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

NCT ID: NCT02074982

Last Updated: 2017-07-21

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

676 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-26

Study Completion Date

2016-06-29

Brief Summary

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

Detailed Description

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Conditions

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Chronic Plaque Type Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

AIN457 300 mg

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

ustekinumab 45/90 mg

Intervention Type DRUG

placebo secukinumab

Intervention Type DRUG

Placebo

Interventions

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AIN457 300 mg

Intervention Type DRUG

ustekinumab 45/90 mg

Intervention Type DRUG

placebo secukinumab

Placebo

Intervention Type DRUG

Other Intervention Names

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secukinumab

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Hot Springs, Arkansas, United States

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Los Angeles, California, United States

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Oceanside, California, United States

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Santa Monica, California, United States

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South Miami, Florida, United States

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Arlington Heights, Illinois, United States

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Champaign, Illinois, United States

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Skokie, Illinois, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Owensboro, Kentucky, United States

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Boston, Massachusetts, United States

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St Louis, Missouri, United States

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East Windsor, New Jersey, United States

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Forest Hills, New York, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Greer, South Carolina, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Seattle, Washington, United States

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Phillip, Australian Capital Territory, Australia

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Sydney, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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East Melbourne, Victoria, Australia

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Innsbruck, , Austria

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Linz, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Ghent, , Belgium

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Liège, , Belgium

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Namur, , Belgium

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Pleven, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Etobicoke, Ontario, Canada

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Hamilton, Ontario, Canada

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Mississauga, Ontario, Canada

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Sainte-Foy, Quebec, Canada

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Arhus C, , Denmark

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Tallinn, , Estonia

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Tartu, , Estonia

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Bordeaux, , France

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Brest, , France

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La Rochelle, , France

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Martigues, , France

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Nice, , France

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Augsburg, , Germany

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Bad Bentheim, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bochum, , Germany

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Darmstadt, , Germany

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Dessau, , Germany

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Dresden, , Germany

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Erlangen, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Kiel, , Germany

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Kiel, , Germany

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Ludwigshafen, , Germany

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Lübeck, , Germany

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Mainz, , Germany

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Münster, , Germany

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Münster, , Germany

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Pommelsbrunn, , Germany

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Heraklion, Crete, GR, Greece

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Budapest, , Hungary

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Szeged, , Hungary

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Afula, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Bologna, BO, Italy

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Modena, MO, Italy

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Verona, VR, Italy

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Breda, CK, Netherlands

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Sneek, , Netherlands

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Zwijndrecht, , Netherlands

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Bergen, , Norway

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Coimbra, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Banská Bystrica, Slovak Republic, Slovakia

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Kosice-Saca, Slovak Republic, Slovakia

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Bojnice, , Slovakia

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Košice, , Slovakia

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Gwangju, , South Korea

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Granada, Andalusia, Spain

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Málaga, Andalusia, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Bilbao, Basque Country, Spain

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Donostia / San Sebastian, Basque Country, Spain

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Badalona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Las Palmas de Gran Canaria, Las Palmas de G.C, Spain

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Alcorcón, Madrid, Spain

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Majadahonda, Madrid, Spain

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Oviedo, Principality of Asturias, Spain

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Alicante, Valencia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Barcelona, , Spain

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Madrid, , Spain

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Lausanne, , Switzerland

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Linkou District, , Taiwan

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Taipei, , Taiwan

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Balcova / Izmir, , Turkey (Türkiye)

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Bursa, , Turkey (Türkiye)

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Salford, Manchester, United Kingdom

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Dundee, Perthshire, United Kingdom

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Redhill, Surrey, United Kingdom

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Bradford, West Yorkshire, United Kingdom

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Coventry, , United Kingdom

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Harrogate, , United Kingdom

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Hull, , United Kingdom

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Stoke-on-Trent, , United Kingdom

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Countries

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United States Australia Austria Belgium Bulgaria Canada Denmark Estonia France Germany Greece Hungary Israel Italy Netherlands Norway Portugal Slovakia South Korea Spain Switzerland Taiwan Turkey (Türkiye) United Kingdom

References

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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.

Reference Type DERIVED
PMID: 36334236 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35305260 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34870789 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30972746 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26092291 (View on PubMed)

Other Identifiers

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2013-003434-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457A2317

Identifier Type: -

Identifier Source: org_study_id

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