Optimizing treatment for moderate-severe atopic dermatitis

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

This study is testing a new approach to help people with moderate to severe atopic dermatitis who haven't had success with previous treatments to see if it can improve their skin condition.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sex: All
• Sponsor: Instituto de Investigación Hospital Universitario La Paz (Academic / other)
• Locations: 1 site (Madrid)
• Trial ID: NCT06366932 on ClinicalTrials.gov

What this trial studies

This phase IV trial aims to enhance the treatment of patients with moderate to severe atopic dermatitis who require systemic therapy after previous treatments have failed or are not suitable. The study will recruit approximately 150 patients from the Dermatology Department of La Paz University Hospital, divided into two cohorts: one for patients starting second-line treatment and another for those already receiving it. The primary outcome will measure the percentage of patients who do not respond to the second-line treatment, defined as failing to achieve a 75% improvement in their EASI score after 16 weeks.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with moderate to severe atopic dermatitis who are either about to start or are currently receiving second-line systemic therapy.

Not a fit: Patients with mild atopic dermatitis or those who have not yet tried first-line treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment strategies for patients with difficult-to-manage atopic dermatitis.

How similar studies have performed: Other studies have shown promise in optimizing treatment for atopic dermatitis, but this specific approach is novel.

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.

Where this trial is running

Madrid

• Hospital La Paz — Madrid, Spain (Recruiting)

Study contacts

• Principal investigator: Irene García, MD — Hospital La Paz
• Study coordinator: Irene García, MD

Conditions Atopic Dermatitis