A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis
NCT ID: NCT02424253
Last Updated: 2021-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
98 participants
INTERVENTIONAL
2015-05-18
2016-02-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ZPL-3893787
30 mg ZPL-3893787 orally once daily for 8 weeks.
ZPL-3893787
ZPL-3893787
Placebo
1 capsule orally once daily for 8 weeks.
Placebo
Matched Placebo
Interventions
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ZPL-3893787
ZPL-3893787
Placebo
Matched Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Ziarco Pharma Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Belgium Study Site
Brussels, , Belgium
Belgium Study Site
Leuven, , Belgium
Belgium Study Site
Liège, , Belgium
German Study Site
Goch, , Germany
German Study Site
Hamburg, , Germany
German Study Site
Hanover, , Germany
German Study Site
Mainz, , Germany
German Study Site
Münster, , Germany
Polish Study Site
Bialystok, , Poland
Polish Study Site
Gdansk, , Poland
Polish Study Site
Lodz, , Poland
Polish Study Site
Poznan, , Poland
Polish Study Site
Tarnów, , Poland
UK Study Centre
Blackpool, , United Kingdom
UK Study Centre
Cannock, , United Kingdom
UK Study Centre
Leeds, , United Kingdom
UK Study Centre
Manchester, , United Kingdom
Countries
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Other Identifiers
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ZPL389/101
Identifier Type: -
Identifier Source: org_study_id
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