A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01071252
First received: February 18, 2010
Last updated: May 31, 2012
Last verified: May 2012
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Purpose
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Plaque-type Psoriasis |
Drug: AIN457 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo Controlled, Multicenter Dose Ranging Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Efficacy of 3 different doses of AIN457 s.c. administered monthly (25 mg, 75 mg and 150 mg) or as a single administration (25 mg) in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 achievement, compared to placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate treatment success as assessed by the Investigator's Global Assessment (static IGA) 12 weeks after start of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To evaluate the efficacy of the three different doses administered monthly as well as the single dosing at 12 weeks after start of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To assess the time to relapse [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
- To measure the effect of AIN457 on PASI over time [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
- To investigate the safety and tolerability [ Time Frame: 37 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 120 |
| Study Start Date: | March 2010 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 3x150mg | Drug: AIN457 |
| Experimental: 3x75mg | Drug: AIN457 |
| Experimental: 3x25mg | Drug: AIN457 |
| Experimental: 1x25mg | Drug: AIN457 |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
At randomization, moderate to severe psoriasis as defined by:
- PASI score of 12 or greater and,
- IGA score of 3 or greater and,
- Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.
Exclusion Criteria:
- Forms of psoriasis other than chronic plaque-type
- Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization
- Previous exposure to AIN457
- Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
- Known immunosuppression (e.g., AIDS) at screening and / or randomization
- History or evidence of active tuberculosis at screening
- Active systemic infections (other than common cold)
- History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
- Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
- Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study
- Inability or unwillingness to undergo repeated venipuntures
- History or evidence of drug or alcohol abuse
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071252
Locations
| United States, California | |
| Therapeutics Clinical Research | |
| San Diego, California, United States, 92123 | |
| United States, Kentucky | |
| Physician Skin Care | |
| Louisville, Kentucky, United States, 40217 | |
| United States, New York | |
| Dermatology Associates of Rochester, P.C. | |
| Rochester, New York, United States, 14623 | |
| United States, Oregon | |
| Allergy, Asthma & Dermatology Research Center, LLC | |
| Lake Oswego, Oregon, United States, 97035 | |
| Oregon Dermatology and Research Center | |
| Portland, Oregon, United States, 97210 | |
| Canada, Nova Scotia | |
| Novartis Investigative site | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Novartis Investigative site | |
| North Bay, Ontario, Canada | |
| Novartis Investigative site | |
| Waterloo, Ontario, Canada | |
| Estonia | |
| Novartis Investigative site | |
| Talinn, Estonia | |
| Novartis Investigative site | |
| Tallinn, Estonia | |
| Novartis Investigative site | |
| Tartu, Estonia | |
| Iceland | |
| Novartis Investigative Site | |
| Kopavogur, Iceland | |
| Japan | |
| Novartis Investigative Site | |
| Nagoya, Aichi, Japan | |
| Novartis Investigative Site | |
| Maebashi, Gunma, Japan | |
| Novartis Investigative Site | |
| Sapporo, Hokkaido, Japan | |
| Novartis Investigative Site | |
| Saitama, Japan | |
| Latvia | |
| Novartis Investigative site | |
| Riga, Latvia | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01071252 History of Changes |
| Other Study ID Numbers: | CAIN457A2220, 2009-016807-42 |
| Study First Received: | February 18, 2010 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Iceland: Icelandic Medicines Control Agency Estonia: The State Agency of Medicine Latvia: Agency of Medicines |
Keywords provided by Novartis:
|
Moderate to severe chronic plaque-type psoriasis AIN457 dermatology |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013