drugset / Trial / NCT05561140

Resolution of Sickle Cell Leg Ulcers With Voxelotor

NCT05561140

Phase 3 Terminated 88 enrolled Pfizer
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

EvaluationDrugModalityDoseRoute
Subject Voxelotor Small molecule 500 mg Oral