Phase 2
Completed N=15
Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT00770965 ↗Enrolled (actual)
15
Serious AEs
2.5%
Results posted
Feb 2015
Primary outcomePrimary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores |
— | — |
| SECONDARY Change From Baseline in PASI |
— | — |
| SECONDARY Investigator Global Assessment (IGA) Scores |
— | — |
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:
- 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.
Data sourced from ClinicalTrials.gov (NCT00770965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.