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.

August 14, 2013 updated by: Novartis Pharmaceuticals

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.

This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
Time Frame: Week 52
Week 52
Vital signs, laboratory values, electrocardiograms (ECG), adverse events
Time Frame: Week 12 and 52
Week 12 and 52
Patient reported outcome questionnaires
Time Frame: Week 12 and 52
Week 12 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimate)

July 16, 2013

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457A2314
  • 2013-000463-83 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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