# A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

> **NCT05263999** · PHASE3 · TERMINATED · sponsor: **Equillium** · enrollment: 158 (actual)

## Conditions studied

- Graft Versus Host Disease
- GVHD
- Acute-graft-versus-host Disease
- Acute GVHD
- aGVHD

## Interventions

- **BIOLOGICAL:** Itolizumab
- **DRUG:** EQ001 Placebo

## Key facts

- **NCT ID:** NCT05263999
- **Lead sponsor:** Equillium
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2022-04-29
- **Primary completion:** 2025-04-22
- **Final completion:** 2025-05-12
- **Target enrollment:** 158 (ACTUAL)
- **Why stopped:** The FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway based on the EQUATOR study data.
- **Last updated:** 2025-06-17

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05263999

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05263999, "A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT05263999. Licensed CC0.

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