Autopsy report · NCT04210843

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

“Study was terminated due to a strategic decision by Novartis to discontinue development of ligelizumab in CSU. This decision was not based on any safety concerns.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months before it started.
• Ran for about 2 years 5 months before it stopped.
• 1,033 participants enrolled.
• Results were posted on the registry 10 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Novartis Pharmaceuticals

Sponsor type

Industry

Conditions

Chronic Spontaneous Urticaria

Interventions

Ligelizumab

Participants

1,033

Sites

273

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark and more

Trials that died the same way

• LCL161 Plus Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies
  “Clinical program was discontinued by Novartis” (60% match in meaning)
• Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris
  “Novartis has acquired the rights to ofatumumab and terminated the OPV116910 and OPV117059 studies. This decision is not linked to any safety consideration.” (59% match in meaning)
• Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
  “Study terminated in line with Biogen decision to withdraw Zinbryta from the market and not to pursue further studies of daclizumab in MS.” (58% match in meaning)
• A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With Achondroplasia
  “The study was terminated due to lack of efficacy at any of the tested doses on 18th November 2022. The decision to terminate the study is not related to a safety concern.” (58% match in meaning)
• A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
  “Trial was terminated for business reasons. There has been no change in the benefit/risk profile of ofatumumab.” (57% 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.