Investigation of Flare and Remission in Subjects With Atopic Dermatitis

Study Overview
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Brief Summary
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The trial is an exploratory, single-centre, uncontrolled, open-label, interventional trial of up to 19 weeks' duration to investigate flare and remission in subjects with moderate-to-severe atopic dermatitis (AD) treated with cyclosporine A (CsA).

Detailed Description
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40 subjects with moderate-to-severe AD will be treated with a 3-week course of high-dose CsA, which is a standard-of-care treatment regimen. After 3 weeks, all responders shift to oral low-dose CsA treatment (2-2.5 mg/kg/day) until onset of a second flare or until Week 16 (Day 113). In case of a second AD flare, the subjects shift back to oral high-dose CsA treatment (4-5 mg/kg/day) for 3 weeks.

Official Title
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Investigation of Flare and Remission in Atopic Dermatitis in an Integrated Longitudinal Trial: Effects of Systemic Treatment With Cyclosporine A

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Cyclosporine A


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Diagnosis and history of chronic, moderate-to-severe AD (by the Eichenfield revised criteria of Hanifin and Rajka) for at least 3 years before the screening visit. Subjects who have an AD flare at the start of the trial (EASI score ≥10 at screening and ≥16 at the baseline visit). Main Exclusion Criteria: Treatment with allergen immunotherapy within 6 months before the baseline visit. Treatment with leukotriene inhibitors, systemic glucocorticoids, or other systemic treatment for AD (including immunosuppressive treatment, ultraviolet therapy, and biologics) within 4 weeks before the baseline visit. Treatment with topical corticosteroids or topical calcineurin inhibitors within 1 week before the baseline visit. Chronic or acute infection requiring treatment with oral or intravenous antibiotics, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit. History of malignancy within 5 years before the baseline visit, with the following exceptions: subjects with a history of completely treated carcinoma in situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin are allowed. Hypertension (>150/95 mmHg) at the screening visit. Planned surgical procedure during the length of the subject's participation in this trial. Use of a tanning booth/parlour within 4 weeks before the screening visit. Pregnant, breastfeeding, or lactating women. Laboratory abnormalities at the screening visit.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclosporine A treatment<br>Oral cyclosporine A treatment | Drug: Cyclosporine A<br>* Initial treatment: Oral cyclosporine A (CsA) treatment (4-5 mg/kg/day) for 3 weeks. Responders shift to oral low-dose CsA treatment (2-2.5 mg/kg/day) until onset of a second flare or until Week 16 (Day 113). In case of a second AD flare, the subjects shift back to oral high-dose CsA treatment (4-5 mg/kg/day) for 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to flare* in subjects with moderate-to-severe AD who responded to a 3-week course of high-dose CsA treatment. | *A flare is defined as exacerbation of the disease, where intensification of medicine is considered necessary. | Day 1 to Day 113 (end of trial) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment-emergent adverse events (TEAEs) up until end of trial. |  | Up to Day 113 (end of trial) | 
| Number of subjects with TEAEs up until end of trial. |  | Up to Day 113 (end of trial) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, cyclosporine A, atopic dermatitis pathophysiology