Trial Outcomes & Findings for Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection (NCT NCT04749368)
NCT ID: NCT04749368
Last Updated: 2026-07-23
Results Overview
Sustained HBsAg loss was defined as undetectable HBsAg \< 0.05 IU/mL for at least 24 weeks during the 48-week follow-up period after NRTI withdrawal
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Up to Week 96
Results posted on
2026-07-23
Participant Flow
Participant milestones
| Measure |
Cohort A
Participants received BRII-835 (VIR-2218) for 32 weeks
|
Cohort B
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
39
|
41
|
|
Overall Study
COMPLETED
|
10
|
37
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection
Baseline characteristics by cohort
| Measure |
Cohort A
n=11 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
Cohort B
n=39 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 10.52 • n=9 Participants
|
48.5 years
STANDARD_DEVIATION 8.07 • n=27 Participants
|
46.8 years
STANDARD_DEVIATION 8.19 • n=267 Participants
|
47.4 years
STANDARD_DEVIATION 8.40 • n=265 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
26 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
29 Participants
n=27 Participants
|
28 Participants
n=267 Participants
|
65 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=9 Participants
|
39 Participants
n=27 Participants
|
41 Participants
n=267 Participants
|
91 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=9 Participants
|
37 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
87 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
HBsAg at screening
|
2.774 log10 IU/mL
STANDARD_DEVIATION 0.355 • n=9 Participants
|
2.976 log10 IU/mL
STANDARD_DEVIATION 0.348 • n=27 Participants
|
2.902 log10 IU/mL
STANDARD_DEVIATION 0.315 • n=267 Participants
|
2.918 log10 IU/mL
STANDARD_DEVIATION 0.337 • n=265 Participants
|
|
HBeAg at screening
Negative
|
9 Participants
n=9 Participants
|
30 Participants
n=27 Participants
|
31 Participants
n=267 Participants
|
70 Participants
n=265 Participants
|
|
HBeAg at screening
Positive
|
2 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
21 Participants
n=265 Participants
|
|
ALT at screening
|
26.8 U/L
STANDARD_DEVIATION 14.08 • n=9 Participants
|
21.8 U/L
STANDARD_DEVIATION 7.48 • n=27 Participants
|
20.3 U/L
STANDARD_DEVIATION 8.93 • n=267 Participants
|
21.7 U/L
STANDARD_DEVIATION 9.23 • n=265 Participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study treatment with evaluable measurements of antiviral activity and immunological markers
Sustained HBsAg loss was defined as undetectable HBsAg \< 0.05 IU/mL for at least 24 weeks during the 48-week follow-up period after NRTI withdrawal
Outcome measures
| Measure |
Cohort B
n=39 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Cohort A
n=10 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
|---|---|---|---|
|
Percentage of Participants With Sustained HBsAg Loss During the 48-week Follow-up Period After NRTI Withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: Safety analysis set included all participants who were randomly assigned and received at least 1 dose of study treatment
Treatment-emergent adverse events (TEAEs) were summarized for each cohort
Outcome measures
| Measure |
Cohort B
n=39 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Cohort A
n=10 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AE)
|
37 Participants
|
37 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: Safety analysis set included all participants who were randomly assigned and received at least 1 dose of study treatment
Serious adverse events (SAEs) were summarized for each cohort
Outcome measures
| Measure |
Cohort B
n=39 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Cohort A
n=10 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAE)
|
3 Participants
|
6 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: Safety analysis set included all participants who were randomly assigned and received at least 1 dose of study treatment
Treatment-emergent laboratory abnormalities of at least grade 3 are summarized for each cohort
Outcome measures
| Measure |
Cohort B
n=39 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Cohort A
n=10 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
|---|---|---|---|
|
Number of Participants With Abnormalities in Clinical Laboratory Tests
>= grade 3 hematology abnormalities
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Clinical Laboratory Tests
>= grade 3 lymphocytes decreased
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Clinical Laboratory Tests
>= grade 3 coagulation abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Clinical Laboratory Tests
>= grade 3 chemistry abnormalities
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Clinical Laboratory Tests
>= grade 3 creatine kinase increased
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 44Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study treatment with evaluable measurements of antiviral activity and immunological markers
Percentage of participants meeting the NRTI withdrawal criteria at Week 44 was summarized for each cohort
Outcome measures
| Measure |
Cohort B
n=39 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Cohort A
n=10 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
|---|---|---|---|
|
Percentage of Participants Meeting the NRTI Withdrawal Criteria at Week 44
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 72Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study treatment with evaluable measurements of antiviral activity and immunological markers
