Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models

Instituto de Investigación Hospital Universitario La Paz150 enrolled

Overview

This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine.

Primary outcome is the 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. A 12-month recruitment period is planned and about 150 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate to severe atopic dermatitis who are going to receive second-line systemic treatment at the Dermatology Department of La Paz University Hospital are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate to severe atopic dermatitis who are receiving second-line systemic treatment at the Dermatology Department of La Paz University Hospital will be selected in cohort 2.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Atopic Dermatitis

Interventions

Second-line systemic treatmentDRUG

Patients with moderate to severe atopic dermatitis refractory to topical medication, who also have previous experience with cyclosporine and an unsatisfactory response, or in whom the use of cyclosporine is considered inappropriate due to contraindication or intolerance, are candidates for treatment with other alternatives (Dupilumab, Tralokinumab, Upadacitinib, Baricitinib, Abrocitinib).

Folllow-up of second-line systemic treatment already startedOTHER

If the patient is receiving second-line therapy at the moment of the inclusion, data will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: Cohort 1: 1. Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive an authorized second-line systemic treatment. 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 already receiving authorized second-line systemic therapy at the time of selection. 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. Any investigational drug within 60 days prior to study drug administration. 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 (estrogen 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.

Locations (1)

Hospital La Paz

Madrid, Spain

RECRUITING

Outcomes

Primary Outcomes

Percentage of patients with primary non-response to second-line treatment.

Fail to achieve EASI-75 (a 75% improvement in Eczema Area and Severity Index \[EASI\] score). The minimum EASI score is 0 and the maximum EASI score is 72.

Time frame: Week 16

Secondary Outcomes

Percentage of patients achieving EASI-75

Fail to achieve EASI-75 (a 75% improvement in Eczema Area and Severity Index \[EASI\] score). The minimum EASI score is 0 and the maximum EASI score is 72.

Time frame: Week 6

Time to treatment failure after week 16

Time to treatment failure with cyclosporine defined as Eczema Area and Severity Index (EASI) ≤ 50 during follow-up after week 16.

Time frame: Week 16

Mean percentage of change in Eczema Area and Severity Index (EASI) score

Mean percentage of change in EASI score from baseline to week 16.

Time frame: Week 16

Percentage of change in SCORAD (SCORing Atopic Dermatitis)

Is the score of the severity of atopic dermatitis. It includes the evaluation of the affected areas. The intensity of the lesions and the subjective symptoms of the patient. Classifies AD as Mild \>25, Moderate 25-50, and Severe \>50

Time frame: Week 16

Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis)

Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value. The SCORAD for that individual is A/5 + 7B/2 + C. The total area is 'A', which has a possible maximum of 100%. The intensity scores are added together to give 'B' (maximum 18). The subjective symptoms is 'C' (maximum 20).

Central Contacts

Irene García, MD

CONTACT

+34-912071466 irene.ucicec@gmail.com

Data from ClinicalTrials.gov

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