Trial Outcomes & Findings for Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis (NCT NCT03156023)
NCT ID: NCT03156023
Last Updated: 2024-05-14
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 clinically significant changes in laboratory test results and physical exam findings. The event does not necessarily have a causal relationship with study treatment. AEs were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe or medically significant, Grade 4 = Life-threatening, and Grade 5 = Death. 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; * other medically important serious event. The investigator assessed whether each AE was related to study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
Results posted on
2024-05-14
Participant Flow
This study was conducted at 4 centers in the United States and Germany. Participants with rheumatoid arthritis were enrolled from 14 August 2017 to 20 February 2019.
The study consisted of 4 multiple ascending dose cohorts. Within each cohort participants were randomized in a 3:1 ratio to receive rozibafusp alfa or placebo. Escalation to a higher dose cohort was contingent on a review to confirm that the previous dose regimen(s) demonstrated an acceptable safety and tolerability profile.
Participant milestones
| Measure |
Placebo
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
6
|
6
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
4
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
n=7 Participants
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
n=6 Participants
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
n=6 Participants
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
n=7 Participants
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
58.7 years
STANDARD_DEVIATION 4.9 • n=21 Participants
|
60.2 years
STANDARD_DEVIATION 9.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug to 24 weeks after last dose (up to 34 weeks).Population: All randomized participants who received at least 1 dose of rozibafusp alfa or placebo.
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 clinically significant changes in laboratory test results and physical exam findings. The event does not necessarily have a causal relationship with study treatment. AEs were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe or medically significant, Grade 4 = Life-threatening, and Grade 5 = Death. 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; * other medically important serious event. The investigator assessed whether each AE was related to study drug.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
n=7 Participants
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
n=6 Participants
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
n=6 Participants
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
n=7 Participants
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
Any treatment-emergent adverse event (TEAE)
|
7 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
TEAE Grade ≥ 2
|
4 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
TEAE Grade ≥ 3
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
TEAE Grade ≥ 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Serious adverse events
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
TEAE leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Severe adverse events
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Life-threatening adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Fatal adverse events
|
0.0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Treatment-related TEAE (TRAE)
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
TRAE Grade ≥ 2
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
TRAE Grade ≥ 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
TRAE Grade ≥ 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Treatment-related serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
TRAE leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Severe TRAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Life-threatening TRAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Fatal TRAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.Population: The pharmacokinetic (PK) parameter analysis set includes all randomized participants who received rozibafusp alfa and for whom PK parameters were adequately estimated.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
n=6 Participants
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
n=6 Participants
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
n=7 Participants
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of Rozibafusp Alfa
Day 1
|
3.0 days
Interval 3.0 to 7.0
|
3.0 days
Interval 2.0 to 6.0
|
4.5 days
Interval 3.0 to 7.0
|
6.0 days
Interval 3.0 to 6.1
|
—
|
|
Time to Maximum Observed Concentration (Tmax) of Rozibafusp Alfa
Week 10
|
3.0 days
Interval 3.0 to 7.0
|
5.0 days
Interval 2.0 to 7.0
|
2.5 days
Interval 2.0 to 3.0
|
2.5 days
Interval 0.98 to 8.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.Population: PK parameter analysis set with available data at each time point
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
n=6 Participants
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
n=6 Participants
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
n=7 Participants
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Rozibafusp Alfa
Day 1
|
2.56 μg/mL
Standard Deviation 1.51
|
8.34 μg/mL
Standard Deviation 4.09
|
13.7 μg/mL
Standard Deviation 7.22
|
24.1 μg/mL
Standard Deviation 11.1
|
—
|
|
Maximum Observed Serum Concentration (Cmax) of Rozibafusp Alfa
Week 10
|
6.85 μg/mL
Standard Deviation 4.59
|
22.7 μg/mL
Standard Deviation 12.6
|
44.1 μg/mL
Standard Deviation 13.4
|
67.9 μg/mL
Standard Deviation 18.7
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose.Population: PK parameter analysis set with available data at each time point
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
n=6 Participants
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
n=6 Participants
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
n=5 Participants
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From 0 to 14 Days Postdose (AUC0-tau) for Rozibafusp Alfa
Day 1
|
22.6 day*μg/mL
Standard Deviation 14.7
|
86.2 day*μg/mL
Standard Deviation 47.1
|
143 day*μg/mL
Standard Deviation 85.3
|
265 day*μg/mL
Standard Deviation 162
|
—
|
|
Area Under the Concentration-time Curve From 0 to 14 Days Postdose (AUC0-tau) for Rozibafusp Alfa
Week 10
|
57.1 day*μg/mL
Standard Deviation 33.6
|
284 day*μg/mL
Standard Deviation 170
|
510 day*μg/mL
Standard Deviation 151
|
864 day*μg/mL
Standard Deviation 206
|
—
|
SECONDARY outcome
Timeframe: Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.Population: PK parameter analysis set with available data at each time point
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
n=4 Participants
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
n=6 Participants
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
n=5 Participants
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Rozibafusp Alfa
|
107 day*μg/mL
Standard Deviation 82.4
|
651 day*μg/mL
Standard Deviation 483
|
1110 day*μg/mL
Standard Deviation 447
|
2160 day*μg/mL
Standard Deviation 606
|
—
|
SECONDARY outcome
Timeframe: Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.Population: PK parameter analysis set with available data at each time point
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
n=4 Participants
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
n=6 Participants
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
n=5 Participants
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Terminal Half-life of Rozibafusp Alfa
|
4.62 days
Standard Deviation 1.05
|
5.62 days
Standard Deviation 1.14
|
6.68 days
Standard Deviation 3.48
|
9.50 days
Standard Deviation 3.44
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dosePopulation: PK parameter analysis set with available AUCtau data at day 1 and week 10
Accumulation ratio is the ratio of AUCtau after the last dosing interval (week 10) divided by AUCtau after the first dosing interval (day 1).
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
n=4 Participants
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
n=5 Participants
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
n=4 Participants
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Accumulation Ratio of AUCtau
|
2.94 ratio
Standard Deviation 1.75
|
3.55 ratio
Standard Deviation 1.20
|
4.41 ratio
Standard Deviation 2.28
|
4.27 ratio
Standard Deviation 3.24
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dosePopulation: PK parameter analysis set with available Cmax data at day 1 and week 10
Accumulation ratio is the ratio of Cmax after the last dosing interval (week 10) divided by Cmax after the first dosing interval (day 1).
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
n=4 Participants
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
n=6 Participants
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
n=6 Participants
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Accumulation Ratio of Cmax
|
3.08 ratio
Standard Deviation 1.96
|
3.00 ratio
Standard Deviation 1.05
|
4.06 ratio
Standard Deviation 2.12
|
3.71 ratio
Standard Deviation 2.38
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Rozibafusp Alfa 70 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Rozibafusp Alfa 140 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Rozibafusp Alfa 210 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Rozibafusp Alfa 420 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=8 participants at risk
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
n=7 participants at risk
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
n=6 participants at risk
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
n=6 participants at risk
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
n=7 participants at risk
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Participants received placebo administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 70 mg
n=7 participants at risk
Participants received 70 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 140 mg
n=6 participants at risk
Participants received 140 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 210 mg
n=6 participants at risk
Participants received 210 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
Rozibafusp Alfa 420 mg
n=7 participants at risk
Participants received 420 mg rozibafusp alfa administered by subcutaneous injection once every 2 weeks for 10 weeks (6 doses).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
General disorders
Chest pain
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
General disorders
Fatigue
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Eye disorders
Blepharospasm
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Eye disorders
Photopsia
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
General disorders
Injection site pain
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
General disorders
Oedema
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
28.6%
2/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Breast abscess
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
33.3%
2/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Coxsackie viral infection
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Eye infection
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Influenza
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Mycoplasma infection
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Nasopharyngitis
|
37.5%
3/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
28.6%
2/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
33.3%
2/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
33.3%
2/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Investigations
Weight decreased
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
28.6%
2/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
33.3%
2/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
28.6%
2/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Nervous system disorders
Migraine
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
28.6%
2/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Surgical and medical procedures
Tooth extraction
|
12.5%
1/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
16.7%
1/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
0.00%
0/6 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
14.3%
1/7 • From first dose of study drug to 24 weeks after last dose (up to 34 weeks).
|
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