Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis

NCT ID: NCT00805480

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-09-30

Brief Summary

Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.

Conditions

Chronic Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AIN457 3 mg/kg

Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.

Group Type: EXPERIMENTAL

AIN457

Intervention Type: DRUG

AIN457 was administered intravenously.

Placebo

Intervention Type: DRUG

Matching placebo to AIN457 was administered intravenously.

AIN457 10 mg/kg

Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.

Group Type: EXPERIMENTAL

AIN457

Intervention Type: DRUG

AIN457 was administered intravenously.

Placebo

Intervention Type: DRUG

Matching placebo to AIN457 was administered intravenously.

AIN457 10 mg/kg x3

Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.

Group Type: EXPERIMENTAL

AIN457

Intervention Type: DRUG

AIN457 was administered intravenously.

Placebo

Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo to AIN457 was administered intravenously.

Interventions

AIN457

AIN457 was administered intravenously.

Intervention Type: DRUG

Placebo

Matching placebo to AIN457 was administered intravenously.

Intervention Type: DRUG

Other Intervention Names

Secukinumab

Eligibility Criteria

Inclusion Criteria

• Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:

1. Coverage of the body surface area (BSA) of 10% or more with plaques

2. A score of 3 or more on the IGA scale

3. A PASI score of at least 12 at baseline

Exclusion Criteria

• Have forms of psoriasis other than the required "plaque psoriasis"
• Women of childbearing potential
• Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
• Previous treatment with this investigational drug
• Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis Investigator Site

Other Identifiers

CAIN457A2212

Identifier Type: -

Identifier Source: org_study_id