Tralokinumab for moderate-to-severe atopic dermatitis affecting the genital area
Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Schleswig-Holstein Academic / other |
| Drugs / interventions | tralokinumab |
| Locations | 2 sites (Augsburg, München and 1 other locations) |
| Trial ID | NCT07444801 on ClinicalTrials.gov |
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).
Who should consider this trial
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.
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.
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 performed: Tralokinumab has demonstrated efficacy for moderate-to-severe atopic dermatitis in prior randomized trials, but prospective data focused specifically on genital involvement are limited.
Eligibility criteria
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 this trial is running
Augsburg, München and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.