A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
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ClinicalTrials.gov Identifier: NCT01071252 |
Recruitment Status :
Completed
First Posted : February 19, 2010
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Plaque-type Psoriasis | Drug: AIN457 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 125 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | February 2011 |
Actual Study Completion Date : | February 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: AIN457 1x25mg |
Drug: AIN457 |
Experimental: AIN457 3x25mg |
Drug: AIN457 |
Experimental: AIN457 3x75mg |
Drug: AIN457 |
Experimental: AIN457 3x150mg |
Drug: AIN457 |
Placebo Comparator: Placebo |
Drug: Placebo |
- Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 [ Time Frame: week 13 ]PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
- Percentage of Participants With Investigator's Global Assessment (IGA) Response [ Time Frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 ]IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) [ Time Frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 ]PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
- To Assess the Time to Relapse [ Time Frame: 37 weeks ]Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071252
United States, California | |
Novartis Investigative Site | |
San Diego, California, United States, 92123 | |
United States, Kentucky | |
Novartis Investigative Site | |
Louisville, Kentucky, United States, 40217 | |
United States, New York | |
Novartis Investigative Site | |
Rochester, New York, United States, 14623 | |
United States, Oregon | |
Novartis Investigative Site | |
Lake Oswego, Oregon, United States, 97035 | |
Novartis Investigative Site | |
Portland, Oregon, United States, 97210 | |
Canada, Nova Scotia | |
Novartis Investigative Site | |
Halifax, Nova Scotia, Canada, B3H 1Z2 | |
Canada, Ontario | |
Novartis Investigative Site | |
North Bay, Ontario, Canada, P1B 3Z7 | |
Novartis Investigative Site | |
Waterloo, Ontario, Canada, N2J 1C4 | |
Estonia | |
Novartis Investigative Site | |
Tallinn, Estonia, 10138 | |
Novartis Investigative Site | |
Tallinn, Estonia, 13419 | |
Novartis Investigative Site | |
Tartu, Estonia, 51014 | |
Iceland | |
Novartis Investigative Site | |
Kopavogur, Iceland, IS-201 | |
Japan | |
Novartis Investigative Site | |
Nagoya-city, Aichi, Japan, 467-8602 | |
Novartis Investigative Site | |
Maebashi-city, Gunma, Japan, 371-8511 | |
Novartis Investigative Site | |
Sapporo-city, Hokkaido, Japan, 060-0063 | |
Novartis Investigative Site | |
Saitama-city, Saitama, Japan, 330-0854 | |
Latvia | |
Novartis Investigative Site | |
Riga, Latvia, 1012 | |
Novartis Investigative Site | |
Riga, Latvia, LV-1001 | |
Novartis Investigative Site | |
Riga, Latvia |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01071252 |
Other Study ID Numbers: |
CAIN457A2220 2009-016807-42 |
First Posted: | February 19, 2010 Key Record Dates |
Results First Posted: | February 16, 2015 |
Last Update Posted: | February 16, 2015 |
Last Verified: | February 2015 |
Moderate to severe chronic plaque-type psoriasis AIN457 dermatology |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |