← Back to Search

Other

Epeleuton for Sickle Cell Anemia

Phase 2

Recruiting

Research Sponsored by Afimmune

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

Study Summary

This trial will study the effects of taking a medication on people with sickle cell anemia aged 18 and over.

Who is the study for?

Adults aged 18+ with sickle cell disease (HbSS or HbSβ0-thalassemia) can join. They must have had 2-10 vaso-occlusive crises in the past year and, if on hydroxyurea, be on a stable dose for at least 3 months. Participants need to use effective contraception and cannot have had recent blood transfusions or stem cell transplants.Check my eligibility

What is being tested?

The trial is testing Epeleuton capsules to understand how they're processed by the body (pharmacokinetics), their effects (pharmacodynamics), and safety in adults with sickle cell disease.See study design

What are the potential side effects?

Specific side effects of Epeleuton are not listed but generally could include reactions where the drug is metabolized or interacts with other bodily functions. Safety assessments will monitor any adverse events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in PROMIS Pain Interference Short Form

Change from baseline in PROMIS Physical Activity Short Form

Changes from baseline in D-dimer

+14 more

Side effects data

From 2019 Phase 2 trial • 96 Patients • NCT02941549

16%

Headache

Blood creatine phosphokinase increased

Fatigue

Diarrhea

Dizziness

Nausea

Upper respiratory tract infection

Cough

Abdominal pain upper

Blood folate decreased

Bronchitis

Dyspepsia

Abdominal Discomfort

Somnolence

Eructation

Flatulence

Vomiting

Nasopharyngitis

Subcutaneous abscess

Tracheitis

Viral infection

Hepatic enzyme increased

White blood cell count decreased

Asthenia

Hyperthermia

Pyrexia

Arthralgia

Musculoskeletal pain

Back pain

Dry skin

Rash

Night sweats

Urticaria

Fall

Muscle strain

Oropharyngeal pain

Productive cough

Tachycardia

Vertigo

Influenza

Pneumonia

Viral upper respiratory tract infection

Photopsia

Depressed mood

Physiotherapy

Abdominal pain

Blood potassium increased

Blood pressure increased

Gastrointestinal sounds abnormal

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

1000 mg Epeleuton

2000 mg Epeleuton

Trial Design

1Treatment groups

Experimental Treatment

Group I: Epeleuton 4g/dayExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Epeleuton

2016

Completed Phase 2

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AfimmuneLead Sponsor

4 Previous Clinical Trials

387 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of people being included in this research?

"This medical study requires 30 individuals who meet the specified participation qualifications. Those interested in joining can do so from New England Sickle cell Institute, UConn Health in Farmington (CT), or Emory University - Georgia Comprehensive Sickle Cell Center in Atlanta (GA)."

Answered by AI

Has Epeleuton achieved regulatory assent for a 4g/day dosage?

"Taking into consideration the Phase 2 nature of this trial, our team at Power has assigned Epeleuton 4g/day a score of 2 on its safety scale. This indicates that there is some data to suggest safety but no evidence for efficacy yet."

Answered by AI

Are there any enrollment opportunities available for this clinical study?

"According to the data accessible on clinicaltrials.gov, this medical research is actively recruiting patients. The study was initially announced on October 1st 2023 and was most recently modified on October 9th 2023."

Answered by AI

Are there various medical centers in this state participating in the clinical research?

"The 10 participating sites for this trial are the New England Sickle cell Institute, UConn Health in Farmington, Emory University - Georgia Comprehensive Sickle Cell Center in Atlanta, Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta in Chicago; additionally there are other medical centres located across the US."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease

2024. "Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05861453.