A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises
NCT ID: NCT04927247
Last Updated: 2024-12-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
72 participants
INTERVENTIONAL
2021-12-09
2023-11-24
Brief Summary
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Detailed Description
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Eligible participants will be administered inclacumab or placebo intravenous (IV) as a single dose.
Participants that complete the study through Day 90 will be provided the opportunity to enroll in an open-label extension (OLE) study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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inclacumab 30 mg/kg
Inclacumab 30 mg/kg administered intravenously (IV)
Inclacumab
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
Placebo administered IV
Placebo
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.
Interventions
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Inclacumab
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
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.
Eligibility Criteria
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Inclusion Criteria
1. A hospital admission, or
2. An admission to an emergency room, observation unit, or infusion center for ≥ 12 hours, or
3. 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period
for an acute episode of pain with no other cause other than a vaso- occlusive event that includes the following:
* Uncomplicated VOC,
* Acute chest syndrome (ACS),
* Acute hepatic sequestration,
* Acute splenic sequestration, or
* Priapism.
2. Participant has a confirmed diagnosis of SCD (any genotype). Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing at Baseline.
3. Participant is male or female, ≥ 12 years of age at the time of informed consent.
4. Participant has experienced between 2 and 10 VOCs within the 12 months prior to Screening as determined by documented medical history. The index VOC is not to be considered as one of the 2 to 10 events. A prior VOC is defined as an acute episode of pain that:
1. Has no medically determined cause other than a vaso-occlusive event, and
2. Results in a visit to a healthcare facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or results in a remote contact with a healthcare provider; and
3. Requires parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics.
5. Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin \[EPO\]) must be on a stable dose for at least 90 days prior to Screening and expected to continue with the stabilized regimen throughout the course of the study.
6. Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) must be on a stable dose for at least 30 days prior to Screening and expected to continue with the stabilized regimen throughout the course of the study.
Exclusion Criteria
2. Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to Screening.
3. Participant weighs \> 133 kg (292 lbs.).
Other protocol-defined Inclusion/Exclusion may apply.
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Strada Patient Care Center
Mobile, Alabama, United States
University of South Alabama Children's and Women's Hospital
Mobile, Alabama, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
UCSF Benioff Children's Hospital, Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
St. Joseph's Hospital
Tampa, Florida, United States
University of Michigan Hospitals - Michigan Medicine
Ann Arbor, Michigan, United States
Functional Fluidics, Inc.
Detroit, Michigan, United States
Alliance for Childhood Diseases dba Cure 4 The Kids Foundation
Las Vegas, Nevada, United States
Erie County Medical Center
Buffalo, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
DUMC Investigational Drug Services Pharmacy
Durham, North Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
PPD Bioanalytical
Richmond, Virginia, United States
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Estado de Bahia, Brazil
Multihemo Servicos Medicos S/A
Recife, Pernambuco, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Casa de Saude Santa Marcelina
São Paulo, São Paulo, Brazil
Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO
Rio de Janeiro, , Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSP
São Paulo, , Brazil
CEPEC-Centro de Pesquisa Clinica
São Paulo, , Brazil
Clinica de la Costa Ltda.
Barranquilla, Atlántico, Colombia
Organizacion Clinica Bonnadona Prevenir S.A.S.
Barranquilla, Atlántico, Colombia
Hopital Avicenne
Bobigny, , France
Hopital Henri Mondor
Créteil, , France
Universitatsklinikum Regensburg Padiatrische Hamatologie, Onkologie und Stammzelltransplantation
Regensburg, , Germany
Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera
Genova, Genoa, Italy
S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro
Genova, , Italy
DAI Materno-Infantile, UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi Vanvitell
Napoli, , Italy
UO di Farmacia Clinica, Dipartimento di Medicina Sperimentale Azienda Ospedaliera Universitaria
Napoli, , Italy
UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
Napoli, , Italy
UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
Napoli, , Italy
Kemri/Crdr, Siaya, Kemri Clinical Research Annex,
Kisumu, Siaya County, Kenya
International Cancer Institute
Eldoret, , Kenya
Kenya medical Research Institute-centre for Respiratory Disease Research
Nairobi, , Kenya
Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES)
Nairobi, , Kenya
American University of Beirut Medical Center
Hamra, Beyrouth, Lebanon
Nini Hospital
Tripoli, North Lebanon, Lebanon
University of Calabar Teaching Hospital
Calabar, Cross River State, Nigeria
National Hospital Abuja
Abuja, Federal Capital Territory, Nigeria
University of Abuja Teaching Hospital
Gwagwalada, Federal Capital Territory, Nigeria
Ahmadu Bello University Teaching Hospital (ABUTH)
Zaria, Kaduna State, Nigeria
University of Nigeria Teaching Hospital
Enugu, , Nigeria
Barau Dikko Teaching Hospital/Kaduna State University
Kaduna, , Nigeria
Aminu Kano Teaching Hospital
Kano, , Nigeria
Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital
Lagos, , Nigeria
Sultan Qaboos University Hospital
Muscat, , Oman
Prince Mohammed bin Nasser Hospital
Jizan, Southern, Saudi Arabia
Hacettepe University
Ankara, Altindag/sihhiye, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi
Yenischir, Mersin, Mersin, Turkey (Türkiye)
Baskent University Hospital
Adana, Yuregir, Turkey (Türkiye)
Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji
Adana, , Turkey (Türkiye)
Guy's & Thomas' NHS Foundation Trust
London, England, United Kingdom
Matero Clinical Research Site,
Lusaka, , Zambia
University Teaching Hospital- Children's Hospital
Lusaka, , Zambia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5361002
Identifier Type: OTHER
Identifier Source: secondary_id
2020-005287-60
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2020-005287-60
Identifier Type: REGISTRY
Identifier Source: secondary_id
GBT2104-132
Identifier Type: -
Identifier Source: org_study_id