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| Sponsored by: |
Novartis |
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00669916 |
Purpose
This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study comparing 3 mg/kg of AIN457 to placebo. Subjects with a diagnosis of moderate to severe stable plaque psoriasis will be randomized to receive either AIN457 or placebo. AIN457 or placebo will be administered by single infusion at baseline and subjects will be observed for up to 26 weeks following the infusion.
| Condition | Intervention | Phase |
|
Plaque Psoriasis |
Drug: AIN457 Drug: Placebo |
Phase I Phase II |
| MedlinePlus related topics: | Psoriasis |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase 2a Single-Dose, Randomized, Double Blind, Multi-Center, Parallel-Group, Placebo-Controlled Proof of Concept Study to Assess the Efficacy, Safety, Tolerability, and Population Pharmacokinetics of AIN457 in Patients With Stable Plaque-Type Psoriasis |
| Enrollment: | 36 |
| Study Start Date: | March 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: AIN457
Two treatment groups; single infusion of 3 mg/kg or placebo.
|
| 2: Placebo Comparator |
Drug: Placebo
Two treatment groups; single infusion of 3 mg/kg or placebo.
|
Eligibility
| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet both of the following criterion:
Exclusion Criteria:
Recent previous treatment with anti-TNF-α therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus. The following washout period will be required for such patients to be eligible to participate in the trial.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| United States, California | |||||
| Novartis Investigator Site | |||||
| Santa Monica, California, United States, 90211 | |||||
| United States, Kentucky | |||||
| Novartis Investigator Site | |||||
| Louisville, Kentucky, United States, 40217 | |||||
| United States, New York | |||||
| Novartis Investigator Site | |||||
| Rochester, New York, United States | |||||
| Novartis Investigator Site | |||||
| Stonybrook, New York, United States, 11790 | |||||
| United States, North Carolina | |||||
| Novartis Investigator Site | |||||
| High Point, North Carolina, United States, 27262 | |||||
| United States, Pennsylvania | |||||
| Novartis Investigator Site | |||||
| Duncansville, Pennsylvania, United States, 16635 | |||||
| United States, Tennessee | |||||
| Novartis Investigator Site | |||||
| Nashville, Tennessee, United States, 37215 | |||||
| Novartis Investigator Site | |||||
| Goodlettsville, Tennessee, United States, 37072 | |||||
| United States, Washington | |||||
| Novartis Investigator Site | |||||
| Seattle, Washington, United States, 98101 | |||||
| Novartis |
| Principal Investigator: | Novartis | Novartis investigator site |
More Information
| Responsible Party: | Novartis ( External Affairs ) |
| Study ID Numbers: | CAIN457A2102 |
| First Received: | April 29, 2008 |
| Last Updated: | May 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00669916 |
| Health Authority: | United States: Food and Drug Administration |
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