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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01132612
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : December 5, 2017
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 19, 2010
First Posted Date  ICMJE May 28, 2010
Results First Submitted Date  ICMJE October 17, 2017
Results First Posted Date  ICMJE December 5, 2017
Last Update Posted Date January 4, 2018
Actual Study Start Date  ICMJE May 11, 2010
Actual Primary Completion Date October 18, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
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 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
  • 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 weeks ]
  • To evaluate the long-term immunogenicity by measuring the number of patients developing anti AIN antibodies during the trial. [ Time Frame: 81 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis
Official Title  ICMJE A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Participants With Moderate to Severe Chronic Plaque-type Psoriasis
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Plaque-type Psoriasis
Intervention  ICMJE
  • Drug: AIN457
    AIN457A 150 mg powder for solution
  • Drug: Placebo
    Placebo to AIN457A 150 mg powder for solution
Study Arms  ICMJE
  • Experimental: Fixed-time interval regimen
    Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
    Interventions:
    • Drug: AIN457
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: AIN457
    • Drug: Placebo
  • Experimental: Open-label
    Secukinumab 150 mg sc administered every 4 weeks
    Intervention: Drug: AIN457
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2017)
275
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2010)
250
Actual Study Completion Date  ICMJE October 18, 2016
Actual Primary Completion Date October 18, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Iceland,   Israel,   Japan,   Norway,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01132612
Other Study ID Numbers  ICMJE CAIN457A2211E1
2009-017234-51 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP