Trial Outcomes & Findings for Long-term Safety Study of Brodalumab in Adults With Crohn's Disease (NCT NCT01199302)
NCT ID: NCT01199302
Last Updated: 2021-12-28
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject including worsening of a pre-existing medical condition, and not necessarily having a causal relationship with study treatment. A treatment-emergent AE is an event that occurred after the initiation of study drug or was already present prior to the initiation of study drug but worsened in either intensity or frequency after the initiation of study drug. The investigator assessed whether each AE was possibly related to the study drug. A serious adverse event is defined as an AE that met at least 1 of the following serious criteria: * fatal, * life threatening, * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other significant medical hazard.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
Results posted on
2021-12-28
Participant Flow
This study enrolled participants who had completed the week 12 visit of the parent study 20090072 (NCT01150890). The study was conducted at 28 centers in Australia, Belgium, Canada, Spain, France, Netherlands, Poland, and the United States (US).
In this long-term open-label extension study participants were to receive brodalumab 350 mg every 4 weeks. Results are reported by treatment group assigned in the parent study.
Participant milestones
| Measure |
Placebo / Brodalumab 350 mg
Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
|
Brodalumab 210 mg / 350 mg
Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodalumab 350 mg / 350 mg
Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodaluamb 700 mg / 350 mg
Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
16
|
20
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
16
|
20
|
11
|
Reasons for withdrawal
| Measure |
Placebo / Brodalumab 350 mg
Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
|
Brodalumab 210 mg / 350 mg
Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodalumab 350 mg / 350 mg
Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodaluamb 700 mg / 350 mg
Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
3
|
0
|
|
Overall Study
Disease Progression
|
3
|
4
|
4
|
2
|
|
Overall Study
Study Termination
|
13
|
8
|
11
|
9
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Participants with available data
Baseline characteristics by cohort
| Measure |
Placebo / Brodalumab 350 mg
n=20 Participants
Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
|
Brodalumab 210 mg / 350 mg
n=16 Participants
Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodalumab 350 mg / 350 mg
n=20 Participants
Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodaluamb 700 mg / 350 mg
n=11 Participants
Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 12.0 • n=20 Participants
|
36.3 years
STANDARD_DEVIATION 10.0 • n=16 Participants
|
35.4 years
STANDARD_DEVIATION 13.4 • n=20 Participants
|
37.6 years
STANDARD_DEVIATION 13.2 • n=11 Participants
|
35.9 years
STANDARD_DEVIATION 12.0 • n=67 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
10 Participants
n=16 Participants
|
12 Participants
n=20 Participants
|
7 Participants
n=11 Participants
|
38 Participants
n=67 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
6 Participants
n=16 Participants
|
8 Participants
n=20 Participants
|
4 Participants
n=11 Participants
|
29 Participants
n=67 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=67 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=20 Participants
|
12 Participants
n=16 Participants
|
14 Participants
n=20 Participants
|
10 Participants
n=11 Participants
|
54 Participants
n=67 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
4 Participants
n=16 Participants
|
5 Participants
n=20 Participants
|
1 Participants
n=11 Participants
|
12 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=20 Participants
|
11 Participants
n=16 Participants
|
14 Participants
n=20 Participants
|
9 Participants
n=11 Participants
|
51 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=20 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=11 Participants
|
3 Participants
n=67 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=20 Participants
|
4 Participants
n=16 Participants
|
5 Participants
n=20 Participants
|
1 Participants
n=11 Participants
|
12 Participants
n=67 Participants
|
|
Crohn's Disease Activity Index (CDAI) at Baseline of Parent Study
|
317.24 score on a scale
STANDARD_DEVIATION 65.21 • n=20 Participants • Participants with available data
|
321.13 score on a scale
STANDARD_DEVIATION 54.01 • n=15 Participants • Participants with available data
|
336.90 score on a scale
STANDARD_DEVIATION 58.92 • n=20 Participants • Participants with available data
|
298.37 score on a scale
STANDARD_DEVIATION 43.75 • n=11 Participants • Participants with available data
|
320.94 score on a scale
STANDARD_DEVIATION 57.87 • n=66 Participants • Participants with available data
|
|
Crohn's Disease Activity Index (CDAI) at Baseline of Extension Study
|
257.70 score on a scale
STANDARD_DEVIATION 126.60 • n=19 Participants • Participants with available data
|
251.72 score on a scale
STANDARD_DEVIATION 85.23 • n=14 Participants • Participants with available data
|
233.50 score on a scale
STANDARD_DEVIATION 110.74 • n=19 Participants • Participants with available data
|
226.76 score on a scale
STANDARD_DEVIATION 65.49 • n=11 Participants • Participants with available data
|
243.67 score on a scale
STANDARD_DEVIATION 102.89 • n=63 Participants • Participants with available data
|
PRIMARY outcome
Timeframe: From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)Population: All enrolled participants who received at least one dose of brodalumab in the extension study
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject including worsening of a pre-existing medical condition, and not necessarily having a causal relationship with study treatment. A treatment-emergent AE is an event that occurred after the initiation of study drug or was already present prior to the initiation of study drug but worsened in either intensity or frequency after the initiation of study drug. The investigator assessed whether each AE was possibly related to the study drug. A serious adverse event is defined as an AE that met at least 1 of the following serious criteria: * fatal, * life threatening, * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other significant medical hazard.
Outcome measures
| Measure |
Placebo / Brodalumab 350 mg
n=20 Participants
Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
|
Brodalumab 210 mg / 350 mg
n=16 Participants
Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodalumab 350 mg / 350 mg
n=20 Participants
Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodaluamb 700 mg / 350 mg
n=11 Participants
Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
All treatment-emergent adverse events (TEAEs)
|
14 Participants
|
12 Participants
|
18 Participants
|
8 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Serious adverse events
|
4 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Fatal adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs leading to discontinuation of study drug
|
4 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs leading to discontinuation from study
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-related treatment-emergent adverse events
|
8 Participants
|
9 Participants
|
14 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-related serious adverse events
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-related fatal adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-related TEAEs leading to discontinuation of study drug
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment related TEAEs leading to discontinuation from study
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20Population: Participants in the full analysis set with available data at each time point.
CDAI response is defined as a reduction from baseline in CDAI score of ≥ 100 points. The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
Outcome measures
| Measure |
Placebo / Brodalumab 350 mg
n=20 Participants
Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
|
Brodalumab 210 mg / 350 mg
n=16 Participants
Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodalumab 350 mg / 350 mg
n=20 Participants
Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodaluamb 700 mg / 350 mg
n=11 Participants
Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved a CDAI Response
Week 2
|
23.5 percentage of participants
|
21.4 percentage of participants
|
50.0 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants Who Achieved a CDAI Response
Week 4
|
23.1 percentage of participants
|
36.4 percentage of participants
|
47.4 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants Who Achieved a CDAI Response
Week 6
|
38.5 percentage of participants
|
33.3 percentage of participants
|
53.3 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants Who Achieved a CDAI Response
Week 8
|
40.0 percentage of participants
|
42.9 percentage of participants
|
40.0 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants Who Achieved a CDAI Response
Week 10
|
62.5 percentage of participants
|
20.0 percentage of participants
|
27.3 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Who Achieved a CDAI Response
Week 12
|
83.3 percentage of participants
|
25.0 percentage of participants
|
62.5 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Who Achieved a CDAI Response
Week 16
|
100.0 percentage of participants
|
—
|
33.3 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Who Achieved a CDAI Response
Week 20
|
100.0 percentage of participants
|
0.0 percentage of participants
|
100.0 percentage of participants
|
50.0 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 2, 4, 6, 8, 10, 12, 16, and 20Population: Participants in the full analysis set with available data at each time point.
Clinical remission is defined by a CDAI score of ≤ 150 points. The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
Outcome measures
| Measure |
Placebo / Brodalumab 350 mg
n=20 Participants
Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
|
Brodalumab 210 mg / 350 mg
n=16 Participants
Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodalumab 350 mg / 350 mg
n=20 Participants
Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodaluamb 700 mg / 350 mg
n=11 Participants
Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Clinical Remission
Week 2
|
5.9 percentage of participants
|
7.1 percentage of participants
|
27.8 percentage of participants
|
27.3 percentage of participants
|
|
Percentage of Participants Who Achieved Clinical Remission
Week 4
|
15.4 percentage of participants
|
9.1 percentage of participants
|
26.3 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Who Achieved Clinical Remission
Week 6
|
23.1 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Who Achieved Clinical Remission
Week 8
|
40.0 percentage of participants
|
0.0 percentage of participants
|
13.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieved Clinical Remission
Week 10
|
37.5 percentage of participants
|
0.0 percentage of participants
|
18.2 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Who Achieved Clinical Remission
Week 12
|
50.0 percentage of participants
|
0.0 percentage of participants
|
50.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants Who Achieved Clinical Remission
Week 16
|
75.0 percentage of participants
|
—
|
33.3 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Achieved Clinical Remission
Week 20
|
100.0 percentage of participants
|
0.0 percentage of participants
|
100.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 10, 12, 16, and 20Population: Participants in the full analysis set with available data at each time point.
The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
Outcome measures
| Measure |
Placebo / Brodalumab 350 mg
n=20 Participants
Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
|
Brodalumab 210 mg / 350 mg
n=16 Participants
Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodalumab 350 mg / 350 mg
n=20 Participants
Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodaluamb 700 mg / 350 mg
n=11 Participants
Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
|---|---|---|---|---|
|
CDAI Score Over Time
Week 2
|
291.71 score on a scale
Standard Deviation 159.01
|
285.41 score on a scale
Standard Deviation 86.69
|
235.12 score on a scale
Standard Deviation 100.66
|
197.71 score on a scale
Standard Deviation 81.22
|
|
CDAI Score Over Time
Week 4
|
274.21 score on a scale
Standard Deviation 154.79
|
244.11 score on a scale
Standard Deviation 62.60
|
256.22 score on a scale
Standard Deviation 125.24
|
192.04 score on a scale
Standard Deviation 54.62
|
|
CDAI Score Over Time
Week 6
|
257.09 score on a scale
Standard Deviation 154.96
|
274.48 score on a scale
Standard Deviation 93.41
|
241.13 score on a scale
Standard Deviation 134.06
|
219.91 score on a scale
Standard Deviation 121.19
|
|
CDAI Score Over Time
Week 8
|
250.95 score on a scale
Standard Deviation 167.25
|
248.03 score on a scale
Standard Deviation 70.86
|
267.51 score on a scale
Standard Deviation 173.20
|
159.39 score on a scale
Standard Deviation 66.53
|
|
CDAI Score Over Time
Week 10
|
196.56 score on a scale
Standard Deviation 157.07
|
274.81 score on a scale
Standard Deviation 90.70
|
276.37 score on a scale
Standard Deviation 138.48
|
127.57 score on a scale
Standard Deviation 46.38
|
|
CDAI Score Over Time
Week 12
|
120.47 score on a scale
Standard Deviation 93.27
|
317.49 score on a scale
Standard Deviation 27.14
|
224.79 score on a scale
Standard Deviation 131.61
|
159.91 score on a scale
Standard Deviation 61.03
|
|
CDAI Score Over Time
Week 16
|
103.61 score on a scale
Standard Deviation 48.60
|
—
|
220.67 score on a scale
Standard Deviation 178.45
|
186.11 score on a scale
Standard Deviation 10.05
|
|
CDAI Score Over Time
Week 20
|
101.60 score on a scale
Standard Deviation 62.32
|
212.42 score on a scale
|
145.33 score on a scale
|
223.11 score on a scale
Standard Deviation 13.52
|
SECONDARY outcome
Timeframe: Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20Population: Participants in the full analysis set with available data at each time point.
The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
Outcome measures
| Measure |
Placebo / Brodalumab 350 mg
n=20 Participants
Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
|
Brodalumab 210 mg / 350 mg
n=16 Participants
Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodalumab 350 mg / 350 mg
n=20 Participants
Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodaluamb 700 mg / 350 mg
n=11 Participants
Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in CDAI Score Over Time
Week 2
|
-25.8 score on a scale
Standard Deviation 128.0
|
-35.0 score on a scale
Standard Deviation 90.8
|
-97.0 score on a scale
Standard Deviation 106.9
|
-100.7 score on a scale
Standard Deviation 83.7
|
|
Change From Baseline in CDAI Score Over Time
Week 4
|
-49.7 score on a scale
Standard Deviation 112.5
|
-79.2 score on a scale
Standard Deviation 67.6
|
-78.2 score on a scale
Standard Deviation 107.3
|
-101.1 score on a scale
Standard Deviation 62.0
|
|
Change From Baseline in CDAI Score Over Time
Week 6
|
-55.4 score on a scale
Standard Deviation 101.4
|
-51.5 score on a scale
Standard Deviation 106.7
|
-84.3 score on a scale
Standard Deviation 128.3
|
-67.8 score on a scale
Standard Deviation 127.6
|
|
Change From Baseline in CDAI Score Over Time
Week 8
|
-48.7 score on a scale
Standard Deviation 143.2
|
-84.6 score on a scale
Standard Deviation 79.8
|
-55.4 score on a scale
Standard Deviation 157.2
|
-150.4 score on a scale
Standard Deviation 35.6
|
|
Change From Baseline in CDAI Score Over Time
Week 10
|
-116.1 score on a scale
Standard Deviation 103.5
|
-45.3 score on a scale
Standard Deviation 81.5
|
-56.1 score on a scale
Standard Deviation 146.5
|
-182.6 score on a scale
Standard Deviation 32.7
|
|
Change From Baseline in CDAI Score Over Time
Week 12
|
-174.5 score on a scale
Standard Deviation 76.0
|
-20.7 score on a scale
Standard Deviation 69.1
|
-80.8 score on a scale
Standard Deviation 120.4
|
-160.2 score on a scale
Standard Deviation 50.3
|
|
Change From Baseline in CDAI Score Over Time
Week 16
|
-162.1 score on a scale
Standard Deviation 51.3
|
—
|
-55.9 score on a scale
Standard Deviation 155.5
|
-128.8 score on a scale
Standard Deviation 33.6
|
|
Change From Baseline in CDAI Score Over Time
Week 20
|
-164.1 score on a scale
Standard Deviation 53.8
|
-61.3 score on a scale
|
-109.7 score on a scale
|
-91.8 score on a scale
Standard Deviation 57.2
|
SECONDARY outcome
Timeframe: Blood samples were collected at study entry, week 4, 24 and at last visit (maximum time on study was 32 weeks).Population: Enrolled participants who received at least one dose of brodalumab in the extension study and with available antibody results
Binding antibodies to brodalumab were detected using an anti-brodalumab immunoassay.
Outcome measures
| Measure |
Placebo / Brodalumab 350 mg
n=20 Participants
Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
|
Brodalumab 210 mg / 350 mg
n=16 Participants
Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodalumab 350 mg / 350 mg
n=20 Participants
Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodaluamb 700 mg / 350 mg
n=11 Participants
Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Developed Anti-brodalumab Binding Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20Population: Participants in the full analysis set with available data at each time point.
Outcome measures
| Measure |
Placebo / Brodalumab 350 mg
n=20 Participants
Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.
|
Brodalumab 210 mg / 350 mg
n=16 Participants
Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodalumab 350 mg / 350 mg
n=20 Participants
Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
Brodaluamb 700 mg / 350 mg
n=11 Participants
Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in C-reactive Protein (CRP) Levels Over Time
Week 2
|
13.0 mg/dL
Standard Deviation 33.9
|
10.7 mg/dL
Standard Deviation 53.8
|
-3.5 mg/dL
Standard Deviation 22.9
|
3.2 mg/dL
Standard Deviation 19.8
|
|
Change From Baseline in C-reactive Protein (CRP) Levels Over Time
Week 4
|
-0.8 mg/dL
Standard Deviation 9.9
|
-0.8 mg/dL
Standard Deviation 17.9
|
-8.1 mg/dL
Standard Deviation 25.9
|
9.9 mg/dL
Standard Deviation 52.4
|
|
Change From Baseline in C-reactive Protein (CRP) Levels Over Time
Week 6
|
5.2 mg/dL
Standard Deviation 14.1
|
5.9 mg/dL
Standard Deviation 26.2
|
-5.1 mg/dL
Standard Deviation 30.0
|
17.5 mg/dL
Standard Deviation 25.9
|
|
Change From Baseline in C-reactive Protein (CRP) Levels Over Time
Week 8
|
15.5 mg/dL
Standard Deviation 49.2
|
-2.4 mg/dL
Standard Deviation 15.0
|
3.7 mg/dL
Standard Deviation 19.9
|
7.2 mg/dL
Standard Deviation 49.5
|
|
Change From Baseline in C-reactive Protein (CRP) Levels Over Time
Week 10
|
11.5 mg/dL
Standard Deviation 31.9
|
4.3 mg/dL
Standard Deviation 28.8
|
0.9 mg/dL
Standard Deviation 34.1
|
-1.2 mg/dL
Standard Deviation 2.3
|
|
Change From Baseline in C-reactive Protein (CRP) Levels Over Time
Week 12
|
2.9 mg/dL
Standard Deviation 9.7
|
1.2 mg/dL
Standard Deviation 19.1
|
15.4 mg/dL
Standard Deviation 34.9
|
-11.5 mg/dL
Standard Deviation 17.9
|
|
Change From Baseline in C-reactive Protein (CRP) Levels Over Time
Week 16
|
1.0 mg/dL
Standard Deviation 18.1
|
0.2 mg/dL
|
-9.5 mg/dL
Standard Deviation 11.5
|
-15.0 mg/dL
Standard Deviation 23.5
|
|
Change From Baseline in C-reactive Protein (CRP) Levels Over Time
Week 20
|
-3.0 mg/dL
Standard Deviation 3.4
|
-3.2 mg/dL
|
-1.1 mg/dL
|
-10.9 mg/dL
Standard Deviation 21.1
|
Adverse Events
Brodalumab 350 mg Q4W
Serious events: 15 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brodalumab 350 mg Q4W
n=67 participants at risk
Participants received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
2/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Gastrointestinal disorders
Anal stenosis
|
1.5%
1/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Gastrointestinal disorders
Crohn's disease
|
10.4%
7/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Gastrointestinal disorders
Intestinal dilatation
|
1.5%
1/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
General disorders
Pyrexia
|
4.5%
3/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Infections and infestations
Peritoneal abscess
|
1.5%
1/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
1.5%
1/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
Other adverse events
| Measure |
Brodalumab 350 mg Q4W
n=67 participants at risk
Participants received brodalumab 350 mg IV Q4W for up to 132 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.4%
7/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
4.5%
3/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Gastrointestinal disorders
Constipation
|
4.5%
3/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Gastrointestinal disorders
Crohn's disease
|
13.4%
9/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
4/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
3/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.0%
4/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
General disorders
Chills
|
4.5%
3/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
General disorders
Fatigue
|
7.5%
5/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
General disorders
Pyrexia
|
13.4%
9/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Infections and infestations
Oral candidiasis
|
4.5%
3/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
3/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Infections and infestations
Urinary tract infection
|
4.5%
3/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
|
Nervous system disorders
Headache
|
7.5%
5/67 • From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER