2023-506165-62-00RecruitingPhase 4
Optimization of atopic dermatitis treatment that requires second-line systemic therapy through multiomic predictive models of treatment response (DermAtOmics-II)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
1. To identify genetic, biochemical and immunological biomarkers that allow for the selection of the most appropriate therapeutic alternative in each patient and the development of a prediction model using these biomarkers. 2. To optimize therapy in patients with AD requiring second-line systemic treatment by developing predictive response models (PBPK/PK/PD) that incorporate genetic, immunological, biochemical, clinical, and demographic variables.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- First submitted
- 13 Jun 2023
- Start date
- 25 Sept 2023
- Lead sponsor
- Hospital Universitario La Paz
- Diseases
- Atopic dermatitis (eczema)
- EU CT number
- 2023-506165-62-00
What you commit to
- Study type: Interventional · Phase 4
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with moderate-severe atopic dermatitis who are about to start, or are already taking, a second-line systemic treatment.
- Age
- Not stated. Children can join with a parent or guardian's consent; minors over 11 must also agree.
- Sex
- All sexes can join.
- Disease stage
- Moderate-severe atopic dermatitis.
- Earlier treatment
- Cohort 1: about to start second-line systemic treatment. Cohort 2: already taking second-line systemic therapy. Anyone who took an investigational drug within 60 days cannot join.
Main reasons for not taking part
- Took an investigational drug within 60 days before the study drug
- Any condition that prevents or interferes with following the protocol
- Women who can have children must have a negative urine pregnancy test at Screening and Day 0
- Women who can have children must agree not to become pregnant and to use highly effective contraception or abstinence
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any investigational drug within 60 days prior to study drug administration.
Other illness
- Any condition or situation precluding or interfering the compliance with the protocol.
Other
- Women of childbearing potential must have a negative urine pregnancy test at Screening and Day 0.
- Women of childbearing potential must commit not to become pregnant. They must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study.
Who the study is looking for
- Cohort 1: Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive second-line systemic treatment; Cohort 2: Subjects diagnosed with moderate-severe atopic dermatitis who are already receiving second-line systemic therapy at the time of selection.
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
- Participant is willing and able to adhere to the procedures specified in this protocol.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.