NCT01132612

AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis

A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Participants With Moderate to Severe Chronic Plaque-type Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.

Detailed description

In the Proof-of-Concept study (CAIN457A2102/ NCT00669916), AIN457 was proven to be efficacious in the treatment of moderate to severe chronic plaque-type psoriasis. As a result, a phase IIb regimen finding study had been started (CAIN457A2211/NCT00941031). The data gathered in this extension study of the core study (CAIN457A2211)was used to expand the safety database of the compound for the treatment of moderate to severe chronic plaque-type psoriasis. The participants in the extension study continued to stay on the exact same treatment regimen they were taking when completing the core study. The extension trial was first designed to provide long-term safety data of up to 100 weeks of treatment (32 weeks in the core study plus 68 weeks in the extension study (part 1)), and an additional 12 weeks of treatment-free follow-up for participants who did not continue in the extension study. Amendment 2 provided an additional 156 weeks of treatment (32 weeks in the core study plus 224 weeks in the extension study, equaling 256 weeks of total treatment (part 2)), before participants entered the 12 weeks of treatment-free follow-up. Protocol Amendment 3 extended the prolongation part of the study by up to 104 additional weeks of treatment (part 3) or until the drug was commercially available in the market of the country of participation, whichever occurred first.

Conditions

• Plaque-type Psoriasis

Interventions

Type	Name	Description
DRUG	AIN457	AIN457A 150 mg powder for solution
DRUG	Placebo	Placebo to AIN457A 150 mg powder for solution

Timeline

• Start date: 2010-05-11
• Primary completion: 2016-10-18
• Completion: 2016-10-18
• First posted: 2010-05-28
• Last updated: 2018-01-04
• Results posted: 2017-12-05

Locations

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