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Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With 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: NCT01101100
Recruitment Status : Terminated (Sponsor Decision)
First Posted : April 9, 2010
Results First Posted : July 18, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE April 1, 2010
First Posted Date  ICMJE April 9, 2010
Results First Submitted Date  ICMJE November 8, 2016
Results First Posted Date  ICMJE July 18, 2019
Last Update Posted Date July 30, 2019
Study Start Date  ICMJE April 2010
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1) [ Time Frame: 264 weeks ]
    Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)
  • Percent Change in Psoriasis Area and Severity Index (PASI) [ Time Frame: 264 weeks ]
    Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2010)
  • Adverse events [ Time Frame: 264 weeks ]
  • Change in laboratory parameters and vital signs [ Time Frame: 264 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2010)
  • The proportion of subjects with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1) [ Time Frame: 264 weeks ]
  • Percent improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 264 weeks ]
  • The proportion of subjects with a 50% improvement in PASI (PASI 50), PASI 75, PASI 90, and PASI 100 [ Time Frame: 264 weeks ]
  • Body surface area (BSA) involvement [ Time Frame: 264 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Official Title  ICMJE A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis
Brief Summary This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.
Detailed Description This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing of AMG 827 for up to 362 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Drug: AMG 827
210 mg SC or 140 mg SC
Study Arms  ICMJE Experimental: AMG 827
AMG 827
Intervention: Drug: AMG 827
Publications *

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 14, 2014)
181
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2010)
155
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject was randomized into Study 20090062 and completed the week 16 evaluation.

Exclusion Criteria:

  • Subject had any Serious Adverse Event (SAE) reported during Study 20090062 that was considered possibly related to IP.
  • Subject experienced an adverse event in Study 20090062 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject.
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 Australia,   Canada,   Denmark,   France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01101100
Other Study ID Numbers  ICMJE 20090403
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Bausch Health Americas, Inc.
Verification Date July 2019

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