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Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis

NCT ID: NCT01358578

Last Updated: 2021-01-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-07-31

Brief Summary

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This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

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Detailed Description

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Conditions

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Chronic Plaque 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 150mg

AIN457 150mg

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

secukinumab (AIN457)

Intervention Type DRUG

secukinumab (AIN457) 150mg or 300mg subcutaneous

AIN457 300mg

AIN457 300mg

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

secukinumab (AIN457)

Intervention Type DRUG

secukinumab (AIN457) 150mg or 300mg subcutaneous

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Etanercept

Etanercept

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

etanercept

Intervention Type DRUG

etanercept 50mg subcutaneous

AIN457 150mg from Placebo

Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

secukinumab (AIN457)

Intervention Type DRUG

secukinumab (AIN457) 150mg or 300mg subcutaneous

AIN457 300mg from Placebo

Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

secukinumab (AIN457)

Intervention Type DRUG

secukinumab (AIN457) 150mg or 300mg subcutaneous

Interventions

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Placebo

Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Intervention Type DRUG

secukinumab (AIN457)

secukinumab (AIN457) 150mg or 300mg subcutaneous

Intervention Type DRUG

etanercept

etanercept 50mg subcutaneous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with chronic, plaque-type psoriasis for at least 6 months
* Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area
* Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or systemic therapies)

Exclusion Criteria

* Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic and guttate psoriasis)
* Drug induced psoriasis
* Use of other psoriasis treatments during the study
* Prior use of etanercept
* Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the IL-17 receptor
* Pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment
* Significant medical problems such as uncontrolled high blood pressure, congestive heart failure, etc.
* History of an ongoing, chronic or recurrent infection or evidence of tuberculosis
* Allergy to rubber or latex
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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Phoenix, Arizona, United States

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San Diego, California, United States

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San Diego, California, United States

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Indianapolis, Indiana, United States

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High Point, North Carolina, United States

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Warren, Ohio, United States

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Portland, Oregon, United States

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Johnston, Rhode Island, United States

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Charleston, South Carolina, United States

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Kingsport, Tennessee, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires F.D., Argentina

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Buenos Aires, , Argentina

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Mendoza, , Argentina

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Kogarah, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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Carlton, Victoria, Australia

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East Melbourne, Victoria, Australia

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Brussels, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Liège, , Belgium

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Edmonton, Alberta, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Markham, Ontario, Canada

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Richmond Hil, Ontario, Canada

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Waterloo, Ontario, Canada

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Sainte-Foy, Quebec, Canada

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Bucaramanga, , Colombia

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Alexandria, , Egypt

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Helsinki, , Finland

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Turku, , Finland

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Marseille, , France

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Martigues, , France

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Nice, , France

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Paris, , France

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Pessac, , France

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Reims, , France

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Toulouse, , France

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Augsburg, , 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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Erlangen, , Germany

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Essen, , Germany

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Gera, , Germany

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Greifswald, , Germany

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Heidelberg, , Germany

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Kiel, , Germany

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Krefeld, , Germany

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München, , Germany

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Nuremberg, , Germany

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Osnabrück, , Germany

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Plauen, , Germany

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Recklinghausen, , Germany

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Regensburg, , Germany

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Schwerin, , Germany

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Tübingen, , Germany

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Witten, , Germany

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Wuppertal, , Germany

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Guatemala City, , Guatemala

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Kaposvár, , Hungary

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Miskolc, , Hungary

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Szeged, , Hungary

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Nagpur, Maharashtra, India

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Dehli, New Delhi, India

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Hyderabad, , India

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L’Aquila, AQ, Italy

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Catania, CT, Italy

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Genova, GE, Italy

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Terracina, LT, Italy

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Modena, MO, Italy

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Roma, RM, Italy

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Napoli, , Italy

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Las Piñas, , Philippines

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Manila, , Philippines

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Lodz, , Poland

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Poznan, , Poland

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Wroclaw, , Poland

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Bucharest, , Romania

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Singapore, , Singapore

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Anyang-si, Gyeonggi-do, South Korea

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Seoul, Korea, South Korea

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Busan, , South Korea

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Daejeon, , South Korea

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Gwangju, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Sabadell, Barcelona, Spain

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Santa Coloma de Gramanet, Catalonia, Spain

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Valencia, Valencia, Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Gothenburg, , Sweden

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Luleå, , Sweden

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Malmo, , Sweden

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Uppsala, , Sweden

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Plymouth, Devon, United Kingdom

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Salford, Manchester, United Kingdom

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Yeovil, Somerset, United Kingdom

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Dudley, , United Kingdom

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Harrogate, , United Kingdom

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London, , United Kingdom

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Nuneaton, , United Kingdom

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Countries

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United States Argentina Australia Belgium Canada Colombia Egypt Finland France Germany Guatemala Hungary Iceland India Italy Philippines Poland Romania Singapore South Korea Spain Sweden United Kingdom

References

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Sticherling M, Nikkels AF, Hamza AM, Kwong P, Szepietowski JC, El Sayed M, Ghislain PD, Khotko AA, Patekar M, Ortmann CE, Forrer P, Papanastasiou P, Keefe D. Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. Am J Clin Dermatol. 2023 Sep;24(5):821-835. doi: 10.1007/s40257-023-00782-8. Epub 2023 Jun 21.

Reference Type DERIVED
PMID: 37341961 (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)

Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.

Reference Type DERIVED
PMID: 34110605 (View on PubMed)

Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.

Reference Type DERIVED
PMID: 33748660 (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)

Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. doi: 10.1007/s13555-016-0140-7. Epub 2016 Aug 30.

Reference Type DERIVED
PMID: 27576559 (View on PubMed)

Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. doi: 10.1007/s13555-016-0139-0. Epub 2016 Aug 30.

Reference Type DERIVED
PMID: 27573260 (View on PubMed)

Gottlieb AB, Langley RG, Philipp S, Sigurgeirsson B, Blauvelt A, Martin R, Papavassilis C, Mpofu S. Secukinumab Improves Physical Function in Subjects With Plaque Psoriasis and Psoriatic Arthritis: Results from Two Randomized, Phase 3 Trials. J Drugs Dermatol. 2015 Aug;14(8):821-33.

Reference Type DERIVED
PMID: 26267726 (View on PubMed)

Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, Puig L, Nakagawa H, Spelman L, Sigurgeirsson B, Rivas E, Tsai TF, Wasel N, Tyring S, Salko T, Hampele I, Notter M, Karpov A, Helou S, Papavassilis C; ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. doi: 10.1056/NEJMoa1314258. Epub 2014 Jul 9.

Reference Type DERIVED
PMID: 25007392 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=56

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

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2010-022228-66

Identifier Type: -

Identifier Source: secondary_id

CAIN457A2303

Identifier Type: -

Identifier Source: org_study_id

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