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P-selectin inhibitor

Inclacumab for Sickle Cell Disease

Phase 3
Waitlist Available
Research Sponsored by Global Blood Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 91
Awards & highlights

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
  • Sickle Cell Disease
  • Sickle Cell Crisis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 91
This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 91 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Re-admission for a VOC within 90 days of randomization
Secondary outcome measures
Incidence of treatment-emergent adverse events (TEAEs)
Rate of VOCs leading to healthcare visits
Readmission for a VOC within 30 days
+1 more
Other outcome measures
PD parameter (P-selectin inhibition)
PD parameter (Platelet Leukocyte Aggregation)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: inclacumab 30 mg/kgExperimental Treatment1 Intervention
Inclacumab 30 mg/kg administered intravenously (IV)
Group II: placeboPlacebo Group1 Intervention
Placebo administered IV

Find a Location

Who is running the clinical trial?

Global Blood TherapeuticsLead Sponsor
35 Previous Clinical Trials
4,805 Total Patients Enrolled
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,801 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,969 Total Patients Enrolled

Media Library

Inclacumab (P-selectin inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04927247 — Phase 3
Sickle Cell Disease Research Study Groups: inclacumab 30 mg/kg, placebo
Sickle Cell Disease Clinical Trial 2023: Inclacumab Highlights & Side Effects. Trial Name: NCT04927247 — Phase 3
Inclacumab (P-selectin inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04927247 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different research facilities can participants take part in this trial?

"There are 11 clinical trial sites operational at this time, with additional locations in Mobile, Chicago and Memphis. If you are considering participating in this trial, please try and select the location nearest to you in order to reduce travel time and related demands."

Answered by AI

Has Inclacumab been cleared by the FDA?

"There is some evidence from clinical trials to support Inclacumab's efficacy, as well as numerous rounds of data collected to vouch for its safety. Consequently, our team at Power has given Inclacumab a safety rating of 3."

Answered by AI

How many volunteers are needed for this research?

"To successfully run this experiment, the research team needs to recruit 280 patients that meet the eligibility standards. The sponsor, Global Blood Therapeutics, has chosen University of South Alabama Children's and Women's Hospital in Mobile, Alabama and University of Illinois at Chicago in Chicago, Illinois as two of the locations where the trial will take place."

Answered by AI

Are people with the required medical conditions able to enroll in this trial right now?

"Yes, this clinical trial is currently enrolling patients. Information on clinicaltrials.gov shows that the trial was posted on December 13th, 2021 and was last updated on August 23rd, 2022. The study is looking for 280 patients to enroll at 11 sites."

Answered by AI

Could you please summarize the previous research on Inclacumab?

"Inclacumab was first studied in 2021 at Strathmore University. There have been a total of 18,243 completed studies since then. There are currently 2 trials actively recruiting patients, a large number of which are based in Mobile, Alabama."

Answered by AI

Has this sort of research been done before?

"Since 2021, Inclacumab has been the subject of medical research with the first trial being sponsored by Global Blood Therapeutics. Inclacumab received Phase 3 drug approval after the first trial in 2021, which had 240 participants. There are two active trials for Inclacumab being conducted in 29 cities and 13 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises
2021. "A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04927247.
~22 spots leftby Apr 2025
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