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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05348915
Recruitment Status : Recruiting
First Posted : April 27, 2022
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Vaso-occlusive Crisis Vaso-occlusive Pain Episode in Sickle Cell Disease Drug: Inclacumab Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : November 15, 2028
Estimated Study Completion Date : November 15, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Inclacumab 30 mg/kg
Inclacumab 30 mg/kg administered intravenously (IV)
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs). [ Time Frame: Day 1 through study completion, an estimate of 5 years ]

Secondary Outcome Measures :
  1. Annualized rate of VOCs [ Time Frame: Day 1 through study completion, an estimate of 5 years ]
  2. 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 ]
  3. Annualized number of days of inpatient hospitalization for a VOC. [ Time Frame: Day 1 through study completion, an estimate of 5 years ]
  4. 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 ]
  5. 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 ]
  6. Annualized rate of complicated VOCs. [ Time Frame: Day 1 through study completion, an estimate of 5 years ]
  7. Annualized rate of RBC transfusions. [ Time Frame: Day 1 through study completion, an estimate of 5 years ]

Other Outcome Measures:
  1. 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.

  2. Incidence of anti-drug antibodies (ADA) to inclacumab. [ Time Frame: Day 1 through Week 48 ]
  3. PD parameter (P-selectin inhibition) [ Time Frame: Day 1 through Week 48 ]
  4. PD parameter (Platelet Leukocyte Aggregation) [ Time Frame: Day 1 through Week 48 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study.
  2. 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.

  3. 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.

  4. 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.
  5. 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:

  1. Female participant who is breastfeeding or pregnant.
  2. Participant had an infusions-related reaction (IRR) in the originating inclacumab clinical study.
  3. Participant withdrew consent from the originating inclacumab clinical study.
  4. Participant was lost to follow-up from the originating inclacumab clinical study.
  5. 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05348915    
Other Study ID Numbers: GBT2104-133
C5361003 ( Other Identifier: Alias Study Number )
2020-005289-32 ( EudraCT Number )
LBCTR2021074838 ( Registry Identifier: Lebanon Clinical Trials Registry )
PACTR202108532761448 ( Registry Identifier: Pan African Clinical Trials Registry )
020-005289-32 ( Registry Identifier: CTIS (EU) )
First Posted: April 27, 2022    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
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
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn