Autopsy report · NCT01920477

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.”

The sponsor’s own words in the registry.

Life of this trial

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

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Novartis Pharmaceuticals

Sponsor type

Industry

Conditions

Pemphigus Vulgaris

Interventions

Ofatumumab; Placebo

Participants

35

Sites

16

Countries

Australia, Greece, Israel, Italy, Japan, Poland, Romania, United States

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)
• 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.” (59% 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)
• Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403
  “The clinical development of intravenously administered ofatumumab in RA will no longer be pursued, so this study was prematurely terminated by the Sponsor.” (55% 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.