Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)

Conditions

• Plaque-type Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  2 injections of placebo to secukinumab 150mg per dose
• Secukinumab 150mg — DRUG
  Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose were administered
• Secukinumab 300mg — DRUG
  Secukinumab 300mg (2 injections of 150mg secukinumab per dose)

Study Details

The purpose of this study was to demonstrate efficacy of autoinjector administered 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

Oct 17, 2012

Status verified

Sep 2018

Primary completion

Oct 27, 2016

Completion

Oct 27, 2016

Study Design

Enrollment

182 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Subjects who were in placebo at Week 52 cannot continue in the extension treatment period
• Experimental: Secukinumab 150 mg
  After the data base lock of week 52 data has been performed, subjects received secukinumab 150 mg treatment as open label for the remainder of the extension treatment period.
• Experimental: Secukinumab 300 mg
  After the data base lock of week 52 data has been performed, subjects received secukinumab 300 mg treatment as open label for the remainder of the extension treatment period.

Primary Outcome Measure

Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response [ Time Frame: 12 weeks ]

Locations (12)

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