Tralokinumab real world clinical use: An observational cohort study of atopic dermatitis patients prescribed tralokinumab (TRACE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45677
• EU PAS number:
  EUPAS44659
• Study ID:
  45677
• Official title and acronym:
  Tralokinumab real world clinical use: An observational cohort study of atopic dermatitis patients prescribed tralokinumab (TRACE)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Canada

  France

  Germany

  Italy

  Netherlands

  Spain

  Switzerland

  United Arab Emirates

  United Kingdom

  United States
• Study description:
  This longitudinal observational study aims to assess changes in clinical signs and symptoms of atopic dermatitis (AD) in patients treated with tralokinumab in a real-world setting over a 1-year period. The secondary objectives are to observe safety in patients treated with Tralokinumab, describe the patients’ characteristics, explore baseline predictors of clinical response, and describe the real-world use of Tralokinumab. The study enrolls patients with AD who are eligible for treatment with tralokinumab according to the local label (new users). Patients are followed up for approximately 1 year. The study will be conducted in max. 15 countries in Europe, North America and the United Arab Emirates. The primary outcome is AD severity (clear or almost clear: yes/no) measured by physician-assessed AD severity measures (IGA, EASI or SCORAD). Various PROs are collected if considered normal clinical practice. Additional information about demographics, medical history, AD treatment, AD location and adverse events will be collected.
• Study status:
  Ongoing

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 25/05/2021

Study start date

Planned: 01/04/2022

Actual: 23/11/2021

Data analysis start date

Planned: 10/10/2024

Date of final study report

Planned: 24/01/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

LEO Pharma

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable