Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis

Conditions

• Plaque-type Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• secukinumab 150mg — DRUG
  secukinumab 150mg (2 injections per dose)
• secukinumab 10mg/kg i.v. regimen — DRUG
  secukinumab 10mg/kg i.v. regimen

Study Details

The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

Key Dates

Start date

Dec 31, 2011

Status verified

Mar 2015

Primary completion

Apr 30, 2013

Completion

Apr 30, 2013

Study Design

Enrollment

43 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AIN457 subcutaneous (s.c.)
  During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
• Experimental: AIN457 I.V.
  During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.

Primary Outcome Measure

Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI [ Time Frame: Week 8 ]

Locations (6)

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