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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
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.
Investigational site
Rotterdam, Netherlands
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.
Time frame: Day 1 to Day 113 (end of trial)
Number of treatment-emergent adverse events (TEAEs) up until end of trial.
Time frame: Up to Day 113 (end of trial)
Number of subjects with TEAEs up until end of trial.
Time frame: Up to Day 113 (end of trial)
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