A Phase 2 interventional study of Epeleuton in Sickle Cell Disease, sponsored by Afimmune. Completed at 18 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Afimmune · Phase 2, Interventional, and Treatment
Among 733 studies in Anemia, Sickle Cell with a site in United States — 134 open to participants now, 185 under way, 16 of them phase 3. Anemia, Sickle Cell · United States.
Among the 733 studies in Anemia, Sickle Cell with a site in United States, this one is the 266th largest by enrollment of the 559 interventional ones that give a count, is one of 36 that started in 2024, is one of 161 in phase 2, and was the 622nd registered.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
Browse Anemia, Sickle Cell studies →134 of the 733 studies in Anemia, Sickle Cell with a site in United States are open now. Recruiting first, the newest first:
University of Maryland, Baltimore · Sites in United States
Ages 18–88
Mohsen Saidinejad · Sites in United States
Ages 5–20
St. Jude Children's Research Hospital · Sites in United States
Ages up to 22
Emory University · Sites in United States
Ages 8–18
University of Alabama at Birmingham · Sites in United States
Ages 18–50 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 177 Anemia, Sickle Cell studies recruiting now, 64 (36%) set no upper age limit and 97 (55%) stop at 75 or younger; 127 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
733 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 158 · Phase 2 228 · Phase 3 57 · Phase 4 20
First in 1984; this study’s year is marked. 36 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 35 is below the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Median enrollment 31 across the 559 interventional studies, 100 across the 168 observational. Of the 506 that completed or were terminated, 207 (41%) have results posted.
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168 of 733 have an industry lead sponsor. The 10 most frequent:
Afimmune is the lead sponsor of 5 studies on the registry; none are open to participants now.
Afimmune has 1 study filed under Anemia, Sickle Cell — fewer than ten, so there is no comparison to draw.
57 of the studies in Anemia, Sickle Cell with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07247188Phase 3SanofiStudy of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease | 2027-01-07 |
| NCT04293185Phase 3bluebird bioA Study Evaluating Gene Therapy With BB305 Lentiviral Vector in Sickle Cell Disease | 2027-05 |
| NCT06989567Phase 3Asklepion Pharmaceuticals, LLCA Study of Intravenous L-Citrulline in Patients Aged 6-21 Years Old With Sickle Cell Disease Presenting to Emergency Departments in Acute Vaso-Occlusive Crisis | 2027-06 |
| NCT05329649Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Severe Sickle Cell Disease (SCD) | 2027-06-06 |
| NCT05477563Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Efficacy and Safety of a Single Dose of CTX001 in Participants With Transfusion-Dependent β-Thalassemia and Severe Sickle Cell Disease | 2027-06-09 |
Add all 57 to your calendar (.ics) → With an account.
Among the 733 studies in Anemia, Sickle Cell with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To assess the pharmacokinetics, pharmacodynamics and safety of Epeleuton capsules in adult SCD patients who are aged ≥18 years.
The trial will consist of a 28-day screening period, 16 weeks of active treatment and a 30-day post-treatment follow-up period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with sickle cell disease (SCD) including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Epeleuton
Participants will receive 2000mg Epeleuton (DS102) capsules twice daily.
Also known as: DS102 Capsules
Change from baseline in annualized rate of VOCs leading to a healthcare visit, and VOCs that are treated at home
Change in annualized rate of VOCs leading to a healthcare visit, and VOCs that are treated at home from baseline to week 16
Time frame: 16 Weeks
Changes from baseline in RBC Laminin Adhesion
Changes in RBC Laminin Adhesion from baseline to week 16
Time frame: 16 Weeks
Changes from baseline in Vascular Cell Adhesion Molecule 1 (VCAM-1)
Changes in VCAM-1 from baseline to Week 16
Time frame: 16 Weeks
Changes from baseline in P-selectin
Change in P-selectin from baseline at Week 16.
Time frame: 16 Weeks
Changes from baseline in E-selectin
Change in E-selectin from baseline at Week 16.
Time frame: 16 Weeks
Changes from baseline in Dense Red Blood Cells
Changes in Dense Red Blood Cells from baseline to Week 16
Time frame: 16 Weeks
Changes from baseline in Oxygen Point of Sickling
Changes in Oxygen Point of Sickling from baseline to Week 16
Time frame: 16 Weeks
Changes from baseline in Osmoscan
Changes in Osmoscan from baseline to Week 16
Time frame: 16 Weeks
Changes from baseline in absolute reticulocyte count
Change in absolute reticulocyte count from baseline at Week 16.
Time frame: 16 Weeks
Changes from baseline in D-dimer
Changes in D-dimer from baseline to Week 16
Time frame: 16 Weeks
Changes from baseline in Phosphatidylserine
Change in Phosphatidlyserine from baseline to week 16.
Time frame: 16 Weeks
Changes from baseline in Hemoglobin
Change in hemoglobin from baseline at Week 16
Time frame: 16 Weeks
Changes from baseline in Leukocytes
Changes in Leukocytes from baseline to Week 16
Time frame: 16 Weeks
Change from baseline in PROMIS Pain Interference Short Form
Change in PROMIS Pain Interference from baseline to Week 16
Time frame: 16 Weeks
Change from baseline in PROMIS Physical Activity Short Form
Change in PROMIS Physical Activity from baseline to Week 16
Time frame: 16 Weeks
Trough plasma concentrations of total and unesterified 15 HEPE
Trough plasma concentrations of total and unesterified 15 HEPE at baseline and Week 16
Time frame: 16 Weeks
Determination of exploratory biomarkers from baseline
Determination of exploratory biomarkers at baseline and Week 16
Time frame: 16 Weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Jan 2026, 24 months.
Of 34 industry-sponsored phase 2 interventional studies under Anemia, Sickle Cell, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 41. This study's 24 months is below that.
Counting every sponsor, half of 93 studies reached it within 46 months; a quarter within 24 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Afimmune