Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis
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
1 other identifier
interventional
270
2 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2024
Typical duration for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2024
CompletedFirst Posted
Study publicly available on registry
June 10, 2024
CompletedStudy Start
First participant enrolled
October 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
July 28, 2025
October 1, 2024
4.2 years
June 4, 2024
July 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Endpoint
The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs). Safety as assessed by the incidence, type and severity of Treatment Emergent Adverse Events (TEAEs)
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary Outcomes (15)
Treatment Emergent Serious Adverse Events (TEASAEs)
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Treatment Emergent Adverse Events (TEAEs) onset within 24 hours of Study Medication Administration.
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Adverse Events of Special Interest (AESI)
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Change from baseline standard laboratory parameters (Hematology)
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Change from baseline in standard laboratory parameters (Chemistry)
From Baseline (Day 1) through study completion, an average of 156 weeks.]
- +10 more secondary outcomes
Study Arms (1)
Ulviprubart (ABC008) 2.0 mg/kg SC
EXPERIMENTALAll 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \. 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:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abcuro, Inc.lead
Study Sites (21)
Neuromuscular Research Center
Phoenix, Arizona, 85028, United States
University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center
Irvine, California, 92868, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
Yale School of Medicine
New Haven, Connecticut, 06519, United States
Neuromuscular Diagnostic Center - Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Womens Hospital
Boston, Massachusetts, 021158, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Duke Neurological Disorders Clinic
Durham, North Carolina, 27710, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburgh, Pennsylvania, 15213, United States
Austin Neuromuscular Center
Austin, Texas, 78759, United States
Texas Neurology
Dallas, Texas, 75206, United States
Nerve and Muscle Center of Texas
Houston, Texas, 75206, United States
Virginia Commonwealth University
Henrico, Virginia, 23233, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4006, Australia
Perron Institute for Neurological and Translational Science
Nedlands, Washington, 6009, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2024
First Posted
June 10, 2024
Study Start
October 21, 2024
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
July 28, 2025
Record last verified: 2024-10