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P-selectin inhibitor

Inclacumab for Sickle Cell Disease

Phase 3
Waitlist Available
Research Sponsored by Global Blood Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 91
Awards & highlights

Study Summary

This trial will study whether inclacumab can prevent another vaso-occlusive crisis (VOC) in people with sickle cell disease (SCD), by seeing if it is more effective than placebo.

Eligible Conditions
  • Sickle Cell Disease
  • Sickle Cell Crisis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 91
This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 91 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Re-admission for a VOC within 90 days of randomization
Secondary outcome measures
Incidence of treatment-emergent adverse events (TEAEs)
Rate of VOCs leading to healthcare visits
Readmission for a VOC within 30 days
+1 more
Other outcome measures
PD parameter (P-selectin inhibition)
PD parameter (Platelet Leukocyte Aggregation)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: inclacumab 30 mg/kgExperimental Treatment1 Intervention
Inclacumab 30 mg/kg administered intravenously (IV)
Group II: placeboPlacebo Group1 Intervention
Placebo administered IV

Find a Location

Who is running the clinical trial?

Global Blood TherapeuticsLead Sponsor
35 Previous Clinical Trials
4,407 Total Patients Enrolled
PfizerLead Sponsor
4,595 Previous Clinical Trials
12,868,698 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,045,307 Total Patients Enrolled

Media Library

Inclacumab (P-selectin inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04927247 — Phase 3
Sickle Cell Disease Research Study Groups: inclacumab 30 mg/kg, placebo
Sickle Cell Disease Clinical Trial 2023: Inclacumab Highlights & Side Effects. Trial Name: NCT04927247 — Phase 3
Inclacumab (P-selectin inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04927247 — Phase 3
~21 spots leftby Jun 2025
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