Optimization of Cyclosporin therapy in atopic dermatitis through multiomic predictive models of treatment response (DermAtOmics)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundación Para La Investigación Biomédica Del 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

28 Sep 2022 → ongoing

Decision date (initial)

2022-08-09

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: Others, Pharmacogenetic

1. To identify genetic, kinetic and immunological biomarkers that could allow the selection of responders and non- responders to first-line treatment with cyclosporine (CsA) and to develop a response prediction model using these biomarkers.
2. To optimize the dosage and treatment regimen with CsA in responding patients through the development of response predictive models (PBPK/PK/PD) that include omics, clinical and demographic variables.

Secondary objectives 4

1. To identify genetic, immunological and analytical markers related to CsA treatment safety in patients with atopic dermatitis
2. To characterize the pharmacokinetic parameters of cyclosporine in patients with atopic dermatitis by determining the abbreviated area under the curve (AUCa), in order to assess interindividual variability in the disposition of this drug in this pathology to select the most adequate plasma extraction time points to monitor therapy.
3. To evaluate the association between pharmacogenetic biomarkers and pharmacokinetic parameters of CsA in patients with atopic dermatitis.
4. To evaluate the association between immunological biomarkers and clinical variables.

Conditions and MedDRA coding

Adult, adolescent and paediatric patients with moderate-severe atopic dermatitis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. For cohort 1. Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporine.
2. For Cohort 1 and 2. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures
3. For Cohort 1 and 2. For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
4. For Cohort 1 and 2. Participant is willing and able to adhere to the procedures specified in this protocol
5. For Cohort 2. Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received in the past cyclosporine therapy.

Exclusion criteria 4

1. Subjects participating in a clinical trial in the last three months.
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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of patients with primary non-response to treatment with cyclosporine. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up.

Secondary endpoints 14

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. Percentage of patients having a variation of 4 points in their improvement in DLQI (Dermatology Life Quality Index).
12. Change in POEM (Patient Oriented Eccema Measure) and DLQI (Dermatology Life Quality Index) at week 16.
13. Change in the score of the different scales in the different follow-up visits compared to baseline visit.
14. Rate of adverse events associated to CsA treatment.

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundación Para La Investigación Biomédica Del Hospital Universitario La Paz

Sponsor organisation

Fundación Para La Investigación Biomédica Del Hospital Universitario La Paz

Address

Paseo Castellana 261

City

Madrid

Postcode

28046

Country

Spain

Scientific contact point

Organisation

Fundación Para La Investigación Biomédica Del Hospital Universitario La Paz

Contact name

Alberto Borobia Pérez

Public contact point

Organisation

Fundación Para La Investigación Biomédica Del Hospital Universitario La Paz

Contact name

Alberto Borobia Pérez

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

Application history

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