Tralokinumab for moderate-to-severe atopic dermatitis affecting the genital area
Official title: Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
Run by University Hospital Schleswig-Holstein · NCT07444801 · Data updated 2026-11-12
This trial will try tralokinumab in adults with moderate-to-severe atopic dermatitis involving the genital region to see if it improves genital symptoms and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University Hospital Schleswig-Holstein Academic / other |
| Drugs / interventions | tralokinumab |
| Locations | 2 sites (Augsburg, München and 1 other locations) |
| Status | Recruiting |
| Started | October 20, 2025 |
| Main results expected | October 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | March 3, 2026 |
| Trial ID | NCT07444801 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with moderate-to-severe atopic dermatitis involving the genital region who are initiating tralokinumab treatment in routine clinical care and are eligible for systemic therapy.
✕Probably not a fit
Patients who are pregnant or breastfeeding, unable to give informed consent, whose disease is mild or does not involve the genital area, or who are excluded by tralokinumab labeling are unlikely to benefit from or be eligible for this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, open-label, non-randomized observational study enrolling 30 adults with moderate-to-severe atopic dermatitis affecting the genital area who are starting tralokinumab as part of routine care. Patients will be treated according to the licensed product information and followed for 52 weeks with data collection at baseline, week 4, week 16, week 24, and week 52. Outcomes include genital-specific clinical scores (e.g., g-NRS, g-IGA), validated patient-reported outcome measures (e.g., POEM, ADCT), and non-invasive imaging such as OCT, confocal microscopy, or LC-OCT. Recruitment occurs at two German academic dermatology centers (Lübeck and Augsburg).
Why it matters
Potential benefit: If successful, the findings could demonstrate that tralokinumab improves genital AD symptoms and patient-reported outcomes, helping clinicians manage this sensitive disease location.
How similar studies have gone: Tralokinumab has demonstrated efficacy for moderate-to-severe atopic dermatitis in prior randomized trials, but prospective data focused specifically on genital involvement are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Department of Dermatology of the University Hospital Augsburg
Augsburg, München, Germany Recruiting -
CCIM, Institut für Entzündungsmedizin UKSH Lübeck
Lübeck, Schleswig-Holstein, Germany Recruiting
Study contacts
- Study coordinator: Inga Brouer
- Email: IngaCatharina.Brouer@uksh.de
- Phone: +4945150041626
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating Tralokinumab with Corticosteroids for Atopic Dermatitis in Children
This study is testing if a new injection combined with skin creams can help children and infants with moderate-to-severe eczema feel better.
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Monitoring pregnancy and infant outcomes after tralokinumab exposure
This study looks at how using the medication tralokinumab during pregnancy affects both the pregnancy and the baby's health compared to pregnant individuals with atopic dermatitis who didn't use the drug.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.