A Prospective Active Surveillance Study to Monitor the Real-World Safety of Ritlecitinib Among Adolescents with Alopecia Areata

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000421
• EU PAS number:
  EUPAS1000000421
• Study ID:
  1000000421
• Official title and acronym:
  A Prospective Active Surveillance Study to Monitor the Real-World Safety of Ritlecitinib Among Adolescents with Alopecia Areata
• DARWIN EU® study:
  No
• Study countries:
  Canada

  European Union

  United Kingdom

  United States
• Study description:
  This study is designed to actively monitor growth and bone development, including bone fractures, and maturation and pubertal development associated with exposure to ritlecitinib in adolescents 12-17 years old in the post-approval setting. Neurotoxicity, an important potential risk, will also be evaluated.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

CorEvitas

Study timelines

Date when funding contract was signed

Planned: 11/06/2024

Actual: 11/06/2024

Study start date

Planned: 31/03/2026

Data analysis start date

Planned: 31/03/2026

Date of interim report, if expected

Planned: 30/09/2026

Date of final study report

Planned: 31/03/2037

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%

Study protocol

Initial protocol

B7981092_PROTOCOL_V2.0_12JUL2024.pdf

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

B7981092