Investigation of Flare and Remission in Subjects With Atopic Dermatitis

• Status: Withdrawn
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma
• Treatments: Cyclosporine; Cyclosporins

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.