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

February 24, 2026 updated by: University Hospital Schleswig-Holstein
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • München
      • Augsburg, München, Germany, 86156
        • Recruiting
        • Department of Dermatology of the University Hospital Augsburg
        • Contact:
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • CCIM, Institut für Entzündungsmedizin UKSH Lübeck
        • Contact:
        • Principal Investigator:
          • Prof. Diamant Thaci, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Genital-Numerical Rating Scale
Time Frame: 52-week period
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Schleswig-Holstein

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LEO Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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