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.
Study 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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 1\. Able to read, understand, and provide signed informed consent prior to the performance of any study-related procedures.
2\. 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.
3\. Demonstrated adequate compliance, in the opinion of the Investigator, with the study procedures during Study ABC008-IBM-101 or Study ABC008-IBM-201.
4\. 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.
5\. 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.
6\. WOCBP (based on sex assignation at birth) must have a negative urine pregnancy test at the Baseline (Day 1) Visit.
7\. 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.
Exclusion Criteria:
* 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.
2\. 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.
3\. Is not willing or able to comply with the restrictions regarding the use of prohibited medications throughout the study.
4\. Women who are pregnant, lactating, or who plan to become pregnant or initiate lactation during the study.
Primary outcome measure(s)
Primary Endpoint — From Baseline (Day 1) through study completion, an average of 156 weeks.] 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)
Trial sites (21)
Facility
City
Region
Status
Neuromuscular Research Center
Phoenix
Arizona
University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center
Irvine
California
Keck Hospital of USC
Los Angeles
California
Yale School of Medicine
New Haven
Connecticut
Neuromuscular Diagnostic Center - Massachusetts General Hospital
Boston
Massachusetts
Brigham and Womens Hospital
Boston
Massachusetts
Hospital for Special Surgery
New York
New York
Duke Neurological Disorders Clinic
Durham
North Carolina
University Hospitals Cleveland Medical Center
Cleveland
Ohio
Ohio State University Wexner Medical Center
Columbus
Ohio
Penn State Health Milton S. Hershey Medical Center
Hershey
Pennsylvania
University of Pennsylvania
Philadelphia
Pennsylvania
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburgh
Pennsylvania
Austin Neuromuscular Center
Austin
Texas
Texas Neurology
Dallas
Texas
Nerve and Muscle Center of Texas
Houston
Texas
Virginia Commonwealth University
Henrico
Virginia
Medical College of Wisconsin
Milwaukee
Wisconsin
Royal North Shore Hospital
Saint Leonards
New South Wales
Royal Brisbane and Women's Hospital
Herston
Queensland
Perron Institute for Neurological and Translational Science
Nedlands
Washington
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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