Autopsy report · NCT06570772

Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio

“The study has been terminated based on Sponsor decision. This decision is not related to any safety concerns associated with the investigational products. It is related to the fact that study will be not required for product dossier submission.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 1 year 2 months before it stopped.
• 301 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Alvotech Swiss AG

Sponsor type

Industry

Conditions

Ulcerative Colitis

Interventions

AVT16; Vedolizumab

Participants

301

Sites

100

Countries

Argentina, Bulgaria, Croatia, Georgia, Latvia, Poland, Romania, Serbia, Slovakia, Sri Lanka, Ukraine

Trials that died the same way

• Liver Transplantation With Tregs at UCSF
  “The study was terminated by the Sponsor prior to any participants receiving the investigational product.” (86% match in meaning)
• Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs
  “Study terminated based on decision of Sponsor.” (83% match in meaning)
• Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment
  “This study was terminated based on a business decision by the Sponsor.” (83% match in meaning)
• A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome (pSS)
  “Study was terminated based on Sponsor decision” (83% match in meaning)
• Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
  “Study was terminated by Sponsor; the decision was not due to any safety findings.” (83% 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.