The placebo-controlled, randomised, multicentre, double-blind trial will compare the safety and efficacy of intravenous doses of itolizumab against placebo as a first-line treatment for aGVHD plus corticosteroids.
It will enrol up to 200 adult and adolescent subjects with Grade III-IV aGVHD, or Grade II aGVHD with reduced GI involvement.
These trial subjects will be categorised in a 1:1 ratio to receive itolizumab or placebo, along with high doses of corticosteroids.
Complete response rate at day 29 is the primary endpoint of the trial.
Overall response rate at day 29 and complete response rate durability from day 29 to 99 are included as key secondary endpoints.
Early disease response is the primary goal while key secondary goals comprise assessing corticosteroid use, response durability, survival outcomes and occurrence of chronic GVHD.
Safety data from the trial will be consistently analysed by the independent data monitoring committee. The company intends to carry out an interim assessment on nearly 100 participants completing day 29 for futility and efficacy evaluations.
A clinical-stage anti-CD6 monoclonal antibody, itolizumab acts on the CD6-ALCAM pathway.
This pathway plays a key function in regulating T cell activity and trafficking that causes various immuno-inflammatory diseases.
Under an exclusive collaboration with Biocon, Equillium obtained rights to itolizumab.
Equillium CEO Bruce Steel said: “Patients who do not respond to existing standard of care – high-dose corticosteroids – have very poor outcomes with high mortality rates.
“Our Phase III study is supported by the compelling results from our EQUATE study demonstrating rapid and durable complete responses in high-risk acute GVHD patients.
“Haematologists and transplantation specialists have highlighted their enthusiasm for itolizumab as a potential therapeutic option and we are optimistic for these patients as we launch the EQUATOR study.”