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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
9%
Blood creatine phosphokinase increased
9%
Fatigue
9%
Diarrhea
9%
Dizziness
6%
Nausea
6%
Upper respiratory tract infection
6%
Cough
6%
Abdominal pain upper
3%
Rash
3%
Hyperthermia
3%
Back pain
3%
White blood cell count decreased
3%
Urticaria
3%
Dry skin
3%
Asthenia
3%
Musculoskeletal pain
3%
Arthralgia
3%
Tachycardia
3%
Hepatic enzyme increased
3%
Dyspepsia
3%
Abdominal Discomfort
3%
Subcutaneous abscess
3%
Viral infection
3%
Pyrexia
3%
Flatulence
3%
Tracheitis
3%
Vomiting
3%
Somnolence
3%
Bronchitis
3%
Eructation
3%
Nasopharyngitis
3%
Blood folate decreased
3%
Night sweats
3%
Fall
3%
Muscle strain
3%
Oropharyngeal pain
3%
Productive cough
3%
Vertigo
3%
Influenza
3%
Pneumonia
3%
Viral upper respiratory tract infection
3%
Photopsia
3%
Depressed mood
3%
Physiotherapy
3%
Abdominal pain
3%
Blood potassium increased
3%
Blood pressure increased
3%
Gastrointestinal sounds abnormal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
1000 mg Epeleuton
2000 mg Epeleuton

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

AfimmuneLead Sponsor
4 Previous Clinical Trials
387 Total Patients Enrolled
~13 spots leftby Aug 2025
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