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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551898
Recruitment Status : Completed
First Posted : September 16, 2020
Results First Posted : March 17, 2022
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Covid19
Interventions Drug: BGB-DXP593
Drug: Placebo
Enrollment 181
Recruitment Details This study was conducted in 20 centers and 181 participants were treated.
Pre-assignment Details  
Arm/Group Title Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description Single intravenous infusion of placebo solution administered over 30 to 90 minutes Single intravenous infusion of 5 milligrams/kilogram (mg/kg) DXP593 administered for 30 to 90 minutes Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Period Title: Overall Study
Started 47 45 43 46
Completed 39 42 35 41
Not Completed 8 3 8 5
Reason Not Completed
Participant randomized but did not receive study drug             0             1             3             1
Withdrawal by Subject             5             1             2             2
Lost to Follow-up             2             1             2             2
Death             1             0             0             0
Incorrectly randomized and screen failed due to administrative error             0             0             1             0
Arm/Group Title Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg Total
Hide Arm/Group Description Single intravenous infusion of placebo solution administered over 30 to 90 minutes Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes Total of all reporting groups
Overall Number of Baseline Participants 47 45 43 46 181
Hide Baseline Analysis Population Description
Intent to treat (ITT) analysis set includes all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 45 participants 43 participants 46 participants 181 participants
44.3  (14.02) 46.2  (15.56) 43.6  (12.43) 41.1  (13.35) 43.8  (13.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 45 participants 43 participants 46 participants 181 participants
Female
20
  42.6%
17
  37.8%
22
  51.2%
27
  58.7%
86
  47.5%
Male
27
  57.4%
28
  62.2%
21
  48.8%
19
  41.3%
95
  52.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 45 participants 43 participants 46 participants 181 participants
American Indian or Alaska Native
3
   6.4%
2
   4.4%
1
   2.3%
2
   4.3%
8
   4.4%
Asian
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
1
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   6.4%
5
  11.1%
2
   4.7%
5
  10.9%
15
   8.3%
White
40
  85.1%
35
  77.8%
39
  90.7%
33
  71.7%
147
  81.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.1%
2
   4.4%
1
   2.3%
6
  13.0%
10
   5.5%
1.Primary Outcome
Title Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding
Hide Description SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.
Time Frame Baseline and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat (ITT) analysis set. Participants with available data were included in the analysis.
Arm/Group Title Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
Overall Number of Participants Analyzed 41 42 34 42
Mean (Standard Deviation)
Unit of Measure: log10 copies/ml
-2.88  (2.241) -3.52  (2.831) -3.75  (2.513) -3.03  (2.239)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BGB-DXP593 5 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4829
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square Mean
Estimated Value -0.25
Confidence Interval (2-Sided) 90%
-0.84 to 0.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BGB-DXP593 15 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1739
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square Mean
Estimated Value -0.51
Confidence Interval (2-Sided) 90%
-1.13 to 0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BGB-DXP593 30 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6006
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square Mean
Estimated Value 0.19
Confidence Interval (2-Sided) 90%
-0.40 to 0.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, BGB-DXP593 5 mg/kg, BGB-DXP593 15 mg/kg, BGB-DXP593 30 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4996
Comments H0: there is a flat dose response curve comparing change from baseline to Day 8 in viral load in the Placebo and other BGB-DXP593 dose groups
Method t-test, 1 sided
Comments MCP Mod was used to test the primary hypothesis and provide 1-sided p-value accordingly.
2.Secondary Outcome
Title Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
Hide Description [Not Specified]
Time Frame Baseline and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set. Participants with available samples were included in the analysis.
Arm/Group Title Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
Overall Number of Participants Analyzed 45 43 37 44
Mean (Standard Deviation)
Unit of Measure: log10 copies/ml
-2.56  (1.718) -2.93  (1.997) -2.87  (2.049) -2.55  (1.785)
3.Secondary Outcome
Title Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
Hide Description SARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples
Time Frame Baseline and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set. Participants with available samples were included in the analysis.
Arm/Group Title Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
Overall Number of Participants Analyzed 41 41 32 42
Mean (Standard Deviation)
Unit of Measure: log10 copies/ml
-4.16  (2.446) -4.29  (2.675) -4.31  (2.851) -4.04  (2.577)
4.Secondary Outcome
Title Time to Negative RT-qPCR in All Tested Samples
Hide Description The negative RT-qPCR is defined as the value that is below the lower limit of detection
Time Frame From Baseline up to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 47 45 43 46
Median (90% Confidence Interval)
Unit of Measure: Days
17.00
(15.00 to 19.00)
15.00
(13.00 to 17.00)
10.00
(8.00 to 16.00)
17.00
(15.00 to 17.00)
5.Secondary Outcome
Title Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19
Hide Description [Not Specified]
Time Frame Baseline up to End of Study (EOS) /174 Days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 47 45 43 46
Measure Type: Number
Unit of Measure: Percentage of participants
4.3 2.2 2.3 0.0
6.Secondary Outcome
Title Time to Resolution of All COVID-19-Related Symptoms
Hide Description [Not Specified]
Time Frame Baseline up to EOS /174 Days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 47 45 43 46
Median (90% Confidence Interval)
Unit of Measure: Days
16.5
(14.00 to 22.00)
15.0
(14.00 to 22.00)
19.0
(15.00 to 22.00)
14.0
(9.00 to 16.00)
7.Secondary Outcome
Title All-Cause Mortality at Day 29
Hide Description Number of participants that died by Day 29
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 47 45 43 46
Measure Type: Number
Unit of Measure: Percentage of participants
2.13 0 0 0
8.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Up to 174 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set includes all participants who received the study drug or placebo.
Arm/Group Title Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of placebo solution administered over 30 to 90 minutes
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 47 44 40 45
Measure Type: Number
Unit of Measure: Number of participants
With at Least One TEAE 6 6 4 7
Grade 3 or Higher TEAE 1 1 1 0
Serious TEAE 2 2 1 0
9.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593
Hide Description [Not Specified]
Time Frame Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to174 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Arm/Group Title BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 42 40 44
Mean (Standard Deviation)
Unit of Measure: µg/mL
132.95  (53.180) 368.22  (232.040) 714.17  (149.198)
10.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29
Hide Description [Not Specified]
Time Frame Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Arm/Group Title BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 42 37 45
Median (Full Range)
Unit of Measure: day*μg/mL
1188.7
(620 to 3540)
3014.3
(1198 to 4159)
6609.2
(4345 to 8989)
11.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593
Hide Description 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
Time Frame Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Arm/Group Title BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 43 40 45
Median (Full Range)
Unit of Measure: day*μg/mL
AUClast Number Analyzed 43 participants 40 participants 45 participants
1829.3
(843 to 4491)
4707.5
(406 to 6883)
10259.5
(5165 to 16198)
AUCInf Number Analyzed 38 participants 35 participants 40 participants
2098.7
(851 to 4564)
4996.3
(2065 to 7351)
10509.2
(5816 to 17245)
12.Secondary Outcome
Title Time to Reach Cmax (Tmax) of BGB-DXP593
Hide Description [Not Specified]
Time Frame Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Arm/Group Title BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 43 40 45
Median (Full Range)
Unit of Measure: hours
1.500
(0.75 to 322.72)
1.500
(0.73 to 35.50)
1.500
(0.83 to 34.25)
13.Secondary Outcome
Title Terminal Half-Life (t1/2) of BGB-DXP593
Hide Description [Not Specified]
Time Frame Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Arm/Group Title BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 38 35 40
Median (Full Range)
Unit of Measure: Day
21.4
(15 to 40)
23.2
(15 to 32)
20.8
(14 to 32)
14.Secondary Outcome
Title Clearance (CL) of BGB-DXP593
Hide Description [Not Specified]
Time Frame Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Arm/Group Title BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 38 35 40
Median (Full Range)
Unit of Measure: Liters/Day
0.21
(0.1 to 0.5)
0.25
(0.2 to 0.5)
0.24
(0.1 to 0.4)
15.Secondary Outcome
Title Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593
Hide Description [Not Specified]
Time Frame Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
Arm/Group Title BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 38 35 40
Median (Full Range)
Unit of Measure: Liters
6.58
(2.5 to 11.9)
8.07
(5.2 to 18.9)
7.33
(3.3 to 11.6)
16.Secondary Outcome
Title Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593
Hide Description [Not Specified]
Time Frame Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description:
Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Overall Number of Participants Analyzed 44 37 45
Measure Type: Number
Unit of Measure: Number of participants
Treatment Induced 1 0 0
Neutralizing antibody Positive 0 0 0
Time Frame Up to 174 days
Adverse Event Reporting Description Safety Analysis Set included all participants who received the study drug or placebo.
 
Arm/Group Title Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Hide Arm/Group Description Single intravenous infusion of placebo solution administered over 30 to 90 minutes Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
All-Cause Mortality
Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/47 (2.13%)      0/44 (0.00%)      0/40 (0.00%)      0/45 (0.00%)    
Hide Serious Adverse Events
Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/47 (4.26%)      2/44 (4.55%)      1/40 (2.50%)      0/45 (0.00%)    
Infections and infestations         
COVID-19 pneumonia † 1  2/47 (4.26%)  2 2/44 (4.55%)  2 1/40 (2.50%)  1 0/45 (0.00%)  0
1
Term from vocabulary, meddra 24.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo BGB-DXP593 5 mg/kg BGB-DXP593 15 mg/kg BGB-DXP593 30 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/47 (10.64%)      4/44 (9.09%)      4/40 (10.00%)      7/45 (15.56%)    
Cardiac disorders         
Tachycardia † 1  1/47 (2.13%)  1 1/44 (2.27%)  1 0/40 (0.00%)  0 0/45 (0.00%)  0
Ear and labyrinth disorders         
Ear pruritus † 1  0/47 (0.00%)  0 0/44 (0.00%)  0 0/40 (0.00%)  0 1/45 (2.22%)  1
Gastrointestinal disorders         
Diarrhoea † 1  0/47 (0.00%)  0 0/44 (0.00%)  0 0/40 (0.00%)  0 1/45 (2.22%)  1
Gastritis † 1  0/47 (0.00%)  0 1/44 (2.27%)  1 0/40 (0.00%)  0 0/45 (0.00%)  0
Nausea † 1  0/47 (0.00%)  0 2/44 (4.55%)  2 0/40 (0.00%)  0 3/45 (6.67%)  3
Vomiting † 1  0/47 (0.00%)  0 0/44 (0.00%)  0 0/40 (0.00%)  0 1/45 (2.22%)  1
General disorders         
Medical device site hypersensitivity † 1  1/47 (2.13%)  1 0/44 (0.00%)  0 0/40 (0.00%)  0 0/45 (0.00%)  0
Infections and infestations         
Urinary tract infection † 1  0/47 (0.00%)  0 0/44 (0.00%)  0 1/40 (2.50%)  1 0/45 (0.00%)  0
Injury, poisoning and procedural complications         
Toxicity to various agents † 1  0/47 (0.00%)  0 0/44 (0.00%)  0 0/40 (0.00%)  0 1/45 (2.22%)  1
Investigations         
Alanine aminotransferase increased † 1  0/47 (0.00%)  0 0/44 (0.00%)  0 1/40 (2.50%)  1 0/45 (0.00%)  0
Aspartate aminotransferase increased † 1  0/47 (0.00%)  0 0/44 (0.00%)  0 1/40 (2.50%)  1 0/45 (0.00%)  0
Fibrin D dimer increased † 1  1/47 (2.13%)  1 0/44 (0.00%)  0 0/40 (0.00%)  0 0/45 (0.00%)  0
Metabolism and nutrition disorders         
Hypoglycaemia † 1  1/47 (2.13%)  1 0/44 (0.00%)  0 0/40 (0.00%)  0 0/45 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Myalgia † 1  1/47 (2.13%)  1 0/44 (0.00%)  0 0/40 (0.00%)  0 0/45 (0.00%)  0
Nervous system disorders         
Dizziness † 1  0/47 (0.00%)  0 0/44 (0.00%)  0 1/40 (2.50%)  1 0/45 (0.00%)  0
Dysgeusia † 1  0/47 (0.00%)  0 0/44 (0.00%)  0 0/40 (0.00%)  0 1/45 (2.22%)  1
Headache † 1  0/47 (0.00%)  0 0/44 (0.00%)  0 1/40 (2.50%)  1 1/45 (2.22%)  1
Skin and subcutaneous tissue disorders         
Erythema multiforme † 1  0/47 (0.00%)  0 0/44 (0.00%)  0 0/40 (0.00%)  0 1/45 (2.22%)  1
1
Term from vocabulary, meddra 24.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: BeiGene
Phone: +1-877-828-5568
EMail: clinicaltrials@beigene.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04551898    
Other Study ID Numbers: BGB-DXP593-102
First Submitted: September 10, 2020
First Posted: September 16, 2020
Results First Submitted: February 25, 2022
Results First Posted: March 17, 2022
Last Update Posted: March 17, 2022