NCT06815380: ADTrust

A European, Multicenter, Prospective Observational Phase IV Clinical Study to Assess the Impact of Lebrikizumab on Health-Related Well-Being and Control of Skin Manifestations in Patients With Moderate-to-Severe Atopic Dermatitis

Recruiting now Last updated 4 February 2025

What this trial tests

trial testing No Intervention in Atopic Dermatitis in 1,000 participants. Currently enrolling.

Timeline

23 January 2025

Primary endpoint
1 March 2029

1 March 2029

Quick facts

Lead sponsor	Almirall, S.A.
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	23 January 2025
Primary completion	1 March 2029
Estimated completion	1 March 2029
Sites	1 location across Denmark

Drugs / interventions tested

• No Intervention

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →
• Eczema — all drugs for Eczema →

Sponsor

Almirall, S.A. — full company profile →

Who can join

18 and older, any sex, with Atopic Dermatitis or Eczema. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Absolute Measures in the Overall Health-related Well-being Index Evaluated Through World Health Organization (WHO-5) Score Throughout the Study Observation Period
  Time frame: Baseline up to Week 104
  The WHO-5 item well-being index is a generic global rating scale measuring subjective well-being and contains positively phrased items. The respondent is asked to rate how well each of the 5 items applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score therefore theoretically ranges from 0 (absence of we
• Change From Baseline in the Overall Health-related Well-being Index Evaluated Through WHO-5 Score Throughout the Study Observation Period
  Time frame: Baseline up to Week 104
  The WHO-5 item well-being index is a generic global rating scale measuring subjective well-being and contains positively phrased items. The respondent is asked to rate how well each of the 5 items applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score therefore theoretically ranges from 0 (absence of we

Sponsor's own description

The main purpose of this study is to evaluate the impact of lebrikizumab treatment on the overall well-being of adult participants with moderate-to-severe AD in real-world clinical practice settings across Europe, as measured using validated 5-item World Health Organization Well-being Index (WHO-5) and to investigate effectiveness and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on participants in terms of disease symptomatology/control, fatigue, work impairment, patient's relationship with their skin, and overall QOL among adult participants.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. European, multicentre, prospective observational phase IV clinical study to assess the impact of lebrikizumab on health-related well-being and control of skin manifestations in patients with moderate-to-severe atopic dermatitis (ADTrust): study protocol.
   Augustin M, Bewley A, Brüggen MC, de Bruin-Weller MS, et al · · 2025 · cited 1× · PMID 40645621 · DOI 10.1136/bmjopen-2025-102155