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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 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.

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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.

Conditions Studied

Sickle Cell Disease

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

FieldValue
Enrollment Target 30 participants
Start Date 2024-01-10
Est. Completion 2026-03
Phase Phase 2

Sponsor

Afimmune

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05861453

The ClinicalTrials.gov registry entry for NCT05861453 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (90% lower). The listed sponsor is Afimmune, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 18 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.