Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00805480
First received: December 5, 2008
Last updated: May 31, 2012
Last verified: May 2012
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Purpose
Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Plaque Psoriasis |
Drug: AIN457 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase II Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Multiple-loading Dose Regimen Study to Assess the Safety, Efficacy and Duration of Response of AIN457 in Patients With Chronic Plaque-type Psoriasis. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- To compare the change from baseline in Psoriasis Area and Severity Index (PASI) scores between the placebo and each of the three loading dose regimens of AIN457. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- To compare the proportion of patients who have not relapsed at any time in the trial between each of the three loading dose regimens of AIN457 [ Time Frame: Duration of trial (56 weeks) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the proportion of patients achieving at least 50% improvement as measured by PASI from the baseline visit [ Time Frame: throughout the trial ] [ Designated as safety issue: No ]
- To evaluate the proportion of patients achieving at least 75% and 90% improvement as measured by PASI from the baseline visit [ Time Frame: throughout the trial ] [ Designated as safety issue: No ]
- o evaluate the response as measured by Investigator Global Assessment (IGA) scores [ Time Frame: throughout the trial ] [ Designated as safety issue: No ]
| Enrollment: | 130 |
| Study Start Date: | December 2008 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Arm 1 - 1 x 3mg/kg
|
Drug: AIN457
Dose 1
|
|
Experimental: 2
Arm 2 - 1 x 10 mg/kg
|
Drug: AIN457
Dose 2
|
|
Experimental: 3
Arm 3 - 3 x 10 mg/kg
|
Drug: AIN457
Dose 3
|
| Placebo Comparator: 4 | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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 apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805480
Locations
| United States, Alabama | |
| Novartis Investigator Site | |
| Anniston, Alabama, United States, 36207 | |
| United States, California | |
| Novartis Investigator Site | |
| Santa Monica, California, United States, 90404 | |
| United States, Florida | |
| Novartis Investigator Site | |
| Port Orange, Florida, United States, 32127 | |
| United States, New York | |
| Novartis Investigator Site | |
| Rochester, New York, United States, 14623 | |
| United States, Oklahoma | |
| Novartis Investigator Site | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Oregon | |
| Novartis Investigator Site | |
| Portland, Oregon, United States, 97223-6683 | |
| Canada, New Brunswick | |
| Novartis Investigator Site | |
| Moncton, New Brunswick, Canada | |
| Canada | |
| Novartis Investigator Site | |
| Ontario, Canada | |
| Novartis Investigator Site | |
| Quebec, Canada | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Principal Investigator: | Novartis | Novartis Investigator Site |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00805480 History of Changes |
| Other Study ID Numbers: | CAIN457A2212 |
| Study First Received: | December 5, 2008 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Novartis:
|
Plaque psoriasis inflammatory skin disease skin condition, thickening |
flaking scaly patches kin disease |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013