Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis (STATURE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01412944
First received: August 5, 2011
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.


Condition Intervention Phase
Plaque-type Psoriasis
Drug: secukinumab 150mg
Drug: secukinumab 10mg/kg i.v. regimen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy of intravenous administration of secukinumab compared with subcutaneous administration secukinumab with respect to both PASI 75 and IGA 0 or 1 response. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of a higher dose of secukinumab than administered in CAIN457A2304 in achieving PASI 75 or IGA 0 or 1 response over time. [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
  • Efficacy of secukinumab treatment regimens in subjects with respect to PASI 50/75/90/100 response and IGA 0 or 1 response overtime. [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
  • Efficacy treatment regimens with secukinumab with respect to PASI score and IGA mod 2011 score over time. [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
  • Safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, ECGs and adverse events monitoring. [ Time Frame: (Vital signs, Clinical lab variables and AE monitoring) randomization, Wk 2,Wk4,Wk8,Wk12, Wk16, Wk 20, Wk 24,Wk 28,Wk 28,Wk 32,Wk 36,Wk 40,Wk 44,Wk 48 and unscheduled visits. For ECGs, randomization, Wk 8, Wk 24, Wk 40, Wk 48 and unscheduled visits. ] [ Designated as safety issue: Yes ]
  • Effects of treatment regimens with secukinubab with respect to the dermatology life quality index (DLQI) 0 or 1 achievement. [ Time Frame: Randomization, Week 8, Week 16, Week 24, Week 32,up to Week 40 ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: November 2011
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: secukinumab
secukinumab 150 mg (2 injections per dose)
Drug: secukinumab 150mg
secukinumab 150mg(2 injections per dose)
Experimental: secukinumab 10mg/kg i.v. regimen
secukinumab 10mg/kg i.v. regimen
Drug: secukinumab 10mg/kg i.v. regimen
secukinumab 10mg/kg i.v. regimen

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Written Informed Consent must be obtained before any assessment is performed,
  • Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
  • Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.

A partial response is defined as having achieved ≥ PASI 50 but < 75 response.

Exclusion criteria

  • Pregnant women or lactating women
  • Forms of psoriasis other than chronic plaque -type
  • Ongoing use of prohibited psoriasis treatments
  • Ongoing use of other non-psoriasis prohibited treatments
  • Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
  • Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
  • UV therapy or excessive exposure to sunlight
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412944

  Hide Study Locations
Locations
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63117
United States, North Carolina
Pharmquest
Greensboro, North Carolina, United States, 27408
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States
Austria
Novartis Investigative Site
Graz, Austria, 8036
Krankenhaus der Elisabethinen
Linz, Austria, A-401
Donauspital im SMZ Ost
Vienna, Austria, A-1220
Klinikum Wels
Wels, Austria, 460
Bulgaria
UMHAT Dr. Georgi Stranski, EAD
Pleven, Bulgaria, 580
Diagnostic-consulting Centre XXIV - Sofia, OOD
Sofia, Bulgaria, 1231
Military Medical Academy
Sofia, Bulgaria, 160
UMHAT Alexandrovska
Sofia, Bulgaria, 1431
MHAT Stara Zagora
Stara Zagora, Bulgaria, 6000
Hospital Base for Active Treatment at MMA-Varna
Varna, Bulgaria, 8000
Canada, Ontario
Novartis Investigative Site
Barrie, Ontario, Canada, L4M6L2
Mediprobe Research Inc.
London, Ontario, Canada, ON N5X 2P1
XLR8 Medical Research Inc.
Windsor, Ontario, Canada, ON N8W 1E6
Canada
Ultranova Skincare
Barrie, Canada, ON L4M 6L2
Innovaderm Recherches Inc.
Montreal, Canada, QC H2K 4L5
Inst. of Cosmetic and Laser Surgery
Oakville, Canada, ON L6J 7W5
Probity Medical Research
Waterloo, Canada, ON N2J 1C4
Czech Republic
FN Brno - Bohunice
Brno - Bohunice, Czech Republic, 62500
Dermatovenerologie Rendlova s.r.o
Ceske Budejovice, Czech Republic, 37001
Faculty Hospital Hradec Kralove
Hradec Kralove, Czech Republic, 50005
Nemocnice s poliklinikou v Novem Jicine
Novy Jicin, Czech Republic, 741 01
FNKV
Prague, Czech Republic, 10, 100 34
Novartis Investigative Site
Praha 10, Czech Republic, 10034
France
Hopital de l'Archet 2
Nice Cedex, France, 3,6202
Centre Hospitalier Lyon-Sud
Pierre-Benite, France, F-69495
Hopital Charles Nicolle
Rouen, France, 76031
CHU - Hopital Purpan
Toulouse, France, 31059
Germany
Facharzt f. Haut- und Geschlechtskrankheiten
Bad Wildbad, Germany, 75323
Gemeinschaftspraxis
Bochum, Germany, 44803
Novartis Investigational Site
Buchholz i. d. Nordheide, Germany, 21244
Unersitaetsklinnikum Duesseldorf
Duesseldorf, Germany, 40225
St. Barbara Hospital, Abteilung Dermatologie
Duisburg, Germany, 47167
Univ.-Klinikum Essen
Essen, Germany, 45122
Universitaetsklinikum Frankfurt
Frankfurt, Germany, 60590
Universitatshautklinik
Freiburg i. Br, Germany, 79104
Clinical Research Hamburg GmbH
Hamburg, Germany, 22143
MensingDerma Research
Hamburg, Germany, 22391
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30449
Klinikum der Christian-Albrechts-Universitat
Kiel, Germany, 24105
Klinikum der Universität zu Köln
Köln, Germany, 50937
Univ.-Klinikum Leipzig
Leipzig, Germany, 4103
Univ.-Klinikum Luebeck, Klinik für Dermatologie u. Venerolog
Luebeck, Germany, 23538
Novartis Investigational Site
Mahlow, Germany, 15831
Universitätsklinikum Mainz
Mainz, Germany, 55131
Klinik und Poliklinik fur Hautkrankheiten
Muenster, Germany, 48149
KliFOs
Osnabrück, Germany, 49074
Novartis Investigational Site
Schmiedeberg, Germany, 1762
Die Gesundheitsunion, Dermatologie
Wuppertal, Germany, 42103
India
Owaisi Hospital And Research Centre
Hyderabad, Andra Pradesh, India, 500058
MS Ramaiah Memorial Hospital
Bangalore, Karnataka, India, 560054
A. J. Institute of Medical Sciences
Mangalore, Karnataka, India, 575004
Radiance Skin Clinic
Nagpur, Maharashtra, India, 440001
Novartis Investigator Site
Nagpur, Maharashtra, India, 440010
Shree Hospital & Critical Care
Nagpur, Maharashtra, India, 440009
Skin Clinic
Nagpur, Maharashtra, India, 440013
Skin Care Clinic
Nagpur, Maharashtra, India, 422101
Grant Medical College and JJ Hospital
Mumbai, Mahastra, India, 400008
Italy
A.O.Univ.Policl.V.Emanuele Pr.Osp.G.Rodolico Univ.Studi
Catania, Italy, 93123
IRCCS Istituto Ortopedico Galeazzi
Milano, Italy, 20100
Azienda Ospedaliera - Università di Padova Univ. degli Studi
Padova, Italy, 35121
Fondaz.Policlin.Tor Vergata-Univ. degli Studi Tor Vergata
Roma, Italy, 00133
A.O.Universitaria Senese Università degli Studi di Siena
Siena, Italy, 53100
A.O.U. Integrata di Verona-Ospedale Borgo trento
Verona, Italy, 37126
Japan
Asahikawa Medical College Hospital
Asahikawa, Japan, 0788510
Kyushu Rosai Hospital
Fukuoka, Japan
Kyushu Central Hospital
Fukuoka, Japan, 3-23-1 Shiobaru
Nihon University Itabashi Hospital
Itabashi, Japan, 173-8610
Kimitsu Chuou Hospital
Kisarazu, Japan, 292-8535
Gunma University School of Medicine
Maebashi, Japan, 371-8511
The Jikei University Hospital
Minato-ku, Japan, 05-8471
Nagoya City University Hospital
Nagoya, Japan
Nissay Hospital
Osaka, Japan, 550-0012
JR Sapporo Hospital
Saporro, Japan, 0600033
Novartis Investigative Site
Sapporo-city, Japan, 0600033
Jichi Medical University Hospital
Simotsuke, Japan, 3290498
Tokyo Medical University Hospital
Tokyo, Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, Japan
Tokyo Teishin Hospital
Tokyo, Japan
Poland
Novartis Investigative Site
Wroclaw, Poland, 50369
Slovakia
Novartis Investigative Site
Kosice, Slovakia, 04166
Switzerland
Novartis Investigative Site
Bern, Switzerland, 3010
Taiwan
Novartis Investigative Site
Kaohsiung, Taiwan
Vietnam
Novartis Investigative Site
Hanoi, Vietnam, 84
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01412944     History of Changes
Other Study ID Numbers: CAIN457A2307, 2011-002510-36
Study First Received: August 5, 2011
Last Updated: June 16, 2014
Health Authority: Austria: Agency for Health and Food Safety
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Switzerland: Swissmedic
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Novartis:
Psoriasis
plaque
inflammatory skin disease
scaly patches
AIN457
secukinumab
Moderate to severe

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014