Autopsy report · NCT04499235

A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid

“The study was prematurely terminated by the Sponsor due to operational challenges stemming from the coronavirus disease 2019 (COVID-19) pandemic, treatment limitations, rarity of the disease, and drug supply considerations.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 6 months after it had already started.
• Ran for about 1 year 2 months before it stopped.
• 6 participants enrolled.
• Results were posted on the registry 2 years 5 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Alkahest, Inc.

Sponsor type

Industry

Conditions

Pemphigoid, Bullous

Interventions

Mometasone furoate; AKST4290; Placebo

Participants

6

Sites

8

Countries

Germany

Trials that died the same way

• Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
  “Study was terminated early by sponsor due to the challenges and risks introduced by Coronavirus disease 2019 (COVID-19) pandemic.” (93% match in meaning)
• A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors
  “The study was terminated early due to the COVID-19 pandemic and sponsor's funding constraints, based on promising preliminary safety and efficacy data.” (88% match in meaning)
• Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease
  “Study terminated due to COVID-19 pandemic.” (83% match in meaning)
• Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis
  “The study was terminated prematurely due to the COVID-19 pandemic creating uncertainty impacting trial progress and costs.” (83% match in meaning)
• Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
  “The study was prematurely terminated by the Sponsor based on difficulties in meeting enrollment goals, especially during the COVID-19 pandemic, and not for reasons relating to any concerns regarding quality, safety, or efficacy.” (81% 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.