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NCT05861453 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease
A Phase 2 study of Sickle Cell Disease, sponsored by Afimmune.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 18
- Study locations
NCT05861453: Active Phase 2 study of Sickle Cell Disease, sponsored by Afimmune.
NCT05861453 is a Phase 2 study of Sickle Cell Disease that is active but no longer recruiting, run by Afimmune. The registered enrollment target is 30 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (90% lower). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05861453, a Phase 2 study of Sickle Cell Disease, is active but no longer recruiting, sponsored by Afimmune.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 18
- Study locations
Study Summary
To assess the pharmacokinetics, pharmacodynamics and safety of Epeleuton capsules in adult SCD patients who are aged ≥18 years.
Primary Outcome
Change in annualized rate of VOCs leading to a healthcare visit, and VOCs that are treated at home from baseline to week 16
Conditions Studied
Interventions
- DRUG Epeleuton
Study Locations (18)
Georgia
- Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta at Hughes Spalding - Atlanta
- Emory University - Georgia Comprehensive Sickle Cell Center - Atlanta
- Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta at Arthur M. Blank Hospital - Atlanta
Maryland
- The Johns Hopkins University School of Medicine - Baltimore
- The Center for Cancer and Blood Disorders, A Division of American Oncology Partners, PA - Bethesda
- Kaiser Permanente Mid-Atlantic States - Largo
New Jersey
- Robert Wood Johnson Medical School Rutgers - New Brunswick
- Newark Beth Israel Medical Center - Newark
North Carolina
- UNC Health - Chapel Hill
- Science 37 - Morrisville
Alabama
- University of Alabama at Birmingham (UAB) - Birmingham
Connecticut
- New England Sickle Cell Institute, UConn Health - Farmington
District of Columbia
- Medstar Health - Washington D.C.
Illinois
- UI Health Sickle Cell Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-01-10 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
What the registry record for NCT05861453 still lists
NCT05861453 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 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Epeleuton is the first listed.
NCT05861453 lists 18 locations in 12 states (Georgia, Maryland, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05861453 about?
NCT05861453 is a clinical study titled "Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease". To assess the pharmacokinetics, pharmacodynamics and safety of Epeleuton capsules in adult SCD patients who are aged ≥18 years.
What is the current status of trial NCT05861453?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-01-10. Estimated completion is 2026-03.
What conditions does trial NCT05861453 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT05861453?
The interventions under investigation include: Epeleuton (DRUG).
Who is sponsoring clinical trial NCT05861453?
This trial is sponsored by Afimmune, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05861453 being conducted?
This trial has 18 study locations across Alabama, Connecticut, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05861453's enrollment target sits among peer trials
30 139th of 213 higher than 67 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease 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.
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