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ACTIVE NOT RECRUITING Phase 2

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

NCT06450886 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 270 participants
Start Date 2024-10-21
Est. Completion 2029-04
Phase Phase 2

Sponsor

Abcuro

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06450886

The ClinicalTrials.gov registry entry for NCT06450886 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abcuro, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06450886 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Pennsylvania, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06450886?

The interventions under investigation include: Ulviprubart (ABC008) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06450886?

This trial is sponsored by Abcuro, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial