Autopsy report · NCT05263999

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

“The FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway based on the EQUATOR study data.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 7 months before it started.
• Ran for about 3 years before it stopped.
• 158 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Equillium

Sponsor type

Industry

Conditions

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

Interventions

Itolizumab; EQ001 Placebo

Participants

158

Sites

118

Countries

Australia, Belgium, Canada, France, Germany, Israel, Italy, New Zealand, Portugal, South Korea, Spain, United States

Trials that died the same way

• Iontophoresis in Psoriasis
  “FDA did not provide approval of the use of the drug for the study” (70% match in meaning)
• A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
  “The study was terminated due to regulatory approval of newer therapeutic options and slower than anticipated accrual.” (64% match in meaning)
• Topical Cannabidiol Cream and Post-exercise Recovery
  “The researchers were not able to acquire funding to initiate the study. Also, the study was not approved by the local IRB which requested a FDA new drug application.” (62% match in meaning)
• Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
  “FDA request as study could not serve as the confirmatory trial.” (62% match in meaning)
• Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)
  “No longer required study by FDA for NDA approval.” (62% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.