A Prospective Active Surveillance Study to Monitor Growth, Development, and Maturation Among Adolescents with Atopic Dermatitis Exposed to Abrocitinib

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000515
• EU PAS number:
  EUPAS1000000515
• Study ID:
  1000000515
• Official title and acronym:
  A Prospective Active Surveillance Study to Monitor Growth, Development, and Maturation Among Adolescents with Atopic Dermatitis Exposed to Abrocitinib
• DARWIN EU® study:
  No
• Study countries:
  Canada

  European Union

  United States
• Study description:
  This is a prospective observational cohort study of adolescents with moderate-to-severe atopic dermatitis ; (AD) who receive abrocitinib or another advanced systemic therapy approved in adolescents for the treatment of moderate-to-severe AD.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

CorEvitas

Networks

International Adolescent Atopic Dermatitis Registry

Study timelines

Date when funding contract was signed

Actual: 24/05/2023

Study start date

Planned: 30/09/2025

Data analysis start date

Planned: 01/02/2036

Date of interim report, if expected

Planned: 30/04/2030

Date of final study report

Planned: 31/07/2036

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

B7451120