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A Phase 2/3 Study in Adult and Adolescent Participants With SCD
NCT05431088 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05431088
The ClinicalTrials.gov registry entry for NCT05431088 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 389 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05431088 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Louisiana, North Carolina, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05431088?
The interventions under investigation include: Osivelotor (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05431088?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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