Molecular Signatures in Inflammatory Skin Disease

Sponsor
Prof. Dr. Stephan Weidinger
Study ID
NCT03358693
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-TNF — DRUG
    Subject receives anti-TNF antibodies open-label as per guidelines
  • Anti-IL12/23 — DRUG
    Subject receives anti-IL12/23 antibodies open-label as per guidelines
  • Anti-IL17 — DRUG
    Subject receives anti-IL17 antibodies open-label as per guidelines
  • Dupilumab — DRUG
    Subject receives Dupilumab open-label as per guidelines
  • Anti-IL23 — DRUG
    Subject receives anti-IL23 antibodies open-label as per guidelines
  • Baricitinib — DRUG
    Subject receives Baricitinib open-label as per guidelines
  • Abrocitinib — DRUG
    Subject receives Abrocitinib open-label as per guidelines
  • Upadacitinib — DRUG
    Subject receives Upadacitinib open-label as per guidelines
  • Tralokinumab — DRUG
    Subject receives Tralokinumab open-label as per guidelines
  • Lebrikizumab — DRUG
    Subject receives Lebrikizumab open-label as per guidelines
  • Nemolizumab — DRUG
    Subject receives Nemolizumab open-label as per guidelines

Study Details

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.

Key Dates

Start date
Jan 20, 2017
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors
    Pso\_Tumor Necrosis Factor (TNF) Inhibitors
  • Arm: Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors
    Interleukin (IL)-12/23 Inhibitors
  • Arm: Psoriasis patients receiving Interleukin (IL)-17 Inhibitors
    Pso\_Interleukin (IL)-17 Inhibitors
  • Arm: Atopic dermatitis patients receiving dupilumab
    Dupilumab
  • Arm: Atopic dermatitis patients receiving lebrikizumab
    Brodalumab
  • Arm: Atopic dermatitis patients receiving tralokinumab
    Tralokinumab
  • Arm: Atopic dermatitis patients receiving baricitinib
    Baricitinib
  • Arm: Atopic dermatitis patients receiving abrocitinib
    Abrocitinib
  • Arm: Atopic dermatitis patients receiving upadacitinib
    Upadacitinib
  • Arm: Psoriasis patients receiving Interleukin (IL)-23 Inhibitors
    Interleukin (IL)-23 Inhibitors
  • Arm: Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors
    Interleukin (IL)-31 Inhibitors
  • Arm: Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors
    HS\_Interleukin (IL)-17 Inhibitors
  • Arm: Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors
    HS\_Tumor Necrosis Factor (TNF) Inhibitors

Primary Outcome Measure

Changes of molecular profiles over time [ Time Frame: Baseline and week 2, week 4, week 12, week 52 ]

Central Contacts

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