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AIN457 Regimen Finding Extension Study in Patients With Moderate to Severe Psoriasis

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: May 19, 2010
Last updated: February 28, 2017
Last verified: February 2017
The purpose of this study is to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.

Condition Intervention Phase
Plaque-type Psoriasis Drug: AIN457 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Safety and tolerability as measured by the number of patients with Adverse Events and clinically significant changes in vital signs and clinical laboratory variables. [ Time Frame: 81 +157 (prolongation) weeks ]

Secondary Outcome Measures:
  • Long-term efficacy as assessed by the number of patients with a PASI 50, PASI 75 and PASI 90 achievement and an improvement of the Investigator' global assessment score during the trial. [ Time Frame: 81 +157 (prolongation) weeks ]
  • To evaluate the long-term immunogenicity by measuring the number of patients developing anti AIN antibodies during the trial. [ Time Frame: 81 +157 (prolongation) weeks ]

Enrollment: 276
Study Start Date: May 2010
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fixed-time interval regimen
Fixed-time interval regimen
Drug: AIN457
Experimental: Treatment at start of relapse regimen
Treatment at start of relapse regimen
Drug: AIN457
Experimental: Open-label
Drug: AIN457
Placebo Comparator: Placebo
Drug: Placebo

Detailed Description:

The purpose of this study is to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.

In the Proof-of-Concept study (CAIN457A2102), AIN457 has proven to be efficacious in the treatment of moderate to severe chronic plaque-type psoriasis. As a result, a phase IIb regimen finding study has been started (CAIN457A2211).

The data gathered in this extension study of the core study (CAIN457A2211) will be used to expand the safety database of the compound for the treatment of moderate to severe chronic plaque-type psoriasis. The patients in the extension study will continue to stay on the exact same treatment regimen they were taking when completing the core study.


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

Inclusion Criteria:

  • Patients who completed the core study CAIN457A2211. A patient is defined as having completed the core study if he/she completed the study up to and including visit 13 (F4) of the core study
  • Patients must be able to understand and communicate with the investigator and comply with the requirement of the study and must given written, signed and dated informed consent before any study assessment is performed.
  • Patients must be expected to benefit from the ongoing treatment with AIN457, as assessed by the patient and investigator
  • Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration

Exclusion Criteria:

  • Patients who experience a second consecutive full relapse at visit 13 ( week F4) of the core study CAIN457A2211
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG laboratory test (> 5mlU/mL)
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are:

    • women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
    • women whose partners have been sterilized by vasectomy or other means
    • using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, condoms (by the partner) and some intrauterine devices (IUDs); Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01132612

  Hide Study Locations
United States, Alabama
Novartis Investigative Site
Birmingham, Alabama, United States, 35233
United States, Arkansas
Novartis Investigative Site
Little Rock, Arkansas, United States, 72205
United States, California
Novartis Investigative Site
Pasadena, California, United States, 91105
Novartis Investigative Site
San Diego, California, United States, 92123
United States, Georgia
Novartis Investigative Site
Newnan, Georgia, United States, 30263
Novartis Investigative Site
Snellville, Georgia, United States, 30078
United States, Illinois
Novartis Investigative Site
Champaign, Illinois, United States, 61820
Novartis Investigative Site
Springfield, Illinois, United States, 62703
United States, Indiana
Novartis Investigative Site
Evansville, Indiana, United States, 47713
United States, Kansas
Novartis Investigative Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Novartis Investigative Site
Louisville, Kentucky, United States, 40291
United States, Michigan
Novartis Investigative Site
Clinton Twp., Michigan, United States, 48038
Novartis Investigative Site
Detroit, Michigan, United States, 48202
United States, Minnesota
Novartis Investigative Site
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63117
United States, Nebraska
Novartis Investigative Site
Omaha, Nebraska, United States, 68131
Novartis Investigative Site
Omaha, Nebraska, United States, 68144
United States, Nevada
Novartis Investigative Site
Henderson, Nevada, United States, 89052
United States, New York
Novartis Investigative Site
Rochester, New York, United States, 14623
United States, North Carolina
Novartis Investigative Site
High Point, North Carolina, United States, 27262
United States, Oregon
Novartis Investigative Site
Lake Oswego, Oregon, United States, 97035
Novartis Investigative Site
Portland, Oregon, United States, 97210
United States, Texas
Novartis Investigative Site
Austin, Texas, United States, 78759
Novartis Investigative Site
Dallas, Texas, United States, 75204
United States, Virginia
Novartis Investigative Site
Charlottesville, Virginia, United States, 22911
Novartis Investigative Site
Nice, France, 06202
Novartis Investigative Site
Toulouse Cedex, France, 31400
Novartis Investigative Site
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
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Hannover, Germany, 30625
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Kiel, Germany, 24105
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Luebeck, Germany, 23538
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
Tuebingen, Germany, 72076
Novartis Investigative Site
Kopavogur, Iceland, 201
Novartis Investigative Site
Afula, Israel, 1834111
Novartis Investigative Site
Petach Tikva, Israel, 49100
Novartis Investigative Site
Ramat Gan, Israel, 5266202
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 467-8602
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 814-0180
Novartis Investigative Site
Kitakyushu-city, Fukuoka, Japan, 807-8556
Novartis Investigative Site
Kurume-city, Fukuoka, Japan, 830-0011
Novartis Investigative Site
Maebashi-city, Gunma, Japan, 371-8511
Novartis Investigative Site
Chitose, Hokkaido, Japan, 066-0021
Novartis Investigative Site
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
Bergen, Norway, NO-5021
Novartis Investigative Site
Oslo, Norway, 0424
Novartis Investigative Site
Ålesund, Norway, 6017
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01132612     History of Changes
Other Study ID Numbers: CAIN457A2211E1
2009-017234-51 ( EudraCT Number )
Study First Received: May 19, 2010
Last Updated: February 28, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic plaque-type psoriasis
Moderate to severe chronic plaque-type psoriasis

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases processed this record on July 19, 2017