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

June 18, 2019 updated by: Novartis Pharmaceuticals

A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis

Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 5E8
        • Novartis Investigative Site
    • Ontario
      • Etobicoke, Ontario, Canada, M8X 1Y9
        • Novartis Investigative Site
      • Hamilton, Ontario, Canada, L8N 1V6
        • Novartis Investigative Site
    • Quebec
      • Sainte-Hyacinthe, Quebec, Canada, J2S 66
        • Novartis Investigative Site
  • Czechia
      • Praha 10, Czechia, 100 34
        • Novartis Investigative Site
    • CZE
      • Hradec Kralove, CZE, Czechia, 500 05
        • Novartis Investigative Site
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01010
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01015
        • Novartis Investigative Site
  • Hungary
      • Debrecen, Hungary, 4032
        • Novartis Investigative Site
      • Pecs, Hungary, 7632
        • Novartis Investigative Site
      • Szeged, Hungary, 6725
        • Novartis Investigative Site
  • Iceland
      • Kopavogur, Iceland, 201
        • Novartis Investigative Site
  • Korea, Republic of
      • Gwangju, Korea, Republic of, 61469
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 03080
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 03722
        • Novartis Investigative Site
    • Gyeonggi Do
      • Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 06351
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul, Seocho Gu, Korea, Republic of, 06591
        • Novartis Investigative Site
  • Malaysia
      • Johor Bahru, Malaysia, 80100
        • Novartis Investigative Site
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
        • Novartis Investigative Site
  • Poland
      • Gdansk, Poland, 80-803
        • Novartis Investigative Site
      • Lodz, Poland, 90-265
        • Novartis Investigative Site
      • Lodz, Poland, 90-436
        • Novartis Investigative Site
      • Olsztyn, Poland, 10-045
        • Novartis Investigative Site
      • Warszawa, Poland, 02-097
        • Novartis Investigative Site
      • Warszawa, Poland, 02-507
        • Novartis Investigative Site
    • Mazowian
      • Warszawa, Mazowian, Poland, 02 495
        • Novartis Investigative Site
  • Slovakia
      • Bojnice, Slovakia, 972 01
        • Novartis Investigative Site
    • Slovak Republic
      • Kosice, Slovak Republic, Slovakia, 040 15
        • Novartis Investigative Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Novartis Investigative Site
      • Birmingham, Alabama, United States, 35233
        • Novartis Investigative Site
      • Birmingham, Alabama, United States, 35205
        • Novartis Investigative Site
      • Mobile, Alabama, United States, 36608
        • Novartis Investigative Site
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Novartis Investigative Site
      • Phoenix, Arizona, United States, 85032
        • Novartis Investigative Site
      • Phoenix, Arizona, United States, 85018
        • Novartis Investigative Site
      • Scottsdale, Arizona, United States, 85259
        • Novartis Investigative Site
      • Scottsdale, Arizona, United States, 85260
        • Novartis Investigative Site
      • Tucson, Arizona, United States, 85724
        • Novartis Investigative Site
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Novartis Investigative Site
      • Hot Springs, Arkansas, United States, 71913
        • Novartis Investigative Site
      • Rogers, Arkansas, United States, 72758
        • Novartis Investigative Site
    • California
      • Bakersfield, California, United States, 93309
        • Novartis Investigative Site
      • Beverly Hills, California, United States, 90211
        • Novartis Investigative Site
      • California City, California, United States, 93405
        • Novartis Investigative Site
      • Encinitas, California, United States, 92024
        • Novartis Investigative Site
      • Fresno, California, United States, 93710
        • Novartis Investigative Site
      • Fullerton, California, United States, 92835
        • Novartis Investigative Site
      • Irvine, California, United States, 92697
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90033
        • Novartis Investigative Site
      • Oceanside, California, United States, 92056
        • Novartis Investigative Site
      • Sacramento, California, United States, 95819
        • Novartis Investigative Site
      • San Diego, California, United States, 92123
        • Novartis Investigative Site
      • San Diego, California, United States, 92117
        • Novartis Investigative Site
      • San Diego, California, United States, 92103
        • Novartis Investigative Site
      • Santa Monica, California, United States, 90404
        • Novartis Investigative Site
      • Santa Rosa, California, United States, 95405
        • Novartis Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Novartis Investigative Site
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • Novartis Investigative Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Novartis Investigative Site
      • Boca Raton, Florida, United States, 33486
        • Novartis Investigative Site
      • Cape Coral, Florida, United States, 33990
        • Novartis Investigative Site
      • Coral Gables, Florida, United States, 33134
        • Novartis Investigative Site
      • Fort Myers, Florida, United States, 33916
        • Novartis Investigative Site
      • Jacksonville, Florida, United States, 32216
        • Novartis Investigative Site
      • Orange Park, Florida, United States, 32073
        • Novartis Investigative Site
      • South Miami, Florida, United States, 33143
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33609
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33624
        • Novartis Investigative Site
      • West Palm Beach, Florida, United States, 33409
        • Novartis Investigative Site
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Novartis Investigative Site
      • Atlanta, Georgia, United States, 30342
        • Novartis Investigative Site
      • Macon, Georgia, United States, 31217
        • Novartis Investigative Site
      • Marietta, Georgia, United States, 30060
        • Novartis Investigative Site
      • Newnan, Georgia, United States, 30263
        • Novartis Investigative Site
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Novartis Investigative Site
      • Springfield, Illinois, United States, 62703
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Novartis Investigative Site
      • New Albany, Indiana, United States, 47150
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Novartis Investigative Site
      • Owensboro, Kentucky, United States, 42301
        • Novartis Investigative Site
      • Owensboro, Kentucky, United States, 42303
        • Novartis Investigative Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Novartis Investigative Site
      • Lake Charles, Louisiana, United States, 70601
        • Novartis Investigative Site
      • Lake Charles, Louisiana, United States, 70605
        • Novartis Investigative Site
      • Metairie, Louisiana, United States, 70006
        • Novartis Investigative Site
      • New Orleans, Louisiana, United States, 70112
        • Novartis Investigative Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Novartis Investigative Site
      • Rockville, Maryland, United States, 20852
        • Novartis Investigative Site
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Novartis Investigative Site
      • Boston, Massachusetts, United States, 02111
        • Novartis Investigative Site
      • Boston, Massachusetts, United States, 02114
        • Novartis Investigative Site
      • Brighton, Massachusetts, United States, 02135
        • Novartis Investigative Site
      • Quincy, Massachusetts, United States, 02169
        • Novartis Investigative Site
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Novartis Investigative Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • Novartis Investigative Site
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Novartis Investigative Site
      • Saint Louis, Missouri, United States, 63141
        • Novartis Investigative Site
      • Saint Louis, Missouri, United States, 63117
        • Novartis Investigative Site
      • Saint Louis, Missouri, United States, 63104
        • Novartis Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Novartis Investigative Site
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Novartis Investigative Site
      • Verona, New Jersey, United States, 07044
        • Novartis Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Novartis Investigative Site
    • New York
      • Forest Hills, New York, United States, 11375
        • Novartis Investigative Site
      • New York, New York, United States, 10016
        • Novartis Investigative Site
      • New York, New York, United States, 10025 1737
        • Novartis Investigative Site
      • New York, New York, United States, 10075
        • Novartis Investigative Site
      • Rochester, New York, United States, 14623
        • Novartis Investigative Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Novartis Investigative Site
      • Charlotte, North Carolina, United States, 28209
        • Novartis Investigative Site
      • Durham, North Carolina, United States, 27710
        • Novartis Investigative Site
      • Greensboro, North Carolina, United States, 27401
        • Novartis Investigative Site
      • High Point, North Carolina, United States, 27262
        • Novartis Investigative Site
      • Rocky Mount, North Carolina, United States, 27804
        • Novartis Investigative Site
      • Winston-Salem, North Carolina, United States, 27157
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Novartis Investigative Site
      • Cleveland, Ohio, United States, 44106-5028
        • Novartis Investigative Site
      • Columbus, Ohio, United States, 43210
        • Novartis Investigative Site
      • Dublin, Ohio, United States, 43016
        • Novartis Investigative Site
      • Fairborn, Ohio, United States, 45324
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Novartis Investigative Site
      • Oklahoma City, Oklahoma, United States, 73103
        • Novartis Investigative Site
    • Oregon
      • Oregon City, Oregon, United States, 97045
        • Novartis Investigative Site
      • Portland, Oregon, United States, 97210
        • Novartis Investigative Site
      • Portland, Oregon, United States, 97223
        • Novartis Investigative Site
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19341
        • Novartis Investigative Site
      • Jenkintown, Pennsylvania, United States, 19046
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15213-3403
        • Novartis Investigative Site
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Novartis Investigative Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Novartis Investigative Site
      • Charleston, South Carolina, United States, 29407
        • Novartis Investigative Site
      • Greer, South Carolina, United States, 29651
        • Novartis Investigative Site
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072-2301
        • Novartis Investigative Site
      • Knoxville, Tennessee, United States, 37922
        • Novartis Investigative Site
      • Murfreesboro, Tennessee, United States, 37130
        • Novartis Investigative Site
      • Nashville, Tennessee, United States, 37203
        • Novartis Investigative Site
    • Texas
      • Arlington, Texas, United States, 76011
        • Novartis Investigative Site
      • Austin, Texas, United States, 78705
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75230
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75231
        • Novartis Investigative Site
      • Houston, Texas, United States, 77056
        • Novartis Investigative Site
      • Pflugerville, Texas, United States, 78660
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78229
        • Novartis Investigative Site
    • Utah
      • Murray, Utah, United States, 84107
        • Novartis Investigative Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Novartis Investigative Site
    • Washington
      • Everett, Washington, United States, 98201
        • Novartis Investigative Site
      • Seattle, Washington, United States, 98101
        • Novartis Investigative Site
      • Spokane, Washington, United States, 99204
        • Novartis Investigative Site
      • Walla Walla, Washington, United States, 99362
        • Novartis Investigative Site
      • Wenatchee, Washington, United States, 98801
        • Novartis Investigative Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • Novartis Investigative Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Novartis Investigative Site
      • Ho Chi Minh, Vietnam, 7000
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Secukinumab
Drug: Secukinumab
300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48
Active Comparator: Ustekinumab
Drug: Ustekinumab
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12
Time Frame: 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).
Week 12
Participants With IGA Mod 2011 0 or 1 at Week 12
Time Frame: 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)
Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2016

Primary Completion (Actual)

July 9, 2018

Study Completion (Actual)

July 9, 2018

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

July 5, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457A2326
  • 2015-002898-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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