Autopsy report · NCT04533737

Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

“The recruitment was terminated early due to delays and slow recruitment that significantly jeopardized the trial timelines. There were no safety concerns related to the early termination of the trial.”

The sponsor’s own words in the registry.

Life of this trial

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

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

LEO Pharma

Sponsor type

Industry

Conditions

Plaque Psoriasis; Psoriasis Vulgaris; Psoriasis

Interventions

Brodalumab; Placebo; Guselkumab

Participants

113

Sites

65

Countries

Austria, Belgium, Denmark, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom

Trials that died the same way

• Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
  “The trial was prematurely terminated. Termination was not because of safety concerns but due to slow recruitment.” (88% match in meaning)
• Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients
  “The trial was prematurely terminated due to slow recruitment.” (84% match in meaning)
• Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis
  “Recruitment was early terminated due to slow recruitment. Not linked to any safety concern.” (79% match in meaning)
• A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
  “The trial prematurely terminated due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety concerns.” (79% match in meaning)
• Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
  “The trial was terminated early on 05 October 2022 due to non-feasibility and poor recruitment and not based on safety concerns.” (76% 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.