Lebrikizumab in Moderate-to-severe Atopic Dermatitis

NCT06906497 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HUM00261982
• Study Type: interventional
• Target: 48
• Locations: 3 countries
• Sites: 4

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Degree of normalization of transcriptomic/epigenetic profile

  Assessed from skin biopsies using the molecular response to lebrikizumab among patients with atopic dermatitis

  Up to week 60

Secondary Outcomes (5)

• Molecular response to Lebrikizumab

  weeks 36 to 60

• Skin barrier function

  Up to week 60

• Clinical response as assessed be the Eczema Area and Severity Index (EASI)

  Up to week 60

• Clinical response as assessed using the investigator global assessment (IGA)

  Up to week 60

• Clinical response as assessed using the Peak Pruritus Numerical Rating Scale (NRS) (Pruitis NRS)

  Up to week 60

Study Arms (1)

Moderate-to-severe Atopic Dermatitis

EXPERIMENTAL

A total of 48 subjects with active moderate-to-severe Atopic Dermatitis (AD) will be enrolled in a 60-week study from 4 independent sites (2 US sites and 2 EU sites).

Drug: lebrikizumab

Interventions

lebrikizumab DRUG

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

Also known as: Ebglyss

Moderate-to-severe Atopic Dermatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of AD for at least 1 year before the screening visit and topical treatment was inadequate or inadvisable.
• Moderate-to-severe AD with involvement \> 10% of body-surface-area (BSA) and investigator global assessment (IGA) score =3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits.
• Subject has an Eczema Area and Severity Index (EASI) score =16 at screening and baseline.
• Subject has a pruritus NRS =4.
• Subject is biologic naïve.
• Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for at least 17 weeks after the last study drug (SD) injection, when this is in line with the preferred and usual lifestyle of the subject, or to use a highly-effective and approved method of contraception throughout the study and for at least 17 weeks after the last study drug injection.
• Subject willing and able to comply with all of the clinical study protocol's time commitments and procedural requirements.
• Understand and sign an informed consent form (ICF) (and assent form, when applicable) before any investigational procedure(s) are performed.

You may not qualify if:

• Previous treatment with lebrikizumab or participation in a lebrikizumab study.
• History of anaphylaxis as defined by the Sampson criteria.
• Treatment with topical corticosteroids, calcineurin inhibitors, Jak inhibitors, or crisaborole within 1 week prior to the baseline visit.
• Prior treatment with dupilumab or tralokinumab.
• Treatment with any of the following agents within 4 weeks prior to the baseline visit:
• Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-., Janus kinase inhibitors (JAKi), azathioprine, methotrexate).
• Phototherapy and photochemotherapy (PUVA) for AD.
• Treatment with the following prior to the baseline visit:
• An investigational drug within 8 weeks or 5 half-lives (if known), whichever is longer.
• Cell-depleting biologics, including to rituximab, within 6 months.
• Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
• Use of prescription moisturizers within 7 days of the baseline visit.
• Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
• Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
• Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma requiring systemic \[oral and/or parenteral\] corticosteroid treatment or hospitalization for \> 24 hours).

Sponsors & Collaborators

• Johann E Gudjonsson MD PhD: lead
• Dermira, Inc.: collaborator
• Almirall, S.A.: collaborator

Study Sites (4)

Physioseq USA - CA

Folsom, California, 95630, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

University of Freiburg

Freiburg im Breisgau, 79104, Germany

NOT YET RECRUITING

Lausanne University Hospital

Lausanne, CH-1011, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Johann E. Gudjonsson, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Fiolek

CONTACT

734-763-1469; dianemch@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Skin Molecular Immunology, Professor of Dermatology, Professor of Internal Medicine and Research Pr

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 2, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); DE (1); US (2)