Clinical trial NCT06366932: Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models
Official title: Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Multiomic Predictive Models of Treatment Response (DermAtOmics-II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of patients with primary non-response to second-line treatment.
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of patients achieving EASI-75
timeFrame: Week 6
measure: Time to treatment failure after week 16
timeFrame: Week 16
measure: Mean percentage of change in Eczema Area and Severity Index (EASI) score
timeFrame: Week 16
measure: Percentage of change in SCORAD (SCORing Atopic Dermatitis)
timeFrame: Week 16
measure: Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis)
timeFrame: Through study completion, an average of 1 year
measure: Change of IGA (Investigator Global Assessment)
timeFrame: Week 16
measure: Time to IGA score of 0/1 (Investigator Global Assessment)
timeFrame: Through study completion, an average of 1 year
measure: Change of BSA (Body surface area)
timeFrame: Week 16
measure: Change in NRS
timeFrame: Week 16
measure: Change in RECAP
timeFrame: Week 16
measure: Percentage of patients having a variation of 4 points in their improvement in DLQI
timeFrame: Through study completion, an average of 1 year
measure: Change in POEM (Patient-Oriented Eczema Measure)
timeFrame: Week 16
measure: Rate of adverse events associated to second-line systemic treatment
timeFrame: Through study completion, an average of 1 year
measure: Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital La Paz
Study officials:
affiliation: Hospital La Paz
name: Irene García, MD
role: PRINCIPAL_INVESTIGATOR
References: