Autopsy report · NCT01777256

An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184

“This study met a protocol defined futility criterion and will be terminated following completion of the Follow Up Visit on the last subject randomised.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 1 year 1 month before it stopped.
• 51 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

GlaxoSmithKline

Sponsor type

Industry

Conditions

Systemic Lupus Erythematosus

Interventions

GSK2586184 50 mg; GSK2586184 100 mg; GSK2586184 200 mg; GSK2586184 400 mg; Placebo

Participants

51

Sites

53

Countries

Argentina, Chile, Czechia, Estonia, France, Germany, Greece, Hong Kong, Hungary, Peru, Poland, Romania and more

Trials that died the same way

• Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer
  “This study has been terminated due to meeting protocol defined futility.” (76% match in meaning)
• Study of M5049 in DM and PM Participants (NEPTUNIA)
  “Based on interim analyses for futility” (64% match in meaning)
• A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
  “The study was terminated by Sponsor as the futility analysis outcome indicated that the study was unlikely to meet the predefined primary objective of the study. No new safety concerns were identified.” (63% match in meaning)
• Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)
  “This trial was terminated following a futility analysis confirming futility of continuing the study” (63% match in meaning)
• Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
  “Based on results of an interim analysis, the study was halted for futility” (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.