First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks

Conditions

• Moderate to Severe Plaque-type Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• secukinumab 150 mg — DRUG
  After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period
• secukinumab 300 mg — DRUG
  After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period
• placebo — DRUG
  Subjects who were on placebo at Week 52 cannot continue in the extension treatment period

Study Details

The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

Key Dates

Start date

May 8, 2012

Status verified

Aug 2018

Primary completion

Oct 24, 2016

Completion

Oct 24, 2016

Study Design

Enrollment

177 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: secukinumab 150 mg
  Drug
• Experimental: secukinumab 300 mg
  Drug
• Placebo Comparator: placebo

Primary Outcome Measure

Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response. [ Time Frame: 12 weeks ]

Locations (18)

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