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Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis (CLARITY)

Primary Purpose

Plaque Psoriasis

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

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Plaque psoriasis, secukinumab, ustekinumab, ain457, ain457a

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects must give a written, signed and dated informed consent
  • Chronic plaque-type psoriasis present for at least 6 months before randomization

  • Moderate to severe plaque psoriasis as defined at randomization by:

    • PASI score of ≥12 and
    • Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and
    • IGA mod 2011 ≥3 (based on a scale of 0-4)

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

    • Topical treatment (including topical corticosteroids) and/or
    • Phototherapy and/or
    • Previous systemic therapy

Exclusion Criteria:

  • Forms of psoriasis other than plaque psoriasis
  • Drug-induced psoriasis
  • Ongoing use of prohibited treatments
  • Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
  • Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Secukinumab

Ustekinumab

Arm Description

Secukinumab

Ustekinumab

Outcomes

Primary Outcome Measures

Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12
Number of participants who achieved ≥ 90% reduction in PASI compared to baseline. Logistic regression analysis of PASI 90 response at Week 12 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, upper limbs, trunk, lower limbs; 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 body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4).
Participants With IGA Mod 2011 0 or 1 at Week 12
Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)

Secondary Outcome Measures

Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
Number of participants who achieved ≥ 75% reduction in PASI at Week 12 compared to baseline.
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4
Number of participants who achieved ≥ 75% reduction in PASI at Week 4 compared to baseline.
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16
Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline.
Participants With IGA Mod 2011 0 or 1 at 16 Weeks
Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12
Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline.
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
Number of participants who achieved ≥ 75% reduction in PASI at Week 16 compared to baseline.
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Number of participants who achieved ≥ 90% reduction in PASI at Week 16 compared to baseline.
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52
Number of participants who achieved ≥ 90% reduction in PASI at Week 52 compared to baseline.

Full Information

First Posted
November 30, 2015
Last Updated
June 18, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02826603
Brief Title
Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
Acronym
CLARITY
Official Title
A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 22, 2016 (Actual)
Primary Completion Date
July 9, 2018 (Actual)
Study Completion Date
July 9, 2018 (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
Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Plaque psoriasis, secukinumab, ustekinumab, ain457, ain457a

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab
Arm Type
Experimental
Arm Description
Secukinumab
Arm Title
Ustekinumab
Arm Type
Active Comparator
Arm Description
Ustekinumab
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Intervention Description
300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Intervention Description
Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.
Primary Outcome Measure Information:
Title
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12
Description
Number of participants who achieved ≥ 90% reduction in PASI compared to baseline. Logistic regression analysis of PASI 90 response at Week 12 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, upper limbs, trunk, lower limbs; 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 body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4).
Time Frame
Week 12
Title
Participants With IGA Mod 2011 0 or 1 at Week 12
Description
Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
Description
Number of participants who achieved ≥ 75% reduction in PASI at Week 12 compared to baseline.
Time Frame
Week 12
Title
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4
Description
Number of participants who achieved ≥ 75% reduction in PASI at Week 4 compared to baseline.
Time Frame
Week 4
Title
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16
Description
Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline.
Time Frame
Week 16
Title
Participants With IGA Mod 2011 0 or 1 at 16 Weeks
Description
Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)
Time Frame
Week 16
Title
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12
Description
Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline.
Time Frame
Week 12
Title
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
Description
Number of participants who achieved ≥ 75% reduction in PASI at Week 16 compared to baseline.
Time Frame
Week 16
Title
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Description
Number of participants who achieved ≥ 90% reduction in PASI at Week 16 compared to baseline.
Time Frame
Week 16
Title
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52
Description
Number of participants who achieved ≥ 90% reduction in PASI at Week 52 compared to baseline.
Time Frame
Week 52

