AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

July 30, 2015 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06202
        • Novartis Investigative Site
      • Toulouse Cedex, France, 31059
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Bonn, Germany, 53105
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Novartis Investigative Site
      • Göttingen, Germany, 37075
        • Novartis Investigative Site
      • Hamburg, Germany, 20354
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Novartis Investigative Site
      • Luebeck, Germany, 23538
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site
      • Tuebingen, Germany, 72076
        • Novartis Investigative Site
  • Iceland
      • Kopavogur, Iceland, 201
        • Novartis Investigative Site
  • Israel
      • Afula, Israel, 18101
        • Novartis Investigative Site
      • Petach Tikva, Israel, 49100
        • Novartis Investigative Site
      • Ramat Gan, Israel, 52621
        • Novartis Investigative Site
  • Japan
    • Aichi
      • Nagoya-city, Aichi, Japan, 467-8602
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japan, 814-0180
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Novartis Investigative Site
      • Kurume, Fukuoka, Japan, 830-0011
        • Novartis Investigative Site
    • Gunma
      • Maebashi-city, Gunma, Japan, 371-8511
        • Novartis Investigative Site
    • Hokkaido
      • Chitose, Hokkaido, Japan, 066-0021
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • Novartis Investigative Site
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 105-8471
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • Novartis Investigative Site
  • Norway
      • Bergen, Norway, NO-5021
        • Novartis Investigative Site
      • Oslo, Norway, 0424
        • Novartis Investigative Site
      • Ålesund, Norway, 6017
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Novartis Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Novartis Investigative Site
    • California
      • Pasadena, California, United States, 91105
        • Novartis Investigative Site
      • San Diego, California, United States, 92123
        • Novartis Investigative Site
    • Georgia
      • Newnan, Georgia, United States, 30263
        • Novartis Investigative Site
      • Snellville, Georgia, United States, 30078
        • Novartis Investigative Site
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Novartis Investigative Site
      • Springfield, Illinois, United States, 62703
        • Novartis Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Novartis Investigative Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Novartis Investigative Site
    • Michigan
      • Clinton Twp., Michigan, United States, 48038
        • Novartis Investigative Site
      • Detroit, Michigan, United States, 48202
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, United States, 63117
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Novartis Investigative Site
      • Omaha, Nebraska, United States, 68144
        • Novartis Investigative Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Novartis Investigative Site
    • New York
      • New York, New York, United States, 10029
        • Novartis Investigative Site
      • Rochester, New York, United States, 14623
        • Novartis Investigative Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Novartis Investigative Site
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Novartis Investigative Site
      • Portland, Oregon, United States, 97210
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Novartis Investigative Site
    • Texas
      • Austin, Texas, United States, 78759
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75204
        • Novartis Investigative Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Novartis Investigative Site
      • Lynchburg, Virginia, United States, 24501
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women at least 18 years of age at time of consent
  • Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization

  • At time of 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 and/or
    • phototherapy and/or
    • previous systemic therapy

Exclusion Criteria:

  • Patients meeting any of the following criteria will be excluded from entry into the study:
  • Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
  • Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization
  • Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to
  • Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration
  • Known immunosuppression (e.g., AIDS) at screening and / or randomization
  • History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
  • Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)
  • At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
  • History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization
  • History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization
  • Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
  • Pregnant or nursing (lactating) women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction Single Dose
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
Drug: AIN457
Other Names:
  • Secukinumab
Experimental: Induction Monthly Dose
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
Drug: AIN457A
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9
Other Names:
  • Secukinumab
Drug: AIN457A
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5
Other Names:
  • Secukinumab
Experimental: Induction Early Loading Dose
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
Drug: AIN457A
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9
Other Names:
  • Secukinumab
Drug: AIN457A
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5
Other Names:
  • Secukinumab
Placebo Comparator: Placebo Dose
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
Drug: Placebo
Placebo - "Placebo": Placebo administered at weeks 1, 2, 3, 5, 9

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.
Time Frame: 13 weeks
Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29
Time Frame: week 21 to 29
week 21 to 29
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo
Time Frame: 13 weeks
The investigator's global assessment (IGA) was used to evaluate overall psoriatic disease, with scores ranging from 0 (clear) to 5 (very severe disease). Treatment success was defined as patients who achieved IGA 0 or 1 and improvement of at least 2 points on the IGA scale compared to baseline. The IGA rating score for involvement of hands and feet ranged from 0 (clear) to 4 (severe).
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 16, 2009

First Submitted That Met QC Criteria

July 16, 2009

First Posted (Estimate)

July 17, 2009

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457A2211
  • 2008-007525-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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