| April 29, 2008 |
| December 12, 2008 |
| February 2007 |
| November 2007 (final data collection date for primary outcome measure) |
- 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 ]
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- Efficacy of AIN457 will be evaluated by comparing the coprimary endpoint of the reduction in PASI score between the placebo and treatment arms
- This study will have two primary endpoints which are the reduction in PASI score from baseline to 4 weeks of follow-up and the number of responses as determined by an IGA.
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| Complete list of historical versions of study NCT00669916 on ClinicalTrials.gov Archive Site |
- 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 ]
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- To evaluate the safety of AIN457 when administered as a single dose infusion to patients with stable plaque psoriasis
- To evaluate the population pharmacokinetics of AIN457 when administered as a single dose infusion to patients with stable plaque psoriasis
- Characterize the binding kinetics of IL-17/AIN457 complex in blood
- Characterize the pharmacodynamics of AIN457 in a sentinel plaque
- Conduct exploratory genomic, proteomic and metabolomic studies to identify gene expression patterns, proteins, and metabolites of blood that are associated with treatment response to AIN457.
- Perform exploratory analysis of soluble protein markers (by multiplex based immunoassay in serum) and, when applicable, exploratory Pharmacogenomic analysis of skin biopsy if clinical and/or histological response has been demonstrated
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| 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 |
| Plaque Psoriasis |
- Biological: AIN457
- Biological: Placebo
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| Completed |
| 36 |
| November 2007 |
| November 2007 (final data collection date for primary outcome measure) |
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 |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00669916 |
| External Affairs, Novartis Pharmaceuticals |
| CAIN457A2102 |
| Novartis Pharmaceuticals |
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| Study Director: |
Novartis Pharmaceuticals |
Novartis Pharmaceuticals |
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| Novartis |
| December 2008 |