Chronic Plaque PsoriasisPhase 3FIXTURENCT01358578
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
A Phase 3 study testing secukinumab (AIN457) and etanercept in people with Chronic Plaque Psoriasis, run by Novartis Pharmaceuticals at 152 sites in 23 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- secukinumab (AIN457) and etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,306 participants
- Where
- 152 sitesin 23 countries
- Study dates
- Jun 2011to Jul 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
152 sites in 23 countries.
152 sites in 23 countries
Germany36 sites
Novartis Investigative Site
Augsburg, 86179
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Berlin, 10827
Novartis Investigative Site
Berlin, 13187
Novartis Investigative Site
Bielefeld, 33647
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Bochum, 44803
Novartis Investigative Site
Bonn, 53105
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Darmstadt, 64283
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Erfurt, 99089
Novartis Investigative Site
Erlangen, 91052
Novartis Investigative Site
Essen, 45122
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Gera, 07548
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Greifswald, 17475
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Hamburg, 22143
Novartis Investigative Site
Hamburg, 22391
Novartis Investigative Site
Hanau, 63450
Novartis Investigative Site
Heidelberg, 69115
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Krefeld, 47805
Novartis Investigative Site
München, 80802
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Nuremberg, 90419
Novartis Investigative Site
Osnabrück, 49074
Novartis Investigative Site
Plauen, 08529
Novartis Investigative Site
Recklinghausen, 45657
Novartis Investigative Site
Regensburg, 93053
Novartis Investigative Site
Schwerin, 19055
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Witten, 58452
Novartis Investigative Site
Wuppertal, 42275
United States13 sites
Novartis Investigative Site
Birmingham, Alabama, 35205
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Johnston, Rhode Island, 02919
Novartis Investigative Site
Kingsport, Tennessee, 37660
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Phoenix, Arizona, 85013
Novartis Investigative Site
Portland, Oregon, 97210
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
San Diego, California, 92103
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
Warren, Ohio, 44483
India12 sites
Novartis Investigative Site
Bangalore, Karnataka, 400038
Novartis Investigative Site
Bangalore, Karnataka, 560002
Novartis Investigative Site
Bangalore, Karnataka, 560004
Novartis Investigative Site
Dadar (east) Mumbai, Maharashtra, 400018
Novartis Investigative Site
Dehli, New Delhi, 110 051
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500008
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500012
Novartis Investigative Site
Hyderabad, 500044
Novartis Investigative Site
Mangalore, Karnataka, 575002
Novartis Investigative Site
Mumbai, Maharashtra, 400 022
Novartis Investigative Site
Nagpur, Maharashtra, 440019
Novartis Investigative Site
Visakhapatnam, Andhra Pradesh, 532 002
South Korea10 sites
Novartis Investigative Site
Anyang-si, Gyeonggi-do, 431-070
Novartis Investigative Site
Busan, 602-739
Novartis Investigative Site
Daejeon, 301-747
Novartis Investigative Site
Gwangju, 501-575
Novartis Investigative Site
Seoul, Korea, 135-710
Novartis Investigative Site
Seoul, 120-752
Novartis Investigative Site
Seoul, 137-701
Novartis Investigative Site
Seoul, 143-729
Novartis Investigative Site
Seoul, 156-755
Novartis Investigative Site
Seoul, 738-736
Canada8 sites
Novartis Investigative Site
Edmonton, Alberta, T5K 1X3
Novartis Investigative Site
Halifax, Nova Scotia, B3H 1Z2
Novartis Investigative Site
Markham, Ontario, L3P 1A8
Novartis Investigative Site
Richmond Hil, Ontario, L4B 1A5
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4X7
Novartis Investigative Site
Surrey, British Columbia, V3V 0C6
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E8
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
Argentina7 sites
Novartis Investigative Site
Buenos Aires, C1425DKG
Novartis Investigative Site
CABA, Buenos Aires, C1062ABK
Novartis Investigative Site
CABA, Buenos Aires, C1114AAO
Novartis Investigative Site
CABA, Buenos Aires, C1181ACH
Novartis Investigative Site
CABA, Buenos Aires, C1425BEI
Novartis Investigative Site
CABA, Buenos Aires F.D.
Novartis Investigative Site
Mendoza, M5502EZA
France7 sites
Novartis Investigative Site
Marseille, 13913
Novartis Investigative Site
Martigues, 13500
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Paris, 75475
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Toulouse, 31059
Hungary7 sites
Novartis Investigative Site
Budapest, 1036
Novartis Investigative Site
Budapest, 1134
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Kaposvár, 7400
Novartis Investigative Site
Miskolc, 3529
Novartis Investigative Site
Szeged, H-6720
Novartis Investigative Site
Szombathely, 9700
Italy7 sites
Novartis Investigative Site
Catania, CT, 95123
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
L’Aquila, AQ, 67100
Novartis Investigative Site
Modena, MO, 41100
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Roma, RM, 00167
Novartis Investigative Site
Terracina, LT, 04019
United Kingdom7 sites
Novartis Investigative Site
Dudley, DY1 2HQ
Novartis Investigative Site
Harrogate, HG2 7SX
Novartis Investigative Site
London, E11 1NR
Novartis Investigative Site
Nuneaton, CV10 7DJ
Novartis Investigative Site
Plymouth, Devon, PL6 8DH
Novartis Investigative Site
Salford, Manchester, M6 8HD
Novartis Investigative Site
Yeovil, Somerset, BA21 4AT
Spain6 sites
Novartis Investigative Site
Barcelona, 08025
Novartis Investigative Site
Madrid, 28031
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Sabadell, Barcelona, 08208
Novartis Investigative Site
Santa Coloma de Gramanet, Catalonia, 08923
Novartis Investigative Site
Valencia, Valencia, 46014
Australia4 sites
Novartis Investigative Site
Carlton, Victoria, 3053
Novartis Investigative Site
East Melbourne, Victoria, 3002
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
Woolloongabba, Queensland, 4102
Belgium4 sites
Novartis Investigative Site
Brussels, 1090
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Liège, 4000
Poland4 sites
Novartis Investigative Site
Lodz, 90-265
Novartis Investigative Site
Lodz, 90-436
Novartis Investigative Site
Poznan, 60-529
Novartis Investigative Site
Wroclaw, 50-368
Romania4 sites
Novartis Investigative Site
Bucharest, 011461
Novartis Investigative Site
Bucharest, 021105
Novartis Investigative Site
Bucharest, 041335
Novartis Investigative Site
Bucharest, 062272
Sweden4 sites
Novartis Investigative Site
Gothenburg, 413 45
Novartis Investigative Site
Luleå, 972 33
Novartis Investigative Site
Malmö, SE-205 02
Novartis Investigative Site
Uppsala, 751 85
Colombia3 sites
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bogotá
Novartis Investigative Site
Bucaramanga
Finland2 sites
Novartis Investigative Site
Helsinki, 00250
Novartis Investigative Site
Turku, FIN-20520
Guatemala2 sites
Novartis Investigative Site
Guatemala City, 01010
Novartis Investigative Site
Guatemala City, 01015
Philippines2 sites
Novartis Investigative Site
Las Piñas, 1740
Novartis Investigative Site
Manila, 1000
About this study
Official title: 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.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Placebo, secukinumab (AIN457), etanercept
- Keywords
- Psoriasis,, inflammatory skin disease,, scaly patches, Psoriasis, inflammatory skin disease
- Medical subject headings
- Psoriasis, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
secukinumab (AIN457)Drug
secukinumab (AIN457) 150mg or 300mg subcutaneous
etanerceptDrug
etanercept 50mg subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| AIN457 150mg | Experimental | AIN457 150mg Receives: Drug: Placebo; Drug: secukinumab (AIN457) |
| AIN457 300mg | Experimental | AIN457 300mg Receives: Drug: Placebo; Drug: secukinumab (AIN457) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Etanercept | Active comparator | Etanercept Receives: Drug: Placebo; Drug: etanercept |
| AIN457 150mg from Placebo | Experimental | Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase Receives: Drug: Placebo; Drug: secukinumab (AIN457) |
| AIN457 300mg from Placebo | Experimental | Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase Receives: Drug: Placebo; Drug: secukinumab (AIN457) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
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
Measured: 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
Measured: 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.
Measured: 12 wks
Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358578
- Sponsor's protocol ID
- CAIN457A2303
- Other IDs
- 2010-022228-66
- Acronym
- FIXTURE
- Status last verified
- Mar 2019
- First submitted
- 20 May 2011
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 37341961Merola 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.
PubMed 35305260Houghton 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.
PubMed 34110605Dehlin 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.
PubMed 33748660Augustin 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.
PubMed 30972746Menter 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.
PubMed 27576559Kircik 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.
PubMed 27573260Gottlieb 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.
PubMed 26267726Langley 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.
PubMed 25007392
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01358578
- Acronym / sponsor ID
- FIXTURE / CAIN457A2303
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- Psoriasis,, inflammatory skin disease,, scaly patches, Psoriasis, inflammatory skin disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,306 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Posted 23 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AIN457 150mg | Experimental | Drug: Placebo, Drug: secukinumab (AIN457)AIN457 150mg |
| AIN457 300mg | Experimental | Drug: Placebo, Drug: secukinumab (AIN457)AIN457 300mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Etanercept | Active comparator | Drug: Placebo, Drug: etanerceptEtanercept |
| AIN457 150mg from Placebo | Experimental | Drug: Placebo, Drug: secukinumab (AIN457)Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase |
| AIN457 300mg from Placebo | Experimental | Drug: Placebo, Drug: secukinumab (AIN457)Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept | Drug | AIN457 150mg, AIN457 150mg from Placebo, AIN457 300mg, AIN457 300mg from Placebo, Etanercept, Placebo |
| secukinumab (AIN457)secukinumab (AIN457) 150mg or 300mg subcutaneous | Drug | AIN457 150mg, AIN457 150mg from Placebo, AIN457 300mg, AIN457 300mg from Placebo |
| etanerceptetanercept 50mg subcutaneous | Drug | Etanercept |
Primary outcome
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .
Time frame: 12 wks
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
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
Time frame: 12 wks
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.
8 secondary outcomes
Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12
Time frame: 12 wks
Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12
Time frame: 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
Time frame: 12 wks
Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)
Time frame: 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
Time frame: 52 wks
Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
Time frame: baseline to week 12
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept
Time frame: baseline to week 12
Number of Participants Developing Anti-secukinumab Antibodies
Time frame: 60 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37341961Sticherling 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.
- Derived from this study: PubMed 35305260Merola 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.
- Derived from this study: PubMed 34110605Houghton 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.
- Derived from this study: PubMed 33748660Dehlin 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.
- Derived from this study: PubMed 30972746Augustin 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.
- Derived from this study: PubMed 27576559Menter 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.
- Derived from this study: PubMed 27573260Kircik 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.
- Derived from this study: PubMed 26267726Gottlieb 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.
- Derived from this study: PubMed 25007392Langley 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.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
152 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing secukinumab (AIN457) and etanercept in people with Chronic Plaque Psoriasis, run by Novartis Pharmaceuticals at 152 sites in 23 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 152 sites in Germany, United States, India, South Korea, Canada and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (time frame: 12 wks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01358578, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.