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Trial record 1 of 2 for:    AMAGINE-3
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Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-3)

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: NCT01708629
Recruitment Status : Terminated (Sponsor decision)
First Posted : October 17, 2012
Results First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: 210 mg brodalumab
Drug: 140 mg brodalumab
Drug: ustekinumab
Drug: placebo
Enrollment 1881
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Ustekinumab Placebo
Hide Arm/Group Description

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

210 mg brodalumab: 210 mg brodalumab administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

140 mg brodalumab: 140 mg brodalumab administered SC

Administered by subcutaneous (SC) injection per the labeled dosing regimen.

ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.

Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

210 mg brodalumab: 210 mg brodalumab administered SC

placebo: placebo administered SC

Period Title: Overall Study
Started 624 629 313 315
Completed 608 604 303 301
Not Completed 16 25 10 14
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Ustekinumab Placebo Total
Hide Arm/Group Description

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

210 mg brodalumab: 210 mg brodalumab administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

140 mg brodalumab: 140 mg brodalumab administered SC

Administered by subcutaneous (SC) injection per the labeled dosing regimen.

ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.

Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

210 mg brodalumab: 210 mg brodalumab administered SC

placebo: placebo administered SC

Total of all reporting groups
Overall Number of Baseline Participants 624 629 313 315 1881
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 624 participants 629 participants 313 participants 315 participants 1881 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
578
  92.6%
589
  93.6%
292
  93.3%
300
  95.2%
1759
  93.5%
>=65 years
46
   7.4%
40
   6.4%
21
   6.7%
15
   4.8%
122
   6.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 624 participants 629 participants 313 participants 315 participants 1881 participants
45.2  (13.3) 44.6  (13.0) 44.8  (13.1) 44.2  (12.5) 44.8  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 624 participants 629 participants 313 participants 315 participants 1881 participants
Female
193
  30.9%
192
  30.5%
101
  32.3%
107
  34.0%
593
  31.5%
Male
431
  69.1%
437
  69.5%
212
  67.7%
208
  66.0%
1288
  68.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 624 participants 629 participants 313 participants 315 participants 1881 participants
American Indian or Alaska Native
3
   0.5%
3
   0.5%
1
   0.3%
0
   0.0%
7
   0.4%
Asian
20
   3.2%
27
   4.3%
12
   3.8%
9
   2.9%
68
   3.6%
Native Hawaiian or Other Pacific Islander
3
   0.5%
3
   0.5%
1
   0.3%
1
   0.3%
8
   0.4%
Black or African American
17
   2.7%
22
   3.5%
13
   4.2%
6
   1.9%
58
   3.1%
White
565
  90.5%
569
  90.5%
280
  89.5%
294
  93.3%
1708
  90.8%
More than one race
2
   0.3%
1
   0.2%
0
   0.0%
0
   0.0%
3
   0.2%
Unknown or Not Reported
14
   2.2%
4
   0.6%
6
   1.9%
5
   1.6%
29
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 624 participants 629 participants 313 participants 315 participants 1881 participants
Greece 21 23 11 10 65
Canada 72 75 38 34 219
Latvia 33 32 15 16 96
Russia 23 21 9 12 65
Hungary 17 16 10 7 50
Belgium 8 8 3 6 24
United States 276 278 140 141 835
Poland 127 128 63 63 381
Italy 2 3 1 2 8
Australia 17 16 9 8 50
France 28 29 14 16 88
1.Primary Outcome
Title Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
Hide Description The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Placebo Ustekinumab
Hide Arm/Group Description:

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

210 mg brodalumab: 210 mg brodalumab administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

140 mg brodalumab: 140 mg brodalumab administered SC

Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

210 mg brodalumab: 210 mg brodalumab administered SC

placebo: placebo administered SC

Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.
Overall Number of Participants Analyzed 624 629 315 313
Measure Type: Count of Participants
Unit of Measure: Participants
531
  85.1%
435
  69.2%
19
   6.0%
217
  69.3%
2.Primary Outcome
Title Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
Hide Description Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
sPGA was only assessed as a comparison of Brodalumab (210mg and 140mg) to Placebo.
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Placebo
Hide Arm/Group Description:

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

210 mg brodalumab: 210 mg brodalumab administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

140 mg brodalumab: 140 mg brodalumab administered SC

Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

210 mg brodalumab: 210 mg brodalumab administered SC

placebo: placebo administered SC

Overall Number of Participants Analyzed 624 629 315
Measure Type: Count of Participants
Unit of Measure: Participants
497
  79.6%
377
  59.9%
13
   4.1%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Placebo Ustekinumab
Hide Arm/Group Description

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

210 mg brodalumab: 210 mg brodalumab administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

140 mg brodalumab: 140 mg brodalumab administered SC

Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

210 mg brodalumab: 210 mg brodalumab administered SC

placebo: placebo administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
All-Cause Mortality
210 mg Brodalumab 140 mg Brodalumab Placebo Ustekinumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
210 mg Brodalumab 140 mg Brodalumab Placebo Ustekinumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/624 (1.44%)   10/629 (1.59%)   3/315 (0.95%)   2/313 (0.64%) 
Cardiac disorders         
Atrial Fibrillation *  0/624 (0.00%)  1/629 (0.16%)  0/315 (0.00%)  0/313 (0.00%) 
Hypotension *  1/624 (0.16%)  0/629 (0.00%)  0/315 (0.00%)  0/313 (0.00%) 
Myocardial Infarction *  0/624 (0.00%)  1/629 (0.16%)  0/315 (0.00%)  0/313 (0.00%) 
Ear and labyrinth disorders         
Encephalopathy *  1/624 (0.16%)  0/629 (0.00%)  0/315 (0.00%)  0/313 (0.00%) 
Gastrointestinal disorders         
Gastroenteritis *  1/624 (0.16%)  1/629 (0.16%)  0/315 (0.00%)  0/313 (0.00%) 
Gastritis *  1/624 (0.16%)  0/629 (0.00%)  0/315 (0.00%)  0/313 (0.00%) 
General disorders         
Altered State of Consciousness *  1/624 (0.16%)  0/629 (0.00%)  0/315 (0.00%)  0/313 (0.00%) 
Arthritis *  1/624 (0.16%)  0/629 (0.00%)  0/315 (0.00%)  0/313 (0.00%) 
Overdose *  1/624 (0.16%)  0/629 (0.00%)  0/315 (0.00%)  0/313 (0.00%) 
Immune system disorders         
Appendicitus *  0/624 (0.00%)  1/629 (0.16%)  0/315 (0.00%)  0/313 (0.00%) 
Infections and infestations         
Localised Infection *  0/624 (0.00%)  0/629 (0.00%)  1/315 (0.32%)  0/313 (0.00%) 
Meningitis Cryptoccocal *  1/624 (0.16%)  0/629 (0.00%)  0/315 (0.00%)  0/313 (0.00%) 
Peritonsillar Abscess *  0/624 (0.00%)  1/629 (0.16%)  0/315 (0.00%)  0/313 (0.00%) 
Injury, poisoning and procedural complications         
Cerebrovascular Accident *  0/624 (0.00%)  1/629 (0.16%)  0/315 (0.00%)  0/313 (0.00%) 
Nervous system disorders         
Nephrolithiasis *  0/624 (0.00%)  1/629 (0.16%)  0/315 (0.00%)  0/313 (0.00%) 
Psychiatric disorders         
Depression *  0/624 (0.00%)  1/629 (0.16%)  0/315 (0.00%)  0/313 (0.00%) 
Renal and urinary disorders         
Renal Failure *  0/624 (0.00%)  0/629 (0.00%)  1/315 (0.32%)  0/313 (0.00%) 
Bladder Cancer *  1/624 (0.16%)  0/629 (0.00%)  0/315 (0.00%)  0/313 (0.00%) 
Cholecystitis *  1/624 (0.16%)  0/629 (0.00%)  0/315 (0.00%)  0/313 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute Respiratory Failure *  1/624 (0.16%)  0/629 (0.00%)  0/315 (0.00%)  0/313 (0.00%) 
Skin and subcutaneous tissue disorders         
Psoriasis *  0/624 (0.00%)  0/629 (0.00%)  1/315 (0.32%)  0/313 (0.00%) 
Cellulitis *  0/624 (0.00%)  0/629 (0.00%)  0/315 (0.00%)  1/313 (0.32%) 
Dermatitis Contact *  0/624 (0.00%)  1/629 (0.16%)  0/315 (0.00%)  0/313 (0.00%) 
Diverticulitis *  0/624 (0.00%)  0/629 (0.00%)  0/315 (0.00%)  1/313 (0.32%) 
Erythrodermic Psoriasis *  1/624 (0.16%)  0/629 (0.00%)  0/315 (0.00%)  0/313 (0.00%) 
Rash Papular *  0/624 (0.00%)  1/629 (0.16%)  0/315 (0.00%)  0/313 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
210 mg Brodalumab 140 mg Brodalumab Placebo Ustekinumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   353/624 (56.57%)   329/629 (52.31%)   152/315 (48.25%)   168/313 (53.67%) 
Gastrointestinal disorders         
Diarrhoea *  14/624 (2.24%)  6/629 (0.95%)  4/315 (1.27%)  3/313 (0.96%) 
Nausea *  11/624 (1.76%)  11/629 (1.75%)  2/315 (0.63%)  1/313 (0.32%) 
Toothache *  7/624 (1.12%)  4/629 (0.64%)  0/315 (0.00%)  0/313 (0.00%) 
Abdominal Pain *  2/624 (0.32%)  3/629 (0.48%)  2/315 (0.63%)  2/313 (0.64%) 
General disorders         
Fatigue *  20/624 (3.21%)  20/629 (3.18%)  6/315 (1.90%)  4/313 (1.28%) 
Influenza Like Illness *  6/624 (0.96%)  7/629 (1.11%)  3/315 (0.95%)  1/313 (0.32%) 
Pyrexia *  6/624 (0.96%)  4/629 (0.64%)  3/315 (0.95%)  3/313 (0.96%) 
Injection Site Pain *  4/624 (0.64%)  1/629 (0.16%)  2/315 (0.63%)  4/313 (1.28%) 
Injection Site erythema *  2/624 (0.32%)  3/629 (0.48%)  2/315 (0.63%)  3/313 (0.96%) 
Infections and infestations         
Nasopharyngitis *  31/624 (4.97%)  36/629 (5.72%)  22/315 (6.98%)  16/313 (5.11%) 
Upper respiratory tract Infection *  33/624 (5.29%)  19/629 (3.02%)  17/315 (5.40%)  16/313 (5.11%) 
Urinary Tract Infection *  11/624 (1.76%)  5/629 (0.79%)  3/315 (0.95%)  8/313 (2.56%) 
Pharyngitis *  9/624 (1.44%)  5/629 (0.79%)  6/315 (1.90%)  4/313 (1.28%) 
Influenza *  8/624 (1.28%)  5/629 (0.79%)  2/315 (0.63%)  6/313 (1.92%) 
Injury, poisoning and procedural complications         
Injury and Complications *  41/624 (6.57%)  38/629 (6.04%)  14/315 (4.44%)  19/313 (6.07%) 
Excoriation *  0/624 (0.00%)  0/629 (0.00%)  2/315 (0.63%)  3/313 (0.96%) 
Investigations         
Investigations *  31/624 (4.97%)  19/629 (3.02%)  5/315 (1.59%)  15/313 (4.79%) 
Metabolism and nutrition disorders         
Metabolism and Nutritional Disorders *  21/624 (3.37%)  14/629 (2.23%)  4/315 (1.27%)  11/313 (3.51%) 
Musculoskeletal and connective tissue disorders         
Arthralgia *  36/624 (5.77%)  25/629 (3.97%)  6/315 (1.90%)  10/313 (3.19%) 
Pain in Extremity *  10/624 (1.60%)  11/629 (1.75%)  3/315 (0.95%)  6/313 (1.92%) 
Back Pain *  8/624 (1.28%)  11/629 (1.75%)  5/315 (1.59%)  5/313 (1.60%) 
Myalgia *  12/624 (1.92%)  9/629 (1.43%)  2/315 (0.63%)  0/313 (0.00%) 
Psoriatic Arthropathy *  7/624 (1.12%)  7/629 (1.11%)  1/315 (0.32%)  2/313 (0.64%) 
Nervous system disorders         
headache *  21/624 (3.37%)  32/629 (5.09%)  14/315 (4.44%)  11/313 (3.51%) 
Dizziness *  7/624 (1.12%)  3/629 (0.48%)  1/315 (0.32%)  1/313 (0.32%) 
Sciatica *  3/624 (0.48%)  4/629 (0.64%)  1/315 (0.32%)  2/313 (0.64%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain *  18/624 (2.88%)  14/629 (2.23%)  3/315 (0.95%)  7/313 (2.24%) 
Cough *  14/624 (2.24%)  11/629 (1.75%)  7/315 (2.22%)  7/313 (2.24%) 
Nasal Congestion *  4/624 (0.64%)  6/629 (0.95%)  1/315 (0.32%)  3/313 (0.96%) 
Skin and subcutaneous tissue disorders         
Pruritus *  9/624 (1.44%)  17/629 (2.70%)  15/315 (4.76%)  6/313 (1.92%) 
Psoriasis *  6/624 (0.96%)  9/629 (1.43%)  9/315 (2.86%)  1/313 (0.32%) 
Dermatitis Contact *  4/624 (0.64%)  6/629 (0.95%)  1/315 (0.32%)  0/313 (0.00%) 
*
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: Study Director
Organization: Bausch Health
Phone: 510-259-5284
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01708629    
Other Study ID Numbers: 20120104
First Submitted: September 21, 2012
First Posted: October 17, 2012
Results First Submitted: November 8, 2016
Results First Posted: January 3, 2020
Last Update Posted: January 3, 2020