Phase II Single Dose, Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 80
- Locations
- 5
- Primary Endpoint
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Study Overview
Brief Summary
This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:
- •Coverage of the body surface area (BSA) of 10% or more with plaques
- •A score of 3 or more on the IGA (Investigator Global Assessment) scale
- •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 have applied.
Arms & Interventions
Placebo
Participants received placebo to AIN457A IV on day 1.
Intervention: Placebo (Biological)
AIN457 3.0 mg/kg
Participants received AIN457 3.0 mg/kg IV on Day 1.
Intervention: AIN457 (Biological)
AIN457 1.0 mg/kg
Participants received AIN457 1.0 mg/kg IV on Day 1.
Intervention: AIN457 (Biological)
AIN457 0.3 mg/kg
Participants received AIN457 0.3 mg/kg IV on Day 1.
Intervention: AIN457 (Biological)
Outcomes
Primary Outcomes
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Time Frame: baseline, week 4
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Secondary Outcomes
- Investigator Global Assessment (IGA) Scores(baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32)
- Change From Baseline in PASI(baseline, weeks 12, 14, 16, 20, 24, 28 and 32)