Trial Outcomes & Findings for Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE) (NCT NCT04179032)
NCT ID: NCT04179032
Last Updated: 2025-10-23
Results Overview
Blood samples were collected for measurement of serum concentrations of belimumab. Observed belimumab concentrations at Week 12 is presented.
ACTIVE_NOT_RECRUITING
PHASE2
25 participants
At Week 12
2025-10-23
Participant Flow
A total of 28 participants were screened and 25 were enrolled to the study. The primary study included Part A which is an open label 12-week treatment phase and Part B an optional 40-week open-label continuation phase, open to all participants who have completed Part A. An optional access extension phase is ongoing.
The data collection for the access extension phase is still ongoing and additional data will be provided after study completion date is achieved.
Participant milestones
| Measure |
Belimumab 200 mg
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Part A (Up to Week 12)
STARTED
|
25
|
|
Part A (Up to Week 12)
COMPLETED
|
25
|
|
Part A (Up to Week 12)
NOT COMPLETED
|
0
|
|
Part B (Up to Week 52)
STARTED
|
25
|
|
Part B (Up to Week 52)
COMPLETED
|
23
|
|
Part B (Up to Week 52)
NOT COMPLETED
|
2
|
|
Access Extension Phase
STARTED
|
11
|
|
Access Extension Phase
COMPLETED
|
0
|
|
Access Extension Phase
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Belimumab 200 mg
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Part B (Up to Week 52)
Adverse Event
|
1
|
|
Part B (Up to Week 52)
INVESTIGATOR DISCRETION
|
1
|
|
Access Extension Phase
Ongoing
|
11
|
Baseline Characteristics
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
Baseline characteristics by cohort
| Measure |
Belimumab 200 mg
n=25 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Age, Continuous
|
14.0 YEARS
STANDARD_DEVIATION 2.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
MIXED RACE
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 12Population: The analysis was performed on the pharmacokinetic (PK) set that included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
Blood samples were collected for measurement of serum concentrations of belimumab. Observed belimumab concentrations at Week 12 is presented.
Outcome measures
| Measure |
Belimumab 200 mg
n=25 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Observed Belimumab Concentrations at Week 12
|
106.42 microgram per milliliter (ug/ml)
Interval 87.8 to 128.99
|
PRIMARY outcome
Timeframe: Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60Population: The analysis was performed on the PK Set that included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Average concentrations were analyzed and reported for all time-points from Week 1 through Week 60.
Outcome measures
| Measure |
Belimumab 200 mg
n=25 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Estimated Average Concentration (Cavg) of Belimumab at Steady State
|
124 ug/ml
Geometric Coefficient of Variation 37.3
|
PRIMARY outcome
Timeframe: Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60Population: The analysis was performed on the PK Set that included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Cmax was analyzed and reported for all time-points from Week 1 through Week 60.
Outcome measures
| Measure |
Belimumab 200 mg
n=25 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Estimated Maximum Concentration (Cmax) of Belimumab at Steady State
|
131 ug/ml
Geometric Coefficient of Variation 34.9
|
PRIMARY outcome
Timeframe: Pre dose on Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52, and Week 60Population: The analysis was performed on the PK Set that included all participants assigned treatment who received at least one dose of study treatment and for whom at least one post belimumab treatment PK sample was obtained and analyzed.
Blood samples were collected for measurement of serum concentrations of belimumab at steady state. Cmin was analyzed and reported for all time-points from Week 1 through Week 60.
Outcome measures
| Measure |
Belimumab 200 mg
n=25 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Estimated Minimum Concentration (Cmin) of Belimumab at Steady State
|
112 ug/ml
Geometric Coefficient of Variation 41.7
|
SECONDARY outcome
Timeframe: Up to Week 68Population: The safety analysis was performed on the Intent-To-Treat (ITT) set that included all participants assigned treatment who received at least one dose of study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Belimumab 200 mg
n=25 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to Week 68Population: The safety analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment.
A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death.
Outcome measures
| Measure |
Belimumab 200 mg
n=25 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 68Population: The safety analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment.
