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

December 8, 2017 updated by: Novartis Pharmaceuticals

A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Participants With Moderate to Severe Chronic Plaque-type Psoriasis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

275

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, 31400
        • 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
      • 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
        • Novartis Investigative Site
  • Iceland
      • Kopavogur, Iceland, 201
        • Novartis Investigative Site
  • Israel
      • Afula, Israel, 1834111
        • Novartis Investigative Site
      • Petach Tikva, Israel, 49100
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • 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-city, Fukuoka, Japan, 807-8556
        • Novartis Investigative Site
      • Kurume city, 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, 40291
        • Novartis Investigative Site
    • Michigan
      • Clinton Township, 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
      • Saint 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
      • 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
    • 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

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

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.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to week 351

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Extension weeks: 1, 25, 73 and 301 (too few data points were available to perform analysis at week 301)
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.
up to week 351

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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 (ACTUAL)

May 11, 2010

Primary Completion (ACTUAL)

October 18, 2016

Study Completion (ACTUAL)

October 18, 2016

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (ESTIMATE)

May 28, 2010

Study Record Updates

Last Update Posted (ACTUAL)

January 4, 2018

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457A2211E1
  • 2009-017234-51 (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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