Percentage of participants with HBsAg loss with or without antibodies to hepatitis B surface antigen (anti-HBs) at Week 72 was summarized for each cohort
Outcome measures
| Measure |
Cohort B
n=39 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Cohort A
n=10 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
|---|---|---|---|
|
Percentage of Participants With HBsAg Loss With or Without Antibodies to Hepatitis B Surface Antigen (Anti-HBs) at Week 72
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 72Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study treatment with evaluable measurements of antiviral activity and immunological markers
Percentage of participants with HBsAg loss at any timepoint was summarized for each cohort
Outcome measures
| Measure |
Cohort B
n=39 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Cohort A
n=10 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
|---|---|---|---|
|
Percentage of Participants With HBsAg Loss at Any Timepoint
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 72Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study treatment with evaluable measurements of antiviral activity and immunological markers
Percentage of participants with HBsAg seroconversion at any timepoint was summarized for each cohort
Outcome measures
| Measure |
Cohort B
n=39 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Cohort A
n=10 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
|---|---|---|---|
|
Percentage of Participants With HBsAg Seroconversion at Any Timepoint
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 72Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study treatment with evaluable measurements of antiviral activity and immunological markers
Change from baseline in serum HBsAg at Week 72 was summarized for each cohort
Outcome measures
| Measure |
Cohort B
n=39 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Cohort A
n=10 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
|---|---|---|---|
|
Change From Baseline in Serum HBsAg at Week 72
|
-0.913 log10 IU/mL
Standard Deviation 0.461
|
-1.018 log10 IU/mL
Standard Deviation 0.440
|
-1.150 log10 IU/mL
Standard Deviation 0.596
|
SECONDARY outcome
Timeframe: Week 44Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study treatment with evaluable measurements of antiviral activity and immunological markers
Percentage of participants with HBeAg loss and/or anti-HBe seroconversion at Week 44 in those who were HBeAg positive at screening was summarized for each cohort
Outcome measures
| Measure |
Cohort B
n=9 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=10 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Cohort A
n=2 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
|---|---|---|---|
|
Percentage of Participants With HBeAg Loss and/or Anti-HBe Seroconversion at Week 44 in Those Who Were HBeAg Positive at Screening
HBeAg loss
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Percentage of Participants With HBeAg Loss and/or Anti-HBe Seroconversion at Week 44 in Those Who Were HBeAg Positive at Screening
HBeAg seroconversion
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 72Population: Full analysis set included all participants who were randomized and had received at least 1 dose of study treatment with evaluable measurements of antiviral activity and immunological markers
Change from baseline in serum appearance and/or titer of anti-HBs at any timepoint was summarized for each cohort
Outcome measures
| Measure |
Cohort B
n=39 Participants
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 Participants
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
Cohort A
n=10 Participants
Participants received BRII-835 (VIR-2218) for 32 weeks
|
|---|---|---|---|
|
Change From Baseline in Serum Appearance and/or Titer of Anti-HBs at Any Timepoint
No anti-HBs response
|
10 Participants
|
9 Participants
|
9 Participants
|
|
Change From Baseline in Serum Appearance and/or Titer of Anti-HBs at Any Timepoint
Anti-HBs response detected with anti-HBs <= 10 IU/L
|
5 Participants
|
6 Participants
|
1 Participants
|
|
Change From Baseline in Serum Appearance and/or Titer of Anti-HBs at Any Timepoint
Not evaluable
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Serum Appearance and/or Titer of Anti-HBs at Any Timepoint
Anti-HBs response detected with anti-HBs > 10 IU/L
|
22 Participants
|
25 Participants
|
0 Participants
|
Adverse Events
Cohort A
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort B
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Cohort C
Serious events: 6 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A
n=10 participants at risk
Participants received BRII-835 (VIR-2218) for 32 weeks
|
Cohort B
n=39 participants at risk
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 participants at risk
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
|---|---|---|---|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.6%
1/39 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.6%
1/39 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/41 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Infections and infestations
Ludwig angina
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Congenital, familial and genetic disorders
Oesophageal cyst
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.6%
1/39 • Number of events 2 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/41 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.6%
