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Optimization of Cyclosporin therapy in atopic dermatitis through multiomic predictive models of treatment response (DermAtOmics)
EU CTIS ID: 2022-500677-14-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Subjects participating in a clinical trial in the last three months.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.