A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Pfizer
Study ID
NCT04935879
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inclacumab — DRUG
    Inclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion.
  • Placebo — DRUG
    Placebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug

Study Details

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.

Key Dates

Start date
Oct 4, 2021
Status verified
Nov 2025
Primary completion
Jun 6, 2024
Completion
Jun 6, 2024

Study Design

Enrollment
241 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: inclacumab, 30 mg/kg
    Participants will receive inclacumab 30 mg/kg administered IV every 12 weeks
  • Placebo Comparator: placebo
    Participants will receive placebo administered IV every 12 weeks.

Primary Outcome Measure

Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48 [ Time Frame: Randomization (Day 1) up to Week 48 ]

Locations (22)

FacilityCityStateZIPSite coordinators
University of South Alabama Children's and Women's HospitalMobileAlabama36604-
University of South Alabama Mitchell Cancer InstituteMobileAlabama36604-
University of South Alabama Strada Patient Care CenterMobileAlabama36604-
Arkansas Children's HospitalLittle RockArkansas72202-
UC Irvine HealthOrangeCalifornia92868-
UCI Center for clinical researchOrangeCalifornia92868-
Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle CellFarmingtonConnecticut06030-
Hospital Pharmacy Services- Investigational Drug ServicesChicagoIllinois60612-
Rush University Medical CenterChicagoIllinois60612-
Rush University Medical Center Investigator PharmacyChicagoIllinois60612-
University of Illinois Clinical Research Center (CRC)ChicagoIllinois60612-
University of Illinois Hospital and Health Sciences System(UI Health)ChicagoIllinois60612-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Dana-Farber Cancer Institute IDS PharmacyBostonMassachusetts02215-
University of Michigan Hospitals - Michigan MedicineAnn ArborMichigan48109-
Jacobi Medical CenterThe BronxNew York10461-
Duke University Medical CenterDurhamNorth Carolina27705-
DUMC Investigational Drug Services PharmacyDurhamNorth Carolina27710-
McGovern Medical School/Health Science Center HoustonHoustonTexas77030-
Memorial Hermann - TMC Investigational Drugs, IDS PharmacyHoustonTexas77030-
Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)HoustonTexas77030-
UT Physicians Comprehensive Sickle Cell ClinicHoustonTexas77030-

Find similar trials in Mobile, AL

By condition
Sickle cell disease
By research site
University of South Alabama Children's and Women's Hospital· Mobile, ALUniversity of South Alabama Mitchell Cancer Institute· Mobile, ALUniversity of South Alabama Strada Patient Care Center· Mobile, ALArkansas Children's Hospital· Little Rock, ARUC Irvine Health· Orange, CAUCI Center for clinical research· Orange, CA

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