Optimization of Cyclosporin in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response (DermAtOmics)

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Enrolling; Phase 4

Conditions: Atopic Dermatitis

Treatments: Other: Follow-up of Cyclospoin treatment already started; Drug: Cyclosporin A

Study type: Interventional

Funder types: Other

Identifiers

NCT05692843

2022-500677-14-00

Details and patient eligibility

About

This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis who require systemic treatment.

Full description

Primary outcome is the percentage of patients with primary non- response to treatment with cyclosporin. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up. A 12-month recruitment period is planned and about of 100 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporin in the Dermatology Service of La Paz University Hospital and associated Specialty Centers are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate-severe atopic dermatitis who are receiving or have received cyclosporin therapy in the Dermatology Service of La Paz University Hospital and associated Specialty Centers are selected in cohort 2.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Cohort 1:

1. Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporine.
2. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
3. For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
4. Participant is willing and able to adhere to the procedures specified in this protocol.

Cohort 2:

1. Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received in the past treatment with cyclosporine.
2. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
3. For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
4. Participant is willing and able to adhere to the procedures specified in this protocol.

Exclusion criteria

1. Subjects participating in a clinical trial in the last three months.
2. Any condition or situation precluding or interfering the compliance with the protocol.
3. Women of childbearing potential must have a negative urine pregnancy test at Screening and Day 0.
4. 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. Highly effective contraceptive methods include oral, intravaginal, or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner and sexual abstinence.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Start of Cyclosporin treatment

Other group

Description:

Patients will receive the starting dose used in routine clinical practice (maximum dose of 3 mg/kg/day is standard practice in our center). Once the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed: 1. The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life; 2. Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment.

Treatment:

Drug: Cyclosporin A

Receiving or received cyclosporin

Other group

Description:

If the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. If the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records.

Treatment:

Other: Follow-up of Cyclospoin treatment already started