Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency (NCT NCT04561115)
NCT ID: NCT04561115
Last Updated: 2023-06-05
Results Overview
AUC (0-7 days) is calculated as AUC (0-21 days)/3 for subjects with a dosing frequency of every 3 weeks and as AUC(0-28 days)/4 for subjects with a dosing frequency of every 4 weeks.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
Pre-dose, within 10 minutes of last infusion completion, at 1, 3, 6, 24, 48 hours and 4, 7, 14 and 21 days (up to 3 weeks), and 28 days (up to 4 weeks - only for subjects on a 4-week dosing schedule) post-infusion
Results posted on
2023-06-05
Participant Flow
Participants were enrolled at 10 investigative sites in the United States from 02 September 2020 (first participant enrolled to receive the study drug) to 28 March 2022 (last participant completed).
A total of 43 participants were screened, of which 33 participants received study treatment. 22 participants entered the Gamunex-C (GC) Run-in Phase and received GC treatment to achieve an approximate steady-state condition prior to entering the GC pharmacokinetic (PK) Phase as per investigators discretion. Eleven (11) participants directly entered into the GC PK phase.
Participant milestones
| Measure |
Gamunex-C
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
IVIG-PEG
Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.
|
|---|---|---|
|
GC Run-in Phase (Up to 4.5 Months)
STARTED
|
22
|
0
|
|
GC Run-in Phase (Up to 4.5 Months)
COMPLETED
|
22
|
0
|
|
GC Run-in Phase (Up to 4.5 Months)
NOT COMPLETED
|
0
|
0
|
|
GC Run-In + PK Phase (Up to 6 Months)
STARTED
|
33
|
0
|
|
GC Run-In + PK Phase (Up to 6 Months)
COMPLETED
|
32
|
0
|
|
GC Run-In + PK Phase (Up to 6 Months)
NOT COMPLETED
|
1
|
0
|
|
IVIG-PEG Treatment (Up to 4.5 Months)
STARTED
|
0
|
32
|
|
IVIG-PEG Treatment (Up to 4.5 Months)
COMPLETED
|
0
|
31
|
|
IVIG-PEG Treatment (Up to 4.5 Months)
NOT COMPLETED
|
0
|
1
|
|
IVIG-PEG + PK Phase (Up to 6 Months)
STARTED
|
0
|
32
|
|
IVIG-PEG + PK Phase (Up to 6 Months)
COMPLETED
|
0
|
31
|
|
IVIG-PEG + PK Phase (Up to 6 Months)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Gamunex-C
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
IVIG-PEG
Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.
|
|---|---|---|
|
GC Run-In + PK Phase (Up to 6 Months)
Withdrawal by Subject
|
1
|
0
|
|
IVIG-PEG Treatment (Up to 4.5 Months)
The Dose Changed Back and Forth 800-600 Mg/Kg During GC Phase Fulfilling Discontinuation Criteria
|
0
|
1
|
|
IVIG-PEG + PK Phase (Up to 6 Months)
The Dose Changed Back and Forth 800-600 Mg/Kg During GC Phase Fulfilling Discontinuation Criteria
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
Baseline characteristics by cohort
| Measure |
Gamunex-C
n=33 Participants
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 14.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, within 10 minutes of last infusion completion, at 1, 3, 6, 24, 48 hours and 4, 7, 14 and 21 days (up to 3 weeks), and 28 days (up to 4 weeks - only for subjects on a 4-week dosing schedule) post-infusionPopulation: The PK population consisted of all participants who received study drug and had sufficient and valid total IgG concentration versus time data for either the IVIG-PEG PK Phase or GC PK Phase to allow calculation of AUC0-τ. Overall number analyzed are the number of participants with data available for analysis.
AUC (0-7 days) is calculated as AUC (0-21 days)/3 for subjects with a dosing frequency of every 3 weeks and as AUC(0-28 days)/4 for subjects with a dosing frequency of every 4 weeks.
Outcome measures
| Measure |
Gamunex-C
n=29 Participants
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
IVIG-PEG
n=31 Participants
Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.
|
|---|---|---|
|
AUC (0-7): Area Under the Concentration Time Curve Over a Dosing Interval of Either Every 3 Weeks [AUC0-21 Days] or Every 4 Weeks [AUC0-28 Days] for Total Immunoglobulin G (IgG)
|
232088.8 hour*milligrams per decilitres (h*mg/dL)
Standard Deviation 32848.46
|
219149.9 hour*milligrams per decilitres (h*mg/dL)
Standard Deviation 36894.29
|
PRIMARY outcome
Timeframe: Pre-dose, within 10 minutes of last infusion completion, at 1, 3, 6, 24, 48 hours, and 4, 7, 14, 21 and 28 days post-infusion (up to 4 weeks)Population: The PK population consisted of all participants who received study drug and had sufficient and valid total IgG concentration versus time data for either the IVIG-PEG PK Phase or GC PK Phase to allow calculation of AUC0-τ.
