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Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-1)

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ClinicalTrials.gov Identifier: NCT01708590
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 Psoriasis
Interventions Drug: 210 mg brodalumab
Drug: 140 mg brodalumab
Drug: placebo
Enrollment 661
Recruitment Details  
Pre-assignment Details Total number should be calculated from the induction phase at 661 subjects starting the study. At week 12 if subjects achieved sPGA success (clear[0] or almost clear[1]) they were not continued in the study withdrawal phase to receive drug. Those not achieving success were re-randomized for treatment continuation.
Arm/Group Title Induction Phase: 210 mg Brodalumab Induction Phase: 140 mg Brodalumab Induction Phase: Placebo Withdrawal Phase: Placebo (140mg) Withdrawal Phase: 140mg Brodalumab Q2W Withdrawal Phase: Placebo (210mg) Withdrawl Phase: 210mg Brodalumab Q2W
Hide Arm/Group Description Administered by subcutaneous (SC) injection until week 12. 210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC) Administered by subcutaneous (SC) injection until week 12. 140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC) Administered by SC injection until week 12. placebo: Placebo administered subcutaneous (SC) Administered SC injection Week 12 - Week 52 Administered SC injection, Week 12 - Week 52 Administered SC, Week 12 - Week 52 Administered SC injection, Week 12- Week 16
Period Title: Induction Phase
Started 222 219 220 0 0 0 0
Completed 212 212 209 0 0 0 0
Not Completed 10 7 11 0 0 0 0
Period Title: Withdrawal Phase
Started [1] 0 0 0 59 57 84 83
Completed 0 0 0 6 45 2 74
Not Completed 0 0 0 53 12 82 9
[1]
A subset of 283 subjects were rerandomized to Placebo or Brodalumab in the Withdrawal Phase.
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Placebo Total
Hide Arm/Group Description

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.

210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)

placebo: Placebo administered subcutaneous (SC)

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.

140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)

placebo: Placebo administered subcutaneous (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 subcutaneous (SC)

placebo: Placebo administered subcutaneous (SC)

Total of all reporting groups
Overall Number of Baseline Participants 222 219 220 661
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 222 participants 219 participants 220 participants 661 participants
46.3  (12.2) 45.8  (13.4) 46.9  (13.2) 46.3  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 219 participants 220 participants 661 participants
Female
61
  27.5%
57
  26.0%
59
  26.8%
177
  26.8%
Male
161
  72.5%
162
  74.0%
161
  73.2%
484
  73.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 219 participants 220 participants 661 participants
American Indian or Alaska Native
1
   0.5%
1
   0.5%
0
   0.0%
2
   0.3%
Asian
10
   4.5%
10
   4.6%
8
   3.6%
28
   4.2%
Native Hawaiian or Other Pacific Islander
2
   0.9%
1
   0.5%
2
   0.9%
5
   0.8%
Black or African American
3
   1.4%
8
   3.7%
6
   2.7%
17
   2.6%
White
203
  91.4%
196
  89.5%
202
  91.8%
601
  90.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   1.4%
3
   1.4%
2
   0.9%
8
   1.2%
1.Primary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12
Hide Description to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.
Time Frame 0-12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data collected is based off of the data from the induction phase.
Arm/Group Title Induction Phase: 210 mg Brodalumab Induction Phase: 140 mg Brodalumab Induction Phase: Placebo
Hide Arm/Group Description:

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.

210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)

placebo: Placebo administered subcutaneous (SC)

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.

140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)

placebo: Placebo administered subcutaneous (SC)

Administered by SC injection until week 12. placebo: Placebo administered subcutaneous (SC)
Overall Number of Participants Analyzed 222 219 220
Measure Type: Count of Participants
Unit of Measure: Participants
185
  83.3%
132
  60.3%
6
   2.7%
2.Primary Outcome
Title Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
Hide Description To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12
Time Frame 0 - 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data reported is based off of the data collected from the induction phase
Arm/Group Title Induction Phase: 210 mg Brodalumab Induction Phase: 140 mg Brodalumab Induction Phase: Placebo
Hide Arm/Group Description:

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.

210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)

placebo: Placebo administered subcutaneous (SC)

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.

140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)

placebo: Placebo administered subcutaneous (SC)

Administered by SC injection until week 12.

placebo: Placebo administered subcutaneous (SC)

Overall Number of Participants Analyzed 222 219 220
Measure Type: Count of Participants
Unit of Measure: Participants
168
  75.7%
118
  53.9%
3
   1.4%
3.Secondary Outcome
Title Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52
Hide Description to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52.
Time Frame Week 0 - Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with efficacy data available at Week 52 were included in the analysis.
Arm/Group Title Withdrawal Phase: Placebo (140mg) Withdrawal Phase: 140mg Brodalumab Q2W Withdrawal Phase: Placebo (210mg) Withdrawl Phase: 210mg Brodalumab Q2W
Hide Arm/Group Description:
Administered SC injection Week 12 - Week 52
Administered SC injection, Week 12 - Week 52
Administered SC, Week 12 - Week 52
Administered SC injection, Week 12- Week 16
Overall Number of Participants Analyzed 6 47 2 72
Measure Type: Count of Participants
Unit of Measure: Participants
3
  50.0%
40
  85.1%
0
   0.0%
69
  95.8%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
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 placebo or continued treatment. Participants are retreated at return of disease.

210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)

placebo: Placebo administered subcutaneous (SC)

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.

140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)

placebo: Placebo administered subcutaneous (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 subcutaneous (SC)

placebo: Placebo administered subcutaneous (SC)

All-Cause Mortality
210 mg Brodalumab 140 mg Brodalumab Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
210 mg Brodalumab 140 mg Brodalumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/222 (1.80%)      6/219 (2.74%)      3/220 (1.36%)    
Gastrointestinal disorders       
Volvulus of Small Bowel *  0/222 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Immune system disorders       
Diabetes mellitus *  1/222 (0.45%)  1 0/219 (0.00%)  0 0/220 (0.00%)  0
Psoriasis *  0/222 (0.00%)  0 0/219 (0.00%)  0 2/220 (0.91%)  2
Infections and infestations       
Cellulitis *  1/222 (0.45%)  1 1/219 (0.46%)  1 0/220 (0.00%)  0
Diverticulitis *  0/222 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Pancreatitis Acute *  0/222 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Pyrexia *  0/222 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Cholecystitis acute *  1/222 (0.45%)  1 0/219 (0.00%)  0 0/220 (0.00%)  0
Injury, poisoning and procedural complications       
Back Pain *  1/222 (0.45%)  1 0/219 (0.00%)  0 0/220 (0.00%)  0
Invertebral Disk Intusion *  0/222 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
COPD *  0/222 (0.00%)  0 0/219 (0.00%)  0 1/220 (0.45%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
210 mg Brodalumab 140 mg Brodalumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   85/222 (38.29%)      91/219 (41.55%)      46/220 (20.91%)    
Cardiac disorders       
Hypertension *  2/222 (0.90%)  2 8/219 (3.65%)  8 4/220 (1.82%)  4
Gastrointestinal disorders       
Nausea *  5/222 (2.25%)  5 5/219 (2.28%)  5 2/220 (0.91%)  2
General disorders       
Cough *  3/222 (1.35%)  3 6/219 (2.74%)  6 0/220 (0.00%)  0
Dizziness *  0/222 (0.00%)  0 3/219 (1.37%)  3 0/220 (0.00%)  0
Immune system disorders       
Influenza *  4/222 (1.80%)  4 1/219 (0.46%)  1 1/220 (0.45%)  1
Infections and infestations       
Upper Respiratory Tract Infection *  18/222 (8.11%)  18 18/219 (8.22%)  18 14/220 (6.36%)  14
Rhinitis *  5/222 (2.25%)  5 2/219 (0.91%)  2 2/220 (0.91%)  2
Tooth Infection *  1/222 (0.45%)  1 6/219 (2.74%)  6 2/220 (0.91%)  2
Diarrhoea *  4/222 (1.80%)  4 4/219 (1.83%)  4 1/220 (0.45%)  1
Vomiting *  2/222 (0.90%)  2 4/219 (1.83%)  4 1/220 (0.45%)  1
Conjunctivitis *  5/222 (2.25%)  5 2/219 (0.91%)  2 0/220 (0.00%)  0
Myalgia *  4/222 (1.80%)  4 2/219 (0.91%)  2 0/220 (0.00%)  0
Influenza like illness *  4/222 (1.80%)  4 0/219 (0.00%)  0 1/220 (0.45%)  1
Rash *  4/222 (1.80%)  4 0/219 (0.00%)  0 0/220 (0.00%)  0
UTI *  1/222 (0.45%)  1 3/219 (1.37%)  3 0/220 (0.00%)  0
Injury, poisoning and procedural complications       
Arthralgia *  6/222 (2.70%)  6 10/219 (4.57%)  10 6/220 (2.73%)  6
Ligament Sprain *  0/222 (0.00%)  0 3/219 (1.37%)  3 1/220 (0.45%)  1
Musculoskeletal and connective tissue disorders       
Back Pain *  6/222 (2.70%)  6 2/219 (0.91%)  2 4/220 (1.82%)  4
Nervous system disorders       
Headache *  11/222 (4.95%)  11 12/219 (5.48%)  12 7/220 (3.18%)  7
*
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: NCT01708590    
Other Study ID Numbers: 20120102
2012-000651-13 ( EudraCT Number )
First Submitted: September 10, 2012
First Posted: October 17, 2012
Results First Submitted: November 2, 2016
Results First Posted: January 3, 2020
Last Update Posted: January 3, 2020