Optimization of atopic dermatitis treatment that requires second-line systemic therapy through multiomic predictive models of treatment response (DermAtOmics-II)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Universitario La Paz

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

25 Sep 2023 → ongoing

Decision date (initial)

2023-08-01

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenetic

1. To identify genetic, biochemical and immunological biomarkers that allow for the selection of the most appropriate therapeutic alternative in each patient and the development of a prediction model using these biomarkers.
2. To optimize therapy in patients with AD requiring second-line systemic treatment by developing predictive response models (PBPK/PK/PD) that incorporate genetic, immunological, biochemical, clinical, and demographic variables.

Secondary objectives 2

1. To identify genetic, immunological, biochemical and clinical markers related to second-line systemic treatment efficacy and safety in patients with atopic dermatitis.
2. To design strategies to implement the use of the identified biomarkers and developed predictive models in the national healthcare system.

Conditions and MedDRA coding

Atopic dermatitis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Cohort 1: Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive second-line systemic treatment; Cohort 2: Subjects diagnosed with moderate-severe atopic dermatitis who are already receiving 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 4

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 15

1. Percentage of patients achieving EASI-75 at week 6 of follow-up.
2. Percentage of patients reaching 90 percentage (EASI-90) improvement from baseline during follow-up.
3. Time to treatment failure with cyclosporine defined as EASI ≤ 50 during follow-up after week 16.
4. Mean percentage of change in EASI score from baseline to week 16.
5. Percentage of change in SCORAD from baseline to the primary endpoint (week 16).
6. Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value.
7. Reduction of IGA (investigator global assessment) at week 16.
8. Time to IGA score of 0/1 (clear or almost clear).
9. Change of BSA (Body surface area) involment at week 16
10. Change in NRS (numerical rating scale) at week 16
11. Change in RECAP at week 16.
12. Percentage of patients having a variation of 4 points in their improvement in DLQI (Dermatology Life Quality Index).
13. Change in POEM (Patient Oriented Eccema Measure) and DLQI (Dermatology Life Quality Index) at week 16.
14. Change in the score of the different scales in the different follow-up visits compared to baseline visit.
15. Rate of adverse events associated to treatment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitario La Paz

Sponsor organisation

Hospital Universitario La Paz

Address

Paseo Castellana 261

City

Madrid

Postcode

28046

Country

Spain

Scientific contact point

Organisation

Hospital Universitario La Paz

Contact name

Irene García García

Public contact point

Organisation

Hospital Universitario La Paz

Contact name

Irene García García

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications