Inclacumab for Anemia, Sickle Cell

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

Study Summary

This trial will study whether inclacumab can prevent another vaso-occlusive crisis (VOC) in people with sickle cell disease (SCD), by seeing if it is more effective than placebo.

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 · 4 Secondary · Reporting Duration: Through Day 91

Through Day 91
Incidence of treatment-emergent adverse events (TEAEs)
PD parameter (P-selectin inhibition)
PD parameter (Platelet Leukocyte Aggregation)
Day 30
Readmission for a VOC within 30 days
Day 90
Rate of VOCs leading to healthcare visits
Day 90
Re-admission for a VOC within 90 days of randomization
Time to first re-admission for a VOC

Trial Safety

Safety Progress

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

Other trials for Anemia, Sickle Cell

Trial Design

2 Treatment Groups

inclacumab 30 mg/kg
1 of 2
placebo
1 of 2
Experimental Treatment
Non-Treatment Group

280 Total Participants · 2 Treatment Groups

Primary Treatment: Inclacumab · Has Placebo Group · Phase 3

inclacumab 30 mg/kg
Drug
Experimental Group · 1 Intervention: Inclacumab · Intervention Types: Drug
placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through day 91

Who is running the clinical trial?

Global Blood TherapeuticsLead Sponsor
32 Previous Clinical Trials
4,887 Total Patients Enrolled
27 Trials studying Anemia, Sickle Cell
4,775 Patients Enrolled for Anemia, Sickle Cell

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
If you need to be hospitalized or visit an emergency room or infusion center multiple times in a short period of time, you may be able to get help from your health insurance company
Any person with a confirmed diagnosis of sickle cell disease is eligible for this study
This means that you visited a hospital, emergency department, urgent care center, outpatient clinic, or infusion center, or you had a remote contact with a healthcare provider.
Requires the use of narcotic medications that are injected into the body, as well as nonsteroidal anti-inflammatory drugs that are injected into the body, or an increase in the use of narcotic medications that are taken by mouth.
You have a VOC that is uncomplicated.
Acute splenic sequestration is a sudden enlargement of the spleen
The participant is either male or female and is at least 12 years old at the time they give informed consent.
This means that the cause of the event is unknown, but it is likely related to the blood vessels.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 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.