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.

Psoriasis Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01900782
• Other study ID #: CAIN457A2314
• Secondary ID: 2013-000463-83
• Status: Withdrawn
• Phase: Phase 3
• First received: July 12, 2013
• Last updated: August 14, 2013
• Start date: October 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Intervention A
Prefilled syringe.
• Intervention B
Prefilled syringe.
• Placebo
Prefilled syringe to match experimental drug and active comparator.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI (psoriasis area and severity index) and IGA (investigator's global assessment)		Week 12	No
Secondary	PASI (psoriasis area and severity index) and IGA (investigator's global assessment)		Week 52	No
Secondary	Vital signs, laboratory values, electrocardiograms (ECG), adverse events		Week 12 and 52	Yes
Secondary	Patient reported outcome questionnaires		Week 12 and 52	No