RecruitingAtopic Dermatitis
Lebrikizumab in Moderate-to-severe Atopic Dermatitis
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Johann E Gudjonsson MD PhD
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:
- ✕ 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:
Where it's recruiting
California
Folsom
Michigan
Ann Arbor
Source: ClinicalTrials.gov · NCT06906497 · last updated 2025-08-11