Study Stopped
Core terminated due to lack of efficacy
A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients
ZESTExt
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.
2 other identifiers
interventional
123
13 countries
48
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2019
Shorter than P25 for phase_2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2019
CompletedStudy Start
First participant enrolled
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2020
CompletedResults Posted
Study results publicly available
July 20, 2021
CompletedOctober 8, 2021
October 1, 2021
1.3 years
April 4, 2019
April 7, 2021
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. As all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.
16 weeks (week 16 to week 32 referring to core study)
Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. As all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis.
From week 16 to week 67 of this extension study (week 32 to week 83 referring to core study)
Secondary Outcomes (3)
Percentage of Investigator's Global Assessment (IGA) Responders Over Time
Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)
Percentage of EASI50 Responders Over Time
Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)
Percentage of EASI75 Responders Over Time
Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study)
Study Arms (2)
ZPL389 30mg
EXPERIMENTAL30mg 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
ZPL389 50mg
EXPERIMENTAL50mg 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
Interventions
Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) were used concomitantly or intermittently based on disease severity.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Novartis Investigative Site
Litchfield Park, Arizona, 85340, United States
Novartis Investigative Site
Fairborn, Ohio, 45324, United States
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Toronto, Ontario, M4V 1R2, Canada
Novartis Investigative Site
Helsinki, 00250, Finland
Novartis Investigative Site
Turku, 20520, Finland
Novartis Investigative Site
Bielefeld, 33647, Germany
Novartis Investigative Site
Gera, 07548, Germany
Novartis Investigative Site
Hamburg, 20537, Germany
Novartis Investigative Site
Hamburg, 22391, Germany
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Heidelberg, 69120, Germany
Novartis Investigative Site
Memmingen, 87700, Germany
Novartis Investigative Site
München, 80337, Germany
Novartis Investigative Site
Münster, 48149, Germany
Novartis Investigative Site
Osnabrück, 49074, Germany
Novartis Investigative Site
Kopavogur, 201, Iceland
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602, Japan
Novartis Investigative Site
Sapporo, Hokkaido, 060-0063, Japan
Novartis Investigative Site
Yokohama, Kanagawa, 220-6208, Japan
Novartis Investigative Site
Yokohama, Kanagawa, 221-0825, Japan
Novartis Investigative Site
Sakai, Osaka, 593-8324, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, 162 8655, Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-0023, Japan
Novartis Investigative Site
Fukuoka, 819 0167, Japan
Novartis Investigative Site
Fukuoka, 819-0373, Japan
Novartis Investigative Site
Kyoto, 606 8507, Japan
Novartis Investigative Site
Tokyo, 158 0097, Japan
Novartis Investigative Site
Breda, CK, 4818, Netherlands
Novartis Investigative Site
Bergen op Zoom, 4624 VT, Netherlands
Novartis Investigative Site
Warsaw, Mazowian, 02 495, Poland
Novartis Investigative Site
Rzeszów, 35 055, Poland
Novartis Investigative Site
Warsaw, 04141, Poland
Novartis Investigative Site
Chelyabinsk, 454092, Russia
Novartis Investigative Site
Kazan', 420012, Russia
Novartis Investigative Site
Moscow, 123182, Russia
Novartis Investigative Site
Saint Petersburg, 191123, Russia
Novartis Investigative Site
Saint Petersburg, 194354, Russia
Novartis Investigative Site
Saint Petersburg, 196143, Russia
Novartis Investigative Site
Smolensk, 214019, Russia
Novartis Investigative Site
Bardejov, SVK, 085 01, Slovakia
Novartis Investigative Site
Bratislava, 85101, Slovakia
Novartis Investigative Site
Levice, 934 01, Slovakia
Novartis Investigative Site
Svidník, 08901, Slovakia
Novartis Investigative Site
Taichung, Taiwan ROC, 40201, Taiwan
Novartis Investigative Site
Taipei, 10002, Taiwan
Novartis Investigative Site
London, SE1 9RT, United Kingdom
Novartis Investigative Site
Portsmouth, PO6 6AD, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2019
First Posted
May 13, 2019
Study Start
April 4, 2019
Primary Completion
July 23, 2020
Study Completion
August 25, 2020
Last Updated
October 8, 2021
Results First Posted
July 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com