Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact (AD Genital)

Hypothesis: Treatment with tralokinumab in patients with moderate-to-severe AD involving the genital region is expected to lead to significant improvements in PROs and clinical disease severity. These improvements will be assessed using genital-specific scoring systems, validated PRO instruments, and non-invasive imaging techniques, including optical coherence tomography (OCT), confocal microscopy, or line-field optical coherence tomography (LC-OCT). Objectives: To investigate improvements in genital scores and PROs in patients with moderate-to-severe AD involving the genital region during treatment with tralokinumab in routine clinical care. Clinical assessment of genital AD severity will be conducted using genital-specific scoring systems (e.g., Genital-Numerical Rating Scale (g-NRS), Genital-Investigator Global Assessment (g-IGA)), validated PRO instruments (e.g., Patient Oriented Eczema Measure (POEM), Atopic Dermatitis Control Tool (ADCT)), and non-invasive imaging techniques (e.g., confocal microscopy, OCT, LC-OCT)

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region
• Intervention / Treatment: Drug: tralokinumab

Detailed Description

Study design: This is a prospective, open, exploratory, non-randomized, non-blinded study. A total of 30 patients diagnosed with moderate-to-severe AD involving the genital region will be treated with tralokinumab in routine clinical care, in accordance with the tralokinumab Summary of Product Characteristics, over a period of 52 weeks. Data acquisition will take place at treatment initiation and during routine follow-up visits at baseline, week 4, week 16, week 24, and week 52. Sample size: A total of 30 patients with moderate-to-severe AD involving the genital region, for whom the clinical decision to initiate treatment with tralokinumab has been made independently of the study, will be offered enrollment. Patients will be recruited at two centers: approximately two-thirds at the Institute and Comprehensive Center for Inflammation Medicine (CCIM) of the University Medical Center Schleswig-Holstein (UKSH), Campus Lübeck, Lübeck, Germany and approximately one-third at the Department of Dermatology of the University Hospital Augsburg (UKA), Augsburg, Germany.

Subject eligibility criteria:

Inclusion:

• Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study related activity is performed.
• Subjects must be at least 18 years of age at time of enrollment.
• Subjects starting treatment with tralokinumab and for whom the clinical decision has been made independent of the study according to licensed product specifications and treatment guidelines prior to participation in the study.
• Subjects diagnosed with moderate-to-severe AD and genital involvement eligible for systemic therapy according to the local label. Subject eligibility criteria

Exclusion:

• Exclusion criteria will comply with the licensed specifications for tralokinumab.
• Subjects incapable of giving full informed consent.
• Current participation in another study with any investigational products (noninterventional or registries are allowed).
• Currently pregnant or nursing women will be excluded from this study.
• Subjects without genital involvement. Early termination • Treatment failure, defined as no improvement or worsening of EASI at week 16.
• Change in therapy.
• More than 20% of the total treatment duration (i.e., >73 cumulative, non-consecutive days) without receiving the study drug.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Inga Brouer; Phone Number: +4945150041626; Email: IngaCatharina.Brouer@uksh.de

Study Locations

• Germany
  • München
    • Augsburg, München, Germany, 86156
      • Recruiting
      • Department of Dermatology of the University Hospital Augsburg
      • Contact: Andreas Prof. Wollenberg, Prof.; Phone Number: +49 821 400-01; Email: info@uk-augsburg.de
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • CCIM, Institut für Entzündungsmedizin UKSH Lübeck
      • Contact: Diamant Prof. Thaci, Prof.; Phone Number: 0451 500 - 41601; Email: IngaCatharina.Brouer@uksh.de
      • Principal Investigator: Prof. Diamant Thaci, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) diagnosed with moderate-to-severe atopic dermatitis involving the genital region, who are eligible for systemic therapy with tralokinumab according to the local approved label. Patients are recruited from routine clinical practice at two academic centers and must have signed informed consent prior to any study-related activity.

Description

Inclusion Criteria:

• Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study related activity is performed.
• Subjects must be at least 18 years of age at time of enrollment.
• Subjects starting treatment with tralokinumab and for whom the clinical decision has been made independent of the study according to licensed product specifications and treatment guidelines prior to participation in the study.
• Subjects diagnosed with moderate-to-severe AD and genital involvement eligible for systemic therapy according to the local label.

Exclusion Criteria:

• Exclusion criteria will comply with the licensed specifications for tralokinumab.
• Subjects incapable of giving full informed consent.
• Current participation in another study with any investigational products (noninterventional or registries are allowed).
• Currently pregnant or nursing women will be excluded from this study.
• Subjects without genital involvement

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with moderate-to-severe atopic dermatitis involving the genital region treated with traloki; This cohort includes patients diagnosed with moderate-to-severe atopic dermatitis involving the genital region who are treated with tralokinumab as part of routine clinical care over 52 weeks. Data will be collected at baseline and follow-up visits to assess clinical outcomes and patient-reported measures.

Drug: tralokinumab; Patients receive tralokinumab as part of routine clinical care according to the licensed product label and physician's clinical decision. The study is observational and does not dictate or assign treatment; it collects data on patients treated with tralokinumab under real-world conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genital-Numerical Rating Scale	Improvement of ≥50% in Genital-Numerical Rating Scale (g-NRS) or ≥2 points in Genital-Investigator Global Assessment (g-IGA) in patients with moderate-to-severe AD treated with tralokinumab over a 52-week period.	52-week period

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: October 2, 2025
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Non-Interventional Study; Tralokinumab; Moderate-to-Severe Atopic Dermatitis; atopic dermatits; Genital Atopic Dermatitis
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; tralokinumab
• Other Study ID Numbers: IIT-ADG-2025; IIS-TRALO-2419 (Other Grant/Funding Number: Leo Pharma)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED