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.

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.

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01900782

Enrollment

Registered

2013-07-16

Start date

2013-10-31

Completion date

2015-06-30

Last updated

2013-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

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This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type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

Interventions

BIOLOGICALIntervention A

Prefilled syringe.

BIOLOGICALIntervention B

Prefilled syringe.

BIOLOGICALPlacebo

Prefilled syringe to match experimental drug and active comparator.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026