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Resolution of Sickle Cell Leg Ulcers With Voxelotor

NCT05561140 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-07-09

Study results available
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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.

Conditions

Interventions

DRUG

Voxelotor Oral Tablet

Synthetic small molecule supplied as 500 mg tablets, administered Orally

OTHER

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2024-06-26
Completion
2024-10-22
FDA Drug
Yes

Countries

  • Brazil
  • Kenya
  • Nigeria

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561140 on ClinicalTrials.gov