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A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients

NCT ID: NCT03948334

Last Updated: 2021-10-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2020-08-25

Brief Summary

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This extension study (CZPL389A2203E1) was designed as a 2-year (100 weeks) extension to the core study (CZPL389A2203/ NCT03517566) which is disclosed separately. It aimed to assess the short-term and long-term safety of (blinded) 30 mg o.d and 50 mg o.d ZPL389 with concomitant or intermittent use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI).

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Detailed Description

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Subjects who had received ZPL389 30 mg or 50 mg doses in the core study (CZPL389A2203), continued to receive the same doses in double-blinded fashion. Subjects who had received ZPL389 3 mg, 10 mg or placebo in the core study were randomized to 30 mg or 50 mg ZPL389 in a 1:1 ratio. All subjects received concomitant or intermittent TCS and/or TCI along with ZPL389. Short-term safety was assessed up to week 16 of this extension study (week 16 to week 32 referring to the start of core study treatment) and long-term safety was assessed after week 16 of this extension study (after week 32 referring to the start of core study treatment). The entire planned time frame (100 weeks) was not assessed as originally planned due to early termination of the core and extension studies.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ZPL389 30mg

30mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ZPL389 3mg/ 10mg in the core study) and for patients continuing in the same arm from the core study

Group Type EXPERIMENTAL

ZPL389 30mg

Intervention Type DRUG

30mg of ZPL389; once daily

TCS and/or TCI

Intervention Type DRUG

Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) were used concomitantly or intermittently based on disease severity.

ZPL389 50mg

50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ZPL389 3mg/ 10mg in the core study) and for patients continuing in the same arm from the core study

Group Type EXPERIMENTAL

ZPL389 50mg

Intervention Type DRUG

50mg of ZPL389; once daily

TCS and/or TCI

Intervention Type DRUG

Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) were used concomitantly or intermittently based on disease severity.

Interventions

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ZPL389 30mg

30mg of ZPL389; once daily

Intervention Type DRUG

ZPL389 50mg

50mg of ZPL389; once daily

Intervention Type DRUG

TCS and/or TCI

Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) were used concomitantly or intermittently based on disease severity.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must give a written, signed and dated informed consent
* Subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study.
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures.

Exclusion Criteria

* Inability to use TCS and/or TCI due to history of important side effects of topical medication (e.g., intolerance or hypersensitivity reactions).
* Treatment discontinued subject from CZPL389A2203 study.
* Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Litchfield Park, Arizona, United States

Site Status

Novartis Investigative Site

Fairborn, Ohio, United States

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Helsinki, , Finland

Site Status

Novartis Investigative Site

Turku, , Finland

Site Status

Novartis Investigative Site

Bielefeld, , Germany

Site Status

Novartis Investigative Site

Gera, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

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Novartis Investigative Site

Memmingen, , Germany

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Novartis Investigative Site

München, , Germany

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Novartis Investigative Site

Münster, , Germany

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Novartis Investigative Site

Osnabrück, , Germany

Site Status

Novartis Investigative Site

Kopavogur, , Iceland

Site Status

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Sakai, Osaka, Japan

Site Status

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Fukuoka, , Japan

Site Status

Novartis Investigative Site

Fukuoka, , Japan

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Novartis Investigative Site

Kyoto, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative Site

Breda, CK, Netherlands

Site Status

Novartis Investigative Site

Bergen op Zoom, , Netherlands

Site Status

Novartis Investigative Site

Warsaw, Mazowian, Poland

Site Status

Novartis Investigative Site

Rzeszów, , Poland

Site Status

Novartis Investigative Site

Warsaw, , Poland

Site Status

Novartis Investigative Site

Chelyabinsk, , Russia

Site Status

Novartis Investigative Site

Kazan', , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Smolensk, , Russia

Site Status

Novartis Investigative Site

Bardejov, SVK, Slovakia

Site Status

Novartis Investigative Site

Bratislava, , Slovakia

Site Status

Novartis Investigative Site

Levice, , Slovakia

Site Status

Novartis Investigative Site

Svidník, , Slovakia

Site Status

Novartis Investigative Site

Taichung, Taiwan ROC, Taiwan

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

Portsmouth, , United Kingdom

Site Status

Countries

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United States Belgium Canada Finland Germany Iceland Japan Netherlands Poland Russia Slovakia Taiwan United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=725

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

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2018-000595-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CZPL389A2203E1

Identifier Type: -

Identifier Source: org_study_id

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