Autopsy report · NCT01032915

Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis

“Results of a planned interim analysis did not show significant effects for any of the 3 AIN dose regimens versus placebo on any primary or secondary endpoint”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 1 year 4 months before it stopped.
• 125 participants enrolled.
• Results were posted on the registry 4 years 5 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Novartis Pharmaceuticals

Sponsor type

Industry

Conditions

Non-infectious Uveitis

Interventions

AIN457; AIN457; AIN457; Placebo

Participants

125

Sites

94

Countries

Brazil, Germany, India, Israel, Italy, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States

Trials that died the same way

• Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)
  “Based on a review of interim data from participants in the dose-escalation phase, it was determined that the study was unlikely to meet the primary endpoint.” (72% match in meaning)
• Study of the Research Medicine CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D).
  “The study was terminated due to lack of efficacy compared to placebo.” (62% match in meaning)
• Study to Evaluate the Safety of AT2220 (Duvoglustat) in Pompe Disease
  “Per protocol, 3 sequential dose cohorts were planned. Study discontinued by Sponsor based upon serious adverse events in first 2 of 3 participants in Cohort 1.” (62% match in meaning)
• LBH589 in Refractory Myelodysplastic Syndromes (MDS)
  “Per protocol, the results of a planned interim analysis demonstrated insufficient efficacy and led to early termination of the study.” (61% match in meaning)
• Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
  “Interim analysis showed that there was no difference between the two drugs” (60% 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.