Atopic DermatitisNCT07807228
Changes in Skin Myco- and Microbiome After Lebrikizumab Treatment
An observational study of Atopic Dermatitis, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
The goal of this observational study is to characterize the skin myco- and microbiome of patients with atopic dermatitis before and after initiation of treatment with lebrikizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jun 2025to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atopic dermatitis recruited from the Departments of Dermatology at Aarhus University Hospital, Odense University Hospital, or Bispebjerg University Hospital.
Who may be able to join
- Adults ≥18 years diagnosed with atopic dermatitis and initiating treatment with lebrikizumab
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Dermatology Department Bispebjerg
Copenhagen
Ida Marie Nedergaard Thomsen, MD, +45 38 63 61 73, ida.marie.nedergaard.thomsen.01@regionh.dk
About this study
Official title: Changes in Fungal Mycobiome, Bacterial Microbiome, and Abundance of Staphylococcus Species After Lebrikizumab Treatment - a Prospective Multicenter Observational Cohort Study
The goal of this observational study is to characterize the skin myco- and microbiome of patients with atopic dermatitis before and after initiation of treatment with lebrikizumab. The main questions it aims to answer are:
Does the skin mycobiome change with treatment? Does the skin microbiome change with treatment? Does the abundance of Staphylococcus species change with treatment?
Read the detailed description
Research hypothesis: Lebrikizumab changes the skin micro- and mycobiome.
Primary objective:
To observe changes in the skin micro- and mycobiome during treatment with lebrikizumab, a newly available biologic used in adult patients with moderate-to-severe atopic dermatitis (AD). Lebrikizumab is a high-affinity monoclonal antibody that selectively targets interleukin-13; its effect on the skin microbiome and mycobiome has not previously been investigated.
Primary endpoint: Quantification and characterization of bacterial and fungal population diversity on the skin.
Secondary objectives:
To investigate the correlation between changes in the skin micro- and mycobiome and objective and subjective clinical improvement in AD, as measured by validated disease evaluation tools and patient-reported outcomes. Objective improvement will be measured using the Eczema Area and Severity Index (EASI), modified Total Lesion Symptom Score (mTLSS), and affected Body Surface Area (BSA). Subjective patient-reported outcomes will be measured using the Dermatology Life Quality Index (DLQI), Pruritus Numeric Rating Scale (Pruritus NRS), Sleep NRS, and Patient-Oriented Eczema Measure (POEM).
Findings on the microbiome and mycobiome from this study will be compared with findings from previous microbiome and mycobiome research on other AD treatments, including topical therapies and biologics.
Secondary endpoint: Quantification and characterization of bacterial and fungal population diversity on the skin in correlation with AD symptoms.
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Skin Microbiome, Skin Mycobiome, Observational Study, Staphylococcus species
- Medical subject headings
- Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in skin microbiome (taxinomic unit)
Collection of skin swabs at baseline, week 4 and week 16. Analyzing of skin swabs using 16S rRNA gene sequencing, TUF gene sequencing, 18S rRNA gene sequencing and mpsA gene sequencing.
Measured: 16 weeks
Secondary outcomes (7)
Eczema Area and Severity Index (EASI)
The EASI is a well-established tool for measuring eczema severity, assessing both the extent of affected areas and the intensity of inflammation. Scores range from 0 to 72, with categories defined as follows: almost clear (0.1-1), mild (1.1-7), moderate (7.1-21), severe (21.1-50), and very severe (50.1-72).
Measured: 24 weeks
Body Surface Area (BSA)
BSA estimates the percentage of the body affected by eczema, with 100% representing total body surface area involvement. This measure is particularly useful in conditions that affect extensive skin regions, providing a clear view of disease spread.
Measured: 24 weeks
Dermatology Life Quality Index (DLQI)
The DLQI is a validated questionnaire that assesses the impact of skin diseases on quality of life. Scores range from 0 to 30, where higher scores indicate a more significant impact on the patient's life. This tool is widely used in dermatology to capture the subjective burden of skin conditions.
Measured: 24 weeks
Patient-Oriented Eczema Measure (POEM)
The POEM is a patient-reported outcome measure designed to assess eczema symptoms and their impact from the patient's perspective. It includes questions on itch, sleep disturbance, and other symptoms, with scores ranging from 0 to 28, reflecting symptom severity and frequency.
