A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Atopic Dermatitis
In brief
This was a randomized, double-blind, placebo-controlled, parallel-group study to assess safety and efficacy of ZPL389 in subjects with moderate to severe atopic dermatitis with a total study duration up to 24 weeks
Key facts
- Study ID
- NCT03517566
- Run by
- Novartis Pharmaceuticals
- People needed
- 293
- Starts
- 2018-11-14
- Expected to finish
- 2020-08-06
- Last updated by the study team
- 2021-10-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must give a written, signed and dated informed consent
- 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
You may not qualify if…
- Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity
- 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
Where it is running
- 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 — Tampere, Finland
- Novartis Investigative Site — Litchfield Park, Arizona, United States
Full record on ClinicalTrials.gov
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