Trials / Terminated
TerminatedNCT05263999
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
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
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Equillium · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids
Detailed description
This study will enroll 200 subjects at approximately 125 sites globally. Subjects will be randomized in a 1:1 ratio to active or placebo and will receive a total of 7 doses administered intravenously approximately every 2 weeks. The study follows the patients for a total of approximately 365 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Itolizumab | Itolizumab \[Bmab600\] |
| DRUG | EQ001 Placebo | EQ001 Placebo |
Timeline
- Start date
- 2022-04-29
- Primary completion
- 2025-04-22
- Completion
- 2025-05-12
- First posted
- 2022-03-03
- Last updated
- 2025-06-17
Locations
118 sites across 12 countries: United States, Australia, Belgium, Canada, France, Germany, Israel, Italy, New Zealand, Portugal, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05263999. Inclusion in this directory is not an endorsement.