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Trial record 8 of 154 for:    Dermatitis, Atopic, 8

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

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ClinicalTrials.gov Identifier: NCT02424253
Recruitment Status : Completed
First Posted : April 23, 2015
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Ziarco Pharma Ltd

Brief Summary:
This will be 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 will be randomized to receive either oral 30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: ZPL-3893787 Drug: Placebo Phase 2

Detailed Description:
This will be a randomized, double blind, placebo controlled, parallel group study in approximately 90 subjects (60:30 in the active:placebo groups respectively) with a pruritus Numerical Rating Scale (NRS) score of ≥5 (0-10 scale), an Investigator's Global Assessment (IGA) > 3 (0-5 scale) and moderate-severe AD Eczema Area and Severity Index (EASI) ≥12 and ≤ 48 (0-72 scale). Each subject will have a screening visit(s) to confirm suitability to enter the study. At a subsequent visit (start of Run In), the subject will be provided with the electronic diary (eDiary) to capture pruritus, sleep disturbance and emollient use, which must be completed on Days -7 to -1 (Run In). Subjects will then attend the clinic at Baseline (Day 0) when they will be reviewed to confirm they meet inclusion/exclusion criteria and have completed the Run In diary appropriately. If appropriate, they will then be randomized to receive either oral 30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arm Intervention/treatment
Experimental: ZPL-3893787
30mg once daily
Drug: ZPL-3893787
ZPL-3893787

Placebo Comparator: Placebo
Once daily
Drug: Placebo
Matched Placebo




Primary Outcome Measures :
  1. Change from baseline in Numerical Rating Scale (NRS) for Pruritus over 24 hrs [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Eczema Area and Severity Index (EASI) score [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424253


Locations
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Belgium
Belgium Study Site
Brussels, Belgium
Belgium Study Site
Leuven, Belgium
Belgium Study Site
Liege, Belgium
Germany
German Study Site
Goch, Germany
German Study Site
Hamburg, Germany
German Study Centre
Hannover, Germany
German Study Site
Mainz, Germany
German Study Centre
Munster, Germany
Poland
Polish Study Site
Bialystock, Poland
Polish Study Site
Gdansk, Poland
Polish Study Site
Lodz, Poland
Polish Study Site
Poznan, Poland
Polish Study Site
Tarnow, Poland
United Kingdom
UK Study Centre
Blackpool, United Kingdom
UK Study Centre
Cannock, United Kingdom
UK Study Centre
Leeds, United Kingdom
UK Study Centre
Manchester, United Kingdom
Sponsors and Collaborators
Ziarco Pharma Ltd
Investigators
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Study Director: Marina Milutinovic, MD Novartis

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Responsible Party: Ziarco Pharma Ltd
ClinicalTrials.gov Identifier: NCT02424253     History of Changes
Other Study ID Numbers: ZPL389/101
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: April 2015
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases