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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

August 5, 2011
June 16, 2014
November 2011
April 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01412944 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Plaque-type Psoriasis
  • Drug: secukinumab 150mg
    secukinumab 150mg(2 injections per dose)
  • Drug: secukinumab 10mg/kg i.v. regimen
    secukinumab 10mg/kg i.v. regimen
  • Experimental: secukinumab
    secukinumab 150 mg (2 injections per dose)
    Intervention: Drug: secukinumab 150mg
  • Experimental: secukinumab 10mg/kg i.v. regimen
    secukinumab 10mg/kg i.v. regimen
    Intervention: Drug: secukinumab 10mg/kg i.v. regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
Not Provided
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   India,   Italy,   Japan,   Poland,   Slovakia,   Switzerland,   Taiwan,   Vietnam
 
NCT01412944
CAIN457A2307, 2011-002510-36
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceticals Novartis Pharmaceuticals
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP