How lebrikizumab affects the skin microbiome and mycobiome in adults with atopic dermatitis
Official title: Changes in Fungal Mycobiome, Bacterial Microbiome, and Abundance of Staphylococcus Species After Lebrikizumab Treatment - a Prospective Multicenter Observational Cohort Study
Run by University Hospital Bispebjerg and Frederiksberg · NCT07807228 · Data updated 2026-11-12
This study looks at whether lebrikizumab changes the skin bacteria, fungi, and specifically Staphylococcus species, in adults with moderate-to-severe atopic dermatitis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Drugs / interventions | lebrikizumab |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | June 5, 2025 |
| Main results expected | December 2026 |
| Study ends | May 2028 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT07807228 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with atopic dermatitis starting lebrikizumab and without prior lebrikizumab use.
✕Probably not a fit
Patients who do not show skin microbiome changes or clinical improvement may not experience a direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will follow adults with atopic dermatitis who start lebrikizumab to observe changes in the skin's bacterial and fungal communities over time. Researchers will quantify diversity of bacteria and fungi on the skin and relate these findings to clinical improvements using EASI, mTLSS, and affected body surface area, as well as patient-reported outcomes like DLQI, pruritus, sleep, and POEM. Findings will be compared with prior microbiome and mycobiome research in AD patients treated with other therapies. The study does not involve an experimental intervention beyond the standard lebrikizumab treatment and is limited to those initiating this biologic. Primary endpoints focus on characterizing microbial diversity, while secondary endpoints explore correlations with clinical outcomes and quality-of-life measures.
Why it matters
Potential benefit: If successful, the study could clarify how lebrikizumab influences the skin ecosystem and its relation to symptom improvement.
How similar studies have gone: Previous research in AD treatments has shown microbiome shifts with therapy, but this specific lebrikizumab-focused microbiome study is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults ≥18 years diagnosed with atopic dermatitis and initiating treatment with lebrikizumab Exclusion Criteria: * Previous treatment with lebrikizumab * Current treatment with other biologics or JAK-inhibitors * Hypersensitivity to lebrikizumab or any of its constituents * Pregnancy or breastfeeding * Active helminth infection
Where it's running
-
Dermatology Department Bispebjerg
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Ida Marie Nedergaard Thomsen, MD
- Email: ida.marie.nedergaard.thomsen.01@regionh.dk
- Phone: +45 38 63 61 73
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.