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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06366932
• Other study ID #: DermAtOmics-II
• Status: Recruiting
• Phase: Phase 4
• Start date: September 25, 2023
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Irene García, MD
• Phone: +34-912071466
• Email: irene.ucicec[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients achieving EASI-75	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 6
Secondary	Time to treatment failure after week 16	Time to treatment failure with cyclosporine defined as Eczema Area and Severity Index (EASI) = 50 during follow-up after week 16.	Week 16
Secondary	Mean percentage of change in Eczema Area and Severity Index (EASI) score	Mean percentage of change in EASI score from baseline to week 16.	Week 16
Secondary	Percentage of change in SCORAD (SCORing Atopic Dermatitis)	Is the score of the severity of atopic dermatitis. It includes the evaluation of the affected areas. The intensity of the lesions and the subjective symptoms of the patient. Classifies AD as Mild >25, Moderate 25-50, and Severe >50	Week 16
Secondary	Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis)	Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value.; The SCORAD for that individual is A/5 + 7B/2 + C. The total area is 'A', which has a possible maximum of 100%. The intensity scores are added together to give 'B' (maximum 18). The subjective symptoms is 'C' (maximum 20).	Through study completion, an average of 1 year
Secondary	Change of IGA (Investigator Global Assessment)	Investigator Global Assessment (IGA) is a simple objective measure providing an overall evaluation. It uses a 5-point scale (clear=0; almost clear=1; mild=2; moderate=3; severe=4).	Week 16
Secondary	Time to IGA score of 0/1 (Investigator Global Assessment)	Time to IGA score of 0/1 (clear or almost clear).	Through study completion, an average of 1 year
Secondary	Change of BSA (Body surface area)	Change of BSA (Body surface area) involment	Week 16
Secondary	Change in NRS	Change in NRS (numerical rating scale). The NRS is comprised of one item and represents the numbers 0 ("no itch") to 10 ("worst imaginable itch").	Week 16
Secondary	Change in RECAP	RECAP (Recap of atopic eczema) is used to assess the control of different degrees of eczema severity through 7 items.	Week 16
Secondary	Percentage of patients having a variation of 4 points in their improvement in DLQI	Dermatology Life Quality Index is a validated and widely used 10-item questionnaire with paediatric versions (0-3 and 4-16 years). A variation of 4 points is considered a clinically meaningful endpoint.	Through study completion, an average of 1 year
Secondary	Change in POEM (Patient-Oriented Eczema Measure)	The Patient-Oriented Eczema Measure (POEM): is a validated tool in which the patient self-assesses how many days they experienced seven distinct items (itch, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, dryness of the skin) during a period of 1 week. The maximum score is 28 points.	Week 16
Secondary	Rate of adverse events associated to second-line systemic treatment	Any untoward medical occurrence in a patient or clinical trial participant, which does not necessarily have a causal relationship with the research procedures or the investigational medicinal product.	Through study completion, an average of 1 year
Secondary	Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage)	Percentage of patients reaching 90 percentage (EASI-90) improvement from baseline during follow-up. The minimum EASI (Eczema Area and Severity Index) score is 0 and the maximum EASI score is 72.	Through study completion, an average of 1 year