Plaque Psoriasis Efficacy and Safety With Secukinumab

NCT02409667 | Completed Phase 3 Results

• 1 other identifier: CAIN457A3302
• Study Type: interventional
• Target: 16,487
• Locations: 24 countries
• Sites: 200

Brief Summary

To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.

Conditions

Plaque Psoriasis

Keywords

plaque, psoriasis

Outcome Measures

Primary Outcomes (1)

• Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24

  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).

  Week 52

Secondary Outcomes (15)

• Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24

  Week 52

• PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24

  week 52

• PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24

  Week 52

• Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24

  Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52

• Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24

  Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52

Study Arms (4)

Secukinumab 300mg in PASI 90 responders (every 4 weeks)

ACTIVE COMPARATOR

Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.

Biological: Secukinumab

Secukinumab 300mg in PASI 90 responders (longer intervals)

EXPERIMENTAL

Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 6 weeks.

Biological: Secukinumab

Secukinumab 300mg in PASI 75-90 responders (every 4 weeks)

EXPERIMENTAL

Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks will be treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.

Biological: Secukinumab

Secukinumab 300mg in PASI 75-90 responders (shorter intervals)

ACTIVE COMPARATOR

Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 2 weeks.

Biological: Secukinumab

Interventions

Secukinumab BIOLOGICAL

Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.

Secukinumab 300mg in PASI 75-90 responders (every 4 weeks); Secukinumab 300mg in PASI 75-90 responders (shorter intervals); Secukinumab 300mg in PASI 90 responders (every 4 weeks); Secukinumab 300mg in PASI 90 responders (longer intervals)

Eligibility Criteria

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

You may qualify if:

• Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy.
• Moderate to severe psoriasis at Baseline as evidenced by:
• PASI ≥ 10 and
• IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and
• BSA affected by plaque-type psoriasis of ≥ 10%.

You may not qualify if:

• History of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (TNF) alpha, anti interleukin (IL)12/23, or any anti-IL 17A or IL 17A receptor (IL 17AR) antibody.
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
• Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis).
• Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
• Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy).
• Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study drug.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 5 mIU/mL).
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study drug and for 16 weeks after stopping study drug.
• Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy.
• Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (200)

Novartis Investigative Site

Innsbruck, 6020, Austria

Location

Novartis Investigative Site

Linz, A-4020, Austria

Location

Novartis Investigative Site

Vienna, 1090, Austria

Location

Novartis Investigative Site

Vienna, A 1090, Austria

Location

Novartis Investigative Site

Jette, Brussels Capital, 1090, Belgium

Location

Novartis Investigative Site

Brussels, 1070, Belgium

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Loverval, 6280, Belgium

Location

Novartis Investigative Site

Sofia, BGR, 1431, Bulgaria

Location

Novartis Investigative Site

Pleven, 5800, Bulgaria

Location

Novartis Investigative Site

Plovdiv, 4002, Bulgaria

Location

Novartis Investigative Site

Sofia, 1404, Bulgaria

Location

Novartis Investigative Site

Sofia, 1407, Bulgaria

Location

Novartis Investigative Site

Stara Zagora, 6000, Bulgaria

Location

Novartis Investigative Site

Varna, 9000, Bulgaria

Location

Novartis Investigative Site

Ivanić-Grad, 10310, Croatia

Location

Novartis Investigative Site

Osijek, 31000, Croatia

Location

Novartis Investigative Site

Zagreb, 10000, Croatia

Location

Novartis Investigative Site

Brno, Czech Republic, 656 91, Czechia

Location

Novartis Investigative Site

Ostrava Poruba, Czech Republic, 708 52, Czechia

Location

Novartis Investigative Site

Prague, Czech Republic, 180 00, Czechia

Location

Novartis Investigative Site

Olomouc, 775 20, Czechia

Location

Novartis Investigative Site

Prague, 100 34, Czechia

Location

Novartis Investigative Site

Prague, 12808, Czechia

Location

Novartis Investigative Site

Arhus C, DK-8000, Denmark

Location

Novartis Investigative Site

Hellerup, DK-2900, Denmark

Location

Novartis Investigative Site

Tampere, 33100, Finland

Location

Novartis Investigative Site

Turku, FIN-20100, Finland

Location

Novartis Investigative Site

Le Mans, Cedex 09, 72037, France

Location

Novartis Investigative Site

Bordeaux, 33075, France

Location

Novartis Investigative Site

Dijon, 21079, France

Location

Novartis Investigative Site

Grenoble, 38043, France

Location

Novartis Investigative Site

Lille, 59000, France

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Nice, 06202, France

Location

Novartis Investigative Site

Rouen, 76031, France

Location

Novartis Investigative Site

Saint-Etienne, 42055, France

Location

Novartis Investigative Site

Toulouse, 31400, France

Location

Novartis Investigative Site

Trévenans, 90400, France

Location

Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511, France

Location

Novartis Investigative Site

Augsburg, 86179, Germany

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Berlin, 10783, Germany

Location

Novartis Investigative Site

Bochum, 44793, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Braunschweig, 38100, Germany

