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ACTIVE NOT RECRUITING
NCT06450886
PHASE2/PHASE3

Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis

Sponsor: Abcuro, Inc.

View on ClinicalTrials.gov

Summary

ABC008-IBM-202 is an open-label, multicenter study to evaluate the safety and efficacy of long-term administration of ulviprubart (ABC008) in subjects with IBM who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201. Subjects may be enrolled in this study if they meet study eligibility criteria and: * Have completed the Part 2 (Multiple Ascending Dose \[MAD\]) End of-Treatment (EOT) Visit in Study ABC008-IBM-101; subjects who continued further on into Part 3 of the study (MAD Extension) prior to enrolling in this study are also eligible; OR * Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201.

Official title: An Open-label, Multicenter Study to Evaluate the Long-term Safety and Efficacy of Ulviprubart (ABC008) in Subjects Who Have Completed a Trial of Ulviprubart for the Treatment of Inclusion Body Myositis

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

270

Start Date

2024-10-21

Completion Date

2029-04

Last Updated

2025-07-28

Healthy Volunteers

No

Interventions

DRUG

Ulviprubart (ABC008)

All eligible subjects, regardless of treatment assignment or dose level in their initial study, will be administered ulviprubart at a dose of 2.0 mg/kg via subcutaneous (SC) injection Q8W.

Locations (21)

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 Hospital of USC

Los Angeles, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

Neuromuscular Diagnostic Center - Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Womens Hospital

Boston, Massachusetts, United States

Hospital for Special Surgery

New York, New York, United States

Duke Neurological Disorders Clinic

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, 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

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, Washington, Australia