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Monoclonal Antibodies
Inclacumab for Sickle Cell Disease
Phase 3
Recruiting
Research Sponsored by Global Blood Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through week 48
Awards & highlights
Study Summary
This trial will test the safety of a long-term administration of inclacumab, a drug that has been previously studied, in people with sickle cell disease.
Who is the study for?
This trial is for individuals with Sickle Cell Disease who previously participated in an inclacumab study. They must have finished the prior study within 30 days, not be pregnant or breastfeeding, and agree to use effective contraception. Those with conditions that could affect safety assessments or compliance are excluded.Check my eligibility
What is being tested?
The trial is assessing the long-term safety of inclacumab in patients with Sickle Cell Disease. It's an open-label study, meaning everyone knows they're getting inclacumab, and it's given to those who completed a previous inclacumab trial.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants from the original study who had infusion-related reactions to inclacumab are excluded, suggesting such reactions may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have SCD and was part of a GBT inclacumab study.
Select...
I am using or willing to use effective birth control during and for 165 days after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs).
Secondary outcome measures
Annualized number of days of inpatient hospitalization for a VOC.
Annualized rate of RBC transfusions.
Annualized rate of VOCs
+4 moreOther outcome measures
Incidence of anti-drug antibodies (ADA) to inclacumab.
PD parameter (P-selectin inhibition)
PD parameter (Platelet Leukocyte Aggregation)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Inclacumab 30 mg/kgExperimental Treatment1 Intervention
Inclacumab 30 mg/kg administered intravenously (IV)
Find a Location
Who is running the clinical trial?
Global Blood TherapeuticsLead Sponsor
35 Previous Clinical Trials
4,357 Total Patients Enrolled
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,353 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have SCD and was part of a GBT inclacumab study.I am a woman who can have children and have a negative pregnancy test.I agree to take a pregnancy test if I can have children during the study.I am currently pregnant or breastfeeding.I finished my initial inclacumab study less than 30 days ago and had no serious side effects.I am using or willing to use effective birth control during and for 165 days after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Inclacumab 30 mg/kg
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
When might Inclacumab receive FDA approval?
"There is some data supporting the efficacy of Inclacumab and multiple rounds of data supporting its safety, so it received a score of 3."
Answered by AI
Are recruitment efforts for this trial still underway?
"According to the latest information on clinicaltrials.gov, this study is not currently looking for any more patients as recruitment has finished. This specific trial was first posted on March 29th, 2022 and was last updated June 30th, 2022. Although this study is completed in terms of recruitment, there are still 202 other studies that are presently recruiting patients."
Answered by AI
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