| A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis |
| 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 |
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. |
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| Phase I, Phase II |
| Interventional |
| Basic Science, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
To evaluate the preliminary efficacy of AIN457 when administered as a single dose infusion to patients with stable plaque psoriasis; proof-of-concept study comparing 3mg/kg of AIN457 to placebo [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
The comprimary efficacy endpoints will be the Psoriasis Area and Severity Index (PASI) measure at 4 weeks after the infusion and the number of responses as determined by the Investigator's global assessment (IGA). [ Time Frame: At week 5 ] [ Designated as safety issue: No ] |
Characterize compound in blood, in plaque [ Time Frame: throughout the duration of the study ] [ Designated as safety issue: No ]
Perform exploratory analysis [ Time Frame: throughout the duration of the study ] [ Designated as safety issue: No ] |
| Plaque Psoriasis |
Biological: AIN457
Biological: Placebo |
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| Completed |
| 36 |
| February 2007 |
| November 2007 |
Inclusion Criteria:
Exclusion Criteria:
- Currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
- Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
- Men who are planning to initiate a pregnancy while enrolled in the study or for 3 months following completion of the study.
- Women of child-bearing potential are not allowed in the study.
- Used any investigational drug within the previous 4 weeks.
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.
- 2 months washout prior to screening for etanercept, adalimumab, or infliximab.
- 1 month washout prior to screening for cyclosporine, mycophenolate, tacrolimus, and any systemic immunosuppressants including, but not limited to, methotrexate, azathioprine, 6-thioguanine, mercaptopurine, and hydroxyurea
Other protocol-defined inclusion/exclusion criteria may apply |
| Both |
| 18 Years to 69 Years |
| No |
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| United States |
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| NCT00669916 |
| CAIN457A2102 |
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| Novartis |
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| Principal Investigator: |
Novartis |
Novartis investigator site |
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| Novartis |
| November 2008 |
| April 29, 2008 |
| November 21, 2008 |