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A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
NCT04935879 · View on ClinicalTrials.gov ↗
Study Summary
This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inclacumab
Study Locations (20)
Illinois
- Hospital Pharmacy Services- Investigational Drug Services — Chicago
- Rush University Medical Center Investigator Pharmacy — Chicago
- Rush University Medical Center — Chicago
- University of Illinois Clinical Research Center (CRC) — Chicago
- University of Illinois Hospital and Health Sciences System(UI Health) — Chicago
Alabama
- University of South Alabama Children's and Women's Hospital — Mobile
- University of South Alabama Mitchell Cancer Institute — Mobile
- University of South Alabama Strada Patient Care Center — Mobile
California
- UC Irvine Health — Orange
- UCI Center for clinical research — Orange
Massachusetts
- Dana-Farber Cancer Institute IDS Pharmacy — Boston
- Dana-Farber Cancer Institute — Boston
North Carolina
- Duke University Medical Center — Durham
- DUMC Investigational Drug Services Pharmacy — Durham
Texas
- McGovern Medical School/Health Science Center Houston — Houston
- Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy — Houston
Arkansas
- Arkansas Children's Hospital — Little Rock
Connecticut
- Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell — Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2021-10-04 |
| Est. Completion | 2024-06-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04935879
The ClinicalTrials.gov registry entry for NCT04935879 describes a study currently listed as completed. It is categorized as Phase 3, 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 241 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 3 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT04935879 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Illinois, Alabama, California. 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 NCT04935879 about?
NCT04935879 is a clinical study titled "A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises". This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receiv...
What is the current status of trial NCT04935879?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2021-10-04. Estimated completion is 2024-06-06.
What conditions does trial NCT04935879 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Vaso-occlusive Crisis, Vaso-occlusive Pain Episode in 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 NCT04935879?
The interventions under investigation include: Placebo (DRUG), Inclacumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04935879?
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 NCT04935879 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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