Optimization of atopic dermatitis treatment that requires second-line systemic therapy through multiomic predictive models of treatment response (DermAtOmics-II)

Phase 1

Recruiting

Conditions: Atopic dermatitis
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: CTIS2023-506165-62-00

Lead Sponsor: Hospital Universitario La Paz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

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 Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.<br>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.;Secondary Objective: To identify genetic, immunological, biochemical and clinical markers related to second-line systemic treatment efficacy and safety in patients with atopic dermatitis., To design strategies to implement the use of the identified biomarkers and developed predictive models in the national healthcare system.;Primary end point(s): Percentage of patients with primary non-response to second-line treatment. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up.

Secondary Outcome Measures