Trial Outcomes & Findings for Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects (NCT NCT01708629)
NCT ID: NCT01708629
Last Updated: 2020-01-03
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1881 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-01-03
Participant Flow
Participant milestones
| Measure |
210 mg Brodalumab
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
|
140 mg Brodalumab
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
|
Ustekinumab
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
|
Placebo
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 Study
STARTED
|
624
|
629
|
313
|
315
|
|
Overall Study
COMPLETED
|
608
|
604
|
303
|
301
|
|
Overall Study
NOT COMPLETED
|
16
|
25
|
10
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
Baseline characteristics by cohort
| Measure |
210 mg Brodalumab
n=624 Participants
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
|
140 mg Brodalumab
n=629 Participants
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
|
Ustekinumab
n=313 Participants
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
|
Placebo
n=315 Participants
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
n=1881 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
578 Participants
n=5 Participants
|
589 Participants
n=7 Participants
|
292 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
1759 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
122 Participants
n=21 Participants
|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
44.8 years
STANDARD_DEVIATION 13.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
193 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
593 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
431 Participants
n=5 Participants
|
437 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
1288 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
565 Participants
n=5 Participants
|
569 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
294 Participants
n=4 Participants
|
1708 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Region of Enrollment
Greece
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
65 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
72 participants
n=5 Participants
|
75 participants
n=7 Participants
|
38 participants
n=5 Participants
|
34 participants
n=4 Participants
|
219 participants
n=21 Participants
|
|
Region of Enrollment
Latvia
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
15 participants
n=5 Participants
|
16 participants
n=4 Participants
|
96 participants
n=21 Participants
|
|
Region of Enrollment
Russia
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
9 participants
n=5 Participants
|
12 participants
n=4 Participants
|
65 participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
10 participants
n=5 Participants
|
7 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
276 participants
n=5 Participants
|
278 participants
n=7 Participants
|
140 participants
n=5 Participants
|
141 participants
n=4 Participants
|
835 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
127 participants
n=5 Participants
|
128 participants
n=7 Participants
|
63 participants
n=5 Participants
|
63 participants
n=4 Participants
|
381 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
Region of Enrollment
France
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
14 participants
n=5 Participants
|
16 participants
n=4 Participants
|
88 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
210 mg Brodalumab
n=624 Participants
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
|
140 mg Brodalumab
n=629 Participants
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
|
Placebo
n=315 Participants
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
|
Ustekinumab
n=313 Participants
Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.
|
|---|---|---|---|---|
|
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
|
531 Participants
|
435 Participants
|
19 Participants
|
217 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: sPGA was only assessed as a comparison of Brodalumab (210mg and 140mg) to Placebo.
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).
Outcome measures
| Measure |
210 mg Brodalumab
n=624 Participants
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
|
140 mg Brodalumab
n=629 Participants
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
|
Placebo
n=315 Participants
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
|
Ustekinumab
Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.
|
|---|---|---|---|---|
|
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
|
497 Participants
|
377 Participants
|
13 Participants
|
—
|
Adverse Events
210 mg Brodalumab
Serious events: 9 serious events
Other events: 353 other events
Deaths: 0 deaths
140 mg Brodalumab
Serious events: 10 serious events
Other events: 329 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 152 other events
Deaths: 0 deaths
Ustekinumab
Serious events: 2 serious events
Other events: 168 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
210 mg Brodalumab
n=624 participants at risk
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
|
140 mg Brodalumab
n=629 participants at risk
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
|
Placebo
n=315 participants at risk
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
|
Ustekinumab
n=313 participants at risk
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis
|
0.16%
1/624
|
0.16%
1/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Infections and infestations
Localised Infection
|
0.00%
0/624
|
0.00%
0/629
|
0.32%
1/315
|
0.00%
0/313
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/624
|
0.00%
0/629
|
0.32%
1/315
|
0.00%
0/313
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/624
|
0.00%
0/629
|
0.32%
1/315
|
0.00%
0/313
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.16%
1/624
|
0.00%
0/629
|
0.00%
0/315
|
0.00%
0/313
|
|
General disorders
Altered State of Consciousness
|
0.16%
1/624
|
0.00%
0/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Immune system disorders
Appendicitus
|
0.00%
0/624
|
0.16%
1/629
|
0.00%
0/315
|
0.00%
0/313
|
|
General disorders
Arthritis
|
0.16%
1/624
|
0.00%
0/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/624
|
0.16%
1/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Renal and urinary disorders
Bladder Cancer
|
0.16%
1/624
|
0.00%
0/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/624
|
0.00%
0/629
|
0.00%
0/315
|
0.32%
1/313
|
|
Injury, poisoning and procedural complications
Cerebrovascular Accident
|
0.00%
0/624
|
0.16%
1/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Renal and urinary disorders
Cholecystitis
|
0.16%
1/624
|
0.00%
0/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Psychiatric disorders
Depression
|
0.00%
0/624
|
0.16%
1/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/624
|
0.16%
1/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Skin and subcutaneous tissue disorders
Diverticulitis
|
0.00%
0/624
|
0.00%
0/629
|
0.00%
0/315
|
0.32%
1/313
|
|
Ear and labyrinth disorders
Encephalopathy
|
0.16%
1/624
|
0.00%
0/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Skin and subcutaneous tissue disorders
Erythrodermic Psoriasis
|
0.16%
1/624
|
0.00%
0/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Gastrointestinal disorders
Gastritis
|
0.16%
1/624
|
0.00%
0/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Cardiac disorders
Hypotension
|
0.16%
1/624
|
0.00%
0/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Infections and infestations
Meningitis Cryptoccocal
|
0.16%
1/624
|
0.00%
0/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/624
|
0.16%
1/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Nervous system disorders
Nephrolithiasis
|
0.00%
0/624
|
0.16%
1/629
|
0.00%
0/315
|
0.00%
0/313
|
|
General disorders
Overdose
|
0.16%
1/624
|
0.00%
0/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Infections and infestations
Peritonsillar Abscess
|
0.00%
0/624
|
0.16%
1/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/624
|
0.16%
1/629
|
0.00%
0/315
|
0.00%
0/313
|
Other adverse events
| Measure |
210 mg Brodalumab
n=624 participants at risk
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
|
140 mg Brodalumab
n=629 participants at risk
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
|
Placebo
n=315 participants at risk
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
|
Ustekinumab
n=313 participants at risk
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.0%
31/624
|
5.7%
36/629
|
7.0%
22/315
|
5.1%
16/313
|
|
Infections and infestations
Upper respiratory tract Infection
|
5.3%
33/624
|
3.0%
19/629
|
5.4%
17/315
|
5.1%
16/313
|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
11/624
|
0.79%
5/629
|
0.95%
3/315
|
2.6%
8/313
|
|
Infections and infestations
Pharyngitis
|
1.4%
9/624
|
0.79%
5/629
|
1.9%
6/315
|
1.3%
4/313
|
|
Infections and infestations
Influenza
|
1.3%
8/624
|
0.79%
5/629
|
0.63%
2/315
|
1.9%
6/313
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
36/624
|
4.0%
25/629
|
1.9%
6/315
|
3.2%
10/313
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.6%
10/624
|
1.7%
11/629
|
0.95%
3/315
|
1.9%
6/313
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
8/624
|
1.7%
11/629
|
1.6%
5/315
|
1.6%
5/313
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
12/624
|
1.4%
9/629
|
0.63%
2/315
|
0.00%
0/313
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
1.1%
7/624
|
1.1%
7/629
|
0.32%
1/315
|
0.64%
2/313
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
9/624
|
2.7%
17/629
|
4.8%
15/315
|
1.9%
6/313
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.96%
6/624
|
1.4%
9/629
|
2.9%
9/315
|
0.32%
1/313
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.64%
4/624
|
0.95%
6/629
|
0.32%
1/315
|
0.00%
0/313
|
|
General disorders
Fatigue
|
3.2%
20/624
|
3.2%
20/629
|
1.9%
6/315
|
1.3%
4/313
|
|
General disorders
Influenza Like Illness
|
0.96%
6/624
|
1.1%
7/629
|
0.95%
3/315
|
0.32%
1/313
|
|
General disorders
Pyrexia
|
0.96%
6/624
|
0.64%
4/629
|
0.95%
3/315
|
0.96%
3/313
|
|
General disorders
Injection Site Pain
|
0.64%
4/624
|
0.16%
1/629
|
0.63%
2/315
|
1.3%
4/313
|
|
Nervous system disorders
headache
|
3.4%
21/624
|
5.1%
32/629
|
4.4%
14/315
|
3.5%
11/313
|
|
Nervous system disorders
Dizziness
|
1.1%
7/624
|
0.48%
3/629
|
0.32%
1/315
|
0.32%
1/313
|
|
Nervous system disorders
Sciatica
|
0.48%
3/624
|
0.64%
4/629
|
0.32%
1/315
|
0.64%
2/313
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
14/624
|
0.95%
6/629
|
1.3%
4/315
|
0.96%
3/313
|
|
Gastrointestinal disorders
Nausea
|
1.8%
11/624
|
1.7%
11/629
|
0.63%
2/315
|
0.32%
1/313
|
|
Gastrointestinal disorders
Toothache
|
1.1%
7/624
|
0.64%
4/629
|
0.00%
0/315
|
0.00%
0/313
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
18/624
|
2.2%
14/629
|
0.95%
3/315
|
2.2%
7/313
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
14/624
|
1.7%
11/629
|
2.2%
7/315
|
2.2%
7/313
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.64%
4/624
|
0.95%
6/629
|
0.32%
1/315
|
0.96%
3/313
|
|
Investigations
Investigations
|
5.0%
31/624
|
3.0%
19/629
|
1.6%
5/315
|
4.8%
15/313
|
|
Injury, poisoning and procedural complications
Injury and Complications
|
6.6%
41/624
|
6.0%
38/629
|
4.4%
14/315
|
6.1%
19/313
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.32%
2/624
|
0.48%
3/629
|
0.63%
2/315
|
0.64%
2/313
|
|
General disorders
Injection Site erythema
|
0.32%
2/624
|
0.48%
3/629
|
0.63%
2/315
|
0.96%
3/313
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/624
|
0.00%
0/629
|
0.63%
2/315
|
0.96%
3/313
|
|
Metabolism and nutrition disorders
Metabolism and Nutritional Disorders
|
3.4%
21/624
|
2.2%
14/629
|
1.3%
4/315
|
3.5%
11/313
|
Additional Information
Study Director
Bausch Health
Phone: 510-259-5284
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER