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

Sponsor
BeiGene (Industry)
Overall Status
Completed
CT.gov ID
NCT04551898
Collaborator
(none)
181
Enrollment
18
Locations
4
Arms
5.7
Actual Duration (Months)
10.1
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered intravenously as a single dose in participants with mild to moderate COVID-19

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
181 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SARS-CoV-2 Neutralizing Antibody BGB-DXP593 in Patients With Mild-to-Moderate COVID-19
Actual Study Start Date :
Dec 2, 2020
Actual Primary Completion Date :
May 25, 2021
Actual Study Completion Date :
May 25, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: BGB-DXP593 Low Dose

Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days

Drug: BGB-DXP593
Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm

Experimental: BGB-DXP593 Medium Dose

Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days

Drug: BGB-DXP593
Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm

Experimental: BGB-DXP593 High Dose

Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days

Drug: BGB-DXP593
Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm

Placebo Comparator: Placebo

Participants will receive placebo on Day 1, and followed up for safety for up to 85 days

Drug: Placebo
Placebo to match BGB-DXP593 administered as specified in the treatment arm

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding [Baseline and Day 8]

    SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.

Secondary Outcome Measures

  1. Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 [Baseline and Day 15]

  2. Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 [Baseline and Day 15]

    SARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples

  3. Time to Negative RT-qPCR in All Tested Samples [From Baseline up to Day 21]

    The negative RT-qPCR is defined as the value that is below the lower limit of detection

  4. Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19 [Baseline up to End of Study (EOS) /174 Days]

  5. Time to Resolution of All COVID-19-Related Symptoms [Baseline up to EOS /174 Days]

  6. All-Cause Mortality at Day 29 [Day 29]

    Number of participants that died by Day 29

  7. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Up to 174 days]

  8. Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593 [Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to174 days)]

  9. Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29 [Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29]

  10. Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 [Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)]

    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

  11. Time to Reach Cmax (Tmax) of BGB-DXP593 [Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)]

  12. Terminal Half-Life (t1/2) of BGB-DXP593 [Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)]

  13. Clearance (CL) of BGB-DXP593 [Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)]

  14. Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593 [Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)]

  15. Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593 [Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
  1. Laboratory-confirmed severe acute respiratory syndrome (SARS)-CoV-2 infection (positive reverse transcription-polymerase chain reaction [RT-PCR] test or other authorized antigen testing methods) in any samples following local practice ≤ 72 hours prior to screening.

  2. Have experienced COVID-19 symptoms for ≤ 7 days prior to treatment assignment, such as fever, cough, shortness of breath, sore throat, diarrhea, vomiting, and dysgeusia

  3. Agree to the collection of nasopharyngeal swabs, saliva, and venous blood

Key Exclusion Criteria:
  1. Severe COVID-19 having oxygen saturation (SpO2) ≤ 93 % on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) < 300, respiratory rate ≥ 30/min, heart rate ≥ 125/min

  2. Requires mechanical ventilation or anticipated impending need for mechanical ventilation

  3. Known allergies to any of the components used in the formulation of the interventions

  4. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing

  5. Have received treatment with a SARS-CoV-2 specific monoclonal antibody

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Midland Florida Clinical Research Center, LLCDeLandFloridaUnited States32720
2Baptist Medical CenterJacksonvilleFloridaUnited States33207
3Homestead Associates in Research Inc.MiamiFloridaUnited States33032
4Medical Research Center of Miami II, Inc.MiamiFloridaUnited States33134
5US Associates in ResearchMiamiFloridaUnited States33175
6Continental Research NetworkMiamiFloridaUnited States33187
7Omega Research OrlandoOrlandoFloridaUnited States32808
8Revival Research Institute, LLC.DearbornMichiganUnited States48126
9New Phase Research & DevelopmentKnoxvilleTennesseeUnited States37909
10Amarillo Center for Clinical ResearchAmarilloTexasUnited States79124
11PanAmerican Clinical ResearchBrownsvilleTexasUnited States78520
12Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em SaúdePetropolisCaxias Do SulBrazil95070
13Hospital das Clínicas da Faculdade de Medicina de BotucatuBotucatuBrazil18618
14CMPC Pesquisa ClinicaSorocabaBrazil18040
15Hospital Cardiologica AguascalientesAguascalientesMexico20230
16Iecsi S.C.MonterreyMexico58249
17TASKCape TownSouth Africa7500
18Langeberg Clinical TrialsCape TownSouth Africa7570

Sponsors and Collaborators

  • BeiGene

Investigators

  • Principal Investigator: Study Director, BeiGene

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
BeiGene
ClinicalTrials.gov Identifier:
NCT04551898
Other Study ID Numbers:
  • BGB-DXP593-102
First Posted:
Sep 16, 2020
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsThis study was conducted in 20 centers and 181 participants were treated.
Pre-assignment Detail
Arm/Group TitlePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of placebo solution administered over 30 to 90 minutesSingle intravenous infusion of 5 milligrams/kilogram (mg/kg) DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Period Title: Overall Study
STARTED47454346
COMPLETED39423541
NOT COMPLETED8385

Baseline Characteristics

Arm/Group TitlePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kgTotal
Arm/Group DescriptionSingle intravenous infusion of placebo solution administered over 30 to 90 minutesSingle intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutesTotal of all reporting groups
Overall Participants47454346181
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
44.3
(14.02)
46.2
(15.56)
43.6
(12.43)
41.1
(13.35)
43.8
(13.91)
Sex: Female, Male (Count of 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) (Count of Participants)
American Indian or Alaska Native
3
6.4%
2
4.4%
1
2.3%
2
4.3%
8
4.4%
Asian
0
0%
1
2.2%
0
0%
0
0%
1
0.6%
Native Hawaiian or Other Pacific Islander
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%
Unknown or Not Reported
1
2.1%
2
4.4%
1
2.3%
6
13%
10
5.5%

Outcome Measures

1. Primary Outcome
TitleChange From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding
DescriptionSARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.
Time FrameBaseline and Day 8

Outcome Measure Data

Analysis Population Description
Intent To Treat (ITT) analysis set. Participants with available data were included in the analysis.
Arm/Group TitlePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of placebo solution administered over 30 to 90 minutesSingle intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
Measure Participants41423442
Mean (Standard Deviation) [log10 copies/ml]
-2.88
(2.241)
-3.52
(2.831)
-3.75
(2.513)
-3.03
(2.239)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BGB-DXP593 5 mg/kg
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.4829
Comments
MethodMixed Models Analysis
Comments
Method of EstimationEstimation ParameterLeast square Mean
Estimated Value-0.25
Confidence Interval (2-Sided) 90%
-0.84 to 0.34
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BGB-DXP593 15 mg/kg
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.1739
Comments
MethodMixed Models Analysis
Comments
Method of EstimationEstimation ParameterLeast square Mean
Estimated Value-0.51
Confidence Interval (2-Sided) 90%
-1.13 to 0.11
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BGB-DXP593 30 mg/kg
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.6006
Comments
MethodMixed Models Analysis
Comments
Method of EstimationEstimation ParameterLeast square Mean
Estimated Value0.19
Confidence Interval (2-Sided) 90%
-0.40 to 0.77
Parameter Dispersion Type:
Value:
Estimation Comments
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
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.4996
CommentsH0: 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
Methodt-test, 1 sided
CommentsMCP Mod was used to test the primary hypothesis and provide 1-sided p-value accordingly.
2. Secondary Outcome
TitleTime-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
Description
Time FrameBaseline and Day 15

Outcome Measure Data

Analysis Population Description
ITT analysis set. Participants with available samples were included in the analysis.
Arm/Group TitlePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of placebo solution administered over 30 to 90 minutesSingle intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
Measure Participants45433744
Mean (Standard Deviation) [log10 copies/ml]
-2.56
(1.718)
-2.93
(1.997)
-2.87
(2.049)
-2.55
(1.785)
3. Secondary Outcome
TitleChange in SARS-CoV-2 Viral Shedding From Baseline to Day 15
DescriptionSARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples
Time FrameBaseline and Day 15

