A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03517566
Last Updated: 2021-10-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
293 participants
INTERVENTIONAL
2018-11-14
2020-08-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients
NCT03948334
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis
NCT02424253
Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis
NCT06947993
Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)
NCT01228513
A Study to Determine the Safety & Efficacy of ZPL-5212372 in Healthy Subjects and in Subjects With Atopic Dermatitis
NCT02795832
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After the end of treatment visit, subjects were offered the possibility of ongoing treatment in the extension study (CZPL389A2203E1/ NCT03948334), or of entering the 4 week treatment-free follow-up period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
placebo
Placebo
Placebo
once daily from baseline until week 16
ZPL389 3mg
ZPL389 3 mg oral powder
ZPL389 3mg
ZPL389 3 mg oral powder; once daily from baseline to week 16
ZPL389 10 mg
ZPL389 10 mg oral powder
ZPL389 10mg
ZPL389 10 mg oral powder; once daily from baseline to week 16
ZPL389 30mg
ZPL389 30 mg oral powder
ZPL389 30mg
ZPL389 30 mg oral powder; once daily from baseline to week 16
ZPL389 50mg
ZPL389 50 mg oral powder
ZPL389 50mg
ZPL389 50 mg oral powder; once daily from baseline to week 16
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
once daily from baseline until week 16
ZPL389 3mg
ZPL389 3 mg oral powder; once daily from baseline to week 16
ZPL389 10mg
ZPL389 10 mg oral powder; once daily from baseline to week 16
ZPL389 30mg
ZPL389 30 mg oral powder; once daily from baseline to week 16
ZPL389 50mg
ZPL389 50 mg oral powder; once daily from baseline to week 16
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronic atopic dermatitis present for at least 1 year before Baseline
* Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.
* Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
* Candidate for systemic treatment
Exclusion Criteria
* Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
* History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.
* Participation in prior ZPL389 studies
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Litchfield Park, Arizona, United States
Novartis Investigative Site
Fountain Valley, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Fairborn, Ohio, United States
Novartis Investigative Site
Greer, South Carolina, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
West Jordan, Utah, United States
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Markham, Ontario, Canada
Novartis Investigative Site
Newmarket, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Waterloo, Ontario, Canada
Novartis Investigative Site
Sainte-Hyacinthe, Quebec, Canada
Novartis Investigative Site
Karlovy Vary, Czech Republic, Czechia
Novartis Investigative Site
Nový Jičín, Czech Republic, Czechia
Novartis Investigative Site
Prague, Prague 1, Czechia
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Helsinki, , Finland
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Tampere, , Finland
Novartis Investigative Site
Turku, , Finland
Novartis Investigative Site
Bielefeld, , Germany
Novartis Investigative Site
Braunschweig, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Gera, , Germany
Novartis Investigative Site
Halle, , 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
Münster, , Germany
Novartis Investigative Site
Osnabrück, , Germany
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Kopavogur, , Iceland
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Sakai, Osaka, Japan
Novartis Investigative Site
Shinagawa Ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Fukuoka, , Japan
Novartis Investigative Site
Fukuoka, , Japan
Novartis Investigative Site
Kyoto, , Japan
Novartis Investigative Site
Tokyo, , Japan
Novartis Investigative Site
Bergen op Zoom, , Netherlands
Novartis Investigative Site
Breda, , Netherlands
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Warsaw, Mazowian, Poland
Novartis Investigative Site
Katowice, , Poland
Novartis Investigative Site
Rzeszów, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Chelyabinsk, , Russia
Novartis Investigative Site
Kazan', , Russia
Novartis Investigative Site
Krasnodar, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Petrozavodsk, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Smolensk, , Russia
Novartis Investigative Site
Stavropol, , Russia
Novartis Investigative Site
Yekaterinburg, , Russia
Novartis Investigative Site
Yekaterinburg, , Russia
Novartis Investigative Site
Bardejov, SVK, Slovakia
Novartis Investigative Site
Bratislava, , Slovakia
Novartis Investigative Site
Levice, , Slovakia
Novartis Investigative Site
Svidník, , Slovakia
Novartis Investigative Site
Taichung, Taiwan ROC, Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Plymouth, Devon, United Kingdom
Novartis Investigative Site
Dudley, West Midlands, United Kingdom
Novartis Investigative Site
Liverpool, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Portsmouth, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
A Plain Language Trial Summary is available on novartisclinicaltrials.com
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CZPL389A2203
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.