Autopsy report · NCT03608033

Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

“IA did not meet the prespecified primary endpoint.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 3 months after it had already started.
• Ran for about 5 years 9 months before it stopped.
• 360 participants enrolled.
• Results were posted on the registry 1 year 11 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Omeros Corporation

Sponsor type

Industry

Conditions

IgA Nephropathy

Interventions

OMS721; Vehicle (D5W or saline)

Participants

360

Sites

139

Countries

Argentina, Australia, Belgium, Bulgaria, Canada, Czechia, Germany, Greece, Hungary, India, Italy, Lithuania and more

Trials that died the same way

• A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)
  “The primary endpoint at 15 months was not met.” (69% match in meaning)
• A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments
  “The study did not meet the primary endpoint.” (69% match in meaning)
• OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
  “The primary endpoint was not achieved in the study.” (68% match in meaning)
• Ipilimumab, Nivolumab, Tocilizumab and Radiation in Pretreated Patients With Advanced Pancreatic Cancer
  “primary endpoint was not met” (66% match in meaning)
• Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
  “Due to COVID enrollment numbers needed to meet the primary endpoint will not be met.” (64% 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.