Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
FIXTURE
A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
2 other identifiers
interventional
1,306
23 countries
152
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2011
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2011
CompletedFirst Posted
Study publicly available on registry
May 23, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
September 23, 2015
CompletedJanuary 5, 2021
March 1, 2019
2.1 years
May 20, 2011
February 16, 2015
December 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
12 wks
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12
The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.
12 wks
Secondary Outcomes (8)
Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12
12 wks
Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12
12 wks
Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12
12 wks
Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)
52 wks
Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment
52 wks
- +3 more secondary outcomes
Study Arms (6)
AIN457 150mg
EXPERIMENTALAIN457 150mg
AIN457 300mg
EXPERIMENTALAIN457 300mg
Placebo
PLACEBO COMPARATORPlacebo
Etanercept
ACTIVE COMPARATOREtanercept
AIN457 150mg from Placebo
EXPERIMENTALPatients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase
AIN457 300mg from Placebo
EXPERIMENTALPatients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase
Interventions
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
secukinumab (AIN457) 150mg or 300mg subcutaneous
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (152)
Novartis Investigative Site
Birmingham, Alabama, 35205, United States
Novartis Investigative Site
Phoenix, Arizona, 85013, United States
Novartis Investigative Site
San Diego, California, 92103, United States
Novartis Investigative Site
San Diego, California, 92123, United States
Novartis Investigative Site
Indianapolis, Indiana, 46256, United States
Novartis Investigative Site
High Point, North Carolina, 27262, United States
Novartis Investigative Site
Warren, Ohio, 44483, United States
Novartis Investigative Site
Portland, Oregon, 97210, United States
Novartis Investigative Site
Johnston, Rhode Island, 02919, United States
Novartis Investigative Site
Charleston, South Carolina, 29407, United States
Novartis Investigative Site
Kingsport, Tennessee, 37660, United States
Novartis Investigative Site
San Antonio, Texas, 78229, United States
Novartis Investigative Site
Norfolk, Virginia, 23507, United States
Novartis Investigative Site
CABA, Buenos Aires, C1062ABK, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1114AAO, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1181ACH, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1425BEI, Argentina
Novartis Investigative Site
CABA, Buenos Aires F.D., Argentina
Novartis Investigative Site
Buenos Aires, C1425DKG, Argentina
Novartis Investigative Site
Mendoza, M5502EZA, Argentina
Novartis Investigative Site
Kogarah, New South Wales, 2217, Australia
Novartis Investigative Site
Woolloongabba, Queensland, 4102, Australia
Novartis Investigative Site
Carlton, Victoria, 3053, Australia
Novartis Investigative Site
East Melbourne, Victoria, 3002, Australia
Novartis Investigative Site
Brussels, 1090, Belgium
Novartis Investigative Site
Brussels, 1200, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Edmonton, Alberta, T5K 1X3, Canada
Novartis Investigative Site
Surrey, British Columbia, V3V 0C6, Canada
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E8, Canada
Novartis Investigative Site
Halifax, Nova Scotia, B3H 1Z2, Canada
Novartis Investigative Site
Markham, Ontario, L3P 1A8, Canada
Novartis Investigative Site
Richmond Hil, Ontario, L4B 1A5, Canada
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4, Canada
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4X7, Canada
Novartis Investigative Site
Barranquilla, Colombia
Novartis Investigative Site
Bogotá, Colombia
Novartis Investigative Site
Bucaramanga, Colombia
Novartis Investigative Site
Alexandria, 21131, Egypt
Novartis Investigative Site
Helsinki, 00250, Finland
Novartis Investigative Site
Turku, FIN-20520, Finland
Novartis Investigative Site
Marseille, 13913, France
Novartis Investigative Site
Martigues, 13500, France
Novartis Investigative Site
Nice, 06202, France
Novartis Investigative Site
Paris, 75475, France
Novartis Investigative Site
Pessac, 33604, France
Novartis Investigative Site
Reims, 51092, France
Novartis Investigative Site
Toulouse, 31059, France
Novartis Investigative Site
Augsburg, 86179, Germany
Novartis Investigative Site
Berlin, 10117, Germany
Novartis Investigative Site
Berlin, 10827, Germany
Novartis Investigative Site
Berlin, 13187, Germany
Novartis Investigative Site
Bielefeld, 33647, Germany
Novartis Investigative Site
Bochum, 44791, Germany
Novartis Investigative Site
Bochum, 44803, Germany
Novartis Investigative Site
Bonn, 53105, Germany
Novartis Investigative Site
Cologne, 50937, Germany
Novartis Investigative Site
Darmstadt, 64283, Germany
Novartis Investigative Site
Dresden, 01307, Germany
Novartis Investigative Site
Erfurt, 99089, Germany
Novartis Investigative Site
Erlangen, 91052, Germany
Novartis Investigative Site
Essen, 45122, Germany
Novartis Investigative Site
Frankfurt, 60590, Germany
Novartis Investigative Site
Gera, 07548, Germany
Novartis Investigative Site
Göttingen, 37075, Germany
Novartis Investigative Site
Greifswald, 17475, Germany
Novartis Investigative Site
Hamburg, 20354, Germany
Novartis Investigative Site
Hamburg, 22143, Germany
Novartis Investigative Site
Hamburg, 22391, Germany
Novartis Investigative Site
Hanau, 63450, Germany
Novartis Investigative Site
Heidelberg, 69115, Germany
Novartis Investigative Site
Kiel, 24105, Germany
Novartis Investigative Site
Krefeld, 47805, Germany
Novartis Investigative Site
München, 80802, Germany
Novartis Investigative Site
Münster, 48149, Germany
Novartis Investigative Site
Nuremberg, 90419, Germany
Novartis Investigative Site
Osnabrück, 49074, Germany
Novartis Investigative Site
Plauen, 08529, Germany
Novartis Investigative Site
Recklinghausen, 45657, Germany
Novartis Investigative Site
Regensburg, 93053, Germany
Novartis Investigative Site
Schwerin, 19055, Germany
Novartis Investigative Site
Tübingen, 72076, Germany
Novartis Investigative Site
Witten, 58452, Germany
Novartis Investigative Site
Wuppertal, 42275, Germany
Novartis Investigative Site
Guatemala City, 01010, Guatemala
Novartis Investigative Site
Guatemala City, 01015, Guatemala
Novartis Investigative Site
Budapest, 1036, Hungary
Novartis Investigative Site
Budapest, 1134, Hungary
Novartis Investigative Site
Debrecen, 4032, Hungary
Novartis Investigative Site
Kaposvár, 7400, Hungary
Novartis Investigative Site
Miskolc, 3529, Hungary
Novartis Investigative Site
Szeged, H-6720, Hungary
Novartis Investigative Site
Szombathely, 9700, Hungary
Novartis Investigative Site
Kopavogur, IS-201, Iceland
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500008, India
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500012, India
Novartis Investigative Site
Visakhapatnam, Andhra Pradesh, 532 002, India
Novartis Investigative Site
Bangalore, Karnataka, 400038, India
Novartis Investigative Site
Bangalore, Karnataka, 560002, India
Novartis Investigative Site
Bangalore, Karnataka, 560004, India
Novartis Investigative Site
Mangalore, Karnataka, 575002, India
Novartis Investigative Site
Dadar (east) Mumbai, Maharashtra, 400018, India
Novartis Investigative Site
Mumbai, Maharashtra, 400 022, India
Novartis Investigative Site
Nagpur, Maharashtra, 440019, India
Novartis Investigative Site
Dehli, New Delhi, 110 051, India
Novartis Investigative Site
Hyderabad, 500044, India
Novartis Investigative Site
L’Aquila, AQ, 67100, Italy
Novartis Investigative Site
Catania, CT, 95123, Italy
Novartis Investigative Site
Genova, GE, 16132, Italy
Novartis Investigative Site
Terracina, LT, 04019, Italy
Novartis Investigative Site
Modena, MO, 41100, Italy
Novartis Investigative Site
Roma, RM, 00167, Italy
Novartis Investigative Site
Napoli, 80131, Italy
Novartis Investigative Site
Las Piñas, 1740, Philippines
Novartis Investigative Site
Manila, 1000, Philippines
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Lodz, 90-265, Poland
Novartis Investigative Site
Lodz, 90-436, Poland
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Poznan, 60-529, Poland
Novartis Investigative Site
Wroclaw, 50-368, Poland
Novartis Investigative Site
Bucharest, 011461, Romania
Novartis Investigative Site
Bucharest, 021105, Romania
Novartis Investigative Site
Bucharest, 041335, Romania
Novartis Investigative Site
Bucharest, 062272, Romania
Novartis Investigative Site
Singapore, 119074, Singapore
Novartis Investigative Site
Anyang-si, Gyeonggi-do, 431-070, South Korea
Novartis Investigative Site
Seoul, Korea, 135-710, South Korea
Novartis Investigative Site
Busan, 602-739, South Korea
Novartis Investigative Site
Daejeon, 301-747, South Korea
Novartis Investigative Site
Gwangju, 501-575, South Korea
Novartis Investigative Site
Seoul, 120-752, South Korea
Novartis Investigative Site
Seoul, 137-701, South Korea
Novartis Investigative Site
Seoul, 143-729, South Korea
Novartis Investigative Site
Seoul, 156-755, South Korea
Novartis Investigative Site
Seoul, 738-736, South Korea
Novartis Investigative Site
Sabadell, Barcelona, 08208, Spain
Novartis Investigative Site
Santa Coloma de Gramanet, Catalonia, 08923, Spain
Novartis Investigative Site
Valencia, Valencia, 46014, Spain
Novartis Investigative Site
Barcelona, 08025, Spain
Novartis Investigative Site
Madrid, 28031, Spain
Novartis Investigative Site
Madrid, 28041, Spain
Novartis Investigative Site
Gothenburg, 413 45, Sweden
Novartis Investigative Site
Luleå, 972 33, Sweden
Novartis Investigative Site
Malmo, SE-205 02, Sweden
Novartis Investigative Site
Uppsala, 751 85, Sweden
Novartis Investigative Site
Plymouth, Devon, PL6 8DH, United Kingdom
Novartis Investigative Site
Salford, Manchester, M6 8HD, United Kingdom
Novartis Investigative Site
Yeovil, Somerset, BA21 4AT, United Kingdom
Novartis Investigative Site
Dudley, DY1 2HQ, United Kingdom
Novartis Investigative Site
Harrogate, HG2 7SX, United Kingdom
Novartis Investigative Site
London, E11 1NR, United Kingdom
Novartis Investigative Site
Nuneaton, CV10 7DJ, United Kingdom
Related Publications (9)
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.
PMID: 37341961DERIVEDMerola 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.
PMID: 35305260DERIVEDHoughton 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.
PMID: 34110605DERIVEDDehlin 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.
PMID: 33748660DERIVEDAugustin 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.
PMID: 30972746DERIVEDMenter 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.
PMID: 27576559DERIVEDKircik 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.
PMID: 27573260DERIVEDGottlieb 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.
PMID: 26267726DERIVEDLangley 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.
PMID: 25007392DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2011
First Posted
May 23, 2011
Study Start
June 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
January 5, 2021
Results First Posted
September 23, 2015
Record last verified: 2019-03