AESI included post-injection systemic reactions and hypersensitivity reactions, infections, malignancies, and depression/suicidality/self-injury. AESIs were followed until the event is resolved, stabilized, otherwise explained, or the participant is lost to follow-up.
Outcome measures
| Measure |
Belimumab 200 mg
n=25 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Malignancies
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Post-Injection Systemic Reactions
|
3 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Infections
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Depression/Suicide/Self-injury
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 52Population: The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment. Participants who had low baseline C3 and C4 levels were included in the respective analysis. Number of participants analyzed signifies those participants who were evaluable for this outcome.
Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline status are defined as low complement \[C3 less than (\<) 90 milligrams per deciliter (mg/dL)\] or normal/high (C3 \>= 90 mg/dL) and low (C4 \< 13 mg/dL) or normal/high (C4 \>= 13 mg/dL) respectively. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100.
Outcome measures
| Measure |
Belimumab 200 mg
n=15 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Percent Change From Baseline in Complement C3 and Complement C4 at Week 12 and Week 52
Complement C3 (Week 12)
|
8.26 Percent change
Interval 2.0 to 24.8
|
|
Percent Change From Baseline in Complement C3 and Complement C4 at Week 12 and Week 52
Complement C4 (Week 12)
|
31.03 Percent change
Interval -3.5 to 67.3
|
|
Percent Change From Baseline in Complement C3 and Complement C4 at Week 12 and Week 52
Complement C4 (Week 52)
|
67.52 Percent change
Interval 21.8 to 443.2
|
|
Percent Change From Baseline in Complement C3 and Complement C4 at Week 12 and Week 52
Complement C3 (Week 52)
|
23.46 Percent change
Interval -7.6 to 61.6
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 52Population: The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment. Participants who had positive anti-dsDNA antibody levels at baseline were included in the analysis. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected for anti-dsDNA- antibody biomarker analysis. Baseline status are defined as positive (Anti-dsDNA antibody \>= 30 International Units Per Milliliter (IU/mL)) or negative (Anti-dsDNA antibody\< 30 IU/mL). Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100.
Outcome measures
| Measure |
Belimumab 200 mg
n=15 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Percent Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Antibodies at Week 12 and Week 52
Week 12
|
-17.74 Percent change
Interval -68.0 to 40.0
|
|
Percent Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Antibodies at Week 12 and Week 52
Week 52
|
-58.88 Percent change
Interval -85.3 to -2.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 52Population: The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected for biomarker analysis. B cell subsets included CD19+ total B cells and CD 20+ B cells. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100.
Outcome measures
| Measure |
Belimumab 200 mg
n=15 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Percent Change From Baseline in CD19+ Total B Cells and CD20+ B Cells at Week 12 and Week 52
CD19+ Total B cells (Week 12)
|
-42.97 Percent change
Interval -74.4 to 68.8
|
|
Percent Change From Baseline in CD19+ Total B Cells and CD20+ B Cells at Week 12 and Week 52
CD19+ Total B cells (Week 52)
|
-61.32 Percent change
Interval -89.4 to 95.5
|
|
Percent Change From Baseline in CD19+ Total B Cells and CD20+ B Cells at Week 12 and Week 52
CD20+ B cells (Week 12)
|
-41.85 Percent change
Interval -75.8 to 92.1
|
|
Percent Change From Baseline in CD19+ Total B Cells and CD20+ B Cells at Week 12 and Week 52
CD20+ B cells (Week 52)
|
-61.65 Percent change
Interval -89.9 to 92.3
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 52Population: The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected for biomarker analysis and included CD20+ CD27- Naïve B cells and CD20+ CD27+ memory B cell. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100.
