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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03517566
Other study ID # CZPL389A2203
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 14, 2018
Est. completion date August 6, 2020

Study information

Verified date October 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

A screening period of up to 4 weeks was followed by a 16-week double blinded treatment period. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 293
Est. completion date August 6, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Austria Novartis Investigative Site Wien
Belgium Novartis Investigative Site Leuven
Canada Novartis Investigative Site Markham Ontario
Canada Novartis Investigative Site New Market Ontario
Canada Novartis Investigative Site Sainte-Hyacinthe Quebec
Canada Novartis Investigative Site Toronto Ontario
Canada Novartis Investigative Site Waterloo Ontario
Czechia Novartis Investigative Site Karlovy Vary Czech Republic
Czechia Novartis Investigative Site Novy Jicin Czech Republic
Czechia Novartis Investigative Site Prague Prague 1
Czechia Novartis Investigative Site Praha 10
Finland Novartis Investigative Site Helsinki
Finland Novartis Investigative Site Tampere
Finland Novartis Investigative Site Turku
Germany Novartis Investigative Site Bielefeld
Germany Novartis Investigative Site Braunschweig
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Gera
Germany Novartis Investigative Site Halle (Saale)
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Memmingen
Germany Novartis Investigative Site Muenchen
Germany Novartis Investigative Site Muenster
Germany Novartis Investigative Site Osnabrueck
Hungary Novartis Investigative Site Debrecen
Iceland Novartis Investigative Site Kopavogur
Japan Novartis Investigative Site Fukuoka
Japan Novartis Investigative Site Fukuoka
Japan Novartis Investigative Site Kobe Hyogo
Japan Novartis Investigative Site Kyoto
Japan Novartis Investigative Site Nagoya-city Aichi
Japan Novartis Investigative Site Sakai Osaka
Japan Novartis Investigative Site Sapporo Hokkaido
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 Tokyo
Japan Novartis Investigative Site Yokohama Kanagawa
Japan Novartis Investigative Site Yokohama Kanagawa
Netherlands Novartis Investigative Site Bergen op Zoom
Netherlands Novartis Investigative Site Breda
Netherlands Novartis Investigative Site Groningen
Netherlands Novartis Investigative Site Rotterdam
Poland Novartis Investigative Site Katowice
Poland Novartis Investigative Site Rzeszow
Poland Novartis Investigative Site Warszawa
Poland Novartis Investigative Site Warszawa Mazowian
Russian Federation Novartis Investigative Site Chelyabinsk
Russian Federation Novartis Investigative Site Ekaterinburg
Russian Federation Novartis Investigative Site Kazan
Russian Federation Novartis Investigative Site Krasnodar
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Petrozavodsk
Russian Federation Novartis Investigative Site Saint Petersburg
Russian Federation Novartis Investigative Site Saint-Petersburg
Russian Federation Novartis Investigative Site Smolensk
Russian Federation Novartis Investigative Site St Petersburg
Russian Federation Novartis Investigative Site St Petersburg
Russian Federation Novartis Investigative Site St Petersburg
Russian Federation Novartis Investigative Site St Petersburg
Russian Federation Novartis Investigative Site St.Petersburg
Russian Federation Novartis Investigative Site Stavropol
Russian Federation Novartis Investigative Site Yekaterinburg
Slovakia Novartis Investigative Site Bardejov SVK
Slovakia Novartis Investigative Site Bratislava
Slovakia Novartis Investigative Site Levice
Slovakia Novartis Investigative Site Svidnik
Taiwan Novartis Investigative Site Taichung Taiwan ROC
Taiwan Novartis Investigative Site Taipei
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 Plymouth Devon
United Kingdom Novartis Investigative Site Portsmouth
United States Novartis Investigative Site Cincinnati Ohio
United States Novartis Investigative Site Fairborn Ohio
United States Novartis Investigative Site Fountain Valley California
United States Novartis Investigative Site Greer South Carolina
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Litchfield Park Arizona
United States Novartis Investigative Site Louisville Kentucky
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 West Jordan Utah

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  Finland,  Germany,  Hungary,  Iceland,  Japan,  Netherlands,  Poland,  Russian Federation,  Slovakia,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of IGA Responders at Week 16 Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject.
IGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point.
Treatment discontinuations for lack of efficacy or adverse event are considered non-responders.
Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline IGA as covariates.
Week 16
Secondary Percent Change From Baseline in EASI Score at Week 16 Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. Baseline, Week 16
Secondary Percent Change From Baseline in EASI Score Over Time Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. Baseline, Week 2, Week 4, Week 6, Week 8, Week 12
Secondary Percentage of EASI50 Responders Over Time Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.
EASI50 response is defined as achieving = 50% improvement (reduction) in EASI score compared to baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point.
Treatment discontinuations for lack of efficacy or adverse event are considered non-responders.
Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates
Week 2, Week 4, Week 6, Week 8, Week 12, Week 16
Secondary Percentage of EASI75 Responders Over Time Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.
EASI75 response is defined as achieving = 75% improvement (reduction) in EASI score compared to baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point.
Treatment discontinuations for lack of efficacy or adverse event are considered non-responders.
Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates
Week 2, Week 4, Week 6, Week 8, Week 12, Week 16
Secondary Percentage of IGA Responders Over Time Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject.
IGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point.
Treatment discontinuations for lack of efficacy or adverse event are considered non-responders.
Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline IGA as covariates.
Week 2, Week 4, Week 6, Week 8, Week 12
Secondary Number of Patients With Adverse Events 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. Up to week 20
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