Autopsy report · NCT03981744

A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments

“The study did not meet the primary endpoint.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 3 years before it stopped.
• 51 participants enrolled.
• Results were posted on the registry 1 year 10 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Janssen Pharmaceutical K.K.

Sponsor type

Industry

Conditions

Polymyositis; Dermatomyositis

Interventions

Ustekinumab 6 mg/kg; Ustekinumab 90 mg; Placebo IV; Placebo SC

Participants

51

Sites

32

Countries

Japan

Trials that died the same way

• Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients Renal Cell Carcinoma
  “The study did not meet endpoint.” (94% match in meaning)
• OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
  “The primary endpoint was not achieved in the study.” (93% match in meaning)
• Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)
  “The study was terminated as its Part A did not meet the primary endpoint.” (85% match in meaning)
• Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
  “Company decided to terminate this study due to study did not meet the primary endpoint.” (82% match in meaning)
• Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)
  “The study did not meet efficacy end point and did not enroll patients in the randomized phase.” (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.