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NCT05416307 · ClinicalTrials.gov registry record · Phase 2
Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
A Phase 2 study of Secondary Hemophagocytic Lymphohistiocytosis (sHLH), sponsored by Electra Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 156
- Enrollment target
- 20
- Study locations
NCT05416307 is a Phase 2 study of Secondary Hemophagocytic Lymphohistiocytosis (sHLH) that is actively recruiting participants, run by Electra Therapeutics. The registered enrollment target is 156 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT05416307, a Phase 2 study of Secondary Hemophagocytic Lymphohistiocytosis (sHLH), is actively recruiting participants, sponsored by Electra Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 156 participants
- Enrollment target
- 20
- Study locations
Study Summary
Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. Secondary hemophagocytic lymphohistiocytosis (sHLH) is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associated HLH (mHLH), infection, or autoimmune disease). ELA026 is a fully human immunoglobulin G1 (IgG1) signal regulatory protein (SIRP)-directed monoclonal antibody designed to deplete the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, efficacy pharmacokinetics and pharmacodynamics of ELA026 in participants with sHLH.
Conditions Studied
Interventions
- DRUG ELA026
Study Locations (20)
Other
- Medizinische Universität Innsbruck - Innsbruck
- Medical University of Vienna - Vienna
- Schwarzwald-Baar Klinikum Villingen-Schwenningen - Villingen-Schwenningen
- Azienda Ospedaliero Universitaria Meyer - Florence
New York
- Columbia University - New York
- Cornell University - New York
- Memorial Sloan Kettering Cancer Center - New York
Georgia
- Children's Healthcare of Atlanta - Center for Advanced Pediatrics - Atlanta
- Emory University - Atlanta
Texas
- Texas Children's Hospital - Houston
- University of Texas MD Anderson Cancer Center - Houston
Alabama
- University of Alabama at Birmingham School of Medicine - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
California
- University of California, Los Angeles - Los Angeles
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2022-05-19 |
| Est. Completion | 2029-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05416307
The ClinicalTrials.gov registry entry for NCT05416307 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Electra Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Secondary Hemophagocytic Lymphohistiocytosis (sHLH) appearing as the primary indexed condition, and to 1 intervention - of which ELA026 is the first listed.
NCT05416307 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, New York, Georgia.
Frequently Asked Questions
What is clinical trial NCT05416307 about?
NCT05416307 is a clinical study titled "Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)". Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. Secondary hemophagocytic lymphohistiocytosis (sHLH) is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associ...
What is the current status of trial NCT05416307?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 156 participants. The study started on 2022-05-19. Estimated completion is 2029-06.
What conditions does trial NCT05416307 study?
This clinical trial studies the following conditions: Secondary Hemophagocytic Lymphohistiocytosis (sHLH).
What interventions are being tested in trial NCT05416307?
The interventions under investigation include: ELA026 (DRUG).
Who is sponsoring clinical trial NCT05416307?
This trial is sponsored by Electra Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05416307 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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