Location

Novartis Investigative Site

Dresden, 01069, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Düsseldorf, 40212, Germany

Location

Novartis Investigative Site

Düsseldorf, D 40225, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Göttingen, 37075, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Hamburg, 20354, Germany

Location

Novartis Investigative Site

Hamburg, 22391, Germany

Location

Novartis Investigative Site

Hanau, 63450, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Lübeck, 23538, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Osnabrück, 49074, Germany

Location

Novartis Investigative Site

Pommelsbrunn, 91224, Germany

Location

Novartis Investigative Site

Schwerin, 19055, Germany

Location

Novartis Investigative Site

Stade, 21682, Germany

Location

Novartis Investigative Site

Stuttgart, 70178, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Larissa, GR, 411 10, Greece

Location

Novartis Investigative Site

Thessaloniki, GR, 546 29, Greece

Location

Novartis Investigative Site

Athens, 161 21, Greece

Location

Novartis Investigative Site

Thessaloniki, 546 43, Greece

Location

Novartis Investigative Site

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Novartis Investigative Site

Budapest, 1085, Hungary

Location

Novartis Investigative Site

Debrecen, 4032, Hungary

Location

Novartis Investigative Site

Kaposvár, 7400, Hungary

Location

Novartis Investigative Site

Pécs, 7632, Hungary

Location

Novartis Investigative Site

Szeged, 6725, Hungary

Location

Novartis Investigative Site

Afula, 1834111, Israel

Location

Novartis Investigative Site

Haifa, 3109601, Israel

Location

Novartis Investigative Site

Petah Tikva, 49100, Israel

Location

Novartis Investigative Site

Ramat Gan, 5265601, Israel

Location

Novartis Investigative Site

Tel Aviv, 64239, Israel

Location

Novartis Investigative Site

Bolzano, BZ, 39100, Italy

Location

Novartis Investigative Site

Messina, ME, 98125, Italy

Location

Novartis Investigative Site

Modena, MO, 41124, Italy

Location

Novartis Investigative Site

Palermo, PA, 90127, Italy

Location

Novartis Investigative Site

Roma, RM, 00189, Italy

Location

Novartis Investigative Site

Daugavpils, LVA, LV-5404, Latvia

Location

Novartis Investigative Site

Riga, LVA, LV-1003, Latvia

Location

Novartis Investigative Site

Ventspils, LVA, LV-3601, Latvia

Location

Novartis Investigative Site

Riga, 1012, Latvia

Location

Novartis Investigative Site

Riga, LV-1001, Latvia

Location

Novartis Investigative Site

Kaunas, LTU, LT 50161, Lithuania

Location

Novartis Investigative Site

Klaipėda, LTU, 92304, Lithuania

Location

Novartis Investigative Site

Kaunas, LT, 47144, Lithuania

Location

Novartis Investigative Site

Vilnius, LT-07195, Lithuania

Location

Novartis Investigative Site

Vilnius, LT-08661, Lithuania

Location

Novartis Investigative Site

Breda, CK, 4818, Netherlands

Location

Novartis Investigative Site

Alkmaar, 1817 MS, Netherlands

Location

Novartis Investigative Site

Almere Stad, 1315 RA, Netherlands

Location

Novartis Investigative Site

Bergen op Zoom, 4624 VT, Netherlands

Location

Novartis Investigative Site

Geldrop, 5664 EH, Netherlands

Location

Novartis Investigative Site

Leiderdorp, 2353 GA, Netherlands

Location

Novartis Investigative Site

Sittard-Geleen, 6162 BG, Netherlands

Location

Novartis Investigative Site

Voorburg, 2275 CX, Netherlands

Location

Novartis Investigative Site

Krakow, 31-501, Poland

Location

Novartis Investigative Site

Lodz, 90-265, Poland

Location

Novartis Investigative Site

Lodz, 90-436, Poland

Location

Novartis Investigative Site

Lublin, 20-079, Poland

Location

Novartis Investigative Site

Olsztyn, 10-045, Poland

Location

Novartis Investigative Site

Ossy, 42 624, Poland

Location

Novartis Investigative Site

Poznan, 60 529, Poland

Location

Novartis Investigative Site

Warsaw, 02-507, Poland

Location

Novartis Investigative Site

Warsaw, 04141, Poland

Location

Novartis Investigative Site

Wroclaw, 50-368, Poland

Location

Novartis Investigative Site

Braga, 4710243, Portugal

Location

Novartis Investigative Site

Coimbra, 3000 075, Portugal

Location

Novartis Investigative Site

Leiria, 2410-187, Portugal

Location

Novartis Investigative Site

Porto, 4099-001, Portugal

Location

Novartis Investigative Site

Porto, 4200 319, Portugal

Location

Novartis Investigative Site

Vila Nova de Gaia, 4434 502, Portugal

Location

Novartis Investigative Site

Chelyabinsk, 454092, Russia

Location

Novartis Investigative Site

Kazan', 420012, Russia

Location

Novartis Investigative Site

Moscow, 107076, Russia

Location

Novartis Investigative Site

Rostov on Don Region, 346880, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194021, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194044, Russia

Location

Novartis Investigative Site

Bojnice, 972 01, Slovakia

Location

Novartis Investigative Site

Bratislava, 841 04, Slovakia

Location

Novartis Investigative Site

Košice, 04001, Slovakia

Location

Novartis Investigative Site

Považská Bystrica, 017 26, Slovakia

Location

Novartis Investigative Site

Svidník, 08901, Slovakia

Location

Novartis Investigative Site

Villajoyosa, Alicante, 703570, Spain

Location

Novartis Investigative Site

Córdoba, Andalusia, 14004, Spain

Location

Novartis Investigative Site

Granada, Andalusia, 18016, Spain

Location

Novartis Investigative Site

Málaga, Andalusia, 29009, Spain

Location

Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

Location

Novartis Investigative Site

Seville, Andalusia, 41009, Spain

Location

Novartis Investigative Site

Seville, Andalusia, 41013, Spain

Location

Novartis Investigative Site

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Sant Joan Despí, Barcelona, 08970, Spain

Location

Novartis Investigative Site

Bilbao, Basque Country, 48013, Spain

Location

Novartis Investigative Site

Santander, Cantabria, 39008, Spain

Location

Novartis Investigative Site

León, Castille and León, 24071, Spain

Location

Novartis Investigative Site

Salamanca, Castille and León, 37007, Spain

Location

Novartis Investigative Site

Badalona, Catalonia, 08916, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

A Coruña, Galicia, 15006, Spain

Location

Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

Location

Novartis Investigative Site

Las Palmas de Gran Canaria, Las Palmas de G.C, 35010, Spain

Location

Novartis Investigative Site

Alcorcón, Madrid, 28922, Spain

Location

Novartis Investigative Site

Fuenlabrada, Madrid, 28942, Spain

Location

Novartis Investigative Site

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Novartis Investigative Site

Mallorca, Mallorca, 07500, Spain

Location

Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

Location

Novartis Investigative Site

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Novartis Investigative Site

Alicante, Valencia, 03010, Spain

Location

Novartis Investigative Site

Alzira, Valencia, 46600, Spain

Location

Novartis Investigative Site

Castellon, Valencia, 12005, Spain

Location

Novartis Investigative Site

Manises, Valencia, 46940, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46014, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46015, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46017, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46026, Spain

Location

Novartis Investigative Site

Barakaldo, Vizcaya, 48903, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Novartis Investigative Site

Huesca, 22004, Spain

Location

Novartis Investigative Site

Madrid, 28006, Spain

Location

Novartis Investigative Site

Madrid, 28007, Spain

Location

Novartis Investigative Site

Madrid, 28031, Spain

Location

Novartis Investigative Site

Madrid, 28034, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

Novartis Investigative Site

Madrid, 28222, Spain

Location

Novartis Investigative Site

Murcia, 30003, Spain

Location

Novartis Investigative Site

Pontevedra, 36003, Spain

Location

Novartis Investigative Site

Zaragoza, 50009, Spain

Location

Novartis Investigative Site

Falun, 791 82, Sweden

Location

Novartis Investigative Site

Malmo, SE-205 02, Sweden

Location

Novartis Investigative Site

Stockholm, 171 76, Sweden

Location

Novartis Investigative Site

Stockholm, SE-118 83, Sweden

Location

Novartis Investigative Site

Uppsala, 751 85, Sweden

Location

Novartis Investigative Site

Basel, 4031, Switzerland

Location

Novartis Investigative Site

Geneva, 1211, Switzerland

Location

Novartis Investigative Site

Lausanne, 1011, Switzerland

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Novartis Investigative Site

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Novartis Investigative Site

Salford, Manchester, M6 8HD, United Kingdom

Location

Novartis Investigative Site

Cliftonville, Northampton, NN1 5BD, United Kingdom

Location

Novartis Investigative Site

Cannock, Staffordshire, WS11 2XY, United Kingdom

Location

Novartis Investigative Site

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

Novartis Investigative Site

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

Novartis Investigative Site

Cambridge, CB7 5JD, United Kingdom

Location

Novartis Investigative Site

Harrogate, HG2 7SX, United Kingdom

Location

MeSH Terms

Conditions

Plaque, Amyloid; Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 7, 2015
• Study Start: May 7, 2015
• Primary Completion: March 14, 2017
• Study Completion: May 8, 2017
• Last Updated: May 13, 2019
• Results First Posted: May 13, 2019

Record last verified: 2019-02

Locations

HU (6); ES (49); IT (5); SE (5); CH (4); CR (3); CZ (6); FI (2); GR (4); IL (5); FR (12); DE (27); AU (4); LA (5); LI (5); PL (10); PT (6); RU (6); GB (8); BE (6); DK (2); SL (5); BU (7); NL (8)