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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: secukinumab (AIN457); Drug: etanercept

• Study Type: Interventional
• Enrollment (Actual): 1306
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425DKG
    • Novartis Investigative Site
  • Mendoza, Argentina, M5502EZA
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1181ACH
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1062ABK
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1425BEI
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1114AAO
      • Novartis Investigative Site
  • Capital Federal
    • Caba, Capital Federal, Argentina
      • Novartis Investigative Site
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Novartis Investigative Site
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Novartis Investigative Site
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Novartis Investigative Site
    • East Melbourne, Victoria, Australia, 3002
      • Novartis Investigative Site
• Belgium
  • Brussel, Belgium, 1090
    • Novartis Investigative Site
  • Bruxelles, Belgium, 1200
    • Novartis Investigative Site
  • Gent, Belgium, 9000
    • Novartis Investigative Site
  • Liège, Belgium, 4000
    • Novartis Investigative Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5K 1X3
      • Novartis Investigative Site
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Novartis Investigative Site
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • Novartis Investigative Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1Z2
      • Novartis Investigative Site
  • Ontario
    • Markham, Ontario, Canada, L3P 1A8
      • Novartis Investigative Site
    • Richmond Hil, Ontario, Canada, L4B 1A5
      • Novartis Investigative Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Novartis Investigative Site
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1V 4X7
      • Novartis Investigative Site
• Colombia
  • Barranquilla, Colombia
    • Novartis Investigative Site
  • Bogotá, Colombia
    • Novartis Investigative Site
  • Bucaramanga, Colombia
    • Novartis Investigative Site
• Egypt
  • Alexandria, Egypt, 21131
    • Novartis Investigative Site
• Finland
  • Helsinki, Finland, 00250
    • Novartis Investigative Site
  • Turku, Finland, FIN-20520
    • Novartis Investigative Site
• France
  • Marseille Cedex 9, France, 13913
    • Novartis Investigative Site
  • Martigues, France, 13500
    • Novartis Investigative Site
  • Nice Cedex 3, France, 06202
    • Novartis Investigative Site
  • Paris, France, 75475
    • Novartis Investigative Site
  • Pessac Cedex, France, 33604
    • Novartis Investigative Site
  • Reims, France, 51092
    • Novartis Investigative Site
  • Toulouse Cedex, France, 31059
    • Novartis Investigative Site
• Germany
  • Augsburg, Germany, 86179
    • Novartis Investigative Site
  • Berlin, Germany, 10117
    • Novartis Investigative Site
  • Berlin, Germany, 13187
    • Novartis Investigative Site
  • Berlin, Germany, 10827
    • Novartis Investigative Site
  • Bielefeld, Germany, 33647
    • Novartis Investigative Site
  • Bochum, Germany, 44791
    • Novartis Investigative Site
  • Bochum, Germany, 44803
    • Novartis Investigative Site
  • Bonn, Germany, 53105
    • Novartis Investigative Site
  • Darmstadt, Germany, 64283
    • Novartis Investigative Site
  • Dresden, Germany, 01307
    • Novartis Investigative Site
  • Erfurt, Germany, 99089
    • Novartis Investigative Site
  • Erlangen, Germany, 91052
    • Novartis Investigative Site
  • Essen, Germany, 45122
    • Novartis Investigative Site
  • Frankfurt, Germany, 60590
    • Novartis Investigative Site
  • Gera, Germany, 07548
    • Novartis Investigative Site
  • Goettingen, Germany, 37075
    • Novartis Investigative Site
  • Greifswald, Germany, 17475
    • Novartis Investigative Site
  • Hamburg, Germany, 20354
    • Novartis Investigative Site
  • Hamburg, Germany, 22143
    • Novartis Investigative Site
  • Hamburg, Germany, 22391
    • Novartis Investigative Site
  • Hanau, Germany, 63450
    • Novartis Investigative Site
  • Heidelberg, Germany, 69115
    • Novartis Investigative Site
  • Kiel, Germany, 24105
    • Novartis Investigative Site
  • Krefeld, Germany, 47805
    • Novartis Investigative Site
  • Köln, Germany, 50937
    • Novartis Investigative Site
  • Muenster, Germany, 48149
    • Novartis Investigative Site
  • München, Germany, 80802
    • Novartis Investigative Site
  • Nuernberg, Germany, 90419
    • Novartis Investigative Site
  • Osnabrück, Germany, 49074
    • Novartis Investigative Site
  • Plauen, Germany, 08529
    • Novartis Investigative Site
  • Recklinghausen, Germany, 45657
    • Novartis Investigative Site
  • Regensburg, Germany, 93053
    • Novartis Investigative Site
  • Schwerin, Germany, 19055
    • Novartis Investigative Site
  • Tuebingen, Germany, 72076
    • Novartis Investigative Site
  • Witten, Germany, 58452
    • Novartis Investigative Site
  • Wuppertal, Germany, 42275
    • Novartis Investigative Site
• Guatemala
  • Guatemala City, Guatemala, 01010
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 01015
    • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, 1134
    • Novartis Investigative Site
  • Budapest, Hungary, 1036
    • Novartis Investigative Site
  • Debrecen, Hungary, 4032
    • Novartis Investigative Site
  • Kaposvár, Hungary, 7400
    • Novartis Investigative Site