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 plaque-type psoriasis present for at least 6 months before randomization Moderate to severe plaque psoriasis as defined at randomization by: PASI score of ≥12 and Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and IGA mod 2011 ≥3 (based on a scale of 0-4) Candidate for systemic therapy, defined as having psoriasis inadequately controlled by: Topical treatment (including topical corticosteroids) and/or Phototherapy and/or Previous systemic therapy Exclusion Criteria: Forms of psoriasis other than plaque psoriasis Drug-induced psoriasis Ongoing use of prohibited treatments Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23 Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
Facility Information:
Facility Name
Novartis Investigative Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Novartis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Novartis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
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
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Novartis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
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
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Novartis Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Novartis Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
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United States
Facility Name
Novartis Investigative Site
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
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United States
Facility Name
Novartis Investigative Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
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United States
Facility Name
Novartis Investigative Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
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United States
Facility Name
Novartis Investigative Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
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United States
Facility Name
Novartis Investigative Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
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United States
Facility Name
Novartis Investigative Site
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California City
State/Province
California
ZIP/Postal Code
93405
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United States
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Novartis Investigative Site
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Encinitas
State/Province
California
ZIP/Postal Code
92024
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United States
Facility Name
Novartis Investigative Site
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Fresno
State/Province
California
ZIP/Postal Code
93710
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United States
Facility Name
Novartis Investigative Site
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Fullerton
State/Province
California
ZIP/Postal Code
92835
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United States
Facility Name
Novartis Investigative Site
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Irvine
State/Province
California
ZIP/Postal Code
92697
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United States
Facility Name
Novartis Investigative Site
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Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Novartis Investigative Site
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Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Novartis Investigative Site
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Sacramento
State/Province
California
ZIP/Postal Code
95819
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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
92117
Country
United States
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
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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
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Novartis Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
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United States
Facility Name
Novartis Investigative Site
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
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United States
Facility Name
Novartis Investigative Site
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Aventura
State/Province
Florida
ZIP/Postal Code
33180
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United States
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Novartis Investigative Site
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Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
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United States
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Cape Coral
State/Province
Florida
ZIP/Postal Code
33990
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United States
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Novartis Investigative Site
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Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
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United States
Facility Name
Novartis Investigative Site
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Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
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United States
Facility Name
Novartis Investigative Site
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
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United States
Facility Name
Novartis Investigative Site
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
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United States
Facility Name
Novartis Investigative Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
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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
33624
Country
United States
Facility Name
Novartis Investigative Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Novartis Investigative Site
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Novartis Investigative Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Novartis Investigative Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Novartis Investigative Site
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
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
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
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
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New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Novartis Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
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
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Novartis Investigative Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Novartis Investigative Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Novartis Investigative Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Novartis Investigative Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Novartis Investigative Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Novartis Investigative Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Novartis Investigative Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Novartis Investigative Site
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
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
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Novartis Investigative Site
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Novartis Investigative Site
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Novartis Investigative Site
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Novartis Investigative Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
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
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Novartis Investigative Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
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
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Novartis Investigative Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
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
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10025 1737
Country
United States
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Novartis Investigative Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
Novartis Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Novartis Investigative Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Novartis Investigative Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Novartis Investigative Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Novartis Investigative Site
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Novartis Investigative Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Novartis Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5028
Country
United States
Facility Name
Novartis Investigative Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Novartis Investigative Site
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
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
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Novartis Investigative Site
City
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
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
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
Novartis Investigative Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Novartis Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-3403
Country
United States
Facility Name
Novartis Investigative Site
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Novartis Investigative Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Novartis Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
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
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072-2301
Country
United States
Facility Name
Novartis Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Novartis Investigative Site
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Novartis Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Novartis Investigative Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Novartis Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
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
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Novartis Investigative Site
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
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
Murray
State/Province
Utah
ZIP/Postal Code
84107
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
Everett
State/Province
Washington
ZIP/Postal Code
98201
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
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Novartis Investigative Site
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Novartis Investigative Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Novartis Investigative Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
Novartis Investigative Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
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
Sainte-Hyacinthe
State/Province
Quebec
ZIP/Postal Code
J2S 66
Country
Canada
Facility Name
Novartis Investigative Site
City
Hradec Kralove
State/Province
CZE
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Novartis Investigative Site
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Novartis Investigative Site
City
Pecs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Novartis Investigative Site
City
Kopavogur
ZIP/Postal Code
201
Country
Iceland
Facility Name
Novartis Investigative Site
City
Bundang Gu
State/Province
Gyeonggi Do
ZIP/Postal Code
13620
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
Seoul
State/Province
Seocho Gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Johor Bahru
ZIP/Postal Code
80100
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Warszawa
State/Province
Mazowian
ZIP/Postal Code
02 495
Country
Poland
Facility Name
Novartis Investigative Site
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Novartis Investigative Site
City
Olsztyn
ZIP/Postal Code
10-045
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Novartis Investigative Site
City
Kosice
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
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Novartis Investigative Site
City
Ho Chi Minh
ZIP/Postal Code
7000
Country
Vietnam

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
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
32365251
Citation
Bagel J, Blauvelt A, Nia J, Hashim P, Patekar M, de Vera A, Ahmad K, Paguet B, Xia S, Muscianisi E, Lebwohl M. Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY). J Eur Acad Dermatol Venereol. 2021 Jan;35(1):135-142. doi: 10.1111/jdv.16558. Epub 2020 Jun 8.
Results Reference
derived
PubMed Identifier
30334147
Citation
Bagel J, Nia J, Hashim PW, Patekar M, de Vera A, Hugot S, Sheng K, Xia S, Gilloteau I, Muscianisi E, Blauvelt A, Lebwohl M. Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results). Dermatol Ther (Heidelb). 2018 Dec;8(4):571-579. doi: 10.1007/s13555-018-0265-y. Epub 2018 Oct 17.
Results Reference
derived

Learn more about this trial

Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

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