NCT06366932

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

Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Multiomic Predictive Models of Treatment Response (DermAtOmics-II)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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).
OTHER	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.

Timeline

• Start date: 2023-09-25
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-04-16
• Last updated: 2024-04-16

Locations

1 site across 1 country: Spain