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A prospective observational study to evaluate biomarkers and disease mechanisms in patients with moderate to severe atopic dermatitis with systemic therapy

A prospective observational study to evaluate biomarkers and disease mechanisms in patients with moderate to severe atopic dermatitis with systemic therapy - ImmUniverse AD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00024175
Enrollment
300
Registered
2021-02-03
Start date
2020-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

L20.9 L20.8

Interventions

Group 1: Only one study arm There are no study interventions as such. Up to 50 ml of blood will be collected at the routine visits at week 0, week 2, week 12 and week 52 after initiation of a new sy

Sponsors

Department of Dermatology and AllergyUniversity Hospital Schleswig-Holstein (UKSH)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Written informed consent from the study participant prior to performing any study-related activities. 2) Age = 18 years at the time of study entry. 3) Clinically diagnosed atopic dermatitis. 4) Initiation of systemic therapy for atopic dermatitis by the treating physician as part of routine care 5) Study participant agrees and, in the judgment of study personnel, is able to comply with the study protocol for the duration of the study

Exclusion criteria

Exclusion criteria: 1) Study participant is not capable of consenting to study participation or adhering to the study protocol. 2) Tendency to keloid/hypertrophic scarring and/or known wound healing disorder. 3) Tattooing and/or skin lesions due to a dermatosis in the puncture area not investigated in this study 4) Needle phobia 5) Pregnancy 6) Liver/biliary tract disease present at the time of the study and judged unstable by the study physician, manifested by ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, persistent jaundice, and/or liver cir-rhosis 7) Known allergy and/or hypersensitivity to the materials used. 8) Any reason that, in the opinion of the study physician, may prevent safe participation of the study participant.

Design outcomes

Primary

MeasureTime frame
Differentially expressed genes at week 2 as compared to baseline Differentially expressed genes at week 12 as compared to baseline

Secondary

MeasureTime frame
Clinical response at week 12 after treatment start, defined as relative and absolute change in Eczema Area and Severityx Index (EASI) Multiple physician- und patient-reported outcomes

Countries

Germany

Contacts

Public ContactStephan Weidinger

Department of Dermatology and AllergyUniversity Hospital Schleswig-Holstein (UKSH)

sweidinger@dermatology.uni-kiel.de004943121110

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026