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NCT06450886 · ClinicalTrials.gov registry record · Phase 2
Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis
A Phase 2 study of Inclusion Body Myositis (IBM), sponsored by Abcuro.
- Active
- Registry status
- Phase 2
- Development phase
- 270
- Enrollment target
- 20
- Study locations
NCT06450886: Active Phase 2 study of Inclusion Body Myositis (IBM), sponsored by Abcuro.
NCT06450886 is a Phase 2 study of Inclusion Body Myositis (IBM) that is active but no longer recruiting, run by Abcuro. The registered enrollment target is 270 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (103% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06450886, a Phase 2 study of Inclusion Body Myositis (IBM), is active but no longer recruiting, sponsored by Abcuro.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 270 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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)
Conditions Studied
Interventions
- DRUG Ulviprubart (ABC008)
Study Locations (20)
Pennsylvania
- Penn State Health Milton S. Hershey Medical Center - Hershey
- University of Pennsylvania - Philadelphia
- UPMC Arthritis and Autoimmunity Center, Falk Clinic - Pittsburgh
Texas
- Austin Neuromuscular Center - Austin
- Texas Neurology - Dallas
- Nerve and Muscle Center of Texas - Houston
California
- University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center - Irvine
- Keck Hospital of USC - Los Angeles
Massachusetts
- Neuromuscular Diagnostic Center - Massachusetts General Hospital - Boston
- Brigham and Womens Hospital - Boston
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- Ohio State University Wexner Medical Center - Columbus
Arizona
- Neuromuscular Research Center - Phoenix
Connecticut
- Yale School of Medicine - New Haven
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2024-10-21 |
| Est. Completion | 2029-04 |
| Phase | Phase 2 |
What the registry record for NCT06450886 still lists
NCT06450886 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (103% higher).
The record links to 1 condition, with Inclusion Body Myositis (IBM) appearing as the primary indexed condition, and to 1 intervention - of which Ulviprubart (ABC008) is the first listed.
NCT06450886 names 20 study sites across 13 states, led by Pennsylvania, Texas, California.
Frequently Asked Questions
What is clinical trial NCT06450886 about?
NCT06450886 is a clinical study titled "Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis". 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 eligibilit...
What is the current status of trial NCT06450886?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 270 participants. The study started on 2024-10-21. Estimated completion is 2029-04.
What conditions does trial NCT06450886 study?
This clinical trial studies the following conditions: Inclusion Body Myositis (IBM).
What interventions are being tested in trial NCT06450886?
The interventions under investigation include: Ulviprubart (ABC008) (DRUG).
Who is sponsoring clinical trial NCT06450886?
This trial is sponsored by Abcuro, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06450886 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06450886's enrollment target sits among peer trials
270 205th of 2000 higher than 1,793 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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