Atopic Dermatitis (Moderate-to-severe) Involving the Genital RegionAD GenitalNCT07444801
Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
An observational study of Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region, run by University Hospital Schleswig-Holstein at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region
- What is being tested?
- tralokinumab
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Oct 2025to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Department of Dermatology of the University Hospital Augsburg
Augsburg, München, 86156
Andreas Prof. Wollenberg, Prof., +49 821 400-01, info@uk-augsburg.de
- Recruiting
CCIM, Institut für Entzündungsmedizin UKSH Lübeck
Lübeck, Schleswig-Holstein, 23538
Diamant Prof. Thaci, Prof., 0451 500 - 41601, IngaCatharina.Brouer@uksh.de
Prof. Diamant Thaci, Prof.
About this study
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)
Read the 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.
- Being tested
- tralokinumab
- Keywords
- atopic dermatits, Moderate-to-Severe Atopic Dermatitis, Genital Atopic Dermatitis, Tralokinumab, Non-Interventional Study
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tralokinumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: tralokinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start20 Oct 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (Moderate-to-severe) Involving the Genital RegionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444801
- Sponsor's protocol ID
- IIT-ADG-2025
- Other IDs
- IIS-TRALO-2419
- Acronym
- AD Genital
- Status last verified
- Feb 2026
- First submitted
- 2 Oct 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
- ClinicalTrials.gov ID
- NCT07444801
- Acronym / sponsor ID
- AD Genital / IIT-ADG-2025
- Keywords
- atopic dermatits, Moderate-to-Severe Atopic Dermatitis, Genital Atopic Dermatitis, Tralokinumab, Non-Interventional Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with moderate-to-severe atopic dermatitis involving the genital region treated with traloki | – | Drug: tralokinumabThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tralokinumabPatients 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. | Drug | Patients with moderate-to-severe atopic dermatitis involving the genital region treated with traloki |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region, run by University Hospital Schleswig-Holstein at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inga Brouer (+4945150041626, IngaCatharina.Brouer@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genital-Numerical Rating Scale (time frame: 52-week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.