drugset / Trial / NCT05561140
Resolution of Sickle Cell Leg Ulcers With Voxelotor
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease. The study is divided into a 5 study periods: Screening, Run-in, Randomized Treatment, Open-label Treatment, and Follow-up/End of Study (EOS). The study will be conducted in approximately 80 eligible participants at approximately 20 global clinical trial sites.
Timeline
- Start
- 2022-05-30
- Primary completion
- 2024-06-26
- Completion
- 2024-10-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Voxelotor | Small molecule | 500 mg | Oral |