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

NCT ID: NCT06366932

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2025-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: patients who are about to initiate treatment

Patients will receive the dose used in routine clinical practice.

Once the patient is included in the clinical trial their therapeutic management will be conducted according to standard clinical practice, but some 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. Blood samples will be obtained for biochemical, pharmacogenetic and immunological biomarker analysis

Group Type: OTHER

Second-line systemic treatment

Intervention Type: DRUG

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).

Cohort 2: patients who are already receiving second-line systemic treatment

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.

Group Type: OTHER

Folllow-up of second-line systemic treatment already started

Intervention Type: OTHER

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.

Interventions

Second-line systemic treatment

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).

Intervention Type: DRUG

Folllow-up of second-line systemic treatment already started

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.

Intervention Type: OTHER

Other Intervention Names

Dupilumab, Tralokinumab, Upadacitinib, Baricitinib, Abrocitinib

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irene García, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital La Paz

Locations

Hospital La Paz

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Irene García, MD

Role: CONTACT

irene.ucicec@gmail.com

+34-912071466

Facility Contacts

Irene García, MD

Role: primary

irene.ucicec@gmail.com

+34-912071466

Other Identifiers

DermAtOmics-II

Identifier Type: -

Identifier Source: org_study_id