A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
← catalyst calendarSponsored by Equillium (industry) · EQ — their whole pipeline →. With Biocon Limited.
Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
158actual
Sites
118
Countries
Australia, Belgium, Canada +9
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
The FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway based on the EQUATOR study data.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-04-29 | actual | When the study began enrolling |
| Primary completion | 2025-04-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-12 | actual | The whole study's end, after follow-up |
| First posted | 2022-03-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-06-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Graft Versus Host Disease
- GVHD
- Acute-graft-versus-host Disease
- Acute GVHD
- aGVHD
Interventions
- Biological: Itolizumab — also filed as EQ001, Bmab600
- Drug: EQ001 Placebo
Primary outcome
what the primary-completion date above is the date OFThe efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
measured Day 29
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