Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens

NCT01406938 | Completed Phase 3 Results DMC

• 2 other identifiers: CAIN457A23042011-000767-27
• Study Type: interventional
• Target: 967
• Locations: 16 countries
• Sites: 131

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.

Conditions

Moderate to Severe Plaque-type Psoriasis

Keywords

Psoriasis; plaque; inflammatory skin disease; scaly patches; AIN457; secukinumab; Moderate to Severe Plaque-type Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

  PASI: 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)

  Week 40 , week 52

Secondary Outcomes (16)

• 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

  Baseline, week 2, 3 , 4, 8, 12

• 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

  Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52

• 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)

  Baseline, week 2, 4, 6, 8, 12

• 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))

  Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52

• Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)

  Baseline to week 2, 4, 8, 12

Study Arms (6)

AIN457150 mg- Induction period Only(IPO)

EXPERIMENTAL

secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)

Drug: AIN457 150mg

AIN457 300 mg - IPO

EXPERIMENTAL

secukinumab- 2 x 150mg injections per dose

Drug: AIN457 300mg

AIN457 150 mg - Fixed Interval (FI)

EXPERIMENTAL

1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection

Drug: AIN457 150mg

AIN457 300 mg FI

EXPERIMENTAL

2 s.c. secukinumab 150 mg injections

Drug: AIN457 300mg

AIN457 150 mg- Start of relapse (SoR)

EXPERIMENTAL

1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection

Drug: AIN457 150mg

AIN457 300 mg- SoR

EXPERIMENTAL

2 s.c. secukinumab 150 mg injections

Drug: AIN457 300mg

Interventions

AIN457 150mg DRUG

(1 injection per dose) and placebo to secukinumab 150 mg

Also known as: secukinumab 150 mg

AIN457 150 mg - Fixed Interval (FI); AIN457 150 mg- Start of relapse (SoR); AIN457150 mg- Induction period Only(IPO)

AIN457 300mg DRUG

secukinumab 150 mg (2 injections per dose)

Also known as: secukinumab

AIN457 300 mg - IPO; AIN457 300 mg FI; AIN457 300 mg- SoR

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 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.

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 (131)

Novartis Investigative Site

Fresno, California, 93710, United States

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Pasadena, California, 91105, United States

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Sacramento, California, 95817, United States

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San Francisco, California, 94118, United States

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Jacksonville, Florida, 32204, United States

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Jacksonville, Florida, 32216, United States

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Miami, Florida, 33136, United States

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Naples, Florida, 34119, United States

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South Miami, Florida, 33143, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30342, United States

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Champaign, Illinois, 61820, United States

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Skokie, Illinois, 60077, United States

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Springfield, Illinois, 62703, United States

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Indianapolis, Indiana, 46256, United States

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Overland Park, Kansas, 66215, United States

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Owensboro, Kentucky, 42301, United States

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Boston, Massachusetts, 02111, United States

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Fridley, Minnesota, 55432, United States

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St Louis, Missouri, 63117, United States

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Henderson, Nevada, 89052, United States

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Las Vegas, Nevada, 89119, United States

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Verona, New Jersey, 07044, United States

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Greensboro, North Carolina, 27401, United States

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High Point, North Carolina, 27262, United States

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Winston-Salem, North Carolina, 27103, United States

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Anderson, South Carolina, 29621, United States

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Greer, South Carolina, 29651, United States

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Goodlettsville, Tennessee, 37072-2301, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84124, United States

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Wels, Austria, 4600, Austria

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Graz, A-8036, Austria

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Linz, A-4010, Austria

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Vienna, A-1220, Austria

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Sofia, Bulgaria, 1606, Bulgaria

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Pleven, 5800, Bulgaria

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Sofia, 1231, Bulgaria

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Sofia, 1404, Bulgaria

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Sofia, 1431, Bulgaria

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Varna, 9010, Bulgaria

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Barrie, Ontario, L4M 6L2, Canada

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Oakville, Ontario, L6J 7W5, Canada

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Waterloo, Ontario, N2J 1C4, Canada

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Windsor, Ontario, N8W 1E6, Canada

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Montreal, Quebec, H2K 4L5, Canada

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Brno-Bohunice, Czech Republic, 625 00, Czechia

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Hradec Králové, CZE, 500 05, Czechia

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Prague, CZE, 180 81, Czechia

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České Budějovice, 370 01, Czechia

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Nový Jičín, 741 01, Czechia

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Prague, 100 34, Czechia

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Toulouse, France, 31059, France

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Antony, 92160, France

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Nice, 06202, France

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Pierre-Benite Cédex, F-69495, France

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Rouen, 76031, France

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Münster, Germany, 48149, Germany

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Bad Wildbad, 75323, Germany

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Bochum, 44803, Germany

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Buchholz I. D. Nordheide, 21244, Germany

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Cologne, 50937, Germany

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Dippoldiswalde-Schmiedeberg, 01744, Germany

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Duisburg, 47167, Germany

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Düsseldorf, 40225, Germany

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Essen, 45147, Germany

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Frankfurt, 60590, Germany

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Freiburg im Breisgau, 79104, Germany

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Hamburg, 20246, Germany

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Hamburg, 22143, Germany

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Hamburg, 22391, Germany

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Hanover, 30625, Germany

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Kiel, 24105, Germany

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Lübeck, 23538, Germany

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Mahlow, 15831, Germany

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Mainz, 55131, Germany

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Mannheim, 68167, Germany

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Pommelsbrunn, 91224, Germany

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Wuppertal, 42103, Germany

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Hyderabad, Andhra Pradesh, 500 058, India

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Secunderabad, Andhra Pradesh, 500 094, India

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Bangalore, Karnataka, 560054, India

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Mangalore, Karnataka, 575 004, India

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Mumbai, Maharashtra, 400 008, India

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Nagpur, Maharashtra, 440 010, India

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Nagpur, Maharashtra, 440013, India

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Nagpur, Maharashtra, India

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Nashik, Maharashtra, India

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Roma, RM, 00133, Italy

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Roma, RM, 00144, Italy

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Siena, SI, 53100, Italy

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Verona, VR, 37126, Italy

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Nagoya, Aichi-ken, 467-8602, Japan

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Kisarazu, Chiba, 292-8535, Japan

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Fukuoka, Fukuoka, 815-8588, Japan

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Kitakyushu, Fukuoka, 800-0296, Japan

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Maebashi, Gunma, 371-8511, Japan

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Asahikawa, Hokkaido, 078-8510, Japan

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Sapporo, Hokkaido, 060-0033, Japan

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Osaka, Osaka, 550-0012, Japan

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Shimotsuke, Tochigi, 329-0498, Japan

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Chiyoda-ku, Tokyo, 102-8798, Japan

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Hachiōji, Tokyo, 193-0998, Japan

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Itabashi-ku, Tokyo, 173-8610, Japan

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Minato-ku, Tokyo, 105-8471, 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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Lodz, 90-265, Poland

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Poznan, 60-539, Poland

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Wroclaw, 50-368, Poland

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Singapore, Singapore, 119074, Singapore

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Singapore, Singapore, 308205, Singapore

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Košice, Slovak Republic, 040 15, Slovakia

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Košice, Slovakia, 04011, Slovakia

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Poprad, Slovakia, 05845, Slovakia

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Svidník, Slovakia, 089 01, Slovakia

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Žilina, Slovakia, 01207, Slovakia

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Bratislava, SK-81369, Slovakia

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Bern, 3010, Switzerland

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Lausanne, 1011, Switzerland

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Zurich, 8091, Switzerland

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London, England, E11 1NR, United Kingdom

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Birmingham, B15 2TH, United Kingdom

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Blackpool, FY3 7EN, United Kingdom

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Leicester, LE7 5WW, United Kingdom

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Poole, BH15 2JB, United Kingdom

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Hanoi, Vietnam, 1000, Vietnam

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Hanoi, 1000, Vietnam

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Novartis Investigative Site

Ho Chi Minh City, 7000, Vietnam

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Related Publications (2)

• 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

• 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

MeSH Terms

Conditions

Psoriasis; Plaque, Amyloid; Dermatitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

A limitation of this study is the lack of a placebo group; however, because the placebo response is very low in psoriasis, it is inappropriate to maintain patients on placebo for 52 weeks. .

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceutical

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  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: July 12, 2011
• First Posted: August 1, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 19, 2015
• Results First Posted: May 19, 2015

Record last verified: 2015-04

Locations

GB (5); CA (5); IN (9); IT (4); CH (3); DE (22); SL (6); BU (6); CZ (6); PL (3); JP (15); AU (4); SG (2); US (33); VN (3); FR (5)