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

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: Placebo; Drug: AIN457

Study type: Interventional

Funder types: Industry

Identifiers

NCT00805480

CAIN457A2212

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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;

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 4 patient groups, including a placebo group

AIN457 3 mg/kg

Experimental group

Description:

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

Treatment:

Drug: AIN457

Drug: Placebo

AIN457 10 mg/kg

Experimental group

Description:

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

Treatment:

Drug: AIN457

Drug: Placebo

AIN457 10 mg/kg x3

Experimental group

Description:

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

Treatment:

Drug: AIN457

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo