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Anti-cytokine Signatures in Inflammatory Skin Disease

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ClinicalTrials.gov Identifier: NCT03358693
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Stephan Weidinger, University of Schleswig-Holstein

Brief 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 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.

Condition or disease Intervention/treatment
Atopic Dermatitis Psoriasis Drug: Ustekinumab Drug: Infliximab Drug: Secukinumab Drug: Dupilumab

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Systematic Profiling of Anti-cytokine Signatures in the Treatment of Chronic Inflammatory Skin Disorders
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ustekinumab

Group/Cohort Intervention/treatment
Psoriasis patients receiving ustekinumab
Ustekinumab
Drug: Ustekinumab
Subject receives Ustekinumab open-label as per guidelines

Psoriasis patients receiving infliximab
Infliximab
Drug: Infliximab
Subject receives Infliximab open-label as per guidelines

Psoriasis patients receiving secukinumab
Secukinumab
Drug: Secukinumab
Subject receives Secukinumab open-label as per guidelines

Atopic dermatitis patients receiving dupilumab
Dupilumab
Drug: Dupilumab
Subject receives Dupilumab open-label as per guidelines




Primary Outcome Measures :
  1. Changes of molecular signatures associated with treatment [ Time Frame: Baseline and day 1, day 7, day 14, day 42, day 84 ]
    Changes of transcriptome and microbiome signatures

  2. Changes of molecular signatures associated with treatment response [ Time Frame: Baseline and day 1, day 7, day 14, day 42, day 84 ]
    Changes of transcriptome and microbiome signatures

  3. Changes of molecular signatures associated with disease severity/remission [ Time Frame: Baseline and day 1, day 7, day 14, day 42, day 84 ]
    Changes of transcriptome and microbiome signatures


Secondary Outcome Measures :
  1. Change in Eczema area and severity index (EASI) score [ Time Frame: Baseline and day 1, day 7, day 14, day 42, day 84 ]
    Clinical severity score

  2. Change in Score of Atopic Dermatitis (SCORAD) [ Time Frame: Baseline and day 1, day 7, day 14, day 42, day 84 ]
    Clinical severity score

  3. Change in Psoriasis Area Severity Index (PASI) score [ Time Frame: Baseline and day 1, day 7, day 14, day 42, day 84 ]
    Clinical severity score


Biospecimen Retention:   Samples With DNA
Blood, skin biopsies, swabs, tape strips, stool


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with moderate to severe psoriasis or atopic dermatitis who receive specified biologics from their treating dermatologist during routine care
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358693


Contacts
Contact: Stephan Weidinger, MD sweidinger@dermatology.uni-kiel.de
Contact: Sascha Gerdes, MD sgerdes@dermatology.uni-kiel.de

Locations
Germany
Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel Recruiting
Kiel, Germany, 24105
Contact: Stephan Weidinger, MD         
Contact: Sascha Gerdes, MD         
Sponsors and Collaborators
Prof. Dr. Stephan Weidinger
Investigators
Principal Investigator: Stephan Weidinger, MD Department of Dermatology, university Hospital Schleswig-Holstein, Campus Kiel

Responsible Party: Prof. Dr. Stephan Weidinger, Head, Inflammatory Skin Disease Center, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03358693     History of Changes
Other Study ID Numbers: A100/12
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Eczema
Psoriasis
Dermatitis
Dermatitis, Atopic
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Infliximab
Ustekinumab
Antibodies, Monoclonal
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs