Optimization of atopic dermatitis treatment that requires second-line systemic therapy through multiomic predictive models of treatment response (DermAtOmics-II)
Key facts
- Where
- Madrid, SpanyolországSee the site
- Phase
- 4. fázis
Where in Spanyolország
- Hospital Universitario La PazMadrid, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitario La Paz
- Trial code
- EU 2023-506165-62-00
- Record updated
- 2025. augusztus 20.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Any investigational drug within 60 days prior to study drug administration; Any condition or situation precluding or interfering the compliance with the protocol; 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.