search
Back to results

Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis

Primary Purpose

Chronic Plaque Type Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AIN457 300 mg
ustekinumab 45/90 mg
placebo secukinumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plaque Type Psoriasis focused on measuring chronic plaque type psoriasis, secukinumab, ustekinumab, inflammatory skin disease, scaling

Eligibility Criteria

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

Inclusion Criteria:

  • patients with moderate to severe plaque type psoriasis for at least 6 months before randomization
  • patients eligible for systemic therapy with inadequately controlled psoriasis

Exclusion Criteria:

  • forms of sporiasis other than plaque type psoriasis
  • previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA

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
  • 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
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AIN457 300 mg

Ustekinumab

Arm Description

patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive

patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive

Outcomes

Primary Outcome Measures

Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16

Secondary Outcome Measures

Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52

Full Information

First Posted
February 27, 2014
Last Updated
June 23, 2017
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT02074982
Brief Title
Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
Official Title
A 52-week, Multicenter, Randomized, Double-blind Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Psoriasis Area and Severity Index at 16 Weeks of Treatment Compared to Ustekinumab and to Assess Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 26, 2014 (Actual)
Primary Completion Date
June 29, 2016 (Actual)
Study Completion Date
June 29, 2016 (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
No

5. Study Description

Brief Summary
This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Type Psoriasis
Keywords
chronic plaque type psoriasis, secukinumab, ustekinumab, inflammatory skin disease, scaling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
676 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIN457 300 mg
Arm Type
Experimental
Arm Description
patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
Arm Title
Ustekinumab
Arm Type
Active Comparator
Arm Description
patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
Intervention Type
Drug
Intervention Name(s)
AIN457 300 mg
Other Intervention Name(s)
secukinumab
Intervention Type
Drug
Intervention Name(s)
ustekinumab 45/90 mg
Intervention Type
Drug
Intervention Name(s)
placebo secukinumab
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
Description
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4
Description
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4
Time Frame
Week 4
Title
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52
Description
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with moderate to severe plaque type psoriasis for at least 6 months before randomization patients eligible for systemic therapy with inadequately controlled psoriasis Exclusion Criteria: forms of sporiasis other than plaque type psoriasis previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA 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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Novartis Investigative Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Novartis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Novartis Investigative Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Novartis Investigative Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Novartis Investigative Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Novartis Investigative Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Novartis Investigative Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Novartis Investigative Site
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Novartis Investigative Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Novartis Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Novartis Investigative Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Novartis Investigative Site
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Novartis Investigative Site
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
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
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novartis Investigative Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Novartis Investigative Site
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Novartis Investigative Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Novartis Investigative Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Novartis Investigative Site
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Novartis Investigative Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Novartis Investigative Site
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
A-1030
Country
Austria
Facility Name
Novartis Investigative Site
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1404
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M8X 1Y9
Country
Canada
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
Facility Name
Novartis Investigative Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Novartis Investigative Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Novartis Investigative Site
City
Arhus C
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Novartis Investigative Site
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Novartis Investigative Site
City
La Rochelle
ZIP/Postal Code
17019
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
Augsburg
ZIP/Postal Code
86179
Country
Germany
Facility Name
Novartis Investigative Site
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13187
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Novartis Investigative Site
City
Bielefeld
ZIP/Postal Code
33647
Country
Germany
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44803
Country
Germany
Facility Name
Novartis Investigative Site
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Novartis Investigative Site
City
Dessau-Rosslau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
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
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24148
Country
Germany
Facility Name
Novartis Investigative Site
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Novartis Investigative Site
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novartis Investigative Site
City
Münster
ZIP/Postal Code
48159
Country
Germany
Facility Name
Novartis Investigative Site
City
Pommelsbrunn
ZIP/Postal Code
91224
Country
Germany
Facility Name
Novartis Investigative Site
City
Heraklion, Crete
State/Province
GR
ZIP/Postal Code
71110
Country
Greece
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
H-6725
Country
Hungary
Facility Name
Novartis Investigative Site
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel Aviv
ZIP/Postal Code
6209804
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
State/Province
MO
ZIP/Postal Code
41100
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
State/Province
VR
ZIP/Postal Code
37126
Country
Italy
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Breda
State/Province
CK
ZIP/Postal Code
4818
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Nijmegen
ZIP/Postal Code
6500 MB
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Sneek
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Zwijndrecht
ZIP/Postal Code
3331 LZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Bergen
ZIP/Postal Code
NO-5021
Country
Norway
Facility Name
Novartis Investigative Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisbon
ZIP/Postal Code
1069-166
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Novartis Investigative Site
City
Banska Bystrica
State/Province
Slovak Republic
ZIP/Postal Code
97401
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice-Saca
State/Province
Slovak republic
ZIP/Postal Code
040 15
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bojnice
ZIP/Postal Code
972 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
04001
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18012
Country
Spain
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Novartis Investigative Site
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Novartis Investigative Site
City
Badalona
State/Province
Catalunya
ZIP/Postal Code
08916
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Facility Name
Novartis Investigative Site
City
Alicante
State/Province
Comunidad Valenciana
ZIP/Postal Code
03010
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
Las Palmas de Gran Canaria
State/Province
Las Palmas de G.C
ZIP/Postal Code
35010
Country
Spain
Facility Name
Novartis Investigative Site
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Novartis Investigative Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Novartis Investigative Site
City
Bilbao
State/Province
Pais Vasco
ZIP/Postal Code
48013
Country
Spain
Facility Name
Novartis Investigative Site
City
San Sebastian
State/Province
Pais Vasco
ZIP/Postal Code
20080
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
28007
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novartis Investigative Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Lin-Kou
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Balcova / Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Novartis Investigative Site
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
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
Redhill
State/Province
Surrey
ZIP/Postal Code
RH1 5RH
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Harrogate
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
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
Citations:
PubMed Identifier
36334236
Citation
Alpalhao M, Duarte J, Diogo R, Vandemeulebroecke M, Ortmann CE, Kasparek T, Filipe P. Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region. BioDrugs. 2022 Nov;36(6):781-789. doi: 10.1007/s40259-022-00558-2. Epub 2022 Nov 5.
Results Reference
derived
PubMed Identifier
35305260
Citation
Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
Results Reference
derived
PubMed Identifier
34870789
Citation
Conrad C, Ortmann CE, Vandemeulebroecke M, Kasparek T, Reich K. Nail Involvement as a Predictor of Differential Treatment Effects of Secukinumab Versus Ustekinumab in Patients with Moderate to Severe Psoriasis. Dermatol Ther (Heidelb). 2022 Jan;12(1):233-241. doi: 10.1007/s13555-021-00654-1. Epub 2021 Dec 6.
Results Reference
derived
PubMed Identifier
30972746
Citation
Augustin M, Thaci D, Eyerich K, Pinter A, Radtke M, Lauffer F, Mrowietz U, Gerdes S, Pariser D, Lebwohl M, Sieder C, Melzer N, Reich K. Continued treatment with secukinumab is associated with high retention or regain of response. Br J Dermatol. 2020 Jan;182(1):67-75. doi: 10.1111/bjd.17991. Epub 2019 Jul 17.
Results Reference
derived
PubMed Identifier
26092291
Citation
Thaci D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo K, Ziv M, Pinter A, Hugot S, You R, Milutinovic M. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015 Sep;73(3):400-9. doi: 10.1016/j.jaad.2015.05.013. Epub 2015 Jun 17.
Results Reference
derived

Learn more about this trial

Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis

We'll reach out to this number within 24 hrs