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Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

Primary Purpose

Palmoplantar Pustular Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Secukinumab 300mg
Secukinumab 150mg
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Palmoplantar Pustular Psoriasis focused on measuring palmoplantar, pustular, psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Palmoplantar pustular psoriasis for at least 6 months before Randomization

  • Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by:

    • ppPASI score of ≥ 12 and
    • DLQI ≥ 10

  • Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by:

    • Topical treatment, and/or
    • Phototherapy, and/or
    • Previous systemic therapy

Exclusion Criteria:

  • Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)
  • Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis
  • Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
  • Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to
  • Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment
  • Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
  • Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer

Other protocol-defined inclusion/exclusion criteria may apply.

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
  • 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Secukinumab 300mg

Secukinumab 150mg

Placebo

Arm Description

Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148.

Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148.

Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148.

Outcomes

Primary Outcome Measures

Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.

Secondary Outcome Measures

ppPASI: Absolute Change From Baseline to Week 16
A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events

Full Information

First Posted
December 8, 2013
Last Updated
January 1, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02008890
Brief Title
Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab
Official Title
A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 26, 2013 (Actual)
Primary Completion Date
November 24, 2014 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmoplantar Pustular Psoriasis
Keywords
palmoplantar, pustular, psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab 300mg
Arm Type
Experimental
Arm Description
Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148.
Arm Title
Secukinumab 150mg
Arm Type
Experimental
Arm Description
Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148.
Intervention Type
Biological
Intervention Name(s)
Secukinumab 300mg
Intervention Description
Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered
Intervention Type
Biological
Intervention Name(s)
Secukinumab 150mg
Intervention Description
secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
secukinumab placebo s.c. (two PFS injections of placebo) self-administered
Primary Outcome Measure Information:
Title
Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)
Description
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
ppPASI: Absolute Change From Baseline to Week 16
Description
A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time Frame
Baseline to Week 16
Title
Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
Description
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time Frame
Baseline to Week 16
Title
Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
Description
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time Frame
Week 16 to Week 52
Title
Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Description
A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time Frame
Week 52 to Week 148
Title
Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Description
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Time Frame
Baseline to Week 16 (Period 1)
Title
Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Description
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Time Frame
Week 16 to Week 52 (Period 2)
Title
Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Description
Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Time Frame
Week 52 to Week 148 (extension period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Palmoplantar pustular psoriasis for at least 6 months before Randomization Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by: ppPASI score of ≥ 12 and DLQI ≥ 10 Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by: Topical treatment, and/or Phototherapy, and/or Previous systemic therapy Exclusion Criteria: Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis) Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab) Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer Other protocol-defined inclusion/exclusion criteria may apply.
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
Feldkirch
ZIP/Postal Code
A-6807
Country
Austria
Facility Name
Novartis Investigative Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Novartis Investigative Site
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Novartis Investigative Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Novartis Investigative Site
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Limoges cedex
State/Province
Haute Vienne
ZIP/Postal Code
87000
Country
France
Facility Name
Novartis Investigative Site
City
Bordeaux Cedex
ZIP/Postal Code
33075
Country
France
Facility Name
Novartis Investigative Site
City
Clermont Ferrand cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Novartis Investigative Site
City
Martigues
ZIP/Postal Code
13500
Country
France
Facility Name
Novartis Investigative Site
City
Nice Cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Novartis Investigative Site
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Novartis Investigative Site
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse Cedex
ZIP/Postal Code
31400
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10827
Country
Germany
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44803
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Duesseldorf
ZIP/Postal Code
D 40225
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Facility Name
Novartis Investigative Site
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Novartis Investigative Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Novartis Investigative Site
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Novartis Investigative Site
City
Hanau
ZIP/Postal Code
63450
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Novartis Investigative Site
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Novartis Investigative Site
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novartis Investigative Site
City
Plauen
ZIP/Postal Code
08529
Country
Germany
Facility Name
Novartis Investigative Site
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany
Facility Name
Novartis Investigative Site
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Facility Name
Novartis Investigative Site
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Novartis Investigative Site
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Novartis Investigative Site
City
Olsztyn
ZIP/Postal Code
10-045
Country
Poland
Facility Name
Novartis Investigative Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Rostov on Don region
ZIP/Postal Code
346880
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ryazan
ZIP/Postal Code
390046
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain
Facility Name
Novartis Investigative Site
City
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Novartis Investigative Site
City
A Coruna
ZIP/Postal Code
15001
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Novartis Investigative Site
City
Göteborg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
Novartis Investigative Site
City
Joenkoeping
ZIP/Postal Code
551 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Malmo
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Novartis Investigative Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Leytonstone
State/Province
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Salford
State/Province
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Dundee
State/Province
Perthshire
ZIP/Postal Code
DD1 9SY
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
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Newport
ZIP/Postal Code
NP20 4SZ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Portsmouth
ZIP/Postal Code
PO6 6AD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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

Learn more about this trial

Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

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