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NCT06479863 · ClinicalTrials.gov registry record · Early Phase 1
Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis
A Early Phase 1 study of Idiopathic Inflammatory Myopathies and Sporadic Inclusion Body Myositis (sIBM), sponsored by Austin Neuromuscular Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT06479863: Recruiting Early Phase 1 study of Idiopathic Inflammatory Myopathies and Sporadic Inclusion Body Myositis (sIBM), sponsored by Austin Neuromuscular Center.
NCT06479863 is a Early Phase 1 study of Idiopathic Inflammatory Myopathies and Sporadic Inclusion Body Myositis (sIBM) that is actively recruiting participants, run by Austin Neuromuscular Center. The registered enrollment target is 10 participants, below the 207-participant average among 7 other Idiopathic Inflammatory Myopathies trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06479863, a Early Phase 1 study of Idiopathic Inflammatory Myopathies and Sporadic Inclusion Body Myositis (sIBM), is actively recruiting participants, sponsored by Austin Neuromuscular Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
To evaluate the efficacy of Pozelimab/Cemdisiran combination therapy in patients with sIBM
Primary Outcome
The IBM-FRS is a 10-item interviewer-administered patient-reported outcomes (PRO) measure that assesses physical function in patients with IBM. The IBMFRS includes items assessing lower body physical function, general physical function, the ability to perform certain activities of daily living, fine motor skills, and swallowing. On a Likert scale ranging from 0 (unable to perform activity) to 4 (normal), patients are asked to rate their difficulty in performing tasks relative to each concept bef
Conditions Studied
Interventions
- COMBINATION_PRODUCT Pozelimab/Cemdisiran
Study Locations (2)
Texas
- Austin Neuromuscular Center - Austin
- Austin Neuromuscular Center - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-08-08 |
| Est. Completion | 2027-08-30 |
| Phase | Early Phase 1 |
What NCT06479863 shows while recruiting
NCT06479863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 207-participant average among 7 other Idiopathic Inflammatory Myopathies trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Idiopathic Inflammatory Myopathies appearing as the primary indexed condition, and to 1 intervention - of which Pozelimab/Cemdisiran is the first listed.
NCT06479863 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06479863 about?
NCT06479863 is a clinical study titled "Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis". To evaluate the efficacy of Pozelimab/Cemdisiran combination therapy in patients with sIBM
What is the current status of trial NCT06479863?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2024-08-08. Estimated completion is 2027-08-30.
What conditions does trial NCT06479863 study?
This clinical trial studies the following conditions: Idiopathic Inflammatory Myopathies, Sporadic Inclusion Body Myositis (sIBM).
What interventions are being tested in trial NCT06479863?
The interventions under investigation include: Pozelimab/Cemdisiran (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06479863?
This trial is sponsored by Austin Neuromuscular Center, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06479863 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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