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Lebrikizumab in Moderate-to-severe Atopic Dermatitis

NCT06906497 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-08-11

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Dermira, Inc.

    collaborator INDUSTRY

  • Almirall, S.A.

    collaborator INDUSTRY

  • Johann E Gudjonsson MD PhD

    lead OTHER

Principal Investigators

  • Johann E. Gudjonsson, MD, PhD · University of Michigan

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-02
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06906497 on ClinicalTrials.gov