Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Multiomic Predictive Models of Treatment Response (DermAtOmics-II)
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Percentage of patients with primary non-response to second-line treatment.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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.
Exclusion Criteria
- •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
- •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.
Arms & Interventions
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:
- The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life.
- Blood samples will be obtained for biochemical, pharmacogenetic and immunological biomarker analysis
Intervention: Second-line systemic treatment (Drug)
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.
Intervention: Folllow-up of second-line systemic treatment already started (Other)
Outcomes
Primary Outcomes
Percentage of patients with primary non-response to second-line treatment.
Time Frame: Week 16
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.
Secondary Outcomes
- Percentage of change in SCORAD (SCORing Atopic Dermatitis)(Week 16)
- Change of IGA (Investigator Global Assessment)(Week 16)
- Time to IGA score of 0/1 (Investigator Global Assessment)(Through study completion, an average of 1 year)
- Change of BSA (Body surface area)(Week 16)
- Time to treatment failure after week 16(Week 16)
- Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis)(Through study completion, an average of 1 year)
- Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage)(Through study completion, an average of 1 year)
- Mean percentage of change in Eczema Area and Severity Index (EASI) score(Week 16)
- Change in RECAP(Week 16)
- Change in POEM (Patient-Oriented Eczema Measure)(Week 16)
- Rate of adverse events associated to second-line systemic treatment(Through study completion, an average of 1 year)
- Percentage of patients achieving EASI-75(Week 6)
- Change in NRS(Week 16)
- Percentage of patients having a variation of 4 points in their improvement in DLQI(Through study completion, an average of 1 year)