Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dermatitis Atopic
- Sponsor
- Sanofi
- Enrollment
- 266
- Locations
- 48
- Primary Endpoint
- Biomarker identification: New presentation or resolution of atopic comorbidity
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
Primary Objective:
To explore associations between biomarkers of atopic dermatitis (AD) and:
- Disease state and time course of AD,
- Disease state and evolution of selected atopic comorbid conditions,
- Effectiveness of specific AD treatments.
Detailed Description
The estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Biomarker identification: New presentation or resolution of atopic comorbidity
Time Frame: Up to 5 years
Identification of biomarkers associated with onset of a new atopic comorbidity or resolution of an existing atopic comorbidity
Biomarker identification: Demographics
Time Frame: Baseline
Identification of biomarkers associated with demographic characteristics
Biomarker evaluation: High versus low disease severity across participants
Time Frame: Up to 5 years
Examination of biomarker expression in participants with high disease severity versus those with low disease severity
Biomarker identification: Introduction of new systemic treatment
Time Frame: Up to 5 years
Identification of biomarkers associated with introduction of new systemic treatment
Biomarker identification: Response to systemic treatment
Time Frame: Up to 5 years
Identification of biomarkers associated with response to systemic treatment
Biomarker identification: Baseline disease characteristics
Time Frame: Baseline
Identification of biomarkers associated with disease characteristics at study entry (eg, disease severity, presence of other co-morbidities)
Biomarker identification: Changes in disease severity
Time Frame: Up to 5 years
Identification of biomarkers associated with disease severity increases/decreases (including remission) over time
Biomarker identification: Loss of response to systemic treatment
Time Frame: Up to 5 years
Identification of biomarkers associated with loss of response to systemic treatment
Biomarker evaluation: Start of systemic therapy early in life versus later in life
Time Frame: Up to 5 years
Examination of whether biomarker expression in participants who started systemic therapy for AD early in life (within 6 months) differs from those who started it later in life