Atopic DermatitisMSIDNCT03358693
Molecular Signatures in Inflammatory Skin Disease
An observational study of Atopic Dermatitis and Psoriasis, run by Prof. Dr. Stephan Weidinger at 1 site in Germany.
Trial summary
This pilot project intends to examine the utility of a systems medicine approach to identify regulatory networks and their perturbation in psoriasis and atopic dermatitis, and to obtain a comprehensive perspective on disease and disease control by integrating and modelling data across multiple cellular levels and time… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Dermatitis, Psoriasis
- What is being tested?
- Anti-TNF, Anti-IL12/23 and Anti-IL17
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jan 2017to 31 Dec 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic inflammatory skin disease who receive systemic therapy from their treating dermatologist during routine care
Who may be able to join
- Ability to provide written informed consent and comply with the protocol
- Dermatologist-diagnosed chronic inflammatory skin disease
- Subject receives systemic therapy within routine care (in-label use of biologics)
Who cannot join
- Subject is unable to provide written informed consent or comply with the protocol.
- Having used immunosuppressive/immunomodulating therapy or phototherapy within 4 weeks before the baseline visit.
- Treatment of selected skin areas to be examined with topical corticosteroid or topical calcineurin inhibitor within 1 week before the baseline visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel
Kiel, 24105
Stephan Weidinger, MD
Sascha Gerdes, MD
About this study
Official title: Systematic Profiling of Anti-cytokine Signatures in the Treatment of Chronic Inflammatory Skin Disorders
This pilot project intends to examine the utility of a systems medicine approach to identify regulatory networks and their perturbation in psoriasis and atopic dermatitis, and to obtain a comprehensive perspective on disease and disease control by integrating and modelling data across multiple cellular levels and time following specific blockade of single pathophysiological factors through use of licensed biologics during routine care as systems biology challenge. To this end, ultra-deep phenotyping and prospective molecular characterization in short time-intervals and different disease equilibrium states will be carried out in targeted small sets of patients. The different layers and types of clinical and molecular information will then be integrated (integrative personal omics profiling iPOP) for generating insights into disease pathways and for extraction of molecular signatures that correspond to clinical severity scores. It will provide a good starting point for planning future trials aimed at identifying biological patterns useful for guiding targeted treatment.
Read the detailed description
This is an exploratory study with the aim to identify molecular profiles and signatures in skin and blood that correlate with inflammatory skin disease, disease activity and disease progression, and that are associated with possible disease subtypes/endotypes. Primary target variables are differentially expressed genes (alone or in combination), secondary target variables are genetic, immunological and microbiological signatures. Influencing variables of interest include age of manifestation, disease duration, disease activity/severity, disease progression, comorbidities and therapy/treatment. Obtained biomaterial will be used for molecular profiling including DNA/RNA sequencing, ELISA, mass spectrometry, flow cytometry to identify markers and/or signatures that can correlate with individual disease courses.
- Conditions
- Atopic Dermatitis, Psoriasis
- Being tested
- Anti-TNF, Anti-IL12/23, Anti-IL17, Dupilumab, Anti-IL23
- Medical subject headings
- Dermatitis, Atopic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TNFDrug
Subject receives anti-TNF antibodies open-label as per guidelines
Anti-IL12/23Drug
Subject receives anti-IL12/23 antibodies open-label as per guidelines
Anti-IL17Drug
Subject receives anti-IL17 antibodies open-label as per guidelines
DupilumabDrug
Subject receives Dupilumab open-label as per guidelines
Anti-IL23Drug
Subject receives anti-IL23 antibodies open-label as per guidelines
BaricitinibDrug
Subject receives Baricitinib open-label as per guidelines
AbrocitinibDrug
Subject receives Abrocitinib open-label as per guidelines
UpadacitinibDrug
Subject receives Upadacitinib open-label as per guidelines
TralokinumabDrug
Subject receives Tralokinumab open-label as per guidelines
LebrikizumabDrug
Subject receives Lebrikizumab open-label as per guidelines
NemolizumabDrug
Subject receives Nemolizumab open-label as per guidelines
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors | Pso_Tumor Necrosis Factor (TNF) Inhibitors Receives: Drug: Anti-TNF | |
| Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors | Interleukin (IL)-12/23 Inhibitors Receives: Drug: Anti-IL12/23 | |
| Psoriasis patients receiving Interleukin (IL)-17 Inhibitors | Pso_Interleukin (IL)-17 Inhibitors Receives: Drug: Anti-IL17 | |
| Atopic dermatitis patients receiving dupilumab | Dupilumab Receives: Drug: Dupilumab | |
| Atopic dermatitis patients receiving lebrikizumab | Brodalumab Receives: Drug: Lebrikizumab | |
| Atopic dermatitis patients receiving tralokinumab | Tralokinumab Receives: Drug: Tralokinumab | |
| Atopic dermatitis patients receiving baricitinib | Baricitinib Receives: Drug: Baricitinib | |
| Atopic dermatitis patients receiving abrocitinib | Abrocitinib Receives: Drug: Abrocitinib | |
| Atopic dermatitis patients receiving upadacitinib | Upadacitinib Receives: Drug: Upadacitinib | |
| Psoriasis patients receiving Interleukin (IL)-23 Inhibitors | Interleukin (IL)-23 Inhibitors Receives: Drug: Anti-IL23 | |
| Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors | Interleukin (IL)-31 Inhibitors Receives: Drug: Nemolizumab | |
| Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors | HS_Interleukin (IL)-17 Inhibitors Receives: Drug: Anti-IL17 | |
| Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors | HS_Tumor Necrosis Factor (TNF) Inhibitors Receives: Drug: Anti-TNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of molecular profiles over time
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Measured: Baseline and week 2, week 4, week 12, week 52
Changes of molecular profiles associated with disease severity/remission
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Measured: Baseline and week 2, week 4, week 12, week 52
Changes of molecular profiles associated with treatment
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Measured: Baseline and week 2, week 4, week 12, week 52
Changes of molecular profiles associated with treatment response
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Measured: Baseline and week 2, week 4, week 12, week 52
Secondary outcomes (4)
Change in Eczema Area and Severity Index (EASI) score
Clinical severity score
Measured: Baseline and week 1, week 2, week 12, week 52
Change in Score of Atopic Dermatitis (SCORAD)
Clinical severity score
Measured: Baseline and week 1, week 2, week 12, week 52
Change in Psoriasis Area and Severity Index (PASI)
Clinical severity score
Measured: Baseline and week 1, week 2, week 12, week 52
Change in Hidradenitis Suppurativa Severity Score (IHS4)
Clinical severity score
Measured: Baseline and week 1, week 2, week 12, week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start20 Jan 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
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.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Stephan Weidinger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Stephan Weidinger, University Hospital Schleswig-Holstein
- Investigators
- Stephan Weidinger, MD, Principal investigator, Department of Dermatology, university Hospital Schleswig-Holstein, Campus Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358693
- Sponsor's protocol ID
- A100/12
- Other IDs
- A100/12_A
- Acronym
- MSID
- Status last verified
- Jul 2025
- First submitted
- 4 Nov 2017
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Profiling of Anti-cytokine Signatures in the Treatment of Chronic Inflammatory Skin Disorders
- ClinicalTrials.gov ID
- NCT03358693
- Acronym / sponsor ID
- MSID / A100/12
- Conditions
- Atopic Dermatitis, Psoriasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Prof. Dr. Stephan WeidingerUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Nov 2017 (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.
This pilot project intends to examine the utility of a systems medicine approach to identify regulatory networks and their perturbation in psoriasis and atopic dermatitis, and to obtain a comprehensive perspective on disease and disease control by integrating and modelling data across multiple cellular levels and time following specific blockade of single pathophysiological factors through use of licensed biologics during routine care as systems biology challenge. To this end, ultra-deep phenotyping and prospective molecular characterization in short time-intervals and different disease equilibrium states will be carried out in targeted small sets of patients. The different layers and types of clinical and molecular information will then be integrated (integrative personal omics profiling iPOP) for generating insights into disease pathways and for extraction of molecular signatures that correspond to clinical severity scores. It will provide a good starting point for planning future trials aimed at identifying biological patterns useful for guiding targeted treatment.
