Optimization of Cyclosporin in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response

NCT05692843 | Unknown Phase 4 DMC

• 1 other identifier: 2022-500677-14-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 who require systemic treatment.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with primary non-response to treatment with cyclosporine.

  Fail to achieve EASI-75 (a 75% improvement in EASI score)

  Week 16

Secondary Outcomes (14)

• Percentage of patients achieving EASI-75

  week 6

• Percentage of patients reaching EASI-90

  through study completion, an average of 1 year

• Time to treatment failure after week 16

  Week 24, week 32, week 40, week 48.

• Mean percentage of change in EASI score

  Week 16

• Percentage of change in SCORAD

  Week 16

Study Arms (2)

Start of Cyclosporin treatment

OTHER

Patients will receive the starting dose used in routine clinical practice (maximum dose of 3 mg/kg/day is standard practice in our center). Once the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed: 1. The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life; 2. Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment.

Drug: Cyclosporin A

Receiving or received cyclosporin

OTHER

If the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. If the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records.

Other: Follow-up of Cyclospoin treatment already started

Interventions

Cyclosporin A DRUG

Once the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed: 1. The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life; 2. Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment.

Also known as: Prospective

Start of Cyclosporin treatment

Follow-up of Cyclospoin treatment already started OTHER

If the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. If the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records.

Also known as: Ambispective

Receiving or received cyclosporin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort 1:
• Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporine.
• 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.
• Cohort 2:
• Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received in the past treatment with cyclosporine.
• 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.

You may not qualify if:

• Subjects participating in a clinical trial in the last three months.
• 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 0.
• 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 (oestrogen 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital La Paz

Madrid, 28046, Spain

RECRUITING

Related Publications (1)

• Marin-Candon A, Garcia-Garcia I, Arias P, Carcas AJ, Diaz-Garcia L, Feltes Ochoa R, Hernandez Cano N, Herranz Pinto P, Jimenez Gonzalez M, Lopez-Granados E, Martinez-Feito A, Mayor-Ibarguren A, Rosas-Alonso R, Seco-Meseguer E, Borobia AM. Identifying biomarkers of treatment response to ciclosporin in atopic dermatitis through multiomic predictive modelling: DERMATOMICS study protocol. BMJ Open. 2023 Jul 10;13(7):e072350. doi: 10.1136/bmjopen-2023-072350.

  PMID: 37429687 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Cyclosporine; Longitudinal Studies

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alberto M Borobia, MD, PhD

  Hospital la Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto M Borobia, MD, PhD

CONTACT

+34-917277558; alberto.borobia@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized clinical trial. The intervention consists in additional follow-up visits out of usual clinical practice. According to RD 1090/2015 of December 4, which regulates clinical trials with drugs, it is considered a low level intervention clinical.

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: January 20, 2023
• Study Start: October 10, 2022
• Primary Completion: November 1, 2023
• Study Completion: July 1, 2024
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will be available at the same time as the results will be published, and will be kept available to everyone without any time limit.
• Access Criteria: Data will be available indefinitely on the publisher's website, as long as it is kept by the Publisher, for anyone who wishes to access the data, for non-commercial purposes

Locations

ES (1)