A Randomized, Double Blind, Multicenter Extension to CZPL389A2203 Dose-ranging Study to Assess the Short-term and Long-term Safety and Efficacy of Oral ZPL389 With Concomitant Use of TCS and/or TCI in Adult Patients With Atopic Dermatitis.
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
This study is planned to assess long term safety and efficacy of ZPL389 by continuing 2 year treatment in atopic dermatitis patients.
Jul 24, 2020
Apr 04, 2019
Dec 16, 2022
18 Years and older (Adult, Older Adult)
Dose 1 of ZPL389; once daily from week 16 to week 116.
Dose 2 of ZPL389; once daily from week 16 to week 116.
TCS and/or TCI
Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) will be used concomitantly or intermittently based on disease severity.
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.
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.