Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year

NCT01365455 | Completed Phase 3 Results

• 2 other identifiers: CAIN457A23022010-023512-13
• Study Type: interventional
• Target: 738
• Locations: 12 countries
• Sites: 88

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.

Conditions

Moderate to Severe Plaque-type Psoriasis

Keywords

Psoriasis; plaque; plaque-type psoriasis; IL-17 blocker; subcutaneous; psoriatic arthritis; injection; AIN457; AIN457A; secukinumab

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks

  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. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

  12 weeks

• Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1

  The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. IGA score of 0 or 1 as an indicator of efficacy.

  12 weeks

Secondary Outcomes (19)

• Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12

  12 weeks

• 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

  12 and 52 weeks

• 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

  12 and 52 weeks

• Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo

  Week 12

• Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period

  Week 1,2,3,4,8,12,

Study Arms (5)

AIN457 150 mg

EXPERIMENTAL

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

Drug: secukinumab 150 mg; Drug: placebo to secukinumab 150 mg

AIN457 300 mg

EXPERIMENTAL

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

Drug: secukinumab 150 mg; Drug: placebo to secukinumab 150 mg

placebo

PLACEBO COMPARATOR

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.

Drug: placebo to secukinumab 150 mg

AIN457 150mg from Placebo

EXPERIMENTAL

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.

Drug: secukinumab 150 mg; Drug: placebo to secukinumab 150 mg

AIN457 300mg from Placebo

EXPERIMENTAL

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.

Drug: secukinumab 150 mg; Drug: placebo to secukinumab 150 mg

Interventions

secukinumab 150 mg DRUG

secukinumab (AIN457) 150mg or 300mg subcutaneous

AIN457 150 mg; AIN457 150mg from Placebo; AIN457 300 mg; AIN457 300mg from Placebo

placebo to secukinumab 150 mg DRUG

Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous

AIN457 150 mg; AIN457 150mg from Placebo; AIN457 300 mg; AIN457 300mg from Placebo; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (88)

Novartis Investigative Site

Birmingham, Alabama, 35205, United States

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Novartis Investigative Site

Birmingham, Alabama, 35233, United States

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Novartis Investigative Site

Phoenix, Arizona, 85032, United States

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Novartis Investigative Site

Los Angeles, California, 90045, United States

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Novartis Investigative Site

Oceanside, California, 92056, United States

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Pasadena, California, 91105, United States

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San Diego, California, 92123, United States

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Colorado Springs, Colorado, 80915, United States

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Novartis Investigative Site

Boca Raton, Florida, 33486, United States

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Novartis Investigative Site

Snellville, Georgia, 30078, United States

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Novartis Investigative Site

Evansville, Indiana, 47713, United States

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Topeka, Kansas, 66606, United States

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Novartis Investigative Site

Louisville, Kentucky, 40202, United States

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Novartis Investigative Site

Louisville, Kentucky, 40291, United States

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Ann Arbor, Michigan, 48103, United States

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Novartis Investigative Site

Ann Arbor, Michigan, 48109, United States

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Omaha, Nebraska, 68144, United States

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New York, New York, 10029, United States

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Rochester, New York, 14623, United States

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Oregon City, Oregon, 97045, United States

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Portland, Oregon, 97210, United States

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Portland, Oregon, 97223, United States

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Duncansville, Pennsylvania, 16635, United States

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Philadelphia, Pennsylvania, 19104, United States

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Charleston, South Carolina, 29407, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78759, United States

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Bryan, Texas, 77802, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75246-1613, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84117, United States

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Norfolk, Virginia, 23507, United States

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CABA, Buenos Aires, C1122AAF, Argentina

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CABA, Buenos Aires, C1181ACH, Argentina

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CABA, Buenos Aires, C1425AWC, Argentina

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Mendoza, M5502EZA, Argentina

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Moncton, New Brunswick, E1C 8X3, Canada

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Hamilton, Ontario, L8N 1V6, Canada

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Peterborough, Ontario, K9J 5K2, Canada

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Waterloo, Ontario, N2J 1C4, Canada

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Montreal, Quebec, H3H 1V4, 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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Novartis Investigative Site

Tallinn, 10138, Estonia

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Novartis Investigative Site

Tallinn, 10617, Estonia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Kopavogur, IS-201, Iceland

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Afula, 18101, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 52621, Israel

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Novartis Investigative Site

Nagoya, Aichi-ken, 467-8602, Japan

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Fukuoka, Fukuoka, 814-0180, Japan

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Novartis Investigative Site

Kurume, Fukuoka, 830-0011, Japan

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Novartis Investigative Site

Maebashi, Gunma, 371-8511, Japan

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Asahikawa, Hokkaido, 078-8510, Japan

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Novartis Investigative Site

Sapporo, Hokkaido, 060-0063, Japan

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Novartis Investigative Site

Kobe, Hyōgo, 654-0155, Japan

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Inashiki-gun, Ibaraki, 300-0395, Japan

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Isehara, Kanagawa, 259-1193, Japan

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Kawasaki, Kanagawa, 213-8507, Japan

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Sagamihara, Kanagawa, 228-8522, Japan

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Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8655, Japan

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Novartis Investigative Site

Chiyoda-ku, Tokyo, 102-8798, Japan

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Novartis Investigative Site

Minato-ku, Tokyo, 105-8471, Japan

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Novartis Investigative Site

Shinagawa-ku, Tokyo, 141-8625, Japan

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Shinjuku-ku, Tokyo, 160-0023, Japan

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Shinjuku-ku, Tokyo, 160-8582, Japan

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Kyoto, 602-8566, Japan

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Daugavpils, LV-5404, Latvia

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Riga, 1012, Latvia

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Riga, LV-1001, Latvia

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Ventspils, LV-3601, Latvia

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Novartis Investigative Site

Kaunas, 50009, Lithuania

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Novartis Investigative Site

Klaipėda, 92304, Lithuania

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Novartis Investigative Site

Vilnius, LT-07195, Lithuania

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Novartis Investigative Site

Vilnius, LT-08661, Lithuania

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Novartis Investigative Site

Zapopan, Jalisco, 45190, Mexico

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Novartis Investigative Site

Mexico City, Mexico City, 06780, Mexico

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Novartis Investigative Site

Mexico City, Mexico City, 14050, Mexico

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Novartis Investigative Site

Monterrey, Nuevo León, 64460, Mexico

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Novartis Investigative Site

Taoyuan District, Taiwan, Taiwan

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Novartis Investigative Site

Taichung, 40447, Taiwan

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Novartis Investigative Site

Taipei, 10002, Taiwan

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Related Publications (9)

• 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.

  PMID: 37341961 DERIVED

• 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.

  PMID: 35305260 DERIVED

• 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.

  PMID: 34110605 DERIVED

• 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.

  PMID: 33748660 DERIVED

• 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.

  PMID: 27576559 DERIVED

• 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.

  PMID: 27573260 DERIVED

• 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.

  PMID: 26267726 DERIVED

• 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.

  PMID: 25354738 DERIVED

• 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.

  PMID: 25007392 DERIVED

Related Links

• Plain Language Trial Summaries available on novartisclinicaltrials.com

MeSH Terms

Conditions

Psoriasis; Plaque, Amyloid; Arthritis, Psoriatic

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis Pharmceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 3, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 5, 2021
• Results First Posted: May 29, 2015

Record last verified: 2019-03

Locations

LA (4); CA (5); IL (3); CO (4); JP (18); US (34); LI (4); ME (4); IC (1); TW (3); ES (4); AR (4)