Atopic DermatitisAD-SysNCT05098821
Extrinsic and Intrinsic Factors in Atopic Dermatitis Upon Systemic Immune Modulation
An observational study of Atopic Dermatitis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Currently, patients with moderate to severe atopic dermatitis are treated with dupilumab if unresponsive to topical treatment. However, not all patients who suffer from atopic dermatitis respond similarly to this treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- not applicable, observational study
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 8 Nov 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with moderate to severe atopic dermatitis presenting in the clinic of Dermatology, Charité - Universitätsmedizin Berlin, Germany
Who may be able to join
- Age 18 and above
- Diagnosis of atopic dermatitis for ≥1 year
- Inadequate response to treatment with topical medications
- Confirmed dupilumab treatment
Who cannot join
- Age below 18
- Known or suspected allergy or reaction to any component of the dupilumab formulation
- Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of the severity of AD
- Severe conjunctivitis or blepharitis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin
Berlin, 10117
About this study
Official title: Pattern Recognition of Immune Cells in Atopic Dermatitis Patients Receiving Dupilumab
Currently, patients with moderate to severe atopic dermatitis are treated with dupilumab if unresponsive to topical treatment. However, not all patients who suffer from atopic dermatitis respond similarly to this treatment. Pattern recognition of immune cells (PRI) is an efficient method to screen patients to allow a more personalized therapy.
The main aim of this scientific explorative study is to unravel the changes in peripheral blood immune cell compositions in patients with atopic eczema undergoing dupilumab treatment. This allows the identification of phenotypes of treatment responders and non-responders and possible approaches of treatment modifications for non-responders.
Read the detailed description
A better understanding of the pathology of atopic dermatitis could lead to the development of new therapeutic strategies for this disease and contribute to better and more targeted disease management - an advantage for all patients with atopic dermatitis.
The PRI is a new bioinformatic analysis strategy that allows in-depth data analysis from flow cytometry with multiple variables. This facilitates the identification of meaningful T cell subpopulations, which are differentially abundant between two groups to predict responders and non-responders prior to dupilumab treatment.
Peripheral blood will be collected before, 4 weeks, 8 weeks, and 16 weeks after initiating the systemic treatment with dupilumab to identify recognition patterns/markers on the T cells. Therefore, a predefined multicolor flow cytometry panel was developed to analyse lineage, differentiation and activation markers.
Patients will receive a systemic therapy (dupilumab 600 mg loading dose, followed by 300 mg in two weeks intervals). Follow up visits will be performed every 3 months starting from the second visit (2nd visit will take place 4 weeks after initiating Dupilumab treatment).
The blood samples that are taken as part of this scientific study are pseudonymized in the research laboratories and stored for a period of 5 years after the end of this study or the publication of the results and destroyed.
- Conditions
- Atopic Dermatitis
- Being tested
- not applicable, observational study
- Keywords
- dupilumab, pattern recognition, immune cells
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not applicable, observational studyOther
Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab treated Patients | Patients with atopic dermatitis with indication for dupilumab treatments will be observed Receives: Other: not applicable, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of T-cell inflammatory markers
Identification of at least one pattern recognition profile showing a strong association with responder status to dupilumab therapy
Measured: 1 year
Secondary outcomes (3)
Different T-cell pattern with dupilumab therapy
Time in which the pattern of T-cell modulation after initiation of dupilumab therapy (measured using PRI) shows significant differences from the baseline.
Measured: 1.5 years
Assign recognition patterns to clinical symptoms
Association of recognition patterns with clinical symptoms of atopic dermatitis (measured using Cramer's V > 0.5) with a specific interest in conjunctivitis, pruritus, asthma and herpes infections.
Measured: 3 months
Connection of molecular profile and phenotype
Classification and clustering of at least two molecular profiles of peripheral blood immune cells in relation to phenotypes of atopic dermatitis (Cramer's V either with association to IgE levels or early/late onset AD).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Oct 2019
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, LEO Pharma
- Responsible party
- Principal investigator, Margitta Worm, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098821
- Sponsor's protocol ID
- PRI-ADD
- Acronym
- AD-Sys
- Status last verified
- Mar 2026
- First submitted
- 20 Oct 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern Recognition of Immune Cells in Atopic Dermatitis Patients Receiving Dupilumab
- ClinicalTrials.gov ID
- NCT05098821
- Acronym / sponsor ID
- AD-Sys / PRI-ADD
- Conditions
- Atopic Dermatitis
- Keywords
- dupilumab, pattern recognition, immune cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Sanofi, LEO Pharma
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 28 Oct 2021 (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.
Currently, patients with moderate to severe atopic dermatitis are treated with dupilumab if unresponsive to topical treatment. However, not all patients who suffer from atopic dermatitis respond similarly to this treatment. Pattern recognition of immune cells (PRI) is an efficient method to screen patients to allow a more personalized therapy.
The main aim of this scientific explorative study is to unravel the changes in peripheral blood immune cell compositions in patients with atopic eczema undergoing dupilumab treatment. This allows the identification of phenotypes of treatment responders and non-responders and possible approaches of treatment modifications for non-responders.
Detailed description
A better understanding of the pathology of atopic dermatitis could lead to the development of new therapeutic strategies for this disease and contribute to better and more targeted disease management - an advantage for all patients with atopic dermatitis.
The PRI is a new bioinformatic analysis strategy that allows in-depth data analysis from flow cytometry with multiple variables. This facilitates the identification of meaningful T cell subpopulations, which are differentially abundant between two groups to predict responders and non-responders prior to dupilumab treatment.
Peripheral blood will be collected before, 4 weeks, 8 weeks, and 16 weeks after initiating the systemic treatment with dupilumab to identify recognition patterns/markers on the T cells. Therefore, a predefined multicolor flow cytometry panel was developed to analyse lineage, differentiation and activation markers.
Patients will receive a systemic therapy (dupilumab 600 mg loading dose, followed by 300 mg in two weeks intervals). Follow up visits will be performed every 3 months starting from the second visit (2nd visit will take place 4 weeks after initiating Dupilumab treatment).
The blood samples that are taken as part of this scientific study are pseudonymized in the research laboratories and stored for a period of 5 years after the end of this study or the publication of the results and destroyed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab treated Patients | – | Other: not applicable, observational studyPatients with atopic dermatitis with indication for dupilumab treatments will be observed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with moderate to severe atopic dermatitis presenting in the clinic of Dermatology, Charité - Universitätsmedizin Berlin, Germany
Key inclusion criteria (4 listed)
- Age 18 and above
- Diagnosis of atopic dermatitis for ≥1 year
- Inadequate response to treatment with topical medications
- Confirmed dupilumab treatment
Key exclusion criteria (4 listed)
- Age below 18
- Known or suspected allergy or reaction to any component of the dupilumab formulation
- Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of the severity of AD
- Severe conjunctivitis or blepharitis
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 |
|---|---|---|
| not applicable, observational studyPatients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study | Other | Dupilumab treated Patients |
Primary outcome
Comparison of T-cell inflammatory markers
Time frame: 1 year
Identification of at least one pattern recognition profile showing a strong association with responder status to dupilumab therapy
3 secondary outcomes
Different T-cell pattern with dupilumab therapy
Time frame: 1.5 years
Assign recognition patterns to clinical symptoms
Time frame: 3 months
Connection of molecular profile and phenotype
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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, run by Charite University, Berlin, Germany at 1 site 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 4 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: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of T-cell inflammatory markers (time frame: 1 year). 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 22 Oct 2026.