Back to resultsOptimization of Cyclosporin in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response (DermAtOmics)
Primary Purpose
Atopic Dermatitis
Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Cyclosporin A
Follow-up of Cyclospoin treatment already started
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Hospital La PazRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Start of Cyclosporin treatment
Receiving or received cyclosporin
Arm Description
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: The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life; Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment.
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.
Outcomes
Primary Outcome Measures
Percentage of patients with primary non-response to treatment with cyclosporine.
Fail to achieve EASI-75 (a 75% improvement in EASI score)
Secondary Outcome Measures
Percentage of patients achieving EASI-75
Fail to achieve EASI-75 (a 75% improvement in EASI score)
Percentage of patients reaching EASI-90
Percentage of patients reaching 90 percentage (EASI-90) improvement from baseline during follow-up
Time to treatment failure after week 16
Time to treatment failure with cyclosporine defined as EASI ≤ 50 during follow-up after week 16.
Mean percentage of change in EASI score
Mean percentage of change in EASI score from baseline to week 16
Percentage of change in SCORAD
The Scoring of Atopic Dermatitis (SCORAD) 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
improvement of at least 75% in SCORAD
Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value
Change of IGA
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).
Time to IGA score of 0/1
Time to IGA score of 0/1 (clear or almost clear)
Change of BSA
Change of BSA (Body surface area) involment
Change in NRS
NRS (Numerical Rating Scale) is a numerical scale that measures the intensity of pruritus, with 10 being the greatest intensity
Change in POEM
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.
Change 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.
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.
Rate of adverse events associated to CsA 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
Full Information
NCT ID
NCT05692843
First Posted
December 24, 2022
Last Updated
April 27, 2023
Sponsor
Instituto de Investigación Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT05692843
Brief Title
Optimization of Cyclosporin in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response
Acronym
DermAtOmics
Official Title
Optimization of Cyclosporin Therapy in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response (DermAtOmics)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Primary outcome is the percentage of patients with primary non- response to treatment with cyclosporin. 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 of 100 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporin in the Dermatology Service of La Paz University Hospital and associated Specialty Centers are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate-severe atopic dermatitis who are receiving or have received cyclosporin therapy in the Dermatology Service of La Paz University Hospital and associated Specialty Centers are selected in cohort 2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Start of Cyclosporin treatment
Arm Type
Other
Arm Description
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:
The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life;
Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment.
Arm Title
Receiving or received cyclosporin
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclosporin A
Other Intervention Name(s)
Prospective
Intervention Description
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:
The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life;
Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment.
Intervention Type
Other
Intervention Name(s)
Follow-up of Cyclospoin treatment already started
Other Intervention Name(s)
Ambispective
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients with primary non-response to treatment with cyclosporine.
Description
Fail to achieve EASI-75 (a 75% improvement in EASI score)
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of patients achieving EASI-75
Description
Fail to achieve EASI-75 (a 75% improvement in EASI score)
Time Frame
week 6
Title
Percentage of patients reaching EASI-90
Description
Percentage of patients reaching 90 percentage (EASI-90) improvement from baseline during follow-up
Time Frame
through study completion, an average of 1 year
Title
Time to treatment failure after week 16
Description
Time to treatment failure with cyclosporine defined as EASI ≤ 50 during follow-up after week 16.
Time Frame
Week 24, week 32, week 40, week 48.
Title
Mean percentage of change in EASI score
Description
Mean percentage of change in EASI score from baseline to week 16
Time Frame
Week 16
Title
Percentage of change in SCORAD
Description
The Scoring of Atopic Dermatitis (SCORAD) 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
Time Frame
Week 16
Title
improvement of at least 75% in SCORAD
Description
Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value
Time Frame
through study completion, an average of 1 year
Title
Change of IGA
Description
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).
Time Frame
week 16
Title
Time to IGA score of 0/1
Description
Time to IGA score of 0/1 (clear or almost clear)
Time Frame
through study completion, an average of 1 year
Title
Change of BSA
Description
Change of BSA (Body surface area) involment
Time Frame
week 16
Title
Change in NRS
Description
NRS (Numerical Rating Scale) is a numerical scale that measures the intensity of pruritus, with 10 being the greatest intensity
Time Frame
week 16
Title
Change in POEM
Description
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.
Time Frame
week 16
Title
Change in DLQI
Description
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.
Time Frame
week 16
Title
Percentage of patients having a variation of 4 points in their improvement in DLQI
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Rate of adverse events associated to CsA treatment
Description
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
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto M Borobia, MD, PhD
Phone
+34-917277558
Email
alberto.borobia@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto M Borobia, MD, PhD
Organizational Affiliation
Hospital la Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto M Borobia, MD, PhD
Phone
MD, PhD
Email
alberto.borobia@salud.madrid.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A copy of the database of data collected during the clinical trial will be attached as an appendix to the publication resulting from this clinical trial.
IPD Sharing 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.
IPD Sharing 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
Learn more about this trial
Optimization of Cyclosporin in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response
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