Recruiting
PHASE4
INTERVENTIONAL
NCT06906497
Lebrikizumab in Moderate-to-severe Atopic Dermatitis
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This research is studying a drug already approved for the treatment of atopic dermatitis (AD). This research collects health-related information and blood and skin samples to understand if the study drug, lebrikizumab, leads to long-term improvement in AD skin.
Detailed Description
Lebrikizumab, the drug used in the study, has been deemed IND exempt by the FDA.
Interventions
Name:
lebrikizumab
Type:
DRUG
Description:
Patients will receive lebrikizumab with a 500 mg loading dose administered subcutaneously at baseline and Week 2 followed by 250 mg every 2 weeks until Week 24.
At week 24, patients with ≥ Eczema Area and Severity Index (EASI) 50 will continue in the study and begin receiving lebrikizumab 250mg every 4 weeks (Q4W), while patients with \<EASI 50 will be discontinued from the study.
At week 36, patients with EASI ≥50 to \<90 will remain on Q4W through W60 (do not enter withdrawal arm), while patients with sustained low disease activity (IGA 0/1 or EASI≥90 response for at least 3 months assessed at W24 and W36) will withdraw from lebrikizumab treatment
Primary Outcomes
Measure:
Degree of normalization of transcriptomic/epigenetic profile
TimeFrame:
Up to week 60
Description:
Assessed from skin biopsies using the molecular response to lebrikizumab among patients with atopic dermatitis
Trial Information
NCT ID
NCT06906497
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Johann E Gudjonsson MD PhD
Last Updated
December 15, 2025