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Inclacumab for Sickle Cell Disease
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Inclacumab 30 mg/kg
- 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.
- 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
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."
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."
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