Outcome measures
| Measure |
Belimumab 200 mg
n=15 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Percent Change From Baseline in Naïve B Cells and Memory B Cells at Week 12 and Week 52
Naïve B Cells (Week 12)
|
-53.19 Percent change
Interval -81.5 to 21.0
|
|
Percent Change From Baseline in Naïve B Cells and Memory B Cells at Week 12 and Week 52
Naïve B Cells (Week 52)
|
-72.13 Percent change
Interval -94.5 to 20.3
|
|
Percent Change From Baseline in Naïve B Cells and Memory B Cells at Week 12 and Week 52
Memory B Cells (Week 12)
|
69.06 Percent change
Interval -36.7 to 531.8
|
|
Percent Change From Baseline in Naïve B Cells and Memory B Cells at Week 12 and Week 52
Memory B Cells (Week 52)
|
27.10 Percent change
Interval -63.2 to 402.9
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 52Population: The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected for CD27bright CD38bright Plasma blasts biomarker analysis. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 and 52 divided by the Baseline value X 100.
Outcome measures
| Measure |
Belimumab 200 mg
n=15 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Percent Change From Baseline in in CD27bright CD38bright Plasma Blasts at Week 12 and Week 52
Week 12
|
9.40 Percent change
Interval -81.8 to 428.1
|
|
Percent Change From Baseline in in CD27bright CD38bright Plasma Blasts at Week 12 and Week 52
Week 52
|
-70.07 Percent change
Interval -88.9 to 193.1
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected for analysis of immunoglobulins: Immunoglobulin A (IgA), Immunoglobulin G (IgG), and Immunoglobulin M (IgM). Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 12 divided by the Baseline value X 100.
Outcome measures
| Measure |
Belimumab 200 mg
n=25 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Percent Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 12
Immunoglobulin A (IgA)
|
-3.13 Percent change
Interval -35.2 to 8.0
|
|
Percent Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 12
Immunoglobulin G (IgG)
|
-3.40 Percent change
Interval -30.7 to 12.7
|
|
Percent Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 12
Immunoglobulin M (IgM)
|
-10.41 Percent change
Interval -49.2 to 4.3
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: The analysis was performed on the ITT set that included all participants assigned treatment who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected for analysis of immunoglobulins: Immunoglobulin A (IgA), Immunoglobulin A (IgG), and Immunoglobulin M (IgM). Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100.
Outcome measures
| Measure |
Belimumab 200 mg
n=21 Participants
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Percent Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 52
Immunoglobulin A (IgA)
|
-13.06 Percent change
Interval -37.5 to 41.0
|
|
Percent Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 52
Immunoglobulin G (IgG)
|
-12.29 Percent change
Interval -34.0 to 10.6
|
|
Percent Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 52
Immunoglobulin M (IgM)
|
-30.79 Percent change
Interval -56.7 to -8.9
|
Adverse Events
Belimumab 200 mg
Serious adverse events
| Measure |
Belimumab 200 mg
n=25 participants at risk
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Infections and infestations
COVID-19
|
4.0%
1/25 • Number of events 1 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Belimumab 200 mg
n=25 participants at risk
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
2/25 • Number of events 3 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.0%
4/25 • Number of events 4 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.0%
3/25 • Number of events 3 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.0%
4/25 • Number of events 5 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
General disorders
Injection site erythema
|
8.0%
2/25 • Number of events 3 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
General disorders
Injection site pain
|
16.0%
4/25 • Number of events 9 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19
|
32.0%
8/25 • Number of events 8 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
12.0%
3/25 • Number of events 3 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.0%
3/25 • Number of events 3 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
Infections and infestations
Viral infection
|
8.0%
2/25 • Number of events 2 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
8.0%
2/25 • Number of events 2 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
Investigations
Urine protein/creatinine ratio increased
|
8.0%
2/25 • Number of events 2 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
8.0%
2/25 • Number of events 2 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
2/25 • Number of events 2 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
|
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Skin and subcutaneous tissue disorders
Erythema
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8.0%
2/25 • Number of events 2 • Up to Week 68 (treatment: up to 52 weeks [12 weeks Part A; 40 weeks Part B extension phase] and follow-up: 16 weeks)
The safety analysis was based on the Intent-To-Treat set that comprised of all participants assigned treatment who received at least one dose of study treatment.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER