A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis
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
1 other identifier
interventional
98
4 countries
17
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2015
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2015
CompletedFirst Posted
Study publicly available on registry
April 23, 2015
CompletedStudy Start
First participant enrolled
May 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2016
CompletedResults Posted
Study results publicly available
May 13, 2021
CompletedJune 10, 2021
May 1, 2021
8 months
April 17, 2015
April 20, 2021
May 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change From Baseline in Eczema Area and Severity Index (EASI) Score
Baseline to Week 8
Study Arms (2)
ZPL-3893787
EXPERIMENTAL30 mg ZPL-3893787 orally once daily for 8 weeks.
Placebo
PLACEBO COMPARATOR1 capsule orally once daily for 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Study Director
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2015
First Posted
April 23, 2015
Study Start
May 18, 2015
Primary Completion
January 1, 2016
Study Completion
February 3, 2016
Last Updated
June 10, 2021
Results First Posted
May 13, 2021
Record last verified: 2021-05