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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

Tracking Information
First Submitted Date  ICMJE March 29, 2022
First Posted Date  ICMJE April 27, 2022
Last Update Posted Date March 15, 2024
Actual Study Start Date  ICMJE March 29, 2022
Estimated Primary Completion Date November 15, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2022)		 Incidence of treatment-emergent adverse events (TEAEs). [ Time Frame: Day 1 through study completion, an estimate of 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2022)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 21, 2022)
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sickle Cell Disease
  • Vaso-occlusive Crisis
  • Vaso-occlusive Pain Episode in Sickle Cell Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Inclacumab 30 mg/kg
Inclacumab 30 mg/kg administered intravenously (IV)
Intervention: Drug: Inclacumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2022)		 520
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2028
Estimated Primary Completion Date November 15, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Brazil,   Colombia,   Germany,   Italy,   Kenya,   Lebanon,   Nigeria,   Oman,   Saudi Arabia,   Tanzania,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05348915
Other Study ID Numbers  ICMJE 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) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Pfizer
Original Responsible Party Global Blood Therapeutics
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Global Blood Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP