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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516064-28-00

Acronym

EQ-100-02

Enrollment

Registered

2024-08-20

Start date

2022-09-27

Completion date

2025-05-12

Last updated

2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Graft Versus Host Disease

Brief summary

Complete Response rate at Day 29.

Detailed description

1. Overall response rate at Day 29., 2. Durable complete response rate from Day 29 through Day 99.

Interventions

DRUGitolizumab-matching placebo

DRUGEQ001

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete Response rate at Day 29.	—

Secondary

Measure	Time frame
1. Overall response rate at Day 29., 2. Durable complete response rate from Day 29 through Day 99.	—

Countries

Belgium, France, Germany, Italy, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026