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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02424253
Recruitment Status : Completed
First Posted : April 23, 2015
Results First Posted : May 13, 2021
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Ziarco Pharma Ltd

Study Description
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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).

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

Study Design
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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
Actual Study Start Date : May 18, 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 3, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arms and Interventions
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Arm Intervention/treatment
Experimental: ZPL-3893787
30 mg ZPL-3893787 orally once daily for 8 weeks.
 Drug: ZPL-3893787
ZPL-3893787
Placebo Comparator: Placebo
1 capsule orally once daily for 8 weeks.
 Drug: Placebo
Matched Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) [ Time Frame: Baseline to Week 8 ]

    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.



Secondary Outcome Measures :
  1. Change From Baseline in Eczema Area and Severity Index (EASI) Score [ Time Frame: Baseline to Week 8 ]

    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

    1. - Mild
    2. - Moderate
    3. - 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



Eligibility Criteria
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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.

Contacts and Locations
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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 Site
Hannover, Germany
German Study Site
Mainz, Germany
German Study Site
Munster, Germany
Poland
Polish Study Site
Białystok, 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: Study Director Novartis Pharmaceuticals
More Information
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Responsible Party: Ziarco Pharma Ltd
ClinicalTrials.gov Identifier: NCT02424253    
Other Study ID Numbers: ZPL389/101
First Posted: April 23, 2015    Key Record Dates
Results First Posted: May 13, 2021
Last Update Posted: June 10, 2021
Last Verified: May 2021
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