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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005289-32 | EudraCT Number | ||
| C5361003 | Other Identifier | Alias Study Number |
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Sponsor decision to terminate study based on results of parent study GBT2104-131.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inclacumab 30 mg/kg | Experimental | Inclacumab 30 mg/kg administered intravenously (IV) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs). | Day 1 through study completion, an estimate of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic (PK) of inclacumab as assessed by population PK analysis using nonlinear mixed-effects modeling. | Inclacumab concentrations will be measured from plasma samples. Population PK analysis using nonlinear mixed effects modeling will be performed to characterize inclacumab PK in plasma. | Day 1 through Week 48 |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strada Patient Care Center, Pediatric Hematology | Mobile | Alabama | 36604 | United States | ||
| University of South Alabama Children's and Women's Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Annualized number of days of inpatient hospitalization for a VOC. | 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 |
| 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 |
| 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 |
| Incidence of anti-drug antibodies (ADA) to inclacumab. |
| Day 1 through Week 48 |
| PD parameter (P-selectin inhibition) | Day 1 through Week 48 |
| PD parameter (Platelet Leukocyte Aggregation) | Day 1 through Week 48 |
| Mobile |
| Alabama |
| 36604 |
| United States |
| South Alabama Medical Science Foundation | Mobile | Alabama | 36606 | United States |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
| UC Irvine Medical Center | Orange | California | 92868 | United States |
| UConn-Neag Comprehensive Cancer Center | Farmington | Connecticut | 06030 | United States |
| University of Illinois at Chicago (UIC) Clinical Research Center | Chicago | Illinois | 60612 | United States |
| University of Illinois Hospital and Health Sciences System (UI Health) | Chicago | Illinois | 60612 | United States |
| Brigham And Woman's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute IDS Pharmacy | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan Hospitals - Michigan Medicine | Ann Arbor | Michigan | 48109 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| DUMC Investigational Drug Services Pharmacy | Durham | North Carolina | 27710 | United States |
| McGovern Medical School at UTHealth | Houston | Texas | 77030 | United States |
| UT Health Science Center at Houston - Clinical Research Unit at Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| UT Physicians Comprehensive Sickle Cell Center Houston | Houston | Texas | 77030 | United States |
| Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Multihemo Servicos Medicos S/A | Recife | Pernambuco | 50070-460 | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO | Rio de Janeiro | 20211-030 | Brazil |
| Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A | São Paulo | 01232-010 | Brazil |
| Casa de Saude Santa Marcelina | São Paulo | 08270-070 | Brazil |
| CEPEC-Centro de Pesquisa Clinica | São Paulo | 08270-120 | Brazil |
| Clinica de la Costa Ltda. | Barranquilla | Atlántico | 080020 | Colombia |
| Sociedad de Oncología y hematología del Cesar | Valledupar | Cesar Department | 200001 | Colombia |
| KEMRI/CRDR Siaya Clinical Research Annex | Kisumu | Siaya County | 40600 | Kenya |
| International Cancer Institute | Eldoret | 30100 | Kenya |
| Gertrude's Children's Hospital | Nairobi | 00100 | Kenya |
| Kenya Medical Research Institute - Centre for Respiratory Disease Research | Nairobi | 00100 | Kenya |
| Strathmore University CREATES | Nairobi | 00200 | Kenya |
| American University of Beirut Medical Center | Hamra | Beirut | Lebanon |
| Nini Hospital | Tripoli | North Lebanon | Lebanon |
| University of Calabar Teaching Hospital | Calabar | Cross River State | 540242 | Nigeria |
| National Hospital Abuja | Abuja | Federal Capital Territory | 900211 | Nigeria |
| University of Abuja Teaching Hospital | Gwagwalada | Federal Capital Territory | 902101 | Nigeria |
| Ahmadu Bello University Teaching Hospital | Zaria | Kaduna State | 810105 | Nigeria |
| University of Nigeria Teaching Hospital | Enugu | 460000 | Nigeria |
| Barau Dikko Teaching Hospital/Kaduna State University | Kaduna | 800212 | Nigeria |
| Aminu Kano Teaching Hospital | Kano | 700223 | Nigeria |
| Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital | Lagos | 100254 | Nigeria |
| Sultan Qaboos University Hospital | Muscat | 123 | Oman |
| Prince Mohammed bin Nasser Hospital | Jizan | Southern | 82943 | Saudi Arabia |
| National Institute for Medical Research (NIMR) | Dar es Salaam | 11101 | Tanzania |
| Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji | Adana | 01130 | Turkey (Türkiye) |
| Baskent University Adana Appl. and Research Central, Yuregir Baskent Hospital Hematology | Adana | 01250 | Turkey (Türkiye) |
| Hacettepe University Ihsan Dogramaci Children Hospital | Ankara | 06430 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000098644 | Vaso-Occlusive Crises |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C000604431 | inclacumab |
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