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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: Recruiting Phase 2 study of Secondary Hemophagocytic Lymphohistiocytosis (sHLH), sponsored by Electra Therapeutics.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of adverse events (AEs) including dose-limiting toxicities (DLTs), serious adverse events (SAEs), deaths, AEs leading to withdrawal from study
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 |
What NCT05416307 shows while recruiting
NCT05416307 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05416307's enrollment target sits among peer trials
156 445th of 2000 higher than 1,554 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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