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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.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: AMG 827
Enrollment 181
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label AMG 827
Hide Arm/Group Description AMG 827: 210 mg SC or 140 mg SC
Period Title: Overall Study
Started 181
Completed 126
Not Completed 55
Arm/Group Title Open Label
Hide Arm/Group Description AMG 827: 210 mg SC or 140 mg SC
Overall Number of Baseline Participants 181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants
<=18 years
0
   0.0%
Between 18 and 65 years
173
  95.6%
>=65 years
8
   4.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 181 participants
42.7  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants
Female
64
  35.4%
Male
117
  64.6%
1.Primary Outcome
Title Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were enrolled and had a valid measurement value at the specified week. Results are presented for data up to week 264 as all continuing subjects had completed that visit.
Arm/Group Title Open Label AMG 827
Hide Arm/Group Description:
AMG 827: 210 mg SC or 140 mg SC
Overall Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
66
  61.7%
2.Primary Outcome
Title Percent Change in Psoriasis Area and Severity Index (PASI)
Hide Description Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement.
Time Frame 264 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were enrolled and had a valid measurement value at the specified week. Results are presented for data up to week 264 as all continuing subjects had completed that visit.
Arm/Group Title Open Label
Hide Arm/Group Description:
AMG 827: 210 mg SC or 140 mg SC
Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: Percentage change
-85.7  (26.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label AMG 827
Hide Arm/Group Description AMG 827: 210 mg SC or 140 mg SC
All-Cause Mortality
Open Label AMG 827
Affected / at Risk (%)
Total   1/181 (0.55%) 
Hide Serious Adverse Events
Open Label AMG 827
Affected / at Risk (%)
Total   29/181 (16.02%) 
Cardiac disorders   
Angina Pectoris *  1/181 (0.55%) 
Myocardial Infaraction *  3/181 (1.66%) 
Atrial fibrillation *  1/181 (0.55%) 
Cardiac failure congestive *  1/181 (0.55%) 
Supraventricular tachycardia *  1/181 (0.55%) 
Gastrointestinal disorders   
Duodenal Ulcer *  1/181 (0.55%) 
Gastroenteritis eosinophillic *  1/181 (0.55%) 
Intestinal obstruction *  1/181 (0.55%) 
Hepatobiliary disorders   
Bile duct stone *  1/181 (0.55%) 
Cholecystitis *  1/181 (0.55%) 
Cholecystitis acute *  1/181 (0.55%) 
Infections and infestations   
Hepatitis C *  1/181 (0.55%) 
Meningitis Viral *  1/181 (0.55%) 
Pyelonephritis *  1/181 (0.55%) 
Pyelonephritis acute *  1/181 (0.55%) 
Abscess *  1/181 (0.55%) 
Necrotising fascitis streptococcal *  1/181 (0.55%) 
Septic Shock *  1/181 (0.55%) 
Urosepsis *  1/181 (0.55%) 
Injury, poisoning and procedural complications   
Lower Limb Fracture *  1/181 (0.55%) 
Musculoskeletal and connective tissue disorders   
Osteoarthritis *  2/181 (1.10%) 
Intervertabral disc protrusion *  1/181 (0.55%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast Cancer *  1/181 (0.55%) 
Oesophageal adenocarcinoma *  1/181 (0.55%) 
Parathyroid tumour benign *  1/181 (0.55%) 
Pituitary tumour benign *  1/181 (0.55%) 
Prostate cancer *  1/181 (0.55%) 
Nervous system disorders   
Cervical Radiculopathy *  1/181 (0.55%) 
Psychiatric disorders   
Depression *  2/181 (1.10%) 
Suicidal ideation *  1/181 (0.55%) 
Renal and urinary disorders   
Nephrolithiasis *  1/181 (0.55%) 
Skin and subcutaneous tissue disorders   
Pustular Psoriasis *  3/181 (1.66%) 
Toxic Skin Eruptions *  1/181 (0.55%) 
Vascular disorders   
Aortic aneurysm rupture *  1/181 (0.55%) 
Femoral artery occlusion *  1/181 (0.55%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open Label AMG 827
Affected / at Risk (%)
Total   177/181 (97.79%) 
Gastrointestinal disorders   
Gastroenteritis *  24/181 (13.26%) 
Gastrooesophageal reflux disease *  13/181 (7.18%) 
Nausea *  11/181 (6.08%) 
General disorders   
Nasopharyngitis *  53/181 (29.28%) 
Pain in extremity *  16/181 (8.84%) 
Fatigue *  10/181 (5.52%) 
Insomnia *  10/181 (5.52%) 
Infections and infestations   
Upper respiratory tract infection *  43/181 (23.76%) 
Influenza *  28/181 (15.47%) 
Sinusitis *  21/181 (11.60%) 
Pharyngitis streptococcal *  11/181 (6.08%) 
Viral upper respiratory tract infection *  10/181 (5.52%) 
Injury, poisoning and procedural complications   
Contusion *  11/181 (6.08%) 
Musculoskeletal and connective tissue disorders   
Arthralgia *  37/181 (20.44%) 
Back pain *  26/181 (14.36%) 
Psoriatic arthropathy *  18/181 (9.94%) 
Muscle strain *  16/181 (8.84%) 
Tendonitis *  12/181 (6.63%) 
Osteoarthritis *  10/181 (5.52%) 
Nervous system disorders   
Hypertension *  18/181 (9.94%) 
Headache *  14/181 (7.73%) 
Psychiatric disorders   
Anxiety *  15/181 (8.29%) 
Renal and urinary disorders   
Nephrolithiasis *  10/181 (5.52%) 
Urinary tract infection *  10/181 (5.52%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain *  18/181 (9.94%) 
Bronchitis *  15/181 (8.29%) 
Pharyngitis *  13/181 (7.18%) 
Rhinitis *  11/181 (6.08%) 
Cough *  10/181 (5.52%) 
Skin and subcutaneous tissue disorders   
Psoriasis *  19/181 (10.50%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Lindsey Mathew
Organization: Valeant Pharmaceuticals International
Phone: 908
EMail: lindsey.mathew@valeant.com
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01101100    
Other Study ID Numbers: 20090403
First Submitted: April 1, 2010
First Posted: April 9, 2010
Results First Submitted: November 8, 2016
Results First Posted: July 18, 2019
Last Update Posted: July 30, 2019