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NCT01358578 Clinical Trial

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

Chronic Plaque Psoriasis Clinical Trial

— FIXTURE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01358578
Other study ID # CAIN457A2303
Secondary ID 2010-022228-66
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2011
Est. completion date July 2013

Study information
Verified date March 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 1306
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
• secukinumab (AIN457)
secukinumab (AIN457) 150mg or 300mg subcutaneous
• etanercept
etanercept 50mg subcutaneous

Locations
Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba Capital Federal
Argentina Novartis Investigative Site Mendoza
Australia Novartis Investigative Site Carlton Victoria
Australia Novartis Investigative Site East Melbourne Victoria
Australia Novartis Investigative Site Kogarah New South Wales
Australia Novartis Investigative Site Woolloongabba Queensland
Belgium Novartis Investigative Site Brussel
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Gent
Belgium Novartis Investigative Site Liège
Canada Novartis Investigative Site Edmonton Alberta
Canada Novartis Investigative Site Halifax Nova Scotia
Canada Novartis Investigative Site Markham Ontario
Canada Novartis Investigative Site Richmond Hil Ontario
Canada Novartis Investigative Site Sainte-Foy Quebec
Canada Novartis Investigative Site Surrey British Columbia
Canada Novartis Investigative Site Vancouver British Columbia
Canada Novartis Investigative Site Waterloo Ontario
Colombia Novartis Investigative Site Barranquilla
Colombia Novartis Investigative Site Bogotá
Colombia Novartis Investigative Site Bucaramanga
Egypt Novartis Investigative Site Alexandria
Finland Novartis Investigative Site Helsinki
Finland Novartis Investigative Site Turku
France Novartis Investigative Site Marseille Cedex 9
France Novartis Investigative Site Martigues
France Novartis Investigative Site Nice Cedex 3
France Novartis Investigative Site Paris
France Novartis Investigative Site Pessac Cedex
France Novartis Investigative Site Reims
France Novartis Investigative Site Toulouse Cedex
Germany Novartis Investigative Site Augsburg
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Bielefeld
Germany Novartis Investigative Site Bochum
Germany Novartis Investigative Site Bochum
Germany Novartis Investigative Site Bonn
Germany Novartis Investigative Site Darmstadt
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Erfurt
Germany Novartis Investigative Site Erlangen
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Gera
Germany Novartis Investigative Site Goettingen
Germany Novartis Investigative Site Greifswald
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hanau
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Kiel
Germany Novartis Investigative Site Köln
Germany Novartis Investigative Site Krefeld
Germany Novartis Investigative Site Muenster
Germany Novartis Investigative Site München
Germany Novartis Investigative Site Nuernberg
Germany Novartis Investigative Site Osnabrück
Germany Novartis Investigative Site Plauen
Germany Novartis Investigative Site Recklinghausen
Germany Novartis Investigative Site Regensburg
Germany Novartis Investigative Site Schwerin
Germany Novartis Investigative Site Tuebingen
Germany Novartis Investigative Site Witten
Germany Novartis Investigative Site Wuppertal
Guatemala Novartis Investigative Site Guatemala City
Guatemala Novartis Investigative Site Guatemala City
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Debrecen
Hungary Novartis Investigative Site Kaposvár
Hungary Novartis Investigative Site Miskolc
Hungary Novartis Investigative Site Szeged
Hungary Novartis Investigative Site Szombathely
Iceland Novartis Investigative Site Kopavogur
India Novartis Investigative Site Bangalore Karnataka
India Novartis Investigative Site Bangalore Karnataka
India Novartis Investigative Site Bangalore Karnataka
India Novartis Investigative Site Dadar (east) Mumbai Maharashtra
India Novartis Investigative Site Dehli New Delhi
India Novartis Investigative Site Hyderabad
India Novartis Investigative Site Hyderabad Andhra Pradesh
India Novartis Investigative Site Hyderabad Andhra Pradesh
India Novartis Investigative Site Mangalore Karnataka
India Novartis Investigative Site Mumbai Maharashtra
India Novartis Investigative Site Nagpur Maharashtra
India Novartis Investigative Site Vishakhapatnam Andhra Pradesh
Italy Novartis Investigative Site Catania CT
Italy Novartis Investigative Site Genova GE
Italy Novartis Investigative Site L'Aquila AQ
Italy Novartis Investigative Site Modena MO
Italy Novartis Investigative Site Napoli
Italy Novartis Investigative Site Roma RM
Italy Novartis Investigative Site Terracina LT
Korea, Republic of Novartis Investigative Site Anyang Gyeonggi-do
Korea, Republic of Novartis Investigative Site Busan
Korea, Republic of Novartis Investigative Site Daejeon
Korea, Republic of Novartis Investigative Site Gwangju
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul Korea
Philippines Novartis Investigative Site Las Pinas
Philippines Novartis Investigative Site Manila
Poland Novartis Investigative Site Lodz
Poland Novartis Investigative Site Lodz
Poland Novartis Investigative Site Poznan
Poland Novartis Investigative Site Wroclaw
Romania Novartis Investigative Site Bucuresti
Romania Novartis Investigative Site Bucuresti
Romania Novartis Investigative Site Bucuresti
Romania Novartis Investigative Site Bucuresti
Singapore Novartis Investigative Site Singapore
Spain Novartis Investigative Site Barcelona
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Sabadell Barcelona
Spain Novartis Investigative Site Santa Coloma De Gramanet Cataluña
Spain Novartis Investigative Site Valencia Comunidad Valenciana
Sweden Novartis Investigative Site Göteborg
Sweden Novartis Investigative Site Luleå
Sweden Novartis Investigative Site Malmo
Sweden Novartis Investigative Site Uppsala
United Kingdom Novartis Investigative Site Dudley
United Kingdom Novartis Investigative Site Harrogate
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Nuneaton
United Kingdom Novartis Investigative Site Plymouth Devon
United Kingdom Novartis Investigative Site Salford Manchester
United Kingdom Novartis Investigative Site Yeovil Somerset
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Charleston South Carolina
United States Novartis Investigative Site High Point North Carolina
United States Novartis Investigative Site Indianapolis Indiana
United States Novartis Investigative Site Johnston Rhode Island
United States Novartis Investigative Site Kingsport Tennessee
United States Novartis Investigative Site Norfolk Virginia
United States Novartis Investigative Site Phoenix Arizona
United States Novartis Investigative Site Portland Oregon
United States Novartis Investigative Site San Antonio Texas
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site Warren Ohio

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation) 52 wks
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT03598790 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3
Completed NCT00799877 - Chronic Plaque Psoriasis (Ps) Registry
Completed NCT02581345 - Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis Phase 3
Withdrawn NCT01200264 - Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy Phase 2
Terminated NCT00972543 - Raptiva in Palm and Sole Psoriasis Phase 4
Not yet recruiting NCT00707070 - Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis Phase 4
Completed NCT00539929 - Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis Phase 2
Completed NCT02852967 - A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis Phase 2
Completed NCT00770965 - Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis Phase 2
Active, not recruiting NCT06011733 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis Phase 3
Completed NCT00245765 - Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy Phase 2
Completed NCT00673556 - A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate Phase 3
Terminated NCT00844363 - Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris N/A
Completed NCT00574249 - Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment Phase 3
Completed NCT00512187 - Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial Phase 4
Completed NCT02570750 - The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Completed NCT00438360 - Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis Phase 3
Active, not recruiting NCT03897075 - Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis Phase 3
Completed NCT03536884 - A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3
Completed NCT03230292 - A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis Phase 2

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