Actively Recruiting
Lebrikizumab in Moderate-to-severe Atopic Dermatitis
Led by Johann E Gudjonsson MD PhD · Updated on 2025-08-11
48
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
Sponsors
J
Johann E Gudjonsson MD PhD
Lead Sponsor
D
Dermira, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Lebrikizumab in Moderate-to-severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
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Previous treatment with lebrikizumab or participation in a lebrikizumab study.
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History of anaphylaxis as defined by the Sampson criteria.
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Treatment with topical corticosteroids, calcineurin inhibitors, Jak inhibitors, or crisaborole within 1 week prior to the baseline visit.
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Prior treatment with dupilumab or tralokinumab.
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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.
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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.
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Use of prescription moisturizers within 7 days of the baseline visit.
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Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
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Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
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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).
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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.
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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.
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Diagnosed active endoparasitic infections or at high risk of these infections.
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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.
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History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
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In the Investigator's opinion, any clinically significant laboratory results from the chemistry, hematology or urinalysis tests available in the medical history.
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Presence of skin comorbidities that may interfere with study assessments.
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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.
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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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Physioseq USA - CA
Folsom, California, United States, 95630
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
3
University of Freiburg
Freiburg im Breisgau, Germany, 79104
Not Yet Recruiting
4
Lausanne University Hospital
Lausanne, Switzerland, CH-1011
Not Yet Recruiting
Research Team
D
Diane Fiolek
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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