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NCT07103746 · ClinicalTrials.gov registry record · Phase 2
Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
A Phase 2 study of Autoimmune Disorders, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 9
- Study locations
NCT07103746: Recruiting Phase 2 study of Autoimmune Disorders, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT07103746 is a Phase 2 study of Autoimmune Disorders that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants, below the 523-participant average among 3 other Autoimmune Disorders trials with a reported enrollment target (94% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07103746, a Phase 2 study of Autoimmune Disorders, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 9
- Study locations
Study Summary
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)
Primary Outcome
TIS is a composite endpoint based on improvement in the 6 Disease Activity Core Set Measure (CSM) scores and ranges from 0 to 100 (2016 American College of Rheumatology \[ACR\] Myositis Response Criteria/European League Against Rheumatism \[EULAR\]). A higher score indicates more improvement.
Conditions Studied
Interventions
- DRUG Ublituximab
- DRUG Placebo for Ublituximab
Study Locations (9)
Alabama
- University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & Rheumatology - Birmingham
California
- University of California, Irvine School of Medicine: Division of Rheumatology - Orange
Georgia
- Emory University School of Medicine: Division of Rheumatology - Atlanta
Illinois
- University of Chicago, Department of Medicine: Rheumatology - Chicago
Maryland
- Johns Hopkins Hospital: Division of Rheumatology - Baltimore
Minnesota
- Mayo Clinic: Division of Rheumatology - Rochester
New York
- Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology - Great Neck
Pennsylvania
- University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-02-26 |
| Est. Completion | 2029-08 |
| Phase | Phase 2 |
What NCT07103746 shows while recruiting
NCT07103746 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 523-participant average among 3 other Autoimmune Disorders trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Autoimmune Disorders appearing as the primary indexed condition, and to 2 interventions - of which Ublituximab is the first listed.
NCT07103746 lists 9 locations in 9 states (Alabama, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT07103746 about?
NCT07103746 is a clinical study titled "Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy". 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 t...
What is the current status of trial NCT07103746?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2026-02-26. Estimated completion is 2029-08.
What conditions does trial NCT07103746 study?
This clinical trial studies the following conditions: Autoimmune Disorders.
What interventions are being tested in trial NCT07103746?
The interventions under investigation include: Ublituximab (DRUG), Placebo for Ublituximab (DRUG).
Who is sponsoring clinical trial NCT07103746?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07103746 being conducted?
This trial has 9 study locations across Alabama, California, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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