Measured: 24 weeks
Pruritus numeric rating scale (NRS)
Describing the highest amount of itch experienced during the last 72 hours on an NRS from 0 (no itch) to 10 (worst imaginable itch)
Measured: 24 weeks
Sleep numeric rating scale (NRS)
Describing to what extent itching interfered with the patient's sleep last 3 night on an NRS scale from 0 (no interference) to 10 (maximal interference).
Measured: 24 weeks
Modified Total Lesion Symptom Score (mTLSS)
The mTLSS is a score designed to assess the severity degree of chronic hand eczema (CHE) which may be present in a substantial part of patients with atopic dermatitis. The score ranges from 0 (no changes) to 21 points (severe hand eczema).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start5 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Sophie Ibler, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807228
- Sponsor's protocol ID
- H-24080179
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Fungal Mycobiome, Bacterial Microbiome, and Abundance of Staphylococcus Species After Lebrikizumab Treatment - a Prospective Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07807228
- Acronym / sponsor ID
- H-24080179
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Skin Microbiome, Skin Mycobiome, Observational Study, Staphylococcus species
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to characterize the skin myco- and microbiome of patients with atopic dermatitis before and after initiation of treatment with lebrikizumab. The main questions it aims to answer are:
Does the skin mycobiome change with treatment? Does the skin microbiome change with treatment? Does the abundance of Staphylococcus species change with treatment?
Detailed description
Research hypothesis: Lebrikizumab changes the skin micro- and mycobiome.
Primary objective:
To observe changes in the skin micro- and mycobiome during treatment with lebrikizumab, a newly available biologic used in adult patients with moderate-to-severe atopic dermatitis (AD). Lebrikizumab is a high-affinity monoclonal antibody that selectively targets interleukin-13; its effect on the skin microbiome and mycobiome has not previously been investigated.
Primary endpoint: Quantification and characterization of bacterial and fungal population diversity on the skin.
Secondary objectives:
To investigate the correlation between changes in the skin micro- and mycobiome and objective and subjective clinical improvement in AD, as measured by validated disease evaluation tools and patient-reported outcomes. Objective improvement will be measured using the Eczema Area and Severity Index (EASI), modified Total Lesion Symptom Score (mTLSS), and affected Body Surface Area (BSA). Subjective patient-reported outcomes will be measured using the Dermatology Life Quality Index (DLQI), Pruritus Numeric Rating Scale (Pruritus NRS), Sleep NRS, and Patient-Oriented Eczema Measure (POEM).
Findings on the microbiome and mycobiome from this study will be compared with findings from previous microbiome and mycobiome research on other AD treatments, including topical therapies and biologics.
Secondary endpoint: Quantification and characterization of bacterial and fungal population diversity on the skin in correlation with AD symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atopic dermatitis recruited from the Departments of Dermatology at Aarhus University Hospital, Odense University Hospital, or Bispebjerg University Hospital.
Key inclusion criteria (1 listed)
- Adults ≥18 years diagnosed with atopic dermatitis and initiating treatment with lebrikizumab
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in skin microbiome (taxinomic unit)
Time frame: 16 weeks
Collection of skin swabs at baseline, week 4 and week 16. Analyzing of skin swabs using 16S rRNA gene sequencing, TUF gene sequencing, 18S rRNA gene sequencing and mpsA gene sequencing.
7 secondary outcomes
Eczema Area and Severity Index (EASI)
Time frame: 24 weeks
Body Surface Area (BSA)
Time frame: 24 weeks
Dermatology Life Quality Index (DLQI)
Time frame: 24 weeks
Patient-Oriented Eczema Measure (POEM)
Time frame: 24 weeks
Pruritus numeric rating scale (NRS)
Time frame: 24 weeks
Sleep numeric rating scale (NRS)
Time frame: 24 weeks
Modified Total Lesion Symptom Score (mTLSS)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ida Marie Nedergaard Thomsen, MD (+45 38 63 61 73, ida.marie.nedergaard.thomsen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in skin microbiome (taxinomic unit) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.