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.

Novartis

Status and phase: Withdrawn; Phase 3

Conditions: Psoriasis

Treatments: Biological: Intervention B; Biological: Intervention A; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01900782

2013-000463-83 (EudraCT Number)

CAIN457A2314

Details and patient eligibility

About

This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 4 patient groups, including a placebo group

Dosing Regimen 1

Experimental group

Description:

Subcutaneous injection

Treatment:

Biological: Intervention A

Active Comparator

Active Comparator group

Description:

Subcutaneous injection

Treatment:

Biological: Intervention B

Placebo

Placebo Comparator group

Description:

Subcutaneous injection

Treatment:

Biological: Placebo

Dosing Regimen 2

Experimental group

Description:

Subcutaneous injection

Treatment:

Biological: Intervention A