Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
NCT ID: NCT01365455
Last Updated: 2021-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
738 participants
INTERVENTIONAL
2011-06-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AIN457 150 mg
AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
secukinumab 150 mg
secukinumab (AIN457) 150mg or 300mg subcutaneous
placebo to secukinumab 150 mg
Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
AIN457 300 mg
AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
secukinumab 150 mg
secukinumab (AIN457) 150mg or 300mg subcutaneous
placebo to secukinumab 150 mg
Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
placebo
placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
placebo to secukinumab 150 mg
Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
AIN457 150mg from Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
secukinumab 150 mg
secukinumab (AIN457) 150mg or 300mg subcutaneous
placebo to secukinumab 150 mg
Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
AIN457 300mg from Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
secukinumab 150 mg
secukinumab (AIN457) 150mg or 300mg subcutaneous
placebo to secukinumab 150 mg
Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
Interventions
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secukinumab 150 mg
secukinumab (AIN457) 150mg or 300mg subcutaneous
placebo to secukinumab 150 mg
Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Phoenix, Arizona, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Pasadena, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Boca Raton, Florida, United States
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Snellville, Georgia, United States
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Evansville, Indiana, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Ann Arbor, Michigan, United States
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Ann Arbor, Michigan, United States
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Omaha, Nebraska, United States
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New York, New York, United States
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Rochester, New York, United States
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Oregon City, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Duncansville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Bryan, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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Mendoza, , Argentina
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Moncton, New Brunswick, Canada
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Hamilton, Ontario, Canada
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Peterborough, Ontario, Canada
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Waterloo, Ontario, Canada
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Montreal, Quebec, Canada
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Barranquilla, Atlántico, Colombia
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Bucaramanga, , Colombia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Kopavogur, , Iceland
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Afula, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Maebashi, Gunma, Japan
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Asahikawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Inashiki-gun, Ibaraki, Japan
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Isehara, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Bunkyo-ku, Tokyo, Japan
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Chiyoda-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Kyoto, , Japan
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Daugavpils, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Ventspils, , Latvia
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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Zapopan, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Taoyuan District, Taiwan, Taiwan
Novartis Investigative Site
Taichung, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Plain Language Trial Summaries available on novartisclinicaltrials.com
Other Identifiers
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2010-023512-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A2302
Identifier Type: -
Identifier Source: org_study_id
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