Clinical trial NCT01406938: Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
Official title: A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Plaque-type Psoriasis
Keywords: Psoriasis
plaque
inflammatory skin disease
scaly patches
AIN457
secukinumab
Moderate to Severe Plaque-type Psoriasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 967
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.


Eligibility criteria: Inclusion criteria:

* Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

Severity of disease meeting all of the following three criteria:

* PASI score of 12 or greater,
* Investigator's Global Assessment (IGA) score of 3 or greater
* Total body surface area (BSA) affected of 10% or greater.
* Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Exclusion criteria:

* Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
* Current drug-induced psoriasis.
* Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
* Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
* Hematological abnormalities.
* History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
* History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
* Pregnant or nursing (lactating) women.
* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52
timeFrame: Week 40 , week 52
Secondary outcomes:
measure: Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12
timeFrame: Baseline, week 2, 3 , 4, 8, 12
measure: Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52
timeFrame: Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52
measure: Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)
timeFrame: Baseline, week 2, 4, 6, 8, 12
measure: Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))
timeFrame: Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52
measure: Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)
timeFrame: Baseline to week 2, 4, 8, 12
measure: Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)
timeFrame: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)
timeFrame: Baseline to week 2, 4, 8, 12
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)
timeFrame: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
measure: % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)
timeFrame: Baseline to week 2, 4, 6, 8, 12
measure: % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).
timeFrame: Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52
measure: Median Time to Relapse (Weeks) From Week 12.
timeFrame: Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.
measure: Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
timeFrame: Week 12
measure: Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy
timeFrame: Week 52
measure: Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1
timeFrame: Week 16, 20, 24,28,32,36,40,44,48,and Week 52
measure: Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12
timeFrame: week 16, 20, 24,28,32,36,40,44,48,and Week 52
measure: Number of Participants Developing Anti-secukinumab Antibodies
timeFrame: Baseline, weeks 12, 24, 52 and 60
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Novartis Investigative Site
state: California
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: San Francisco
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facility: Novartis Investigative Site
state: California
city: Jacksonville
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facility: Novartis Investigative Site
state: Florida
city: Jacksonville
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facility: Novartis Investigative Site
state: Florida
city: Miami
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facility: Novartis Investigative Site
state: Florida
city: Naples
country: United States
facility: Novartis Investigative Site
state: Florida
city: South Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
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facility: Novartis Investigative Site
state: Georgia
city: Champaign
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facility: Novartis Investigative Site
state: Illinois
city: Skokie
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facility: Novartis Investigative Site
state: Illinois
city: Springfield
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facility: Novartis Investigative Site
state: Illinois
city: Indianapolis
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facility: Novartis Investigative Site
state: Indiana
city: Overland Park
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facility: Novartis Investigative Site
state: Kansas
city: Owensboro
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facility: Novartis Investigative Site
state: Kentucky
city: Boston
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facility: Novartis Investigative Site
state: Massachusetts
city: Fridley
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facility: Novartis Investigative Site
state: Minnesota
city: St. Louis
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facility: Novartis Investigative Site
state: Missouri
city: Henderson
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facility: Novartis Investigative Site
state: Nevada
city: Las Vegas
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facility: Novartis Investigative Site
state: Nevada
city: Verona
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facility: Novartis Investigative Site
state: New Jersey
city: Greensboro
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facility: Novartis Investigative Site
state: North Carolina
city: High Point
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Anderson
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facility: Novartis Investigative Site
state: South Carolina
city: Greer
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Goodlettsville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Vienna
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city: Wels
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city: Pleven
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city: Sofia
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city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
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city: Sofia
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city: Varna
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city: Barrie
country: Canada
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city: Oakville
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facility: Novartis Investigative Site
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city: Waterloo
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city: Windsor
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facility: Novartis Investigative Site
state: Ontario
city: Montreal
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state: Quebec
city: Hradec Kralove
country: Czech Republic
facility: Novartis Investigative Site
state: CZE
city: Prague 8
country: Czech Republic
facility: Novartis Investigative Site
state: CZE
city: Brno - Bohunice
country: Czech Republic
facility: Novartis Investigative Site
city: Ceske Budejovice
country: Czech Republic
facility: Novartis Investigative Site
city: Novy Jicin
country: Czech Republic
facility: Novartis Investigative Site
city: Prague 10
country: Czech Republic
facility: Novartis Investigative Site
city: Antony
country: France
facility: Novartis Investigative Site
city: Nice Cedex 3
country: France
facility: Novartis Investigative Site
city: Pierre-Benite Cédex
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex
country: France
facility: Novartis Investigative Site
city: Bad Wildbad
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Buchholz i. d. Nordheide
country: Germany
facility: Novartis Investigative Site
city: Dippoldiswalde-Schmiedeberg
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Düsseldorf
country: Germany
facility: Novartis Investigative Site
city: Essen
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facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Köln
country: Germany
facility: Novartis Investigative Site
city: Luebeck
country: Germany
facility: Novartis Investigative Site
city: Mahlow
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Pommelsbrunn
country: Germany
facility: Novartis Investigative Site
city: Wuppertal
country: Germany
facility: Novartis Investigative Site
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Secunderabad
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facility: Novartis Investigative Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Mangalore
country: India
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state: Karnataka
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nagpur
country: India
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state: Maharashtra
city: Nashik
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city: Roma
country: Italy
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state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Siena
country: Italy
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state: SI
city: Verona
country: Italy
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state: VR
city: Nagoya-city
country: Japan
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state: Aichi
city: Kisarazu
country: Japan
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state: Chiba
city: Fukuoka-city
country: Japan
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state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Maebashi-city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Asahikawa-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Shimotsuke-city
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Svidnik
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
state: England
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Blackpool
country: United Kingdom
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: Poole
country: United Kingdom
facility: Novartis Investigative Site
city: Hanoi
country: Vietnam
facility: Novartis Investigative Site
city: Ho Chi Minh
country: Vietnam
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.