  • Miskolc, Hungary, 3529
    • Novartis Investigative Site
  • Szeged, Hungary, H-6720
    • Novartis Investigative Site
  • Szombathely, Hungary, 9700
    • Novartis Investigative Site
• Iceland
  • Kopavogur, Iceland, IS-201
    • Novartis Investigative Site
• India
  • Hyderabad, India, 500044
    • Novartis Investigative Site
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500008
      • Novartis Investigative Site
    • Hyderabad, Andhra Pradesh, India, 500012
      • Novartis Investigative Site
    • Vishakhapatnam, Andhra Pradesh, India, 532 002
      • Novartis Investigative Site
  • Karnataka
    • Bangalore, Karnataka, India, 560004
      • Novartis Investigative Site
    • Bangalore, Karnataka, India, 400038
      • Novartis Investigative Site
    • Bangalore, Karnataka, India, 560002
      • Novartis Investigative Site
    • Mangalore, Karnataka, India, 575002
      • Novartis Investigative Site
  • Maharashtra
    • Dadar (east) Mumbai, Maharashtra, India, 400018
      • Novartis Investigative Site
    • Mumbai, Maharashtra, India, 400 022
      • Novartis Investigative Site
    • Nagpur, Maharashtra, India, 440019
      • Novartis Investigative Site
  • New Delhi
    • Dehli, New Delhi, India, 110 051
      • Novartis Investigative Site
• Italy
  • Napoli, Italy, 80131
    • Novartis Investigative Site
  • AQ
    • L'Aquila, AQ, Italy, 67100
      • Novartis Investigative Site
  • CT
    • Catania, CT, Italy, 95123
      • Novartis Investigative Site
  • GE
    • Genova, GE, Italy, 16132
      • Novartis Investigative Site
  • LT
    • Terracina, LT, Italy, 04019
      • Novartis Investigative Site
  • MO
    • Modena, MO, Italy, 41100
      • Novartis Investigative Site
  • RM
    • Roma, RM, Italy, 00167
      • Novartis Investigative Site
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Novartis Investigative Site
  • Daejeon, Korea, Republic of, 301-747
    • Novartis Investigative Site
  • Gwangju, Korea, Republic of, 501-575
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 120-752
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 156-755
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 137-701
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 143-729
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 738-736
    • Novartis Investigative Site
  • Gyeonggi-do
    • Anyang, Gyeonggi-do, Korea, Republic of, 431-070
      • Novartis Investigative Site
  • Korea
    • Seoul, Korea, Korea, Republic of, 135-710
      • Novartis Investigative Site
• Philippines
  • Las Pinas, Philippines, 1740
    • Novartis Investigative Site
  • Manila, Philippines, 1000
    • Novartis Investigative Site
• Poland
  • Lodz, Poland, 90-265
    • Novartis Investigative Site
  • Lodz, Poland, 90-436
    • Novartis Investigative Site
  • Poznan, Poland, 60-529
    • Novartis Investigative Site
  • Wroclaw, Poland, 50-368
    • Novartis Investigative Site
• Romania
  • Bucuresti, Romania, 011461
    • Novartis Investigative Site
  • Bucuresti, Romania, 062272
    • Novartis Investigative Site
  • Bucuresti, Romania, 041335
    • Novartis Investigative Site
  • Bucuresti, Romania, 021105
    • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 119074
    • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08025
    • Novartis Investigative Site
  • Madrid, Spain, 28041
    • Novartis Investigative Site
  • Madrid, Spain, 28031
    • Novartis Investigative Site
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Novartis Investigative Site
  • Cataluña
    • Santa Coloma De Gramanet, Cataluña, Spain, 08923
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46014
      • Novartis Investigative Site
• Sweden
  • Göteborg, Sweden, 413 45
    • Novartis Investigative Site
  • Luleå, Sweden, 972 33
    • Novartis Investigative Site
  • Malmo, Sweden, SE-205 02
    • Novartis Investigative Site
  • Uppsala, Sweden, 751 85
    • Novartis Investigative Site
• United Kingdom
  • Dudley, United Kingdom, DY1 2HQ
    • Novartis Investigative Site
  • Harrogate, United Kingdom, HG2 7SX
    • Novartis Investigative Site
  • London, United Kingdom, E11 1NR
    • Novartis Investigative Site
  • Nuneaton, United Kingdom, CV10 7DJ
    • Novartis Investigative Site
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Novartis Investigative Site
  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • Novartis Investigative Site
  • Somerset
    • Yeovil, Somerset, United Kingdom, BA21 4AT
      • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Novartis Investigative Site
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Novartis Investigative Site
  • California
    • San Diego, California, United States, 92123
      • Novartis Investigative Site
    • San Diego, California, United States, 92103
      • Novartis Investigative Site
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Novartis Investigative Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Novartis Investigative Site
  • Ohio
    • Warren, Ohio, United States, 44483
      • Novartis Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Novartis Investigative Site
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Novartis Investigative Site
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Novartis Investigative Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • Novartis Investigative Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Novartis Investigative Site

Participation Criteria

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 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

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
EXPERIMENTAL: AIN457 150mg	Drug: Placebo; Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept; Drug: secukinumab (AIN457); secukinumab (AIN457) 150mg or 300mg subcutaneous
EXPERIMENTAL: AIN457 300mg	Drug: Placebo; Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept; Drug: secukinumab (AIN457); secukinumab (AIN457) 150mg or 300mg subcutaneous
ACTIVE_COMPARATOR: Etanercept	Drug: Placebo; Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept; Drug: etanercept; etanercept 50mg subcutaneous
EXPERIMENTAL: AIN457 150mg from Placebo; Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase	Drug: Placebo; Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept; Drug: secukinumab (AIN457); secukinumab (AIN457) 150mg or 300mg subcutaneous
EXPERIMENTAL: AIN457 300mg from Placebo; Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase	Drug: Placebo; Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept; Drug: secukinumab (AIN457); secukinumab (AIN457) 150mg or 300mg subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12	A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis	12 wks
Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12	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 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	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
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
Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo	The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy	baseline to week 12
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept	The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy	baseline to week 12
Number of Participants Developing Anti-secukinumab Antibodies	Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept)	60 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (ESTIMATE): May 23, 2011

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Psoriasis; Psoriasis,; scaly patches; inflammatory skin disease; inflammatory skin disease,
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: CAIN457A2303; 2010-022228-66