A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease
- Conditions
- Vaso-occlusive CrisisSickle Cell DiseaseVaso-occlusive Pain Episode in Sickle Cell Disease
- Interventions
- Registration Number
- NCT05348915
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 123
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.
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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.
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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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Inclacumab 30 mg/kg Inclacumab Inclacumab 30 mg/kg administered intravenously (IV)
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs). Day 1 through study completion, an estimate of 5 years
- Secondary Outcome Measures
Name Time Method Annualized rate of VOCs Day 1 through study completion, an estimate of 5 years Annualized rate of VOCs that require admission to a healthcare facility and treatment. Day 1 through study completion, an estimate of 5 years Annualized rate of all SCD-related urgent care visits to the clinic, emergency room, and hospital. Day 1 through study completion, an estimate of 5 years Annualized number of days of inpatient hospitalization for a VOC. Day 1 through study completion, an estimate of 5 years Annualized rate of complicated VOCs. Day 1 through study completion, an estimate of 5 years Annualized rate of RBC transfusions. Day 1 through study completion, an estimate of 5 years Proportion of total days missed from school or work due to SCD pain symptoms for the first 48 weeks. Day 1 through study completion, an estimate of 5 years
Trial Locations
- Locations (20)
Brigham And Woman's Hospital
🇺🇸Boston, Massachusetts, United States
University of South Alabama Children's and Women's Hospital
🇺🇸Mobile, Alabama, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
UC Irvine Medical Center
🇺🇸Orange, California, United States
UConn-Neag Comprehensive Cancer Center
🇺🇸Farmington, Connecticut, United States
University of Illinois Hospital and Health Sciences System (UI Health)
🇺🇸Chicago, Illinois, United States
University of Michigan Hospitals - Michigan Medicine
🇺🇸Ann Arbor, Michigan, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
McGovern Medical School at UTHealth
🇺🇸Houston, Texas, United States
Fundação Faculdade Regional de Medicina de São José do Rio Preto
🇧🇷Sao Jose do Rio Preto, SAO Paulo, Brazil
Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A
🇧🇷São Paulo, Brazil
Clinica de la Costa Ltda.
🇨🇴Barranquilla, Atlantico, Colombia
Sociedad de Oncología y hematología del Cesar
🇨🇴Valledupar, Cesar, Colombia
International Cancer Institute
🇰🇪Eldoret, Kenya
Strathmore University CREATES
🇰🇪Nairobi, Kenya
University of Calabar Teaching Hospital
🇳🇬Calabar, Cross River State, Nigeria
National Hospital Abuja
🇳🇬Abuja, FCT, Nigeria
Ahmadu Bello University Teaching Hospital
🇳🇬Zaria, Kaduna, Nigeria
Aminu Kano Teaching Hospital
🇳🇬Kano, Nigeria