Anti-cytokine Signatures in Inflammatory Skin Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Ability to provide written informed consent and comply with the protocol - At least 18 years of age.
  • - Diagnosis of chronic psoriasis or atopic dermatitis for at least 3 years prior to enrollment.
  • - PASI score ≥ 10 or EASI score ≥ 16 - Investigator Global Assessment (IGA) ≥ 3 - 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.
  • - Subject is younger than 18 years of age.
  • - Subject has had psoriasis or atopic dermatitis for less than 3 years prior to enrollment.
  • - Subject with mild psoriasis or atopic dermatitis (PASI<16 or EASI<16 and IGA<3) or is not a candidate or is not eligible for systemic treatment - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03358693
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Prof. Dr. Stephan Weidinger
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stephan Weidinger, MD
Principal Investigator Affiliation Department of Dermatology, university Hospital Schleswig-Holstein, Campus Kiel
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Atopic Dermatitis, Psoriasis
Arms & Interventions

Arms

: Psoriasis patients receiving ustekinumab

Ustekinumab

: Psoriasis patients receiving infliximab

Infliximab

: Psoriasis patients receiving secukinumab

Secukinumab

: Atopic dermatitis patients receiving dupilumab

Dupilumab

: Psoriasis patients receiving brodalumab

Brodalumab

: Psoriasis patients receiving Ixekizumab

Ixekizumab

Interventions

Drug: - Ustekinumab

Subject receives Ustekinumab open-label as per guidelines

Drug: - Infliximab

Subject receives Infliximab open-label as per guidelines

Drug: - Secukinumab

Subject receives Secukinumab open-label as per guidelines

Drug: - Dupilumab

Subject receives Dupilumab open-label as per guidelines

Drug: - Brodalumab

Subject receives Brodalumab open-label as per guidelines

Drug: - Ixekizumab

Subject receives Ixekizumab open-label as per guidelines

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kiel, Germany

Status

Recruiting

Address

Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel

Kiel, , 24105

Site Contact

Stephan Weidinger, MD

[email protected]

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