Investigation of Flare and Remission in Subjects With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03710044
• Other study ID #: EXP-1392
• Secondary ID: 2018-000229-30
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 2019
• Est. completion date: August 2020

Study information

• Verified date: July 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Cyclosporine 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.

Locations

Country	Name	City	State
Netherlands	Investigational site	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of treatment-emergent adverse events (TEAEs) up until end of trial.		Up to Day 113 (end of trial)
Secondary	Number of subjects with TEAEs up until end of trial.		Up to Day 113 (end of trial)