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

Clinical Trial ID: NCT03948334


This study is planned to assess long term safety and efficacy of ZPL389 by continuing 2 year treatment in atopic dermatitis patients.

The patients who complete 16 weeks of treatment in ZPL389 core study will be eligible to participate and patients will be advised to apply TCS and / or TCI concomitantly or intermittently along with once daily oral administration of ZPL389.


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.

  • Start Date


  • Last Updated


  • Sponsor

    Novartis Pharmaceuticals

  • Condition Name

    Atopic Dermatitis

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