drugset / Trial / NCT06450886

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

NCT06450886 ↗

Phase 2/3 Active not recruiting 270 enrolled Abcuro, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-10-21
Primary completion
2029-01
Completion
2029-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulviprubart Monoclonal antibody 2 mg/kg Subcutaneous