Optimization of Cyclosporin therapy in atopic dermatitis through multiomic predictive models of treatment response (DermAtOmics)
Key facts
- Where
- Madrid, SpanyolországSee the site
- Phase
- 4. fázis
Where in Spanyolország
- Hospital Universitario La PazMadrid, SpanyolországNo longer taking part
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
- Fundación Para La Investigación Biomédica Del Hospital Universitario La Paz
- Trial code
- EU 2022-500677-14-00
- Record updated
- 2022. augusztus 9.
- Original description
1. To identify genetic, kinetic and immunological biomarkers that could allow the selection of responders and non- responders to first-line treatment with cyclosporine (CsA) and to develop a response prediction model using these biomarkers. 2. To optimize the dosage and treatment regimen with CsA in responding patients through the development of response predictive models (PBPK/PK/PD) that include omics, clinical and demographic variables.Read full original descriptionShow less
1. To identify genetic, kinetic and immunological biomarkers that could allow the selection of responders and non- responders to first-line treatment with cyclosporine (CsA) and to develop a response prediction model using these biomarkers. 2. To optimize the dosage and treatment regimen with CsA in responding patients through the development of response predictive models (PBPK/PK/PD) that include omics, clinical and demographic variables.
Inclusion: For cohort 1. Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporine; For Cohort 1 and 2. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures; For Cohort 1 and 2. For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent; For Cohort 1 and 2. Participant is willing and able to adhere to the procedures specified in this protocol; For Cohort 2. Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received in the past cyclosporine therapy.
Exclusion: Any condition or situation precluding or interfering the compliance with the protocol; Subjects participating in a clinical trial in the last three months; 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.