Trial Outcomes & Findings for Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis (NCT NCT00771030)
NCT ID: NCT00771030
Last Updated: 2021-11-26
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, including any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event was defined as an adverse event that was fatal; was life threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other significant medical hazard.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
From first dose of study drug up to end of study (week 19).
Results posted on
2021-11-26
Participant Flow
This study was conducted at 11 sites: 7 in the United States, 2 in Canada and 2 in Mexico.
Within each cohort participants were randomized 3:1 to receive ascending doses of brodalumab or placebo subcutaneously (cohorts 1 to 3) or intravenously (cohorts 5 and 6). Cohort 4 was designed to be used in the dose expansion part of the study, however, this cohort was not enrolled because experimental endpoints would be achieved during a separate phase II study.
Participant milestones
| Measure |
Placebo SC (Cohorts 1-3)
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
Received Study Drug
|
6
|
4
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
3
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo SC (Cohorts 1-3)
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=4 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
n=6 Participants
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
n=6 Participants
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
n=6 Participants
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
n=6 Participants
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
n=6 Participants
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 10.3 • n=113 Participants
|
55.5 years
STANDARD_DEVIATION 11.7 • n=163 Participants
|
46.2 years
STANDARD_DEVIATION 11.7 • n=160 Participants
|
56.8 years
STANDARD_DEVIATION 8.7 • n=483 Participants
|
45.7 years
STANDARD_DEVIATION 10.1 • n=36 Participants
|
55.5 years
STANDARD_DEVIATION 7.3 • n=10 Participants
|
50.0 years
STANDARD_DEVIATION 5.9 • n=115 Participants
|
51.4 years
STANDARD_DEVIATION 9.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
6 Participants
n=160 Participants
|
6 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
34 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
6 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
18 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
19 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to end of study (week 19).Population: All randomized participants who received at least 1 dose of study drug (placebo or brodalumab).
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, including any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event was defined as an adverse event that was fatal; was life threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other significant medical hazard.
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=4 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
n=6 Participants
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
n=6 Participants
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
n=6 Participants
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
n=6 Participants
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
n=6 Participants
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
Any treatment-emergent adverse event (TEAE)
|
3 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Deaths on study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Serious TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Treatment-related TEAEs
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Treatment-related serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Discontinuation of study drug due to TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Blood samples were taken on days 2, 8, 15, 29, 43, 57, 71, 85, 106, and 127.Population: All participants who received at least 1 dose of study drug.
The investigator reviewed laboratory test results and determined whether an abnormal value in an individual study participant represented a change from prestudy values and determined if changes were clinically significant. The number of participants with clinically significant changes in lab values at any time during the study is reported.
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=4 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
n=6 Participants
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
n=6 Participants
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
n=6 Participants
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
n=6 Participants
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
n=6 Participants
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Safety Laboratory Tests
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 4 weeks after last dose; 14 weeks for Cohorts 1, 2, and 3 and 8 weeks for Cohorts 5 and 6.Population: All participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=4 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
n=6 Participants
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
n=6 Participants
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
n=6 Participants
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
n=6 Participants
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
n=6 Participants
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Physical Examination Findings, Vital Signs, or Electrocardiogram Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 1 (pre-dose), 29 (pre-dose), 85, and 127Population: All participants who received at least 1 dose of study drug.
Samples were tested in a validated immunoassay for the presence of anti-brodalumab binding antibodies. Samples found to be positive for binding antibodies were further tested using a validated cell-based bioassay to determine if the antibodies were able to neutralize the activity of brodalumab.
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=4 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
n=6 Participants
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
n=6 Participants
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
n=6 Participants
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
n=6 Participants
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
n=6 Participants
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-brodalumab Antibodies
Binding antibodies
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-brodalumab Antibodies
Neutralizing antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.Population: Participants who received subcutaneously administered brodalumab with available data
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=6 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
n=6 Participants
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses
Day 1 (first dose)
|
1.46 days
Interval 0.18 to 2.0
|
3.96 days
Interval 2.0 to 4.0
|
2.99 days
Interval 0.97 to 4.0
|
—
|
—
|
—
|
—
|
|
Time to Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses
Day 71 (last dose)
|
2.00 days
Interval 1.13 to 2.09
|
3.95 days
Interval 1.93 to 4.07
|
4.00 days
Interval 1.02 to 4.02
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.Population: Participants who received subcutaneously administered brodalumab with available data
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=6 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
n=6 Participants
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses
Day 1 (first dose)
|
0.742 μg/mL
Standard Deviation 0.522
|
5.67 μg/mL
Standard Deviation 2.98
|
16.6 μg/mL
Standard Deviation 8.97
|
—
|
—
|
—
|
—
|
|
Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses
Day 71 (last dose)
|
1.35 μg/mL
Standard Deviation 1.07
|
5.93 μg/mL
Standard Deviation 5.15
|
18.4 μg/mL
Standard Deviation 7.21
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.Population: Participants who received subcutaneously administered brodalumab with available data
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=6 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
n=6 Participants
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Subcutaneous Doses
Day 1 (first dose)
|
1.77 days*μg/mL
Standard Deviation 1.61
|
37.6 days*μg/mL
Standard Deviation 27.8
|
142 days*μg/mL
Standard Deviation 67.3
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Subcutaneous Doses
Day 71 (last dose)
|
4.13 days*μg/mL
Standard Deviation 3.20
|
50.8 days*μg/mL
Standard Deviation 51.5
|
191 days*μg/mL
Standard Deviation 82.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.Population: Participants who received subcutaneously administered brodalumab with available data
Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose).
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=6 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
n=6 Participants
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Accumulation Ratio for Brodalumab After Subcutaneous Dosing
|
24.4 ratio
Standard Deviation 51.4
|
1.3 ratio
Standard Deviation 0.8
|
1.5 ratio
Standard Deviation 0.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.Population: Participants who received brodalumab by intravenous infusion with available data
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=6 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses
Day 1 (first dose)
|
4.07 hours
Interval 3.4 to 22.27
|
0.92 hours
Interval 0.82 to 1.53
|
—
|
—
|
—
|
—
|
—
|
|
Time to Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses
Day 29 (last dose)
|
0.98 hours
Interval 0.77 to 4.02
|
0.83 hours
Interval 0.57 to 4.55
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.Population: Participants who received brodalumab by intravenous infusion with available data
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=6 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses
Day 1 (first dose)
|
111 μg/mL
Standard Deviation 19.2
|
240 μg/mL
Standard Deviation 44.8
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses
Day 29 (last dose)
|
127 μg/mL
Standard Deviation 12.1
|
655 μg/mL
Standard Deviation 949
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.Population: Participants who received brodalumab by intravenous infusion with available data
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=6 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Intravenous Doses
Day 1 (first dose)
|
831 days*μg/mL
Standard Deviation 197
|
1840 days*μg/mL
Standard Deviation 602
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Intravenous Doses
Day 29 (last dose)
|
951 days*μg/mL
Standard Deviation 307
|
2230 days*μg/mL
Standard Deviation 998
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.Population: Participants who received brodalumab by intravenous infusion with available data
Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose).
Outcome measures
| Measure |
Placebo SC (Cohorts 1-3)
n=6 Participants
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=5 Participants
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Accumulation Ratio for Brodalumab After Intravenous Dosing
|
1.1 ratio
Standard Deviation 0.2
|
1.2 ratio
Standard Deviation 0.1
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo SC (Cohorts 1-3)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo IV (Cohorts 5-6)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Brodalumab 50 mg SC (Cohort 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Brodalumab 140 mg SC (Cohort 2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Brodalumab 210 mg SC (Cohort 3)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Brodalumab 420 mg IV (Cohort 5)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Brodalumab 700 mg IV (Cohort 6)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo SC (Cohorts 1-3)
n=6 participants at risk
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=4 participants at risk
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
n=6 participants at risk
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
n=6 participants at risk
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
n=6 participants at risk
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
n=6 participants at risk
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
n=6 participants at risk
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Complicated migraine
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
Other adverse events
| Measure |
Placebo SC (Cohorts 1-3)
n=6 participants at risk
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
|
Placebo IV (Cohorts 5-6)
n=4 participants at risk
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
|
Brodalumab 50 mg SC (Cohort 1)
n=6 participants at risk
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 140 mg SC (Cohort 2)
n=6 participants at risk
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 210 mg SC (Cohort 3)
n=6 participants at risk
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
|
Brodalumab 420 mg IV (Cohort 5)
n=6 participants at risk
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
Brodalumab 700 mg IV (Cohort 6)
n=6 participants at risk
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
33.3%
2/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
33.3%
2/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
33.3%
2/6 • From first dose of study drug up to end of study (week 19).
|
33.3%
2/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
33.3%
2/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
General disorders
Administration site pain
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
General disorders
Chills
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
General disorders
Fatigue
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
General disorders
Injection site haematoma
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Furuncle
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • From first dose of study drug up to end of study (week 19).
|
50.0%
2/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
33.3%
2/6 • From first dose of study drug up to end of study (week 19).
|
33.3%
2/6 • From first dose of study drug up to end of study (week 19).
|
33.3%
2/6 • From first dose of study drug up to end of study (week 19).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
25.0%
1/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
33.3%
2/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/4 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
16.7%
1/6 • From first dose of study drug up to end of study (week 19).
|
0.00%
0/6 • From first dose of study drug up to end of study (week 19).
|
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