Molecular Signatures in Inflammatory Skin Disease (MSID)

July 17, 2025 updated by: Prof. Dr. Stephan Weidinger

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Kiel, Germany, 24105
        • Recruiting
        • Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel
        • Contact:
          • Stephan Weidinger, MD
        • Contact:
          • Sascha Gerdes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic inflammatory skin disease who receive systemic therapy from their treating dermatologist during routine care

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Atopic dermatitis patients receiving dupilumab
Dupilumab
Drug: Dupilumab
Subject receives Dupilumab open-label as per guidelines
Atopic dermatitis patients receiving tralokinumab
Tralokinumab
Drug: Tralokinumab
Subject receives Tralokinumab open-label as per guidelines
Atopic dermatitis patients receiving baricitinib
Baricitinib
Drug: Baricitinib
Subject receives Baricitinib open-label as per guidelines
Atopic dermatitis patients receiving abrocitinib
Abrocitinib
Drug: Abrocitinib
Subject receives Abrocitinib open-label as per guidelines
Atopic dermatitis patients receiving upadacitinib
Upadacitinib
Drug: Upadacitinib
Subject receives Upadacitinib open-label as per guidelines
Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors
Pso_Tumor Necrosis Factor (TNF) Inhibitors
Drug: Anti-TNF
Subject receives anti-TNF antibodies open-label as per guidelines
Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors
Interleukin (IL)-12/23 Inhibitors
Drug: Anti-IL12/23
Subject receives anti-IL12/23 antibodies open-label as per guidelines
Psoriasis patients receiving Interleukin (IL)-17 Inhibitors
Pso_Interleukin (IL)-17 Inhibitors
Drug: Anti-IL17
Subject receives anti-IL17 antibodies open-label as per guidelines
Atopic dermatitis patients receiving lebrikizumab
Brodalumab
Drug: Lebrikizumab
Subject receives Lebrikizumab open-label as per guidelines
Psoriasis patients receiving Interleukin (IL)-23 Inhibitors
Interleukin (IL)-23 Inhibitors
Drug: Anti-IL23
Subject receives anti-IL23 antibodies open-label as per guidelines
Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors
Interleukin (IL)-31 Inhibitors
Drug: Nemolizumab
Subject receives Nemolizumab open-label as per guidelines
Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors
HS_Interleukin (IL)-17 Inhibitors
Drug: Anti-IL17
Subject receives anti-IL17 antibodies open-label as per guidelines
Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors
HS_Tumor Necrosis Factor (TNF) Inhibitors
Drug: Anti-TNF
Subject receives anti-TNF antibodies open-label as per guidelines

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline and week 2, week 4, week 12, week 52
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
Baseline and week 2, week 4, week 12, week 52
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
Baseline and week 2, week 4, week 12, week 52
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
Baseline and week 2, week 4, week 12, week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Eczema Area and Severity Index (EASI) score
Time Frame: Baseline and week 1, week 2, week 12, week 52
Clinical severity score
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
Clinical severity score
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
Clinical severity score
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
Clinical severity score
Baseline and week 1, week 2, week 12, week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. Stephan Weidinger

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephan Weidinger, MD, Department of Dermatology, university Hospital Schleswig-Holstein, Campus Kiel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A100/12
  • A100/12_A (Other Identifier: Ethics Committee Medical Faculty Kiel, Amendment 11MAR2017)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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