An interventional, Open-label Study to Evaluate the effect of lebrikizumab on eczema and Skin Barrier Function parameters in lesional and non-lesional skin in Adults and Adolescents with Moderate to Severe Atopic Dermatitis
Key facts
- Where
- Falun, Goteborg, Linkoping és Lund, SvédországSee the 4 sites
- Phase
- 4. fázis
Where in Svédország
- Region DalarnaFalun, SvédországToborzás még nem indult
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGoteborg, SvédországToborzás még nem indult
- Region OestergoetlandLinkoping, SvédországToborzás még nem indult
- Region Skane Skanes UniversitetssjukhusLund, SvédországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Oestergoetland
- Trial code
- EU 2024-519811-32-00
- Record updated
- 2026. február 12.
- Original description
The primary objective of this trial is to confirm the effectiveness of lebrikizumab in improving eczema in patients with moderate-to-severe AD.Read full original descriptionShow less
The primary objective of this trial is to confirm the effectiveness of lebrikizumab in improving eczema in patients with moderate-to-severe AD.
Inclusion: The participant has given their written consent to participate in the trial; Adults (aged 18-64) and adolescents (aged ≥12 to <18 years at the time of ICF/informed assent form (IAF) signature and weighing ≥40 kg) who are candidates for systemic AD therapy; Diagnosis of AD and a history of inadequate topical treatment response as assessed by the clinician; Adolescent participants (aged ≥12 to <18 years) must have their written informed consent signed by the parent/legal guardian. Adolescent participants from 15 years also need to give their own written consent to participate in the trial.
Exclusion: Concomitant use of live and live attenuated vaccines; Hypersensitivity to the active substances or to any of the excipients of lebrikizumab; Patients with pre-existing helminth infections; Pregnant and/or breastfeeding women; Patients unable to comply with the requirements of the study or who, in the opinion of the study physician, should not participate in the study; Patients unable to understand the study’s information and conduct in Swedish or English translations of the material.