Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05431088 · ClinicalTrials.gov registry record · Phase 2
A Phase 2/3 Study in Adult and Adolescent Participants With SCD
A Phase 2 study of Sickle Cell Disease, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 389
- Enrollment target
- 20
- Study locations
NCT05431088: Recruiting Phase 2 study of Sickle Cell Disease, sponsored by Pfizer.
NCT05431088 is a Phase 2 study of Sickle Cell Disease that is actively recruiting participants, run by Pfizer. The registered enrollment target is 389 participants, above the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05431088, a Phase 2 study of Sickle Cell Disease, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 389 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
Primary Outcome
Number of adult participants with change from baseline in hemoglobin (Hb) through week 12 as measured by change in osivelotor concentrations from baseline or percentage change from baseline of clinical measures of anemia Hb and hemolysis (including indirect bilirubin, reticulocytes and lactate dehydrogenase).
Conditions Studied
Interventions
- DRUG Osivelotor
Study Locations (20)
Louisiana
- LSU Health Baton Rouge-North Clinic - Baton Rouge
- Our Lady of the Lake Hospital, Inc. - Baton Rouge
- Our lady of the Lake Hospital - Baton Rouge
- University Medical Center New Orleans - New Orleans
North Carolina
- Clinical & Translational Research Center (CTRC) - Chapel Hill
- UNC Health - Chapel Hill
- UNC Eastowne Medical Office Building - Consent Only - Chapel Hill
- UNC IDS - Morrisville
Florida
- Edward Jenner Research Group Center LLC - Plantation
- Pediatric Hematology / Oncology a division of Kidz Medical services - West Palm Beach
- St. Mary's Medical Center - West Palm Beach
Illinois
- University of Illinois at Chicago Clinical Research Center - Chicago
- University of Illinois Hospital and Health Sciences System - Investigational Drug Services (IDS) - Chicago
- University of Illinois Hospital and Health Sciences System - Chicago
Georgia
- Alpha Clinical Research Georgia - Dunwoody
- Sonar Clinical Research - Riverdale
Connecticut
- Smilow Cancer Hospital - New Haven
Mississippi
- Mississippi Center for Advanced Medicine - Madison
Missouri
- University Health - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 389 participants |
| Start Date | 2022-09-22 |
| Est. Completion | 2032-12-31 |
| Phase | Phase 2 |
What NCT05431088 shows while recruiting
NCT05431088 is an interventional study that assigns participants to a tested intervention. The registered 389 participants enrollment target is mid-sized for trials with a published cap, above the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (34% higher).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Osivelotor is the first listed.
NCT05431088 names 20 study sites across 9 states, led by Louisiana, North Carolina, Florida.
Frequently Asked Questions
What is clinical trial NCT05431088 about?
NCT05431088 is a clinical study titled "A Phase 2/3 Study in Adult and Adolescent Participants With SCD". The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
What is the current status of trial NCT05431088?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 389 participants. The study started on 2022-09-22. Estimated completion is 2032-12-31.
What conditions does trial NCT05431088 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT05431088?
The interventions under investigation include: Osivelotor (DRUG).
Who is sponsoring clinical trial NCT05431088?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05431088 being conducted?
This trial has 20 study locations across Connecticut, Florida, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sickle Cell Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05431088's enrollment target sits among peer trials
389 14th of 213 higher than 200 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults
RECRUITING · Phase 2
-
Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET
RECRUITING · Phase 2
-
Myeloablative Conditioning, Prophylactic Defibrotide and Haplo AlloSCT for Patients With Sickle Cell Disease
RECRUITING · Phase 2
-
A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)
RECRUITING · Phase 2
-
Allo HSCT for High Risk Hemoglobinopathies
RECRUITING · Phase 2
-
Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00397111 · 390 participants
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
- NCT05335928 · 390 participants · Phase 3
Abatacept in Immune Checkpoint Inhibitor Myocarditis
- NCT05445960 · 390 participants · NA
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
- NCT05997615 · 390 participants · Phase 1
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI