First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks (FEATURE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01555125
First received: March 13, 2012
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.


Condition Intervention Phase
Moderate to Severe Plaque-type Psoriasis
Drug: secukinumab 150 mg
Drug: secukinumab 300 mg
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Psoriasis Area and Severity Index (PASI) 75 score and Investigators' Global Assessment (IGA) with 0 or 1 response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To measure Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis


Secondary Outcome Measures:
  • Self-administered Self-Injection Assessment Questionnaire (SIAQ) score and investigator / site staff observation [ Time Frame: Week 0 - Week 48 ] [ Designated as safety issue: No ]
    To measure Subject usability (ability to follow instructions for use and potential use-related hazards) and satisfaction with the secukinumab PFS.

  • PASI score 50 / 75 / 90 / 100 and IGA 0 or 1 response [ Time Frame: up to Week 12, and over time up to Week 52 ] [ Designated as safety issue: No ]
    to measure Efficacy of secukinumab on moderate to severe chronic plaque-type psoriasis

  • PASI 50 / 75 / 90 / 100 and IGA 0 or 1 response [ Time Frame: after Week 52 ] [ Designated as safety issue: No ]
    To assess the long term efficacy of secukinumab on moderate to severe chronic plaque-type psoriasis with respect to PASI 50 / 75 / 90 / 100 and IGA 0 or 1 response, after Week 52

  • PASI score and IGA mod 2011 score after Week 52 [ Time Frame: after Week 52 ] [ Designated as safety issue: No ]
    To assess the long term efficacy of secukinumab on moderate to severe chronic plaque-type psoriasis with respect to PASI score and IGA mod 2011 score after Week 52

  • Long term clinical safety and tolerability of secukinumab [ Time Frame: after Week 52 ] [ Designated as safety issue: Yes ]
    To investigate the clinical safety and tolerability of secukinumab as assessed by vital signs, clinical laboratory variables, ECGs, and adverse events monitoring after Week 52


Enrollment: 177
Study Start Date: May 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: secukinumab 150 mg
Drug
Drug: secukinumab 150 mg
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period
Experimental: secukinumab 300 mg
Drug
Drug: secukinumab 300 mg
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period
Placebo Comparator: placebo Drug: placebo
Subjects who were on placebo at Week 52 cannot continue in the extension treatment period

  Eligibility

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

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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. Other protocol-defined inclusion/exclusion criteria may apply
  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: NCT01555125

  Show 33 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01555125     History of Changes
Other Study ID Numbers: CAIN457A2308, 2011-006057-28
Study First Received: March 13, 2012
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Vaccines and Biomedicines (PEI)

Keywords provided by Novartis:
Psoriasis

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

ClinicalTrials.gov processed this record on October 23, 2014