NCT00805480 - Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

130

Conditions

Chronic Plaque Psoriasis

Interventions

AIN457DRUG

AIN457 was administered intravenously.

PlaceboDRUG

Matching placebo to AIN457 was administered intravenously.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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; Other protocol-defined inclusion/exclusion criteria may apply

Outcomes

Primary Outcomes

Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores

PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

Time frame: Baseline, Week 12

Percentage of Participants Who Had Not Relapsed at Any Time in the Trial

This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.

Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56

Secondary Outcomes

Percentage of Participants With at Least 50% Improvement From Baseline in PASI

PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)

Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI

PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).