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Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis
Sponsor: Abcuro, Inc.
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
Conditions
Interventions
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