Back to resultsA Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
ZPL389 3mg
ZPL389 10mg
ZPL389 30mg
ZPL389 50mg
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, AD, eczema, atopic eczema, itch, pruritus, histamine 4 receptor, antagonist, H4R, ZPL389, ZPL389A2203, dermatitis
Eligibility Criteria
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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
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- Novartis Investigative Site
- Novartis Investigative Site
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- Novartis Investigative Site
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- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
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- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
placebo
ZPL389 3mg
ZPL389 10 mg
ZPL389 30mg
ZPL389 50mg
Arm Description
Placebo
ZPL389 3 mg oral powder
ZPL389 10 mg oral powder
ZPL389 30 mg oral powder
ZPL389 50 mg oral powder
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
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
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.
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.
Full Information
NCT ID
NCT03517566
First Posted
March 27, 2018
Last Updated
October 7, 2021
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03517566
Brief Title
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
Official Title
A Randomized, Double-blind, Placebo-controlled Multicenter Dose Ranging Study to Assess the Safety and Efficacy of Multiple Oral ZPL389 Doses in Patients With Moderate to Severe Atopic Dermatitis (ZEST Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
November 14, 2018 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
August 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, AD, eczema, atopic eczema, itch, pruritus, histamine 4 receptor, antagonist, H4R, ZPL389, ZPL389A2203, dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
293 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
ZPL389 3mg
Arm Type
Experimental
Arm Description
ZPL389 3 mg oral powder
Arm Title
ZPL389 10 mg
Arm Type
Experimental
Arm Description
ZPL389 10 mg oral powder
Arm Title
ZPL389 30mg
Arm Type
Experimental
Arm Description
ZPL389 30 mg oral powder
Arm Title
ZPL389 50mg
Arm Type
Experimental
Arm Description
ZPL389 50 mg oral powder
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily from baseline until week 16
Intervention Type
Drug
Intervention Name(s)
ZPL389 3mg
Intervention Description
ZPL389 3 mg oral powder; once daily from baseline to week 16
Intervention Type
Drug
Intervention Name(s)
ZPL389 10mg
Intervention Description
ZPL389 10 mg oral powder; once daily from baseline to week 16
Intervention Type
Drug
Intervention Name(s)
ZPL389 30mg
Intervention Description
ZPL389 30 mg oral powder; once daily from baseline to week 16
Intervention Type
Drug
Intervention Name(s)
ZPL389 50mg
Intervention Description
ZPL389 50 mg oral powder; once daily from baseline to week 16
Primary Outcome Measure Information:
Title
Percentage of IGA Responders at Week 16
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in EASI Score at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
Percent Change From Baseline in EASI Score Over Time
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 6, Week 8, Week 12
Title
Percentage of EASI50 Responders Over Time
Description
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
Time Frame
Week 2, Week 4, Week 6, Week 8, Week 12, Week 16
Title
Percentage of EASI75 Responders Over Time
Description
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
Time Frame
Week 2, Week 4, Week 6, Week 8, Week 12, Week 16
Title
Percentage of IGA Responders Over Time
Description
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.
Time Frame
Week 2, Week 4, Week 6, Week 8, Week 12
Title
Number of Patients With Adverse Events
Description
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.
Time Frame
Up to week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Litchfield Park
State/Province
Arizona
ZIP/Postal Code
85340
Country
United States
Facility Name
Novartis Investigative Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Novartis Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Novartis Investigative Site
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Novartis Investigative Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Novartis Investigative Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Novartis Investigative Site
City
Wien
ZIP/Postal Code
A 1090
Country
Austria
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
Country
Canada
Facility Name
Novartis Investigative Site
City
New Market
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada
Facility Name
Novartis Investigative Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Novartis Investigative Site
City
Sainte-Hyacinthe
State/Province
Quebec
ZIP/Postal Code
J2S 66
Country
Canada
Facility Name
Novartis Investigative Site
City
Karlovy Vary
State/Province
Czech Republic
ZIP/Postal Code
36001
Country
Czechia
Facility Name
Novartis Investigative Site
City
Novy Jicin
State/Province
Czech Republic
ZIP/Postal Code
74101
Country
Czechia
Facility Name
Novartis Investigative Site
City
Prague
State/Province
Prague 1
ZIP/Postal Code
11000
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
Facility Name
Novartis Investigative Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Novartis Investigative Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Novartis Investigative Site
City
Bielefeld
ZIP/Postal Code
33647
Country
Germany
Facility Name
Novartis Investigative Site
City
Braunschweig
ZIP/Postal Code
38100
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novartis Investigative Site
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Novartis Investigative Site
City
Halle (Saale)
ZIP/Postal Code
06108
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Novartis Investigative Site
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novartis Investigative Site
City
Osnabrueck
ZIP/Postal Code
49074
Country
Germany
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Novartis Investigative Site
City
Kopavogur
ZIP/Postal Code
201
Country
Iceland
Facility Name
Novartis Investigative Site
City
Nagoya-city
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Novartis Investigative Site
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
654 0011
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
220-6208
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Facility Name
Novartis Investigative Site
City
Sakai
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinagawa ku
State/Province
Tokyo
ZIP/Postal Code
141 8625
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinjuku ku
State/Province
Tokyo
ZIP/Postal Code
162 8655
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
819 0167
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
819-0373
Country
Japan
Facility Name
Novartis Investigative Site
City
Kyoto
ZIP/Postal Code
606 8507
Country
Japan
Facility Name
Novartis Investigative Site
City
Tokyo
ZIP/Postal Code
158 0097
Country
Japan
Facility Name
Novartis Investigative Site
City
Bergen op Zoom
ZIP/Postal Code
4624 VT
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Warszawa
State/Province
Mazowian
ZIP/Postal Code
02 495
Country
Poland
Facility Name
Novartis Investigative Site
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Facility Name
Novartis Investigative Site
City
Rzeszow
ZIP/Postal Code
35 055
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
04141
Country
Poland
Facility Name
Novartis Investigative Site
City
Chelyabinsk
ZIP/Postal Code
454092
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ekaterinburg
ZIP/Postal Code
620023
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Krasnodar
ZIP/Postal Code
350020
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
191123
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint-Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
192007
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
194223
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
194325
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
197136
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St.Petersburg
ZIP/Postal Code
196240
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Stavropol
ZIP/Postal Code
355020
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Bardejov
State/Province
SVK
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Levice
ZIP/Postal Code
934 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Svidnik
ZIP/Postal Code
08901
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Taichung
State/Province
Taiwan ROC
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Dudley
State/Province
West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Portsmouth
ZIP/Postal Code
PO3 6AD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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
Links:
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=723
Description
A Plain Language Trial Summary is available on novartisclinicaltrials.com
Learn more about this trial
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
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