Outcome Measure Data

Analysis Population Description
ITT analysis set. Participants with available samples were included in the analysis.
Arm/Group TitlePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of placebo solution administered over 30 to 90 minutesSingle intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
Measure Participants41413242
Mean (Standard Deviation) [log10 copies/ml]
-4.16
(2.446)
-4.29
(2.675)
-4.31
(2.851)
-4.04
(2.577)
4. Secondary Outcome
TitleTime to Negative RT-qPCR in All Tested Samples
DescriptionThe negative RT-qPCR is defined as the value that is below the lower limit of detection
Time FrameFrom Baseline up to Day 21

Outcome Measure Data

Analysis Population Description
ITT analysis set
Arm/Group TitlePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of placebo solution administered over 30 to 90 minutesSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants47454346
Median (90% Confidence Interval) [Days]
17.00
15.00
10.00
17.00
5. Secondary Outcome
TitlePercentage of Participants Who Required Hospitalization Due to Worsened COVID-19
Description
Time FrameBaseline up to End of Study (EOS) /174 Days

Outcome Measure Data

Analysis Population Description
ITT analysis set
Arm/Group TitlePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of placebo solution administered over 30 to 90 minutesSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants47454346
Number [Percentage of participants]
4.3
9.1%
2.2
4.9%
2.3
5.3%
0.0
0%
6. Secondary Outcome
TitleTime to Resolution of All COVID-19-Related Symptoms
Description
Time FrameBaseline up to EOS /174 Days

Outcome Measure Data

Analysis Population Description
ITT analysis set
Arm/Group TitlePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of placebo solution administered over 30 to 90 minutesSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants47454346
Median (90% Confidence Interval) [Days]
16.5
15.0
19.0
14.0
7. Secondary Outcome
TitleAll-Cause Mortality at Day 29
DescriptionNumber of participants that died by Day 29
Time FrameDay 29

Outcome Measure Data

Analysis Population Description
ITT analysis set
Arm/Group TitlePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of placebo solution administered over 30 to 90 minutesSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants47454346
Number [Percentage of participants]
2.13
4.5%
0
0%
0
0%
0
0%
8. Secondary Outcome
TitleNumber of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
Time FrameUp to 174 days

Outcome Measure Data

Analysis Population Description
Safety analysis set includes all participants who received the study drug or placebo.
Arm/Group TitlePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of placebo solution administered over 30 to 90 minutesSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants47444045
With at Least One TEAE
6
12.8%
6
13.3%
4
9.3%
7
15.2%
Grade 3 or Higher TEAE
1
2.1%
1
2.2%
1
2.3%
0
0%
Serious TEAE
2
4.3%
2
4.4%
1
2.3%
0
0%
9. Secondary Outcome
TitleMaximum Observed Plasma Concentration (Cmax) of BGB-DXP593
Description
Time FrameDay 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to174 days)

Outcome Measure Data

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 TitleBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants424044
Mean (Standard Deviation) [µg/mL]
132.95
(53.180)
368.22
(232.040)
714.17
(149.198)
10. Secondary Outcome
TitleArea Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29
Description
Time FrameDay 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29

Outcome Measure Data

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 TitleBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants423745
Median (Full Range) [day*μg/mL]
1188.7
3014.3
6609.2
11. Secondary Outcome
TitleArea Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593
DescriptionAUClast : 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 FrameDay 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)

Outcome Measure Data

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 TitleBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants434045
AUClast
1829.3
4707.5
10259.5
AUCInf
2098.7
4996.3
10509.2
12. Secondary Outcome
TitleTime to Reach Cmax (Tmax) of BGB-DXP593
Description
Time FrameDay 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)

Outcome Measure Data

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 TitleBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants434045
Median (Full Range) [hours]
1.500
1.500
1.500
13. Secondary Outcome
TitleTerminal Half-Life (t1/2) of BGB-DXP593
Description
Time FrameDay 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)

Outcome Measure Data

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 TitleBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants383540
Median (Full Range) [Day]
21.4
23.2
20.8
14. Secondary Outcome
TitleClearance (CL) of BGB-DXP593
Description
Time FrameDay 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)

Outcome Measure Data

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 TitleBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants383540
Median (Full Range) [Liters/Day]
0.21
0.25
0.24
15. Secondary Outcome
TitleVolume of Distribution During the Terminal Phase (Vz) of BGB-DXP593
Description
Time FrameDay 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)

