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

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Inclusion Body Myositis (IBM)

In brief

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.

Key facts

Study ID

NCT06450886

Run by

Abcuro, Inc.

People needed

270

Starts

2024-10-21

Expected to finish

2029-04-01

Last updated by the study team

2025-07-28

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Able to read, understand, and provide signed informed consent prior to the performance of any study-related procedures.
• Has participated in and completed either Study ABC008-IBM-101 or Study ABC008-IBM-201; completion of the prior study will be defined as completion of the Part 2 (MAD) EOT Visit in Study ABC008-IBM-101 (subjects may have continued into Part 3 [MAD Extension]) or completion of the Week 80 Follow-up Visit in Study ABC008-IBM-201.
• Demonstrated adequate compliance, in the opinion of the Investigator, with the study procedures during Study ABC008-IBM-101 or Study ABC008-IBM-201.
• Willing and able to comply with the requirements of the protocol, including traveling to the site for study-related assessments and SC injections of ulviprubart.
• Women of childbearing potential (WOCBP) and male subjects with female partners who are WOCBP (based on sex assignation at birth) must agree to use highly effective (< 1% failure rate) contraception for the duration of the study through 180 days after EOT/ETV.
• WOCBP (based on sex assignation at birth) must have a negative urine pregnancy test at the Baseline (Day 1) Visit.
• Male subjects (based on sex assignation at birth) must refrain from sperm donation for the duration of the study through 180 days after EOT/ETV.

You may not qualify if…

• 1. Has an unresolved clinically significant AE or a clinically significant finding on a clinical laboratory test, ECG, or physical examination during Study ABC008-IBM-101 or Study ABC008 IBM-201 that, in the Investigator's opinion, would limit the subject's ability to participate in or comply with this study.
• Participation in another investigational drug study (other than Study ABC008-IBM-101 or Study ABC008-IBM-201) within 30 days prior to the Baseline (Day 1) Visit or five times the half-life of the investigational drug, whichever is longer.
• Is not willing or able to comply with the restrictions regarding the use of prohibited medications throughout the study.
• Women who are pregnant, lactating, or who plan to become pregnant or initiate lactation during the study.

Where it is running

• 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

Full record on ClinicalTrials.gov

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