Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
Public ClinicalTrials.gov record NCT07103746. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multi-center, Phase 2 trial of ublituximab as first-line combination therapy in early, active autoantibody positive immune-mediated necrotizing myopathy. The primary objective is to estimate the effect of ublituximab as first add-on combination therapy at 24 weeks compared to placebo in treating early, active autoantibody positive immune-mediated necrotizing myopathy using the validated 2016 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Myositis Response Criteria, as measured by the Total Improvement Score (TIS)
Study identification
- NCT ID
- NCT07103746
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 20, 2026
- Primary completion
- Jul 31, 2028
- Completion
- Jul 31, 2029
- Last update posted
- Aug 9, 2026
2026 – 2029
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & Rheumatology | Birmingham | Alabama | 35233 | Not yet recruiting |
| Emory University School of Medicine: Division of Rheumatology | Atlanta | Georgia | 30322 | Not yet recruiting |
| University of Chicago, Department of Medicine: Rheumatology | Chicago | Illinois | 60637 | Not yet recruiting |
| Johns Hopkins Hospital: Division of Rheumatology | Baltimore | Maryland | 21244 | Recruiting |
| Mayo Clinic: Division of Rheumatology | Rochester | Minnesota | 55905 | Not yet recruiting |
| Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology | Great Neck | New York | 11021 | Not yet recruiting |
| University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology | Pittsburgh | Pennsylvania | 15261 | Not yet recruiting |
| University of Texas - Houston | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07103746, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07103746 live on ClinicalTrials.gov.