Given by subcutaneous injection

Locations (45)

Neuromuscular Research Center

Phoenix, Arizona, United States

University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center

Irvine, California, United States

Keck Hosptial of USC

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, California, United States

Stanford Neuroscience Medical Center

Palo Alto, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado Hospital Anschutz Outpatient Pavillion

Aurora, Colorado, United States

Yale School of Medicine

New Haven, Connecticut, United States

Mayo Clinic

Jacksonville, Florida, United States

Northwestern Memorial Hospital, Department of Neurology (Clinic)

Chicago, Illinois, United States

University of Kansas Medical

Kansas City, Kansas, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Neuromuscular Diagnostic Center - Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Womens Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Hospital for Special Surgery

New York, New York, United States

Columbia University Medical Center / The Neurological Institute of New York

New York, New York, United States

Duke Neurological Disorders Clinic -1L

Durham, North Carolina, United States

Wake Forrest School of Medicine

Winston-Salem, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

UPMC Arthritis and Autoimmunity Center, Falk Clinic

Pittsburgh, Pennsylvania, United States

Austin Neuromuscular Center

Austin, Texas, United States

Texas Neurology

Dallas, Texas, United States

Nerve and Muscle Center of Texas

Houston, Texas, United States

Virginia Commonwealth University

Henrico, Virginia, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Perron Institute for Neurological and Translational Science

Nedlands, Western Australia, Australia

AZ Sint-Lucas & Volkskliniek

Ghent, Belgium

Heritage Medical Research Clinic - University of Calgary

Calgary, Alberta, Canada

Genge Partners Inc.

Montreal, Quebec, Canada

Hospital Pitie-Salpetriere - AP-HP

Paris, France

Krankenhaus und Poliklinik Rüdersdorf GmbH

Berlin, Germany

University Hosptial Duesseldorf

Düsseldorf, Germany

University College London Hospitals NHS Foundation Trust, National Hospital for Neurology and Neurosurgery (NHNN)

London, United Kingdom

Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

Salford, United Kingdom