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Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00975637
First Posted: September 11, 2009
Last Update Posted: March 17, 2017
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.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
Results First Submitted: November 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: 70 mg SC
Drug: 210 mg SC
Drug: 140 mg SC
Drug: 280 mg SC
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
210 mg AMG 827: 210 mg SC
140 mg AMG 827: 140 mg SC
280 mg AMG 827: 280 mg SC
Placebo Placebo: Placebo SC
70 mg AMG 827: 70 mg SC

Participant Flow:   Overall Study
    210 mg   140 mg   280 mg   Placebo   70 mg
STARTED   40   39   42   38   39 
COMPLETED   37   38   40   32   37 
NOT COMPLETED   3   1   2   6   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Broda 210 mg AMG 827: 210 mg SC
Broda 140 mg AMG 827: 140 mg SC
Broda 280 mg AMG 827: 280 mg SC
Placebo Placebo: Placebo SC
Broda 70 mg AMG 827: 70 mg SC
Total Total of all reporting groups

Baseline Measures
   Broda 210 mg   Broda 140 mg   Broda 280 mg   Placebo   Broda 70 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   39   42   38   39   198 
Age 
[Units: Participants]
Count of Participants
           
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      39  97.5%      38  97.4%      40  95.2%      35  92.1%      38  97.4%      190  96.0% 
>=65 years      1   2.5%      1   2.6%      2   4.8%      3   7.9%      1   2.6%      8   4.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.1  (12.2)   44.0  (11.7)   42.3  (12.2)   41.8  (14.4)   42.1  (11.1)   42.6  (11.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      15  37.5%      11  28.2%      12  28.6%      16  42.1%      17  43.6%      71  35.9% 
Male      25  62.5%      28  71.8%      30  71.4%      22  57.9%      22  56.4%      127  64.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino      2   5.0%      1   2.6%      0   0.0%      2   5.3%      1   2.6%      6   3.0% 
Not Hispanic or Latino      38  95.0%      38  97.4%      41  97.6%      36  94.7%      38  97.4%      191  96.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      1   2.4%      0   0.0%      0   0.0%      1   0.5% 


  Outcome Measures
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1.  Primary:   To Establish a Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 and to Identify an Appropriate Dose Regimen for Future Trials   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Percent of Body Surface Area (BSA) Affected by Psoriasis   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: Valeant Pharmaceuticals
phone: 908
e-mail: binu.alexander@valeant.com


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00975637     History of Changes
Other Study ID Numbers: 20090062
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: November 2, 2016
Results First Posted: December 30, 2016
Last Update Posted: March 17, 2017