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NCT04017936 · ClinicalTrials.gov registry record · Phase 2
Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis
A Phase 2 study, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT04017936 is a Phase 2 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 17 participants.
The verdict
NCT04017936, a Phase 2 study, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
Sarcoidosis is a heterogeneous disorder of unknown etiology whose signature lesions are granulomatous inflammatory infiltrates in involved tissues. Tissue commonly affected are lungs, skin, eyes, lymph nodes and the heart. In this latter case, cardiac sarcoidosis (CS) can lead to atrioventricular (AV) blocks, ventricular arrhythmias, heart failure (HF) and sudden cardiac death. Similar to other involved organs, cardiac disease generally progresses from areas of focal inflammation to scar. However, the natural history of CS is not well characterized complicating an immediate and definitive diagnosis. The management of CS often requires multidisciplinary care teams and is challenged by data limited to small observational studies and from the high likelihood of side effects of most of the treatments currently used (eg: corticosteroids, methotrexate and TNF-alfa inhibitors). Interleukin-1 (IL-1) is the prototypical pro-inflammatory cytokine, also referred to as master regulator of the inflammatory response, involved in virtually every acute process. There is evidence that IL-1 plays a role in mouse model of sarcoidosis and human pulmonary lesions as the presence of the inflammasome in granulomas of the heart of patients with cardiac sarcoidosis, providing additional support for a role of IL-1 in the pathogenesis of CS. However, IL-1 blockade has never been evaluated as a potential therapeutic agent for cardiac sarcoidosis. In the current study, researchers aim to evaluate the safety and efficacy of IL-1 blockade with anakinra (IL-1 receptor antagonist) in patients with cardiac sarcoidosis.
Interventions
- DRUG Anakinra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-10-23 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04017936
The ClinicalTrials.gov registry entry for NCT04017936 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Anakinra is the first listed.
NCT04017936 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04017936 about?
NCT04017936 is a clinical study titled "Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis". Sarcoidosis is a heterogeneous disorder of unknown etiology whose signature lesions are granulomatous inflammatory infiltrates in involved tissues. Tissue commonly affected are lungs, skin, eyes, lymph nodes and the heart. In this latter case, cardiac sarcoidosis (CS) can lead to atrioventricular (A...
What is the current status of trial NCT04017936?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2020-10-23. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT04017936?
The interventions under investigation include: Anakinra (DRUG).
Who is sponsoring clinical trial NCT04017936?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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