Lebrikizumab in Moderate-to-severe Atopic Dermatitis

NCT ID: NCT06906497

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-02
• Study Completion Date: 2027-07-31

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Moderate-to-severe Atopic Dermatitis

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).

Group Type: EXPERIMENTAL

lebrikizumab

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Ebglyss

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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:

1. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-., Janus kinase inhibitors (JAKi), azathioprine, methotrexate).

2. Phototherapy and photochemotherapy (PUVA) for AD.

• Treatment with the following prior to the baseline visit:

1. An investigational drug within 8 weeks or 5 half-lives (if known), whichever is longer.

2. Cell-depleting biologics, including to rituximab, within 6 months.

3. 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).
• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, anti-parasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: patients may be rescreened after infection resolves.
• Evidence of active acute or chronic hepatitis (as defined by the Department of Health & Human Services Centers for Disease Control and Prevention) or known liver cirrhosis.
• Diagnosed active endoparasitic infections or at high risk of these infections.
• Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgment.
• History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
• In the Investigator's opinion, any clinically significant laboratory results from the chemistry, hematology or urinalysis tests available in the medical history.
• Presence of skin comorbidities that may interfere with study assessments.
• History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
• Severe concomitant illness(es) that in the Investigator's judgment would adversely affect the patient's participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient because of his/her participation in this clinical trial, may make patient's participation unreliable, or may interfere with study assessments.

20. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dermira, Inc.

INDUSTRY

Sponsor Role: collaborator

Almirall, S.A.

INDUSTRY

Sponsor Role: collaborator

Johann E Gudjonsson MD PhD

OTHER

Sponsor Role: lead

Responsible Party

Johann E Gudjonsson MD PhD

Professor of Skin Molecular Immunology, Professor of Dermatology, Professor of Internal Medicine and Research Pr

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johann E. Gudjonsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Physioseq USA - CA

Folsom, California, United States

Site Status: RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status: NOT_YET_RECRUITING

University of Freiburg

Freiburg im Breisgau, , Germany

Site Status: NOT_YET_RECRUITING

Lausanne University Hospital

Lausanne, , Switzerland

Site Status: NOT_YET_RECRUITING

Countries

United States; Germany; Switzerland

Central Contacts

Diane Fiolek

Role: CONTACT

dianemch@med.umich.edu

734-763-1469

Facility Contacts

Stephanie Le

Role: primary

sle@physioseq.com

(916) 603-2157

Stephanie Eyerich, PhD

Role: primary

s.eyerich@dermagnostix-rd.com

Other Identifiers

HUM00261982

Identifier Type: -

Identifier Source: org_study_id