NCT00941031

AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).

Conditions

• Chronic Plaque-type Psoriasis

Interventions

Type	Name	Description
DRUG	AIN457
DRUG	AIN457A	Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9
DRUG	AIN457A	Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5
DRUG	Placebo	Placebo - "Placebo": Placebo administered at weeks 1, 2, 3, 5, 9

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-07-17
• Last updated: 2015-08-20
• Results posted: 2015-03-27

Locations

62 sites across 7 countries: United States, France, Germany, Iceland, Israel, Japan, Norway