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NCT Number: NCT07807228

Changes in Skin Myco- and Microbiome After Lebrikizumab Treatment

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?

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dermatology Department Bispebjerg

Copenhagen, Denmark

Location status: Recruiting

Location contact

Ida Marie Nedergaard Thomsen, MD

CONTACT

[email protected]

+45 38 63 61 73

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Eczema Area and Severity Index (EASI)

    Time frame: 24 weeks

    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).

  2. Body Surface Area (BSA)

    Time frame: 24 weeks

    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.

  3. Dermatology Life Quality Index (DLQI)

    Time frame: 24 weeks

    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.

  4. Patient-Oriented Eczema Measure (POEM)

    Time frame: 24 weeks

    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.

  5. Pruritus numeric rating scale (NRS)

    Time frame: 24 weeks

    Describing the highest amount of itch experienced during the last 72 hours on an NRS from 0 (no itch) to 10 (worst imaginable itch)

  6. Sleep numeric rating scale (NRS)

    Time frame: 24 weeks

    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).

  7. Modified Total Lesion Symptom Score (mTLSS)

    Time frame: 24 weeks

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ida Marie Nedergaard Thomsen, MD

CONTACT

[email protected]

+45 38 63 61 73

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Registry information

Official study title

Changes in Fungal Mycobiome, Bacterial Microbiome, and Abundance of Staphylococcus Species After Lebrikizumab Treatment - a Prospective Multicenter Observational Cohort Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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