Study identification

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
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Teodora Festini

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
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