A trial to evaluate inclacumab for VOC prevention
Research type
Research Study
Full title
An Open-Label Extension Study to Evaluate the Long-Term Safety of Inclacumab Administered to Participants with Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial
IRAS ID
1003852
Contact name
Kalyan Obalampalli
Contact email
Sponsor organisation
Global Blood Therapeutics, Inc.
Eudract number
2020-005289-32
Research summary
The sponsor of this study is Global Blood Therapeutics. This is an open-label follow-on study which will evaluate the long-term safety of inclacumab in participants with Sickle Cell Disease (SCD) who suffer from recurrent vaso-occlusive crises (VOCs) and have already participated in an inclacumab trial.
SCD is an inherited disorder which affects haemoglobin (the part of a red blood cell that carries oxygen through the body). Usually red blood cells are round & flexible to move easily through blood vessels. However, with SCD the red blood cells are misshaped and sticky, which means the cells cannot bend and move easily through the body, causing blockage of blood flow and oxygen to parts of the body. These events are known as VOCs – they can cause severe pain, have the potential to cause organ damage, and in severe cases can lead to stroke or a severe
complication known as Acute Chest Syndrome.
Inclacumab is a fully human monoclonal antibody which binds to a protein, called P-selectin, on the lining of the blood vessels and stops the sickle
red blood cells from sticking to blood vessels and therefore prevents blockage of blood flow. The blockage of the blood vessels leads to painful
VOCs and inclacumab is designed to prevent this from occurring so that blood can flow normally and to reduce the painful events, limiting the
number of VOCs a patient may experience.
Approximately 520 adult & adolescent participants (≥ 12 years of age) with SCD are expected to participate in this study at approx 150 global
clinical sites. . This includes a 30-day screening period, a dose of inclacumab will be given on day 1 and once every 12 weeks afterwards. There is no placebo on this trial; all participants will receive inclacumab. Participants will remain on the trial until inclacumab is available through commercialisation.REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0324
Date of REC Opinion
27 Oct 2021
REC opinion
Further Information Favourable Opinion