Autopsy report · NCT03584516

GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

“The study was terminated due to insufficient efficacy to support moving into Part 2 of the study; there were no safety concerns that contributed to this decision.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 7 months before it started.
• Ran for about 4 years 10 months before it stopped.
• 155 participants enrolled.
• Results were posted on the registry 1 year 3 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2, Phase 3

Sponsor

Incyte Corporation

Sponsor type

Industry

Conditions

Chronic Graft-versus-host Disease

Interventions

Itacitinib; Placebo; Methylprednisolone; Prednisone

Participants

155

Sites

133

Countries

Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Israel, Italy, Poland, Spain and more

Trials that died the same way

• An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
  “The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study” (85% match in meaning)
• A Study of LY3405105 in Participants With Advanced Cancer
  “The study was terminated for lack of sufficient efficacy.” (84% match in meaning)
• Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM
  “The study was terminated due to lack of efficacy.” (84% match in meaning)
• A Dose-finding Study of Birabresib (MK-8628) in Participants With Recurrent Glioblastoma Multiforme (MK-8628-002)
  “This study was terminated due to lack of clinical activity and not due to safety reasons.” (84% match in meaning)
• A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration
  “This study was terminated due to a lack of efficacy.” (83% 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.