A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT05348915|
Recruitment Status : Enrolling by invitation
First Posted : April 27, 2022
Last Update Posted : February 21, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Vaso-occlusive Crisis Vaso-occlusive Pain Episode in Sickle Cell Disease||Drug: Inclacumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||520 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 29, 2022|
|Estimated Primary Completion Date :||March 2027|
|Estimated Study Completion Date :||November 2028|
Experimental: Inclacumab 30 mg/kg
Inclacumab 30 mg/kg administered intravenously (IV)
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.
- Incidence of treatment-emergent adverse events (TEAEs). [ Time Frame: Day 1 through study completion, an estimate of 5 years ]
- Annualized rate of VOCs [ Time Frame: Day 1 through study completion, an estimate of 5 years ]
- Annualized rate of VOCs that require admission to a healthcare facility and treatment. [ Time Frame: Day 1 through study completion, an estimate of 5 years ]
- Annualized number of days of inpatient hospitalization for a VOC. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Day 1 through study completion, an estimate of 5 years ]
- Annualized rate of complicated VOCs. [ Time Frame: Day 1 through study completion, an estimate of 5 years ]
- Annualized rate of RBC transfusions. [ Time Frame: Day 1 through study completion, an estimate of 5 years ]
- Plasma pharmacokinetic (PK) of inclacumab as assessed by population PK analysis using nonlinear mixed-effects modeling. [ Time Frame: Day 1 through Week 48 ]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.
- Incidence of anti-drug antibodies (ADA) to inclacumab. [ Time Frame: Day 1 through Week 48 ]
- PD parameter (P-selectin inhibition) [ Time Frame: Day 1 through Week 48 ]
- PD parameter (Platelet Leukocyte Aggregation) [ Time Frame: Day 1 through Week 48 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05348915
|United States, Arkansas|
|Arkansas Children's Hospital|
|Little Rock, Arkansas, United States, 72202|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|Jacobi Medical Center|
|Bronx, New York, United States, 10461|
|International Cancer Institute (ICI)|
|Eldoret, Kenya, 30100|
|KEMRI CRDR Clinical Research Clinic Nairobi|
|KEMRI/CRDR Siaya Clinical Research Annex|
|American University of Beirut Medical Center|
|National Hospital Abuja|
|Aminu Kano Teaching Hospital|
|Lagos University Teaching Hospital Haematology|
|Suru Lere, Nigeria|
|Baskent University Medical Faculty Adana Practice and Research Center|
|Adana, Turkey, 01250|
|Hacettepe University Ihsan Dogramaci Children's Ho|
|Ankara, Turkey, 06230|
|Responsible Party:||Global Blood Therapeutics|
|Other Study ID Numbers:||
2020-005289-32 ( EudraCT Number )
LBCTR2021074838 ( Registry Identifier: Lebanon Clinical Trials Registry )
PACTR202108532761448 ( Registry Identifier: Pan African Clinical Trials Registry )
|First Posted:||April 27, 2022 Key Record Dates|
|Last Update Posted:||February 21, 2023|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
red blood cells
mutation in hemoglobin gene
Sickle Cell Disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn