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

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ClinicalTrials.gov Identifier: NCT01132612
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.

Condition or disease Intervention/treatment Phase
Plaque-type Psoriasis Drug: AIN457 Drug: Placebo Phase 2

Detailed Description:

In the Proof-of-Concept study (CAIN457A2102/ NCT00669916), AIN457 was proven to be efficacious in the treatment of moderate to severe chronic plaque-type psoriasis. As a result, a phase IIb regimen finding study had been started (CAIN457A2211/NCT00941031).

The data gathered in this extension study of the core study (CAIN457A2211)was used to expand the safety database of the compound for the treatment of moderate to severe chronic plaque-type psoriasis. The participants in the extension study continued to stay on the exact same treatment regimen they were taking when completing the core study. The extension trial was first designed to provide long-term safety data of up to 100 weeks of treatment (32 weeks in the core study plus 68 weeks in the extension study (part 1)), and an additional 12 weeks of treatment-free follow-up for participants who did not continue in the extension study. Amendment 2 provided an additional 156 weeks of treatment (32 weeks in the core study plus 224 weeks in the extension study, equaling 256 weeks of total treatment (part 2)), before participants entered the 12 weeks of treatment-free follow-up. Protocol Amendment 3 extended the prolongation part of the study by up to 104 additional weeks of treatment (part 3) or until the drug was commercially available in the market of the country of participation, whichever occurred first.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Participants With Moderate to Severe Chronic Plaque-type Psoriasis
Actual Study Start Date : May 11, 2010
Primary Completion Date : October 18, 2016
Study Completion Date : October 18, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Fixed-time interval regimen
Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
Drug: AIN457
AIN457A 150 mg powder for solution
Drug: Placebo
Placebo to AIN457A 150 mg powder for solution
Experimental: Treatment at start of relapse regimen
Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
Drug: AIN457
AIN457A 150 mg powder for solution
Drug: Placebo
Placebo to AIN457A 150 mg powder for solution
Experimental: Open-label
Secukinumab 150 mg sc administered every 4 weeks
Drug: AIN457
AIN457A 150 mg powder for solution


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: up to week 351 ]
    Safety was assessed by frequency of adverse events including serious adverse events.


Secondary Outcome Measures :
  1. Number of Participants With at Least 50%, 75% or 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) and IGA Mod 2009 0 or 1 Response [ Time Frame: Extension weeks: 1, 25, 73 and 301 (too few data points were available to perform analysis at week 301) ]
    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). The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.

  2. Long-term Immunogenicity Assessed by the Number of Participants Developing Anti Secukinumab Antibodies During the Trial [ Time Frame: up to week 351 ]
    Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment.


Eligibility Criteria

Information from the National Library of Medicine

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

Key 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 Note: Due to new data available from the toxicology studies, the need for male contraception was removed.

Key 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, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
Contacts and Locations

Information from the National Library of Medicine

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): NCT01132612


  Hide Study Locations
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 Township, 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
Saint 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
France
Novartis Investigative Site
Nice, France, 06202
Novartis Investigative Site
Toulouse Cedex, France, 31400
Germany
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
Gottingen, Germany, 37075
Novartis Investigative Site
Hamburg, Germany, 20354
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Luebeck, Germany, 23538
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
Tuebingen, Germany, 72076
Iceland
Novartis Investigative Site
Kopavogur, Iceland, 201
Israel
Novartis Investigative Site
Afula, Israel, 1834111
Novartis Investigative Site
Petach Tikva, Israel, 49100
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Japan
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
Norway
Novartis Investigative Site
Bergen, Norway, NO-5021
Novartis Investigative Site
Oslo, Norway, 0424
Novartis Investigative Site
Ålesund, Norway, 6017
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01132612     History of Changes
Other Study ID Numbers: CAIN457A2211E1
2009-017234-51 ( EudraCT Number )
First Posted: May 28, 2010    Key Record Dates
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: November 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic plaque-type psoriasis
AIN457
dermatology
Moderate to severe chronic plaque-type psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases