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Идёт набор NCT03358693

Molecular Signatures in Inflammatory Skin Disease

— Наблюдательное Atopic Dermatitis Psoriasis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Anti-TNF, Anti-IL12/23, Anti-IL17, Dupilumab.
Кому может быть актуально
Состояния в реестре: Atopic Dermatitis, Psoriasis. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Systematic Profiling of Anti-cytokine Signatures in the Treatment of Chronic Inflammatory Skin Disorders

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Changes of molecular profiles over time [Срок оценки: Baseline and week 2, week 4, week 12, week 52]
  • Changes of molecular profiles associated with disease severity/remission [Срок оценки: Baseline and week 2, week 4, week 12, week 52]
  • Changes of molecular profiles associated with treatment [Срок оценки: Baseline and week 2, week 4, week 12, week 52]
  • Changes of molecular profiles associated with treatment response [Срок оценки: Baseline and week 2, week 4, week 12, week 52]
Вторичные конечные точки (4)
  • Change in Eczema Area and Severity Index (EASI) score [Срок оценки: Baseline and week 1, week 2, week 12, week 52]
  • Change in Score of Atopic Dermatitis (SCORAD) [Срок оценки: Baseline and week 1, week 2, week 12, week 52]
  • Change in Psoriasis Area and Severity Index (PASI) [Срок оценки: Baseline and week 1, week 2, week 12, week 52]
  • Change in Hidradenitis Suppurativa Severity Score (IHS4) [Срок оценки: Baseline and week 1, week 2, week 12, week 52]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Германия · 1 центр
  • Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel — Kiel

Идентификаторы

NCT: NCT03358693 · A100/12 · A100/12_A

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