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Clinical Trials in Denmark / NCT06815380
Recruiting Observational

A Study to Assess the Impact of Lebrikizumab on Health-Related Well-Being and Control of Skin Manifestations in Participants With Moderate-to-Severe Atopic Dermatitis

NCT06815380 · tracked via the Priya Life Science Denmark tracker
Sponsor
Almirall, S.A
Phase
Observational
Started
2025-01-23
Last updated
2025-02-07

Condition(s) studied

Atopic DermatitisEczema

Investigational drug(s) / intervention(s)

No Intervention

No Intervention: This is non-interventional study.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult (greater than or equal to \[\>=\] 18 years) male or female participants with diagnosis of moderate-to-severe Atopic dermatitis. * Adult participants prescribed lebrikizumab as part of routine/usual care to manage their moderate-to severe Atopic dermatitis. * Willingness and ability to participate in the study; participants must give their written consent to participate. Exclusion Criteria: * Hypersensitivity to the active substances or to any of the excipients of lebrikizumab (Ebglyss®). * Participants with pre-existing helminth infections. These participants should be treated for helminth infection before starting lebrikizumab therapy. * Concomitant use of live and live attenuated vaccines. * Pregnant women, except when the potential benefit justifies the potential risk. * Participants included in a clinical trial at baseline or at any time during the planned study period. * Participants unable to comply with the requirements of the study or who, in the opinion of the study physician, should not participate in the study. * Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.

Primary outcome measure(s)

  • Absolute Measures in the Overall Health-related Well-being Index Evaluated Through World Health Organization (WHO-5) Score Throughout the Study Observation Period — 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 well-being) to 25 (maximal well-being). To standardize the score on a scale from 0 (absent) to 100 (maximal), it is recommended to multiply the raw score by 4.
  • Change From Baseline in the Overall Health-related Well-being Index Evaluated Through WHO-5 Score Throughout the Study Observation Period — 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 well-being) to 25 (maximal well-being). To standardize the score on a scale from 0 (absent) to 100 (maximal), it is recommended to multiply the raw score by 4.

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Denmark Recruiting

Other trials for the same condition

Methotrexat to Hand Eczema in the BIOSKIN Cohort Active, not recruiting
Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood Active, not recruiting
Changes in Skin Myco- and Microbiome After Lebrikizumab Treatment Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06815380 on ClinicalTrials.gov ↗ ← All trials in Denmark