Clinical trial NCT05692843: Optimization of Cyclosporin in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response
Official title: Optimization of Cyclosporin Therapy in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response (DermAtOmics)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Cohort 1:

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

Primary outcomes:
measure: Percentage of patients with primary non-response to treatment with cyclosporine.
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of patients achieving EASI-75
timeFrame: week 6
measure: Percentage of patients reaching EASI-90
timeFrame: through study completion, an average of 1 year
measure: Time to treatment failure after week 16
timeFrame: Week 24, week 32, week 40, week 48.
measure: Mean percentage of change in EASI score
timeFrame: Week 16
measure: Percentage of change in SCORAD
timeFrame: Week 16
measure: improvement of at least 75% in SCORAD
timeFrame: through study completion, an average of 1 year
measure: Change of IGA
timeFrame: week 16
measure: Time to IGA score of 0/1
timeFrame: through study completion, an average of 1 year
measure: Change of BSA
timeFrame: week 16
measure: Change in NRS
timeFrame: week 16
measure: Change in POEM
timeFrame: week 16
measure: Change in DLQI
timeFrame: week 16
measure: Percentage of patients having a variation of 4 points in their improvement in DLQI
timeFrame: through study completion, an average of 1 year
measure: Rate of adverse events associated to CsA treatment
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital La Paz
Study officials:
affiliation: Hospital la Paz
name: Alberto M Borobia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: