Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Plaque Psoriasis
In brief
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.
Key facts
- Study ID
- NCT00770965
- Run by
- Novartis Pharmaceuticals
- People needed
- 80
- Starts
- 2008-09-10
- Expected to finish
- 2009-09-17
- Last updated by the study team
- 2018-03-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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.
Where it is running
- Novartis Investigative Site — Santa Monica, California, United States
- Novartis Investigative Site — Louisville, Kentucky, United States
- Novartis Investigative Site — High Point, North Carolina, United States
- Novartis Investigative Site — Duncansville, Pennsylvania, United States
- Novartis Investigative Site — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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