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Efficacy and Safety Study of Subcutaneous Secukinumab in Treatment of Subjects With Moderate to Severe Chronic Plaque-type Psoriasis as Compared to Etanercept and Placebo.

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01900782
First received: July 12, 2013
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis.


Condition Intervention Phase
Psoriasis
Biological: Intervention A
Biological: Intervention B
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • PASI (psoriasis area and severity index) and IGA (investigator's global assessment) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PASI (psoriasis area and severity index) and IGA (investigator's global assessment) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Vital signs, laboratory values, electrocardiograms (ECG), adverse events [ Time Frame: Week 12 and 52 ] [ Designated as safety issue: Yes ]
  • Patient reported outcome questionnaires [ Time Frame: Week 12 and 52 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing Regimen 1
Subcutaneous injection
Biological: Intervention A
Prefilled syringe.
Active Comparator: Active Comparator
Subcutaneous injection
Biological: Intervention B
Prefilled syringe.
Placebo Comparator: Placebo
Subcutaneous injection
Biological: Placebo
Prefilled syringe to match experimental drug and active comparator.
Experimental: Dosing Regimen 2
Subcutaneous injection
Biological: Intervention A
Prefilled syringe.

  Eligibility

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

Inclusion Criteria:

  • Chronic plaque-type psoriasis, moderate to severe
  • Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy

Exclusion Criteria:

  • Forms of psoriasis other than chronic plaque-type
  • Ongoing use of treatments not allowed for psoriasis

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: NCT01900782

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: NCT01900782     History of Changes
Other Study ID Numbers: CAIN457A2314, 2013-000463-83
Study First Received: July 12, 2013
Last Updated: August 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 25, 2014