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New pill aims to cut sickle cell pain crises

NCT ID NCT05861453

Disease control Sponsor: Afimmune Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 2 trial tested an oral drug called epeleuton in 35 adults with sickle cell disease. The goal was to see if it could reduce painful vaso-occlusive crises and improve blood cell health. Participants took 2000 mg capsules twice daily for 16 weeks, and researchers measured changes in crisis rates, blood markers, and pain levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epeleuton (also called DS102), taken as capsules
What this could lead to
If it works, epeleuton could become a new oral treatment to reduce painful sickle cell crises and improve quality of life.
What could go wrong
This is a small, early-phase study (Phase 2) with only 35 people. It may not show clear benefits, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

35 people

The number who actually took part.

Started

Jan 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with sickle cell disease (SCD) including: * 2 sickle hemoglobin genes \[HbSS\] * HbSβ0 thalassemia * HbSβ+ thalassemia * Heterozygous for hemoglobin S and hemoglobin C \[HbSC\] * Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF) * Patients who have had between 2 and 15 episodes of vaso-occlusive crisis (VOC) in the past year (12 months) * For patients taking hydroxyurea (HU), the dose of HU must be stable for at least 3 months prior to signing the ICD and with no anticipated need for dose adjustment during the study. * Female patients and male patients with female partners of childbearing potential must use highly effective contraceptive methods for the duration of the study. Exclusion Criteria: * Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion), have received an RBC transfusion for any reason within three months of the baseline visit * Patients who have received a hematopoietic stem cell transplant. * Patients with inadequate venous access as determined by the Investigator * Patients who are pregnant, planning pregnancy, breastfeeding and/or are unwilling to use adequate contraception during the trial.

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Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease

Contacts and locations

Locations

  • Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta at Arthur M. Blank Hospital

    Atlanta, Georgia, 30329, United States

  • Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta at Hughes Spalding

    Atlanta, Georgia, 30303, United States

  • Emory University - Georgia Comprehensive Sickle Cell Center

    Atlanta, Georgia, 30303, United States

  • Jacobi Medical Center

    The Bronx, New York, 10461, United States

  • Kaiser Permanente Mid-Atlantic States

    Largo, Maryland, 20774, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Medstar Health

    Washington D.C., District of Columbia, 20010, United States

  • New England Sickle Cell Institute, UConn Health

    Farmington, Connecticut, 06030-1163, United States

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112, United States

  • Robert Wood Johnson Medical School Rutgers

    New Brunswick, New Jersey, 08901, United States

  • Science 37

    Morrisville, North Carolina, 27560, United States

  • St Paul's Hospital Hematology/Oncology Research

    Vancouver, British Columbia, V6E 1M7, Canada

  • The Center for Cancer and Blood Disorders, A Division of American Oncology Partners, PA

    Bethesda, Maryland, 20817, United States

  • The Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205, United States

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • UI Health Sickle Cell Center

    Chicago, Illinois, 60612, United States

  • UNC Health

    Chapel Hill, North Carolina, 27517, United States

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35294, United States

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