Outcome Measure Data

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 TitleBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants383540
Median (Full Range) [Liters]
6.58
8.07
7.33
16. Secondary Outcome
TitleNumber of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593
Description
Time FrameDay 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)

Outcome Measure Data

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 TitleBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
Measure Participants443745
Treatment Induced
1
2.1%
0
0%
0
0%
Neutralizing antibody Positive
0
0%
0
0%
0
0%

Adverse Events

Time FrameUp to 174 days
Adverse Event Reporting Description Safety Analysis Set included all participants who received the study drug or placebo.
Arm/Group TitlePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Arm/Group DescriptionSingle intravenous infusion of placebo solution administered over 30 to 90 minutesSingle intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutesSingle intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes
All Cause Mortality
PlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/47 (2.1%) 0/44 (0%) 0/40 (0%) 0/45 (0%)
Serious Adverse Events
PlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/47 (4.3%) 2/44 (4.5%) 1/40 (2.5%) 0/45 (0%)
Infections and infestations
COVID-19 pneumonia2/47 (4.3%) 22/44 (4.5%) 21/40 (2.5%) 10/45 (0%) 0
Other (Not Including Serious) Adverse Events
PlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/47 (10.6%) 4/44 (9.1%) 4/40 (10%) 7/45 (15.6%)
Cardiac disorders
Tachycardia1/47 (2.1%) 11/44 (2.3%) 10/40 (0%) 00/45 (0%) 0
Ear and labyrinth disorders
Ear pruritus0/47 (0%) 00/44 (0%) 00/40 (0%) 01/45 (2.2%) 1
Gastrointestinal disorders
Diarrhoea0/47 (0%) 00/44 (0%) 00/40 (0%) 01/45 (2.2%) 1
Gastritis0/47 (0%) 01/44 (2.3%) 10/40 (0%) 00/45 (0%) 0
Nausea0/47 (0%) 02/44 (4.5%) 20/40 (0%) 03/45 (6.7%) 3
Vomiting0/47 (0%) 00/44 (0%) 00/40 (0%) 01/45 (2.2%) 1
General disorders
Medical device site hypersensitivity1/47 (2.1%) 10/44 (0%) 00/40 (0%) 00/45 (0%) 0
Infections and infestations
Urinary tract infection0/47 (0%) 00/44 (0%) 01/40 (2.5%) 10/45 (0%) 0
Injury, poisoning and procedural complications
Toxicity to various agents0/47 (0%) 00/44 (0%) 00/40 (0%) 01/45 (2.2%) 1
Investigations
Alanine aminotransferase increased0/47 (0%) 00/44 (0%) 01/40 (2.5%) 10/45 (0%) 0
Aspartate aminotransferase increased0/47 (0%) 00/44 (0%) 01/40 (2.5%) 10/45 (0%) 0
Fibrin D dimer increased1/47 (2.1%) 10/44 (0%) 00/40 (0%) 00/45 (0%) 0
Metabolism and nutrition disorders
Hypoglycaemia1/47 (2.1%) 10/44 (0%) 00/40 (0%) 00/45 (0%) 0
Musculoskeletal and connective tissue disorders
Myalgia1/47 (2.1%) 10/44 (0%) 00/40 (0%) 00/45 (0%) 0
Nervous system disorders
Dizziness0/47 (0%) 00/44 (0%) 01/40 (2.5%) 10/45 (0%) 0
Dysgeusia0/47 (0%) 00/44 (0%) 00/40 (0%) 01/45 (2.2%) 1
Headache0/47 (0%) 00/44 (0%) 01/40 (2.5%) 11/45 (2.2%) 1
Skin and subcutaneous tissue disorders
Erythema multiforme0/47 (0%) 00/44 (0%) 00/40 (0%) 01/45 (2.2%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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

Name/TitleStudy Director
OrganizationBeiGene
Phone+1-877-828-5568
Emailclinicaltrials@beigene.com
Responsible Party:
BeiGene
ClinicalTrials.gov Identifier:
NCT04551898
Other Study ID Numbers:
  • BGB-DXP593-102
First Posted:
Sep 16, 2020
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022