Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, cyclosporine A, atopic dermatitis pathophysiology
Brief summary
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
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.
Interventions
DRUGCyclosporine A
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.
Sponsors
LEO Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to flare* in subjects with moderate-to-severe AD who responded to a 3-week course of high-dose CsA treatment. | Day 1 to Day 113 (end of trial) | \*A flare is defined as exacerbation of the disease, where intensification of medicine is considered necessary. |
Secondary
| Measure | 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) |
Countries
Netherlands
Outcome results
None listed