Autopsy report · NCT04598477

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)

“Based on the lack of observed efficacy in the primary study ARGX-113-1904, the sponsor decided to discontinue the open-label extension study.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 9 months before it started.
• Ran for about 2 years 8 months before it stopped.
• 183 participants enrolled.
• Results were posted on the registry 1 year after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

argenx

Sponsor type

Industry

Conditions

Pemphigus Vulgaris; Pemphigus Foliaceus

Interventions

efgartigimod PH20 SC; prednisone

Participants

183

Sites

127

Countries

Australia, Bulgaria, China, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan and more

Trials that died the same way

• Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
  “Sponsor terminated open-label extension.” (72% match in meaning)
• An Extension Trial for Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.
  “Sponsor decision to close this extension study due to reduction in sample size.” (69% match in meaning)
• A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy
  “After a positive interim analysis, the decision was made to terminate the study early to allow for participants to enroll into an open label study” (68% match in meaning)
• Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day
  “No efficacy could be demonstrated, sponsor decided to prematurely end the study.” (65% match in meaning)
• Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain
  “Sponsor discontinued the study following the discovery of a number of incompletely sealed batches that were unusable.” (65% 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.