Clinical trial NCT03710044: Investigation of Flare and Remission in Subjects With Atopic Dermatitis
Official title: Investigation of Flare and Remission in Atopic Dermatitis in an Integrated Longitudinal Trial: Effects of Systemic Treatment With Cyclosporine A
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
cyclosporine A
atopic dermatitis pathophysiology
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Time to flare* in subjects with moderate-to-severe AD who responded to a 3-week course of high-dose CsA treatment.
timeFrame: Day 1 to Day 113 (end of trial)
Secondary outcomes:
measure: Number of treatment-emergent adverse events (TEAEs) up until end of trial.
timeFrame: Up to Day 113 (end of trial)
measure: Number of subjects with TEAEs up until end of trial.
timeFrame: Up to Day 113 (end of trial)
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Investigational site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: