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

June 23, 2017 updated by: Novartis Pharmaceuticals

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

676

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

  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Novartis Investigative Site
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Novartis Investigative Site
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Novartis Investigative Site
  • Austria
      • Innsbruck, Austria, 6020
        • Novartis Investigative Site
      • Linz, Austria, A-4020
        • Novartis Investigative Site
      • Vienna, Austria, A-1030
        • Novartis Investigative Site
      • Wien, Austria, A-1090
        • Novartis Investigative Site
  • Belgium
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • Liege, Belgium, 4000
        • Novartis Investigative Site
      • Namur, Belgium, 5000
        • Novartis Investigative Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1404
        • Novartis Investigative Site
      • Varna, Bulgaria, 9000
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Etobicoke, Ontario, Canada, M8X 1Y9
        • Novartis Investigative Site
      • Hamilton, Ontario, Canada, L8N 1V6
        • Novartis Investigative Site
      • Mississauga, Ontario, Canada, L5H 1G9
        • Novartis Investigative Site
    • Quebec
      • Sainte-Foy, Quebec, Canada, G1V 4X7
        • Novartis Investigative Site
  • Denmark
      • Arhus C, Denmark, DK-8000
        • Novartis Investigative Site
  • Estonia
      • Tallinn, Estonia, 10138
        • Novartis Investigative Site
      • Tartu, Estonia, 51014
        • Novartis Investigative Site
  • France
      • Bordeaux, France, 33076
        • Novartis Investigative Site
      • Brest, France, 29609
        • Novartis Investigative Site
      • La Rochelle, France, 17019
        • Novartis Investigative Site
      • Martigues, France, 13500
        • Novartis Investigative Site
      • Nice Cedex 3, France, 06202
        • Novartis Investigative Site
  • Germany
      • Augsburg, Germany, 86179
        • Novartis Investigative Site
      • Bad Bentheim, Germany, 48455
        • Novartis Investigative Site
      • Berlin, Germany, 13507
        • Novartis Investigative Site
      • Berlin, Germany, 13187
        • Novartis Investigative Site
      • Berlin, Germany, 10783
        • Novartis Investigative Site
      • Bielefeld, Germany, 33647
        • Novartis Investigative Site
      • Bochum, Germany, 44803
        • Novartis Investigative Site
      • Darmstadt, Germany, 64283
        • Novartis Investigative Site
      • Dessau-Rosslau, Germany, 06847
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Novartis Investigative Site
      • Hamburg, Germany, 20354
        • Novartis Investigative Site
      • Hamburg, Germany, 22391
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Novartis Investigative Site
      • Kiel, Germany, 24148
        • Novartis Investigative Site
      • Lubeck, Germany, 23538
        • Novartis Investigative Site
      • Ludwigshafen, Germany, 67063
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site
      • Münster, Germany, 48159
        • Novartis Investigative Site
      • Pommelsbrunn, Germany, 91224
        • Novartis Investigative Site
  • Greece
    • GR
      • Heraklion, Crete, GR, Greece, 71110
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1134
        • Novartis Investigative Site
      • Szeged, Hungary, H-6725
        • Novartis Investigative Site
  • Israel
      • Afula, Israel, 1834111
        • Novartis Investigative Site
      • Petach Tikva, Israel, 49100
        • Novartis Investigative Site
      • Tel Aviv, Israel, 64239
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6209804
        • Novartis Investigative Site
  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italy, 41100
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italy, 37126
        • Novartis Investigative Site
  • Korea, Republic of
      • Gwangju, Korea, Republic of, 501-757
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 06351
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 03722
        • Novartis Investigative Site
  • Netherlands
      • Nijmegen, Netherlands, 6500 MB
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3015 CE
        • Novartis Investigative Site
      • Sneek, Netherlands, 8601 ZK
        • Novartis Investigative Site
      • Zwijndrecht, Netherlands, 3331 LZ
        • Novartis Investigative Site
    • CK
      • Breda, CK, Netherlands, 4818
        • Novartis Investigative Site
  • Norway
      • Bergen, Norway, NO-5021
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Novartis Investigative Site
      • Lisboa, Portugal, 1649-035
        • Novartis Investigative Site
      • Lisbon, Portugal, 1069-166
        • Novartis Investigative Site
      • Porto, Portugal, 4099-001
        • Novartis Investigative Site
      • Porto, Portugal, 4200-319
        • Novartis Investigative Site
  • Slovakia
      • Bojnice, Slovakia, 972 01
        • Novartis Investigative Site
      • Kosice, Slovakia, 04001
        • Novartis Investigative Site
    • Slovak Republic
      • Banska Bystrica, Slovak Republic, Slovakia, 97401
        • Novartis Investigative Site
    • Slovak republic
      • Kosice-Saca, Slovak republic, Slovakia, 040 15
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Novartis Investigative Site
      • Madrid, Spain, 28006
        • Novartis Investigative Site
      • Madrid, Spain, 28007
        • Novartis Investigative Site
      • Madrid, Spain, 28031
        • Novartis Investigative Site
    • Andalucia
      • Granada, Andalucia, Spain, 18012
        • Novartis Investigative Site
      • Malaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Novartis Investigative Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Novartis Investigative Site
    • Catalunya
      • Badalona, Catalunya, Spain, 08916
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08036
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08003
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03010
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46014
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Novartis Investigative Site
    • Las Palmas de G.C
      • Las Palmas de Gran Canaria, Las Palmas de G.C, Spain, 35010
        • Novartis Investigative Site
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Novartis Investigative Site
      • Majadahonda, Madrid, Spain, 28222
        • Novartis Investigative Site
    • Pais Vasco
      • Bilbao, Pais Vasco, Spain, 48013
        • Novartis Investigative Site
      • San Sebastian, Pais Vasco, Spain, 20080
        • Novartis Investigative Site
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Novartis Investigative Site
  • Taiwan
      • Lin-Kou, Taiwan, 33305
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
  • Turkey
      • Balcova / Izmir, Turkey, 35340
        • Novartis Investigative Site
      • Bursa, Turkey, 16059
        • Novartis Investigative Site
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • Novartis Investigative Site
      • Harrogate, United Kingdom, HG2 7SX
        • Novartis Investigative Site
      • Hull, United Kingdom, HU3 2JZ
        • Novartis Investigative Site
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Novartis Investigative Site
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Novartis Investigative Site
    • Perthshire
      • Dundee, Perthshire, United Kingdom, DD1 9SY
        • Novartis Investigative Site
    • Surrey
      • Redhill, Surrey, United Kingdom, RH1 5RH
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD5 0NA
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Novartis Investigative Site
      • Mobile, Alabama, United States, 36608
        • Novartis Investigative Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Novartis Investigative Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Novartis Investigative Site
    • California
      • Los Angeles, California, United States, 90045
        • Novartis Investigative Site
      • Oceanside, California, United States, 92056
        • Novartis Investigative Site
      • Santa Monica, California, United States, 90404
        • Novartis Investigative Site
    • Florida
      • South Miami, Florida, United States, 33143
        • Novartis Investigative Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Novartis Investigative Site
      • Champaign, Illinois, United States, 61820
        • Novartis Investigative Site
      • Skokie, Illinois, United States, 60077
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Novartis Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Novartis Investigative Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Novartis Investigative Site
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Novartis Investigative Site
    • New York
      • Forest Hills, New York, United States, 11375
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Novartis Investigative Site
      • Portland, Oregon, United States, 97223
        • Novartis Investigative Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78229
        • Novartis Investigative Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, United States, 98101
        • 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:

  • 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

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: AIN457 300 mg
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
Drug: AIN457 300 mg
Other Names:
  • secukinumab
Active Comparator: Ustekinumab
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
Drug: ustekinumab 45/90 mg
Drug: placebo secukinumab
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
Time Frame: 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
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4
Time Frame: 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
Week 4
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52
Time Frame: 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
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)

February 26, 2014

Primary Completion (Actual)

June 29, 2016

Study Completion (Actual)

June 29, 2016

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457A2317
  • 2013-003434-32 (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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