Psoriasis Clinical Trial

A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Summary

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).

View Eligibility Criteria

Eligibility 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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

125

Study ID:

NCT01071252

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 18 Locations for this study

See Locations Near You

Novartis Investigative Site
San Diego California, 92123, United States
Novartis Investigative Site
Louisville Kentucky, 40217, United States
Novartis Investigative Site
Rochester New York, 14623, United States
Novartis Investigative Site
Lake Oswego Oregon, 97035, United States
Novartis Investigative Site
Portland Oregon, 97210, United States
Novartis Investigative Site
Halifax Nova Scotia, B3H 1, Canada
Novartis Investigative Site
North Bay Ontario, P1B 3, Canada
Novartis Investigative Site
Waterloo Ontario, N2J 1, Canada
Novartis Investigative Site
Tallinn , 10138, Estonia
Novartis Investigative Site
Tallinn , 13419, Estonia
Novartis Investigative Site
Tartu , 51014, Estonia
Novartis Investigative Site
Kopavogur , IS-20, Iceland
Novartis Investigative Site
Nagoya-city Aichi, 467-8, Japan
Novartis Investigative Site
Maebashi-city Gunma, 371-8, Japan
Novartis Investigative Site
Sapporo-city Hokkaido, 060-0, Japan
Novartis Investigative Site
Saitama-city Saitama, 330-0, Japan
Novartis Investigative Site
Riga , 1012, Latvia
Novartis Investigative Site
Riga , LV-10, Latvia
Novartis Investigative Site
Riga , , Latvia

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

125

Study ID:

NCT01071252

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider