Investigation of Flare and Remission in Subjects With Atopic Dermatitis

Phase 4

Withdrawn

• Conditions: Atopic Dermatitis
• Interventions: Drug: Cyclosporine A

• Registration Number: NCT03710044
• Lead Sponsor: LEO Pharma

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.

Study Timeline

• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-17
• Study Start: 2019-01-14
• Status Verified: 2019-07
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyclosporine A treatment	Cyclosporine A	Oral cyclosporine A treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of subjects with TEAEs up until end of trial.	Up to Day 113 (end of trial)
Number of treatment-emergent adverse events (TEAEs) up until end of trial.	Up to Day 113 (end of trial)

Trial Locations

Locations (1)

Investigational site; 🇳🇱 Rotterdam, Netherlands