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.

Phase 3WithdrawnNCT01900782

Novartis Pharmaceuticals

Overview

This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Psoriasis

Interventions

Intervention ABIOLOGICAL

Prefilled syringe.

Intervention BBIOLOGICAL

Prefilled syringe.

PlaceboBIOLOGICAL

Prefilled syringe to match experimental drug and active comparator.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

PASI (psoriasis area and severity index) and IGA (investigator's global assessment)

Time frame: Week 12

Secondary Outcomes

PASI (psoriasis area and severity index) and IGA (investigator's global assessment)

Time frame: Week 52

Vital signs, laboratory values, electrocardiograms (ECG), adverse events

Time frame: Week 12 and 52

Patient reported outcome questionnaires

Time frame: Week 12 and 52

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.