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

Overview

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)

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.

Interventions

• 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.

Primary outcome measures

• Genital-Numerical Rating Scale [Time frame: 52-week period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 2 centers

• Department of Dermatology of the University Hospital Augsburg — Augsburg
• CCIM, Institut für Entzündungsmedizin UKSH Lübeck — Lübeck

Identifiers

NCT: NCT07444801 · IIT-ADG-2025 · IIS-TRALO-2419

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