1/39 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/41 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
Other adverse events
| Measure |
Cohort A
n=10 participants at risk
Participants received BRII-835 (VIR-2218) for 32 weeks
|
Cohort B
n=39 participants at risk
Participants received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
|
Cohort C
n=41 participants at risk
Participant received BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
|
|---|---|---|---|
|
General disorders
Injection site reaction
|
60.0%
6/10 • Number of events 9 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
56.4%
22/39 • Number of events 121 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
48.8%
20/41 • Number of events 102 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 3 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
56.4%
22/39 • Number of events 133 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
26.8%
11/41 • Number of events 15 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
41.0%
16/39 • Number of events 84 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
7.3%
3/41 • Number of events 3 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
General disorders
Malaise
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
7.7%
3/39 • Number of events 6 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
9.8%
4/41 • Number of events 16 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
General disorders
Chills
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
10.3%
4/39 • Number of events 14 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
7.7%
3/39 • Number of events 4 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/41 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Infections and infestations
COVID-19
|
40.0%
4/10 • Number of events 4 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
38.5%
15/39 • Number of events 15 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
46.3%
19/41 • Number of events 19 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
7.7%
3/39 • Number of events 5 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
12.2%
5/41 • Number of events 9 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.0%
3/10 • Number of events 3 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
69.2%
27/39 • Number of events 162 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
17.1%
7/41 • Number of events 10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.6%
1/39 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
9.8%
4/41 • Number of events 4 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
3/10 • Number of events 4 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
7.3%
3/41 • Number of events 3 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
59.0%
23/39 • Number of events 167 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
24.4%
10/41 • Number of events 19 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
15.4%
6/39 • Number of events 10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
17.9%
7/39 • Number of events 16 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
9.8%
4/41 • Number of events 6 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
20.5%
8/39 • Number of events 13 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.6%
1/39 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
7.3%
3/41 • Number of events 3 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
7.7%
3/39 • Number of events 3 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
4.9%
2/41 • Number of events 2 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.6%
1/39 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
7.3%
3/41 • Number of events 4 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
4.9%
2/41 • Number of events 2 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
5.1%
2/39 • Number of events 2 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
4.9%
2/41 • Number of events 2 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/39 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.4%
1/41 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
10.0%
1/10 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
2.6%
1/39 • Number of events 1 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/41 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
5.1%
2/39 • Number of events 3 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/41 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
7.7%
3/39 • Number of events 3 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
0.00%
0/41 • Up to 96 weeks
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the study intervention start date, or any existing AEs worsening after treatment. Participants at risk included those who received at least one dose of study treatment (one participant randomized to Cohort A withdrew consent and did not receive any study treatment was not included as Participants at risk).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any proposed publication by the investigators will be submitted for the sponsor review at least 60 days prior to its submission to publishers. Reasonable comments from the sponsor will be incorporated. The sponsor may require delaying the proposed publication to protect its proprietary information for up to 3 months from its first submission to the sponsor. Site-specific results may only be published after the first multi-center publication, unless written consent is obtained from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER