Trial Outcomes & Findings for Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects (NCT NCT01708590)
NCT ID: NCT01708590
Last Updated: 2020-01-03
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
661 participants
Primary outcome timeframe
0-12 weeks
Results posted on
2020-01-03
Participant Flow
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.
Participant milestones
| Measure |
Induction Phase: 210 mg Brodalumab
Administered by subcutaneous (SC) injection until week 12. 210 mg brodalumab: 210 mg brodalumab administered subcutaneous (SC)
|
Induction Phase: 140 mg Brodalumab
Administered by subcutaneous (SC) injection until week 12. 140 mg brodalumab: 140 mg brodalumab administered subcutaneous (SC)
|
Induction Phase: Placebo
Administered by SC injection until week 12. placebo: Placebo administered subcutaneous (SC)
|
Withdrawal Phase: Placebo (140mg)
Administered SC injection Week 12 - Week 52
|
Withdrawal Phase: 140mg Brodalumab Q2W
Administered SC injection, Week 12 - Week 52
|
Withdrawal Phase: Placebo (210mg)
Administered SC, Week 12 - Week 52
|
Withdrawl Phase: 210mg Brodalumab Q2W
Administered SC injection, Week 12- Week 16
|
|---|---|---|---|---|---|---|---|
|
Induction Phase
STARTED
|
222
|
219
|
220
|
0
|
0
|
0
|
0
|
|
Induction Phase
COMPLETED
|
212
|
212
|
209
|
0
|
0
|
0
|
0
|
|
Induction Phase
NOT COMPLETED
|
10
|
7
|
11
|
0
|
0
|
0
|
0
|
|
Withdrawal Phase
STARTED
|
0
|
0
|
0
|
59
|
57
|
84
|
83
|
|
Withdrawal Phase
COMPLETED
|
0
|
0
|
0
|
6
|
45
|
2
|
74
|
|
Withdrawal Phase
NOT COMPLETED
|
0
|
0
|
0
|
53
|
12
|
82
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects
Baseline characteristics by cohort
| Measure |
210 mg Brodalumab
n=222 Participants
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)
|
140 mg Brodalumab
n=219 Participants
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)
|
Placebo
n=220 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 subcutaneous (SC)
placebo: Placebo administered subcutaneous (SC)
|
Total
n=661 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
484 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
203 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
601 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0-12 weeksPopulation: Data collected is based off of the data from the induction phase.
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.
Outcome measures
| Measure |
Induction Phase: 210 mg Brodalumab
n=222 Participants
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)
|
Induction Phase: 140 mg Brodalumab
n=219 Participants
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)
|
Induction Phase: Placebo
n=220 Participants
Administered by SC injection until week 12. placebo: Placebo administered subcutaneous (SC)
|
Withdrawl Phase: 210mg Brodalumab Q2W
Administered SC injection, Week 12- Week 16
|
|---|---|---|---|---|
|
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12
|
185 Participants
|
132 Participants
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: 0 - 12 WeeksPopulation: Data reported is based off of the data collected from the induction phase
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
Outcome measures
| Measure |
Induction Phase: 210 mg Brodalumab
n=222 Participants
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)
|
Induction Phase: 140 mg Brodalumab
n=219 Participants
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)
|
Induction Phase: Placebo
n=220 Participants
Administered by SC injection until week 12. placebo: Placebo administered subcutaneous (SC)
|
Withdrawl Phase: 210mg Brodalumab Q2W
Administered SC injection, Week 12- Week 16
|
|---|---|---|---|---|
|
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
|
168 Participants
|
118 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 - Week 52Population: Only subjects with efficacy data available at Week 52 were included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase: 210 mg Brodalumab
n=6 Participants
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)
|
Induction Phase: 140 mg Brodalumab
n=47 Participants
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)
|
Induction Phase: Placebo
n=2 Participants
Administered by SC injection until week 12. placebo: Placebo administered subcutaneous (SC)
|
Withdrawl Phase: 210mg Brodalumab Q2W
n=72 Participants
Administered SC injection, Week 12- Week 16
|
|---|---|---|---|---|
|
Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52
|
3 Participants
|
40 Participants
|
0 Participants
|
69 Participants
|
Adverse Events
210 mg Brodalumab
Serious events: 4 serious events
Other events: 85 other events
Deaths: 0 deaths
140 mg Brodalumab
Serious events: 6 serious events
Other events: 91 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
210 mg Brodalumab
n=222 participants at risk
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)
|
140 mg Brodalumab
n=219 participants at risk
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)
|
Placebo
n=220 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 subcutaneous (SC)
placebo: Placebo administered subcutaneous (SC)
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.45%
1/222 • Number of events 1
|
0.46%
1/219 • Number of events 1
|
0.00%
0/220
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
0.00%
0/220
|
|
Infections and infestations
Pancreatitis Acute
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
0.00%
0/220
|
|
Gastrointestinal disorders
Volvulus of Small Bowel
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
0.00%
0/220
|
|
Injury, poisoning and procedural complications
Back Pain
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
0.00%
0/220
|
|
Injury, poisoning and procedural complications
Invertebral Disk Intusion
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
0.00%
0/220
|
|
Infections and infestations
Pyrexia
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
0.00%
0/220
|
|
Infections and infestations
Cholecystitis acute
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
0.00%
0/220
|
|
Immune system disorders
Diabetes mellitus
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
0.00%
0/220
|
|
Immune system disorders
Psoriasis
|
0.00%
0/222
|
0.00%
0/219
|
0.91%
2/220 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.00%
0/222
|
0.00%
0/219
|
0.45%
1/220 • Number of events 1
|
Other adverse events
| Measure |
210 mg Brodalumab
n=222 participants at risk
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)
|
140 mg Brodalumab
n=219 participants at risk
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)
|
Placebo
n=220 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 subcutaneous (SC)
placebo: Placebo administered subcutaneous (SC)
|
|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.1%
18/222 • Number of events 18
|
8.2%
18/219 • Number of events 18
|
6.4%
14/220 • Number of events 14
|
|
Nervous system disorders
Headache
|
5.0%
11/222 • Number of events 11
|
5.5%
12/219 • Number of events 12
|
3.2%
7/220 • Number of events 7
|
|
Injury, poisoning and procedural complications
Arthralgia
|
2.7%
6/222 • Number of events 6
|
4.6%
10/219 • Number of events 10
|
2.7%
6/220 • Number of events 6
|
|
Cardiac disorders
Hypertension
|
0.90%
2/222 • Number of events 2
|
3.7%
8/219 • Number of events 8
|
1.8%
4/220 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.7%
6/222 • Number of events 6
|
0.91%
2/219 • Number of events 2
|
1.8%
4/220 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
2.3%
5/222 • Number of events 5
|
2.3%
5/219 • Number of events 5
|
0.91%
2/220 • Number of events 2
|
|
Infections and infestations
Rhinitis
|
2.3%
5/222 • Number of events 5
|
0.91%
2/219 • Number of events 2
|
0.91%
2/220 • Number of events 2
|
|
Infections and infestations
Tooth Infection
|
0.45%
1/222 • Number of events 1
|
2.7%
6/219 • Number of events 6
|
0.91%
2/220 • Number of events 2
|
|
Infections and infestations
Diarrhoea
|
1.8%
4/222 • Number of events 4
|
1.8%
4/219 • Number of events 4
|
0.45%
1/220 • Number of events 1
|
|
General disorders
Cough
|
1.4%
3/222 • Number of events 3
|
2.7%
6/219 • Number of events 6
|
0.00%
0/220
|
|
Infections and infestations
Vomiting
|
0.90%
2/222 • Number of events 2
|
1.8%
4/219 • Number of events 4
|
0.45%
1/220 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
2.3%
5/222 • Number of events 5
|
0.91%
2/219 • Number of events 2
|
0.00%
0/220
|
|
Immune system disorders
Influenza
|
1.8%
4/222 • Number of events 4
|
0.46%
1/219 • Number of events 1
|
0.45%
1/220 • Number of events 1
|
|
Infections and infestations
Myalgia
|
1.8%
4/222 • Number of events 4
|
0.91%
2/219 • Number of events 2
|
0.00%
0/220
|
|
Infections and infestations
Influenza like illness
|
1.8%
4/222 • Number of events 4
|
0.00%
0/219
|
0.45%
1/220 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/222
|
1.4%
3/219 • Number of events 3
|
0.45%
1/220 • Number of events 1
|
|
Infections and infestations
Rash
|
1.8%
4/222 • Number of events 4
|
0.00%
0/219
|
0.00%
0/220
|
|
Infections and infestations
UTI
|
0.45%
1/222 • Number of events 1
|
1.4%
3/219 • Number of events 3
|
0.00%
0/220
|
|
General disorders
Dizziness
|
0.00%
0/222
|
1.4%
3/219 • Number of events 3
|
0.00%
0/220
|
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