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

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 15 to 21v4
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 13 to 15
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Aug 31, 2028 to Jan 2029
    • Study completion date: Feb 28, 2029 to Apr 2029
    • Start date: Sep 23, 2024 to Oct 21, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06450886
Lead Sponsor Abcuro, Inc.
Conditions
(from sponsor)		 Inclusion Body Myositis (IBM)
Related terms Myositis, Inclusion Body
Enrollment 270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov