Trial Outcomes & Findings for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19) (NCT NCT04551898)
NCT ID: NCT04551898
Last Updated: 2024-10-26
Results Overview
SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
181 participants
Primary outcome timeframe
Baseline and Day 8
Results posted on
2024-10-26
Participant Flow
This study was conducted in 20 centers and 181 participants were treated.
Participant milestones
| Measure |
Placebo
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
Single intravenous infusion of 5 milligrams/kilogram (mg/kg) DXP593 administered for 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
45
|
43
|
46
|
|
Overall Study
COMPLETED
|
39
|
42
|
35
|
41
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
8
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
Single intravenous infusion of 5 milligrams/kilogram (mg/kg) DXP593 administered for 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
|
|---|---|---|---|---|
|
Overall Study
Participant randomized but did not receive study drug
|
0
|
1
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
2
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Incorrectly randomized and screen failed due to administrative error
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Baseline characteristics by cohort
| Measure |
Placebo
n=47 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=45 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=43 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
n=46 Participants
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 14.02 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 15.56 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 13.35 • n=4 Participants
|
43.8 years
STANDARD_DEVIATION 13.91 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
147 Participants
n=21 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 8Population: Intent To Treat (ITT) analysis set. Participants with available data were included in the analysis.
SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.
Outcome measures
| Measure |
Placebo
n=41 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=42 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=34 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
n=42 Participants
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding
|
-2.88 log10 copies/ml
Standard Deviation 2.241
|
-3.52 log10 copies/ml
Standard Deviation 2.831
|
-3.75 log10 copies/ml
Standard Deviation 2.513
|
-3.03 log10 copies/ml
Standard Deviation 2.239
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: ITT analysis set. Participants with available samples were included in the analysis.
Outcome measures
| Measure |
Placebo
n=45 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=43 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=37 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
n=44 Participants
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
|
-2.56 log10 copies/ml
Standard Deviation 1.718
|
-2.93 log10 copies/ml
Standard Deviation 1.997
|
-2.87 log10 copies/ml
Standard Deviation 2.049
|
-2.55 log10 copies/ml
Standard Deviation 1.785
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: ITT analysis set. Participants with available samples were included in the analysis.
SARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples
Outcome measures
| Measure |
Placebo
n=41 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=41 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=32 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
n=42 Participants
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
|
-4.16 log10 copies/ml
Standard Deviation 2.446
|
-4.29 log10 copies/ml
Standard Deviation 2.675
|
-4.31 log10 copies/ml
Standard Deviation 2.851
|
-4.04 log10 copies/ml
Standard Deviation 2.577
|
SECONDARY outcome
Timeframe: From Baseline up to Day 21Population: ITT analysis set
The negative RT-qPCR is defined as the value that is below the lower limit of detection
Outcome measures
| Measure |
Placebo
n=47 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=45 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=43 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
n=46 Participants
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Time to Negative RT-qPCR in All Tested Samples
|
17.00 Days
Interval 15.0 to 19.0
|
15.00 Days
Interval 13.0 to 17.0
|
10.00 Days
Interval 8.0 to 16.0
|
17.00 Days
Interval 15.0 to 17.0
|
SECONDARY outcome
Timeframe: Baseline up to End of Study (EOS) /174 DaysPopulation: ITT analysis set
Outcome measures
| Measure |
Placebo
n=47 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=45 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=43 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
n=46 Participants
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19
|
4.3 Percentage of participants
|
2.2 Percentage of participants
|
2.3 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to EOS /174 DaysPopulation: ITT analysis set
Outcome measures
| Measure |
Placebo
n=47 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=45 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=43 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
n=46 Participants
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Time to Resolution of All COVID-19-Related Symptoms
|
16.5 Days
Interval 14.0 to 22.0
|
15.0 Days
Interval 14.0 to 22.0
|
19.0 Days
Interval 15.0 to 22.0
|
14.0 Days
Interval 9.0 to 16.0
|
SECONDARY outcome
Timeframe: Day 29Population: ITT analysis set
Number of participants that died by Day 29
Outcome measures
| Measure |
Placebo
n=47 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=45 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=43 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
n=46 Participants
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
All-Cause Mortality at Day 29
|
2.13 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 174 daysPopulation: Safety analysis set includes all participants who received the study drug or placebo.
Outcome measures
| Measure |
Placebo
n=47 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=44 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=40 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
n=45 Participants
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Grade 3 or Higher TEAE
|
1 Number of participants
|
1 Number of participants
|
1 Number of participants
|
0 Number of participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
With at Least One TEAE
|
6 Number of participants
|
6 Number of participants
|
4 Number of participants
|
7 Number of participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Serious TEAE
|
2 Number of participants
|
2 Number of participants
|
1 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to174 days)Population: Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Outcome measures
| Measure |
Placebo
n=42 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=40 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=44 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593
|
132.95 µg/mL
Standard Deviation 53.180
|
368.22 µg/mL
Standard Deviation 232.040
|
714.17 µg/mL
Standard Deviation 149.198
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29Population: PK analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Outcome measures
| Measure |
Placebo
n=42 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=37 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=45 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29
|
1188.7 day*μg/mL
Interval 620.0 to 3540.0
|
3014.3 day*μg/mL
Interval 1198.0 to 4159.0
|
6609.2 day*μg/mL
Interval 4345.0 to 8989.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)Population: PK analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
AUClast : AUC from time zero to the time of the last quantifiable concentration AUCinf: AUC from zero to infinite time with extrapolation of the terminal phase
Outcome measures
| Measure |
Placebo
n=43 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=40 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=45 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593
AUCInf
|
2098.7 day*μg/mL
Interval 851.0 to 4564.0
|
4996.3 day*μg/mL
Interval 2065.0 to 7351.0
|
10509.2 day*μg/mL
Interval 5816.0 to 17245.0
|
—
|
|
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593
AUClast
|
1829.3 day*μg/mL
Interval 843.0 to 4491.0
|
4707.5 day*μg/mL
Interval 406.0 to 6883.0
|
10259.5 day*μg/mL
Interval 5165.0 to 16198.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)Population: Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Outcome measures
| Measure |
Placebo
n=43 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=40 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=45 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) of BGB-DXP593
|
1.500 hours
Interval 0.75 to 322.72
|
1.500 hours
Interval 0.73 to 35.5
|
1.500 hours
Interval 0.83 to 34.25
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)Population: Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Outcome measures
| Measure |
Placebo
n=38 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=35 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=40 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of BGB-DXP593
|
21.4 Day
Interval 15.0 to 40.0
|
23.2 Day
Interval 15.0 to 32.0
|
20.8 Day
Interval 14.0 to 32.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)Population: Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Outcome measures
| Measure |
Placebo
n=38 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=35 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=40 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Clearance (CL) of BGB-DXP593
|
0.21 Liters/Day
Interval 0.1 to 0.5
|
0.25 Liters/Day
Interval 0.2 to 0.5
|
0.24 Liters/Day
Interval 0.1 to 0.4
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)Population: Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Outcome measures
| Measure |
Placebo
n=38 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=35 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=40 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593
|
6.58 Liters
Interval 2.5 to 11.9
|
8.07 Liters
Interval 5.2 to 18.9
|
7.33 Liters
Interval 3.3 to 11.6
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)Population: The ADA Analysis Set includes all the participants who have received the study drug and in whom both baseline ADA and at least 1 postbaseline ADA results are available
Outcome measures
| Measure |
Placebo
n=44 Participants
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=37 Participants
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=45 Participants
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
|
|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593
Treatment Induced
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593
Neutralizing antibody Positive
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
—
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
BGB-DXP593 5 mg/kg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
BGB-DXP593 15 mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
BGB-DXP593 30 mg/kg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=47 participants at risk
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=44 participants at risk
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=40 participants at risk
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
n=45 participants at risk
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
4.3%
2/47 • Number of events 2 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
4.5%
2/44 • Number of events 2 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.5%
1/40 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/45 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
Other adverse events
| Measure |
Placebo
n=47 participants at risk
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
|
BGB-DXP593 5 mg/kg
n=44 participants at risk
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
|
BGB-DXP593 15 mg/kg
n=40 participants at risk
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
|
BGB-DXP593 30 mg/kg
n=45 participants at risk
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
|
|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
2.1%
1/47 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.3%
1/44 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/45 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.2%
1/45 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.2%
1/45 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.3%
1/44 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/45 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
4.5%
2/44 • Number of events 2 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
6.7%
3/45 • Number of events 3 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.2%
1/45 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
General disorders
Medical device site hypersensitivity
|
2.1%
1/47 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/45 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.5%
1/40 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/45 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.2%
1/45 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.5%
1/40 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/45 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.5%
1/40 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/45 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Investigations
Fibrin D dimer increased
|
2.1%
1/47 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/45 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.1%
1/47 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/45 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
1/47 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/45 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.5%
1/40 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/45 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.2%
1/45 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Nervous system disorders
Headache
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.5%
1/40 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.2%
1/45 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/47 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/44 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
0.00%
0/40 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
2.2%
1/45 • Number of events 1 • Up to 174 days
Safety Analysis Set included all participants who received the study drug or placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER