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

Stopped early · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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).

Key facts

Study ID

NCT03948334

Run by

Novartis Pharmaceuticals

People needed

123

Starts

2019-04-04

Expected to finish

2020-08-25

Last updated by the study team

2021-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Litchfield Park, Arizona, United States
• Novartis Investigative Site — Fairborn, Ohio, United States
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Helsinki, Finland
• Novartis Investigative Site — Turku, Finland
• Novartis Investigative Site — Bielefeld, Germany
• Novartis Investigative Site — Gera, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Memmingen, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Münster, Germany
• Novartis Investigative Site — Osnabrück, Germany
• Novartis Investigative Site — Kopavogur, Iceland
• Novartis Investigative Site — Nagoya, Aichi-ken, Japan
• Novartis Investigative Site — Sapporo, Hokkaido, Japan
• Novartis Investigative Site — Yokohama, Kanagawa, Japan
• Novartis Investigative Site — Yokohama, Kanagawa, Japan
• Novartis Investigative Site — Sakai, Osaka, Japan
• Novartis Investigative Site — Shinjuku Ku, Tokyo, Japan
• Novartis Investigative Site — Shinjuku-ku, Tokyo, Japan
• Novartis Investigative Site — Fukuoka, Japan

Full record on ClinicalTrials.gov

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