A Phase 3 Trial of Itolizumab with Corticosteroids for Acute Graft Versus Host Disease
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination with Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease
IRAS ID
1004475
Contact name
Maple Fung
Contact email
Sponsor organisation
Equillium, Inc.
Eudract number
2021-004529-57
Clinicaltrials.gov Identifier
Research summary
Acute graft versus host disease (aGVHD) is a complication developed in patients who have recently undergone a transplant procedure known as allogeneic hematopoietic stem cell transplantation (HSCT), whereby patients receive donor blood cells. aGVHD causes donor blood cells to mistakenly attack a patient’s body cells leading to organ damage. Acute GVHD (aGVHD) generally occurs within the first 100 days post-HSCT, and the organs commonly affected include the skin, liver, and gastrointestinal (GI) tract. Although numerous medications have been investigated, there are currently no approved therapies for the initial treatment of aGVHD for adults or children. The main purpose of this EQ-100-02 study is to test the efficacy and safety (benefit and risks) of the study medication, itolizumab, when added to corticosteroids, as treatment for aGVHD. Itolizumab is a protein that selectively binds with a specific protein in the body, called CD6, that plays an important role in the immune system. Itolizumab has been given to animals with a form of graft versus host disease, and the animals receiving itolizumab showed improvement, in comparison to animals that did not receive itolizumab.
The safety of itolizumab administered as an intravenous infusion (IV) has been studied in patients with aGVHD. In this study, study medication (itolizumab or placebo) will be administered as an intravenous infusion. Patients will receive study medication, Itlolizumab in addition to corticosteroids, which are the standard treatment for aGVHD.
The primary endpoint for this study is the complete Response rate at Day 29.
This study consists of 3 periods: screening, treatment and follow-up. The screening period is approximately 3 days, the treatment period is approximately 99 days and the follow-up period is approximately 265 days. Participation in this study will last up to 382 days. In addition, up to 200 participants will take part in this study at about 125 study sites globally.REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0370
Date of REC Opinion
18 Jun 2024
REC opinion
Further Information Favourable Opinion