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

NCT06366932 | Recruiting Phase 4 DMC

• 1 other identifier: DermAtOmics-II
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 16

Secondary Outcomes (14)

• Percentage of patients achieving EASI-75

  Week 6

• Time to treatment failure after week 16

  Week 16

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

  Week 16

• Percentage of change in SCORAD (SCORing Atopic Dermatitis)

  Week 16

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

  Through study completion, an average of 1 year

Study Arms (2)

Cohort 1: patients who are about to initiate treatment

OTHER

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

Drug: Second-line systemic treatment

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

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.

Other: Folllow-up of second-line systemic treatment already started

Interventions

Second-line systemic treatment 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).

Also known as: Dupilumab, Tralokinumab, Upadacitinib, Baricitinib, Abrocitinib

Cohort 1: patients who are about to initiate treatment

Folllow-up of second-line systemic treatment already started 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.

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort 1:
• Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive an authorized second-line systemic treatment.
• 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.
• Cohort 2:
• Subjects diagnosed with moderate-severe atopic dermatitis who are already receiving authorized 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.

You may not qualify if:

• 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. 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital La Paz

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab; tralokinumab; upadacitinib; baricitinib; abrocitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Irene García, MD

  Hospital La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene García, MD

CONTACT

+34-912071466; irene.ucicec@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase IV, low-intervention clinical trial to develop prediction models that allow to determine the most appropriate therapeutic strategy in patients diagnosed with atopic dermatitis that need second-line systemic treatment.

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: April 16, 2024
• Study Start: September 25, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)