Active, not recruitingPhase 2/3
Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis
Key facts
- Who runs it
- Abcuro, Inc.
- Where
- Austin, Boston, Cleveland, Columbus, Dallas, Durham, Henrico, Hershey, Houston, Irvine, Los Angeles, Milwaukee, New Haven, New York, Philadelphia, Phoenix, and Pittsburgh, United StatesSee the 18 sitesAlso in 1 other country, 3 sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 2/3
- People taking part
- 270 people, planned
- Started
- 21 Oct 2024
- Expected to end
- Apr 2029
- Type of study
- Interventional
- Treatments tested
- Ulviprubart (ABC008)
- Record updated
- 28 July 2025
Who can take part
- Age
- 40 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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 in United States
Also in 1 other country, 3 sites
- Austin Neuromuscular CenterAustin, United StatesNo longer taking part
- Brigham and Womens HospitalBoston, United StatesNo longer taking part
- Neuromuscular Diagnostic Center - Massachusetts General HospitalBoston, United StatesNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
- Ohio State University Wexner Medical CenterColumbus, United StatesNo longer taking part
- Texas NeurologyDallas, United StatesNo longer taking part
- Duke Neurological Disorders ClinicDurham, United StatesNo longer taking part
- Virginia Commonwealth UniversityHenrico, United StatesNo longer taking part
- Penn State Health Milton S. Hershey Medical CenterHershey, United StatesNo longer taking part
- Nerve and Muscle Center of TexasHouston, United StatesNo longer taking part
- University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular CenterIrvine, United StatesNo longer taking part
- Keck Hospital of USCLos Angeles, United StatesNo longer taking part
- Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- Yale School of MedicineNew Haven, United StatesNo longer taking part
- Hospital for Special SurgeryNew York, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- Neuromuscular Research CenterPhoenix, United StatesNo longer taking part
- UPMC Arthritis and Autoimmunity Center, Falk ClinicPittsburgh, United StatesNo longer taking part
About the trial
What the trial wants to find out
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:
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* 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.
The group in the trial
- Ulviprubart (ABC008) 2.0 mg/kg SCTreatment being tested
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.
Treatment: Ulviprubart (ABC008)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 28 July 2025