NCT06906497 · Johann E Gudjonsson MD PhD
Lebrikizumab in Moderate-to-severe Atopic Dermatitis
(ADfind)
What this study 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.
View original scientific description
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.
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
Primary outcome measures
Degree of normalization of transcriptomic/epigenetic profile
Time frame: Up to week 60
Assessed from skin biopsies using the molecular response to lebrikizumab among patients with atopic dermatitis
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 a
Where
- Folsom, California
- Ann Arbor, Michigan
Collaborators
Dermira, Inc., Almirall, S.A.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 11, 2025 · Source of record for eligibility and locations