NCT06906497

Lebrikizumab in Moderate-to-severe Atopic Dermatitis

A Phase IV, Non-randomized, Open-label Multinational Trial to Assess the Mechanism of Action for Lebrikizumab in Moderate-to-severe Atopic Dermatitis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Johann E Gudjonsson MD PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	lebrikizumab	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

Timeline

• Start date: 2025-07-02
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-04-02
• Last updated: 2025-08-11

Locations

4 sites across 3 countries: United States, Germany, Switzerland

Regulatory

• FDA-regulated drug study