Detailed description
This is an exploratory study with the aim to identify molecular profiles and signatures in skin and blood that correlate with inflammatory skin disease, disease activity and disease progression, and that are associated with possible disease subtypes/endotypes. Primary target variables are differentially expressed genes (alone or in combination), secondary target variables are genetic, immunological and microbiological signatures. Influencing variables of interest include age of manifestation, disease duration, disease activity/severity, disease progression, comorbidities and therapy/treatment. Obtained biomaterial will be used for molecular profiling including DNA/RNA sequencing, ELISA, mass spectrometry, flow cytometry to identify markers and/or signatures that can correlate with individual disease courses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors | – | Drug: Anti-TNFPso_Tumor Necrosis Factor (TNF) Inhibitors |
| Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors | – | Drug: Anti-IL12/23Interleukin (IL)-12/23 Inhibitors |
| Psoriasis patients receiving Interleukin (IL)-17 Inhibitors | – | Drug: Anti-IL17Pso_Interleukin (IL)-17 Inhibitors |
| Atopic dermatitis patients receiving dupilumab | – | Drug: DupilumabDupilumab |
| Atopic dermatitis patients receiving lebrikizumab | – | Drug: LebrikizumabBrodalumab |
| Atopic dermatitis patients receiving tralokinumab | – | Drug: TralokinumabTralokinumab |
| Atopic dermatitis patients receiving baricitinib | – | Drug: BaricitinibBaricitinib |
| Atopic dermatitis patients receiving abrocitinib | – | Drug: AbrocitinibAbrocitinib |
| Atopic dermatitis patients receiving upadacitinib | – | Drug: UpadacitinibUpadacitinib |
| Psoriasis patients receiving Interleukin (IL)-23 Inhibitors | – | Drug: Anti-IL23Interleukin (IL)-23 Inhibitors |
| Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors | – | Drug: NemolizumabInterleukin (IL)-31 Inhibitors |
| Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors | – | Drug: Anti-IL17HS_Interleukin (IL)-17 Inhibitors |
| Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors | – | Drug: Anti-TNFHS_Tumor Necrosis Factor (TNF) Inhibitors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic inflammatory skin disease who receive systemic therapy from their treating dermatologist during routine care
Key inclusion criteria (3 listed)
- Ability to provide written informed consent and comply with the protocol
- Dermatologist-diagnosed chronic inflammatory skin disease
- Subject receives systemic therapy within routine care (in-label use of biologics)
Key exclusion criteria (3 listed)
- Subject is unable to provide written informed consent or comply with the protocol.
- Having used immunosuppressive/immunomodulating therapy or phototherapy within 4 weeks before the baseline visit.
- Treatment of selected skin areas to be examined with topical corticosteroid or topical calcineurin inhibitor within 1 week before the baseline visit.
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 |
|---|---|---|
| Anti-TNFSubject receives anti-TNF antibodies open-label as per guidelines | Drug | Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors, Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors |
| Anti-IL12/23Subject receives anti-IL12/23 antibodies open-label as per guidelines | Drug | Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors |
| Anti-IL17Subject receives anti-IL17 antibodies open-label as per guidelines | Drug | Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors, Psoriasis patients receiving Interleukin (IL)-17 Inhibitors |
| DupilumabSubject receives Dupilumab open-label as per guidelines | Drug | Atopic dermatitis patients receiving dupilumab |
| Anti-IL23Subject receives anti-IL23 antibodies open-label as per guidelines | Drug | Psoriasis patients receiving Interleukin (IL)-23 Inhibitors |
| BaricitinibSubject receives Baricitinib open-label as per guidelines | Drug | Atopic dermatitis patients receiving baricitinib |
| AbrocitinibSubject receives Abrocitinib open-label as per guidelines | Drug | Atopic dermatitis patients receiving abrocitinib |
| UpadacitinibSubject receives Upadacitinib open-label as per guidelines | Drug | Atopic dermatitis patients receiving upadacitinib |
| TralokinumabSubject receives Tralokinumab open-label as per guidelines | Drug | Atopic dermatitis patients receiving tralokinumab |
| LebrikizumabSubject receives Lebrikizumab open-label as per guidelines | Drug | Atopic dermatitis patients receiving lebrikizumab |
| NemolizumabSubject receives Nemolizumab open-label as per guidelines | Drug | Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors |
Primary outcome
Changes of molecular profiles over time
Time frame: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles associated with disease severity/remission
Time frame: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles associated with treatment
Time frame: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles associated with treatment response
Time frame: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
4 secondary outcomes
Change in Eczema Area and Severity Index (EASI) score
Time frame: Baseline and week 1, week 2, week 12, week 52
Change in Score of Atopic Dermatitis (SCORAD)
Time frame: Baseline and week 1, week 2, week 12, week 52
Change in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline and week 1, week 2, week 12, week 52
Change in Hidradenitis Suppurativa Severity Score (IHS4)
Time frame: Baseline and week 1, week 2, week 12, week 52
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 22 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Stephan Weidinger, MD principal investigator
Department of Dermatology, university Hospital Schleswig-Holstein, Campus Kiel
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 and Psoriasis, run by Prof. Dr. Stephan Weidinger 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 3 inclusion and 3 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 22 Jul 2025. 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?
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 Stephan Weidinger, MD (004943150021101, sweidinger@dermatology.uni-kiel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of molecular profiles over time (time frame: Baseline and week 2, week 4, week 12, week 52). The study lists 4 primary outcomes in all. 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 Jul 2025.