View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
March 7, 2022

Equillium begins Phase III acute graft-versus-host disease trial

The trial will have 200 adult and adolescent subjects with Grade III-IV aGVHD, or Grade II aGVHD with reduced GI involvement.

Equillium has commenced the Phase III EQUATOR clinical trial of itolizumab to treat acute graft-versus-host disease (aGVHD) patients. 

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.”

Related Companies

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU