Clinical trial NCT01365455: Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
Official title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Plaque-type Psoriasis
Keywords: Psoriasis
plaque
plaque-type psoriasis
IL-17 blocker
subcutaneous
psoriatic arthritis
injection
AIN457
AIN457A
secukinumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 738
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 secukinumab compared to placebo 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 psoriasis disease meeting all of the following three criteria:
* Psoriasis Area and Severity Index (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.
* Subjects not willing to limit UV light exposure during the study Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks
timeFrame: 12 weeks
measure: Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12
timeFrame: 12 weeks
measure: Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12
timeFrame: 12 and 52 weeks
measure: Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12
timeFrame: 12 and 52 weeks
measure: Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
timeFrame: Week 12
measure: Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period
timeFrame: Week 1,2,3,4,8,12,
measure: Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52
timeFrame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52
measure: Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period
timeFrame: Baseline, Week 1,2,3,4,8,12,
measure: Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52
timeFrame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52
measure: Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period
timeFrame: Baseline, Week 1,2,3,4,8,12,
measure: Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52
timeFrame: Week 13,14,15,16,20,24,28,32,36,40,44,48,52
measure: Time to PASI 75 Response up to 12 Weeks
timeFrame: Week 12
measure: Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period
timeFrame: Baseline, Week 4,8, 12
measure: Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period
timeFrame: Week 12, 24, 36, 52
measure: Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period
timeFrame: Baseline, Week 4, 8 & 12
measure: Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period
timeFrame: Week 12,24, 36 & 52
measure: Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period
timeFrame: Week 4, 8, 12
measure: Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period
timeFrame: Week 12,24,36, & 52
measure: Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy
timeFrame: Week 12
measure: Number of Participants Who Developed Anti-secukinumab Antibodies
timeFrame: Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Oceanside
country: United States
facility: Novartis Investigative Site
state: California
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Boca Raton
country: United States
facility: Novartis Investigative Site
state: Florida
city: Snellville
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Evansville
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Ann Arbor
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Ann Arbor
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Oregon City
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Duncansville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Bryan
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
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: Norfolk
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Peterborough
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Waterloo
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
state: Atlantico
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
city: Bucaramanga
country: Colombia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Kopavogur
country: Iceland
facility: Novartis Investigative Site
city: Afula
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kurume
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: Kobe-City
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Inashiki-gun
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Isehara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sagamihara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-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: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Ventspils
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: México
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: México
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo León
city: Hsin Chu
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmceuticals
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: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: Ohtsuki M, Morita A, Abe M, Takahashi H, Seko N, Karpov A, Shima T, Papavassilis C, Nakagawa H; ERASURE Study Japanese subgroup. Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study. J Dermatol. 2014 Dec;41(12):1039-46. doi: 10.1111/1346-8138.12668. Epub 2014 Oct 30.
citation: 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.