Clinical trial NCT02424253: A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Determine the Effects of 8 Weeks Treatment With Oral ZPL-3893787 (30 mg od x 56 Days) on Pruritus in Adult Subjects With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Ziarco Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2015-04-23
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a randomized, double blind, placebo controlled, parallel group study in approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12 and ≤ 48 (0-72 scale). Following a run-in subjects were randomized to receive either oral 30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).


Eligibility criteria: Inclusion Criteria:

Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 12 months prior to screening. Chronic AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka (Eichenfield, 2004)

Eczema Area and Severity Index (EASI) of ≥12 and \<48.

An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0.

A mean pruritus score of ≥ 5 on a 0-10 scale over the 7 day Run In (Days -7 to -1)

Atopic dermatitis affecting ≥10% BSA

Exclusion Criteria:

AD of such severity (EASI \>48) that the subject could not comply with the demands of the study and/or the subject is not a suitable candidate for a placebo-controlled study

Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments.

Have an active skin infection or any other clinically apparent infections.

Hypersensitivity to mometasone or to any other ingredients contained by the topical corticosteroid product used as rescue medication in the study.

Have received phototherapy (e.g. UVA, UVB), or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the Run In.

Have received systemic corticosteroids (\[CS\] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of the start of the Run in. Subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal CS may participate.

Were treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting Run In; intranasal antihistamines for the treatment of allergic rhinitis are acceptable.

Primary outcomes:
measure: Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Belgium Study Site
city: Leuven
country: Belgium
facility: Belgium Study Site
city: Liege
country: Belgium
facility: Belgium Study Site
city: Goch
country: Germany
facility: German Study Site
city: Hamburg
country: Germany
facility: German Study Site
city: Hannover
country: Germany
facility: German Study Site
city: Mainz
country: Germany
facility: German Study Site
city: Munster
country: Germany
facility: German Study Site
city: Białystok
country: Poland
facility: Polish Study Site
city: Gdansk
country: Poland
facility: Polish Study Site
city: Lodz
country: Poland
facility: Polish Study Site
city: Poznan
country: Poland
facility: Polish Study Site
city: Tarnow
country: Poland
facility: Polish Study Site
city: Blackpool
country: United Kingdom
facility: UK Study Centre
city: Cannock
country: United Kingdom
facility: UK Study Centre
city: Leeds
country: United Kingdom
facility: UK Study Centre
city: Manchester
country: United Kingdom
facility: UK Study Centre
Study officials:
affiliation: Novartis Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References: