2022-500677-14-00Active, not recruitingPhase 4
Optimization of Cyclosporin therapy in atopic dermatitis through multiomic predictive models of treatment response (DermAtOmics)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Aug 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 13 Jun 2022
- Start date
- 28 Sept 2022
- Lead sponsor
- Fundación Para La Investigación Biomédica Del Hospital Universitario La Paz
- Diseases
- Atopic dermatitis (eczema)
- EU CT number
- 2022-500677-14-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- 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.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition or situation precluding or interfering the compliance with the protocol.
Other
- 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
Who the study is looking for
- 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.
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 | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.