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A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease

Primary Purpose

Sickle Cell Disease, Vaso-occlusive Crisis, Vaso-occlusive Pain Episode in Sickle Cell Disease

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Inclacumab

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring blood disorders, hemoglobin, red blood cells, RBCs, sickle-like shape, mutation in hemoglobin gene, Sickle Cell Disease, SCD, Vaso-occlusive Crisis, VOC, SCA, Open Label

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants who meet all the following criteria will be eligible for study enrollment:

Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study.
Participant has completed the originating inclacumab study within 30 calendar days of the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related AE, but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab.
Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.
Note: Female participants who become of childbearing potential during the study must be willing to have a negative urine pregnancy test to remain in the study.
If sexually active, female participants of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug.
Participant has provided written informed consent/assent. For underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirement.

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:

Female participant who is breastfeeding or pregnant.
Participant had an infusions-related reaction (IRR) in the originating inclacumab clinical study.
Participant withdrew consent from the originating inclacumab clinical study.
Participant was lost to follow-up from the originating inclacumab clinical study.
Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.

Sites / Locations

Strada Patient Care Center, Pediatric HematologyRecruiting
University of South Alabama Children's and Women's HospitalRecruiting
Arkansas Children's HospitalRecruiting
Children's Hospital and Research Center at OaklandRecruiting
UC Irvine Medical CenterRecruiting
University of South Florida, Department of PediatricsRecruiting
USF Health South Tampa Center for Advanced Healthcare (STC)Recruiting
St. Joseph's HospitalRecruiting
John S Curran,MD, Children's Health Center/Children's Medical Center (CMS)Recruiting
USF Health Carol and Frank Morsani Center for Advanced HealthcareRecruiting
University of Illinois at ChicagoRecruiting
University of Illinois Hospital and Health SystemsRecruiting
Brigham And Woman's HospitalRecruiting
Dana-Farber Cancer Institute IDS PharmacyRecruiting
Dana-Farber Cancer InstituteRecruiting
University of Michigan Hospitals - Michigan MedicineRecruiting
Jacobi Medical CenterRecruiting
Erie Country Medical CenterRecruiting
Duke University Medical CenterRecruiting
DUMC Investigational Drug Services PharmacyRecruiting
Instituto D'Or de Pesquisa e Ensino - Hospital São RafaelRecruiting
Hemocentro de Belo Horizonte - Fundacao HemominasRecruiting
Hospital das Clinicas da Universidade Federal de Minas GeraisRecruiting
Multihemo Servicos Medicos S/ARecruiting
Hospital de Clínicas de Porto AlegreRecruiting
Fundação Faculdade Regional de Medicina de São José do Rio PretoRecruiting
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USPRecruiting
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIORecruiting
Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.ARecruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSPRecruiting
Clinica de la Costa Ltda.Recruiting
Sociedad de Oncología y hematología del CesarRecruiting
Universitätsklinikum Regensburg Pädiatrische Hämatologie, Onkologie und StammzelltransplantationRecruiting
Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali GallieraRecruiting
S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferroRecruiting
DAI Materno-Infantile,- UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi VanvitelRecruiting
UO di Farmacia Clinica,Dipartimento di Medicina Sperimentale
UO di Farmacia Clinica,Dipartimento di Medicina SperimentaleRecruiting
UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"Recruiting
UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"Recruiting
Dipartimento Strutturale Aziendale Salute della Donna e del Bambino Clinica Ginecologica
Farmacia Azienda Ospedale Universita Padova
U.O.C. Farmacia Istituto Oncologico Veneto
KEMRI/CRDR Siaya Clinical Research AnnexRecruiting
International Cancer InstituteRecruiting
Kenya Medical Research Institute - Centre for Respiratory Disease ResearchRecruiting
Strathmore University CREATESRecruiting
American University of Beirut Medical CenterRecruiting
Nini HospitalRecruiting
University of Calabar Teaching Hospital
National Hospital AbujaRecruiting
University of Abuja Teaching Hospital
Ahmadu Bello University Teaching Hospital
Aminu Kano Teaching Hospital
Department of Pediatrics, College of Medicine, Lagos University Teaching HospitalRecruiting
Sultan Qaboos University HospitalRecruiting
Prince Mohammed bin Nasser HospitalRecruiting
NIMR-Mbeya Medical Research CenterRecruiting
Acibadem Adana Hastanesi Cocuk Hematoloji OnkolojiRecruiting
Baskent University Adana Appl. and Research Central, Yuregir Baskent Hospital HematologyRecruiting
Hacettepe University Ihsan Dogramaci Children HospitalRecruiting
Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi HastanesiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inclacumab 30 mg/kg

Arm Description

Inclacumab 30 mg/kg administered intravenously (IV)

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs).

Secondary Outcome Measures

Annualized rate of VOCs

Annualized rate of VOCs that require admission to a healthcare facility and treatment.

Annualized number of days of inpatient hospitalization for a VOC.

Annualized rate of all SCD-related urgent care visits to the clinic, emergency room, and hospital.

Proportion of total days missed from school or work due to SCD pain symptoms for the first 48 weeks.

Annualized rate of complicated VOCs.

Annualized rate of RBC transfusions.

Full Information

NCT ID

NCT05348915

First Posted

March 29, 2022

Last Updated

September 26, 2023

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT05348915

Brief Title

A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease

Official Title

An Open-label Extension Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 29, 2022 (Actual)

Primary Completion Date

November 15, 2028 (Anticipated)

Study Completion Date

November 15, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is an open-label study to evaluate the safety of long-term administration of inclacumab in participants with sickle cell disease (SCD). Participants in this study will have completed a prior study of inclacumab.

Detailed Description

The study will include approximately 520 adult and adolescent participants (≥ 12 years of age) with SCD. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Disease, Vaso-occlusive Crisis, Vaso-occlusive Pain Episode in Sickle Cell Disease

Keywords

blood disorders, hemoglobin, red blood cells, RBCs, sickle-like shape, mutation in hemoglobin gene, Sickle Cell Disease, SCD, Vaso-occlusive Crisis, VOC, SCA, Open Label

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Inclacumab 30 mg/kg

Arm Type

Experimental

Arm Description

Inclacumab 30 mg/kg administered intravenously (IV)

Intervention Type

Drug

Intervention Name(s)

Inclacumab

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events (TEAEs).

Time Frame