MedDataX Logo

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.

NCT ID: NCT01900782

Last Updated: 2013-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dosing Regimen 1

Subcutaneous injection

Group Type EXPERIMENTAL

Intervention A

Intervention Type BIOLOGICAL

Prefilled syringe.

Active Comparator

Subcutaneous injection

Group Type ACTIVE_COMPARATOR

Intervention B

Intervention Type BIOLOGICAL

Prefilled syringe.

Placebo

Subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Prefilled syringe to match experimental drug and active comparator.

Dosing Regimen 2

Subcutaneous injection

Group Type EXPERIMENTAL

Intervention A

Intervention Type BIOLOGICAL

Prefilled syringe.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention A

Prefilled syringe.

Intervention Type BIOLOGICAL

Intervention B

Prefilled syringe.

Intervention Type BIOLOGICAL

Placebo

Prefilled syringe to match experimental drug and active comparator.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-000463-83

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457A2314

Identifier Type: -

Identifier Source: org_study_id