Randomized, double blind, multicenter extension to CZPL389A2203 dose-ranging study to assess the shortterm and long-term safety and efficacy of oral ZPL389 with concomitant or intermittent use of TCS and/or TCI in adult patients with atopic dermatitis (ZEST Extension)
- Conditions
- atopic eczemaNeurodermitis10014982
- Registration Number
- NL-OMON49671
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
* Signed informed consent must be obtained before any assessment is performed.
* Female and male subjects with atopic dermatitis who have participated in and
completed 16 weeks of study 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 concomitantly or intermittently due to
history of important side effects of topical medication (e.g. intolerance to
treatment, hypersensitivity reactions, significant skin atrophy, systemic
effects), as assessed by the investigator or subject*s treating physician.
* Subjects who met any study and/or treatment discontinuation criteria during
the
CZPL389A2203 study.
* Any active skin disease that, in the opinion of the investigator, would
confound the diagnosis
or evaluation of AD disease activity (e.g. Netherton Syndrome, Cutaneous T-Cell
Lymphoma, extensive contact dermatitis, chronic actinic dermatitis).
* Subjects taking medications prohibited by the protocol.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential (WOCBP), defined as all women
physiologically capable of becoming pregnant, unless they use required methods
of contraception during dosing and for 4 weeks after stopping of
investigational medication.
* Sexually active males unless they use a condom during intercourse while
taking drug and for 4 weeks after stopping investigational medication and
should not father a child in this period. A condom is required to be used also
by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the short-term and long-term safety of 30 mg o.d. and 50 mg o.d.<br /><br>ZPL389 with concomitant or intermittent use of TCS and/or TCI up to total of 32<br /><br>weeks and 116 weeks of treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* To evaluate the efficacy of 30 mg o.d. and 50 mg o.d. ZPL389 with concomitant<br /><br>or intermittent use of TCS and/or TCI as assessed by investigator's global<br /><br>assessment (IGA) response over time.<br /><br>* To evaluate the efficacy of 30 mg o.d. and 50 mg o.d. ZPL389 with concomitant<br /><br>or intermittent use of TCS and/or TCI as assessed by eczema area and severity<br /><br>index (EASI) over time.</p><br>