A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424253
• Other study ID #: ZPL389/101
• Status: Completed
• Phase: Phase 2
• Start date: May 18, 2015
• Est. completion date: February 3, 2016

Study information

• Verified date: May 2021
• Source: Ziarco Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 3, 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• ZPL-3893787
ZPL-3893787
• Placebo
Matched Placebo

Locations

Country	Name	City	State
Belgium	Belgium Study Site	Brussels
Belgium	Belgium Study Site	Leuven
Belgium	Belgium Study Site	Liege
Germany	German Study Site	Goch
Germany	German Study Site	Hamburg
Germany	German Study Site	Hannover
Germany	German Study Site	Mainz
Germany	German Study Site	Munster
Poland	Polish Study Site	Bialystok
Poland	Polish Study Site	Gdansk
Poland	Polish Study Site	Lodz
Poland	Polish Study Site	Poznan
Poland	Polish Study Site	Tarnow
United Kingdom	UK Study Centre	Blackpool
United Kingdom	UK Study Centre	Cannock
United Kingdom	UK Study Centre	Leeds
United Kingdom	UK Study Centre	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Ziarco Pharma Ltd

Countries where clinical trial is conducted

Belgium,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)	The participant used the Pruritus NRS to rate his or her worst itch in the previous 12 hours. This was assessed twice daily (in the morning soon after rising and the evening prior to retiring) and recorded in the eDiary. The scale ranges from 0 (no itching) to 10 (itching as bad as can be imagined).; If only 1 measurement was collected on a particular day, that score was counted as the worst measurement.	Baseline to Week 8
Secondary	Change From Baseline in Eczema Area and Severity Index (EASI) Score	The EASI is a validated tool used to measure the severity and extent of atopic eczema over 4 body regions (head and neck, upper limbs, trunk, and lower limbs). The intensity of a representative area of eczema and the approximate percentage affected by eczema are calculated for each region. A representative area of eczema is selected for each body region. The intensity of redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) of eczema is assessed as: 0 - None; - Mild; - Moderate; - Severe The total score incorporates the extent of body regions affected. Scores range from 0 to 72 with higher scores indicating more severe eczema.; Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions	Baseline to Week 8