Inclacumab for Anemia, Sickle Cell

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Nini Hospital, Tripoli, Lebanon
Anemia, Sickle Cell+3 More
Inclacumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Anemia, Sickle Cell
  • Vaso-occlusive Crisis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Anemia, Sickle Cell

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Day 1 through Week 48

Week 48
Incidence of anti-drug antibodies (ADA) to inclacumab.
PD parameter (P-selectin inhibition)
PD parameter (Platelet Leukocyte Aggregation)
Plasma pharmacokinetic (PK) of inclacumab as assessed by population PK analysis using nonlinear mixed-effects modeling.
Year 5
Annualized number of days of inpatient hospitalization for a VOC.
Annualized rate of RBC transfusions.
Annualized rate of VOCs
Annualized rate of VOCs that require admission to a healthcare facility and treatment.
Annualized rate of all SCD-related urgent care visits to the clinic, emergency room, and hospital.
Annualized rate of complicated VOCs.
Incidence of treatment-emergent adverse events (TEAEs).
Proportion of total days missed from school or work due to SCD pain symptoms for the first 48 weeks.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Anemia, Sickle Cell

Trial Design

1 Treatment Group

Inclacumab 30 mg/kg
1 of 1
Experimental Treatment

520 Total Participants · 1 Treatment Group

Primary Treatment: Inclacumab · No Placebo Group · Phase 3

Inclacumab 30 mg/kg
Drug
Experimental Group · 1 Intervention: Inclacumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 through week 48
Closest Location: University of Michigan · Ann Arbor, MI
Photo of university of michigan comprehensive cancer center 1Photo of university of michigan comprehensive cancer center 2Photo of university of michigan comprehensive cancer center 3
2022First Recorded Clinical Trial
11 TrialsResearching Anemia, Sickle Cell
1005 CompletedClinical Trials

Who is running the clinical trial?

Global Blood TherapeuticsLead Sponsor
31 Previous Clinical Trials
4,567 Total Patients Enrolled
26 Trials studying Anemia, Sickle Cell
4,455 Patients Enrolled for Anemia, Sickle Cell

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female and of childbearing potential.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.