Outcome measures
| Measure |
Gamunex-C
n=32 Participants
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
IVIG-PEG
n=31 Participants
Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.
|
|---|---|---|
|
Cmax: Maximum Concentration in a Dosing Interval for Total IgG
|
2328.8 milligrams per decilitre (mg/dL)
Standard Deviation 426.73
|
2330.4 milligrams per decilitre (mg/dL)
Standard Deviation 660.99
|
SECONDARY outcome
Timeframe: Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 monthsPopulation: The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
The rate of SBI events per participant per year during treatment was calculated as the total number of SBI events divided by the total duration of exposure in years across all participants. The 2-sided 98% confidence interval (CI) was determined from a generalized linear model for Poisson regression for the log-transformed number of events with log-transformed duration of exposure in years as an offset variable.
Outcome measures
| Measure |
Gamunex-C
n=33 Participants
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
IVIG-PEG
n=32 Participants
Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.
|
|---|---|---|
|
Rate of Serious Bacterial Infections (SBIs)
|
0 rate of events per participant per year
Here NA signifies that 98% CI was not estimable due to zero number of events.
|
0 rate of events per participant per year
Here NA signifies that 98% CI was not estimable due to zero number of events.
|
SECONDARY outcome
Timeframe: Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 monthsPopulation: The safety population included all participants who received any amount of study drug (IVIG-PEG and/or Gamunex-C).
Rate of events per participant per year is calculated as the total number of events divided by the total duration of exposure in years across all participants. Any kind of infections included serious/nonserious including acute sinusitis, exacerbation of chronic sinusitis, acute otitis media, pneumonia, acute bronchitis, infectious diarrhea etc.) as determined by the Investigator.
Outcome measures
| Measure |
Gamunex-C
n=33 Participants
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
IVIG-PEG
n=32 Participants
Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.
|
|---|---|---|
|
Rate of Events Per Participant Per Year in Participants With Any Kind of Infection
|
1.332 rate of events per participant per year
Interval 0.789 to 2.249
|
1.580 rate of events per participant per year
Interval 1.041 to 2.4
|
SECONDARY outcome
Timeframe: Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 monthsPopulation: The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
Rate of days per person per year is calculated as the total number of days divided by the total duration of exposure in years across all participants. Antibiotics included prophylactic and therapeutic.
Outcome measures
| Measure |
Gamunex-C
n=33 Participants
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
IVIG-PEG
n=32 Participants
Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.
|
|---|---|---|
|
Rate of Days Per Person Per Year That Participants Were on Antibiotics
Prophylactic Antibiotics
|
0 rate of days per participant per year
Interval 0.0 to 0.0
|
9.410 rate of days per participant per year
Interval 7.929 to 11.167
|
|
Rate of Days Per Person Per Year That Participants Were on Antibiotics
Therapeutic Antibiotics
|
28.257 rate of days per participant per year
Interval 25.22 to 31.661
|
27.079 rate of days per participant per year
Interval 24.479 to 29.956
|
SECONDARY outcome
Timeframe: Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 monthsPopulation: The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
Hospitalization was considered only in cases of hospital admission (including emergency room stay) for equal or more than 24 hours.
Outcome measures
| Measure |
Gamunex-C
n=33 Participants
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
IVIG-PEG
n=32 Participants
Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.
|
|---|---|---|
|
Number of Participants Hospitalized Due to Infection
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 monthsPopulation: The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
Rate of days per person per year is calculated as the total number of days divided by the total duration of exposure in years across all participants.
Outcome measures
| Measure |
Gamunex-C
n=33 Participants
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
IVIG-PEG
n=32 Participants
Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.
|
|---|---|---|
|
Rate of Days of Work/School/Daily Activities Missed Per Participant Due to Infections and Their Treatment
|
7.421 rate of days missed/participant per year
Interval 5.944 to 9.265
|
6.177 rate of days missed/participant per year
Interval 5.0 to 7.631
|
Adverse Events
Gamunex-C
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
IVIG-PEG
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gamunex-C
n=33 participants at risk
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
IVIG-PEG
n=32 participants at risk
Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
Other adverse events
| Measure |
Gamunex-C
n=33 participants at risk
Participants received GC by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. The participant's usual mg/kg dose (given on either a 3 or 4 week repeating schedule) was the same mg/kg dose and schedule that the participant was receiving prior to entering screening. This mg/kg dose and schedule were used throughout the study duration. GC was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of GC treatment included the GC PK Phase (up to 4 weeks) plus the additional GC Run-in Phase (up to 4.5 months) for participants not receiving GC or not on a stable dose of GC upon entering the trial. The approximate maximum duration was up to 6 months.
|
IVIG-PEG
n=32 participants at risk
Participants received IVIG-PEG by means of an infusion pump at a dose of 200 to 800 mg/kg per infusion at an infusion rate of 1 mg/kg/min or up to 8 mg/kg/min depending on participant tolerance. IVIG-PEG was administered every 3 weeks (±4 days) or 4 weeks (±4 days), depending on the participant's prior IVIG dosing schedule. The duration of IVIG-PEG treatment included the IVIG-PEG Treatment Phase (up to 4.5 months) and the IVIG-PEG PK Phase (up to 4 weeks), for an approximate maximum of up to 6 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Congenital, familial and genetic disorders
Methylenetetrahydrofolate Reductase Gene Mutation
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Ear and labyrinth disorders
Tinnitus
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Eye disorders
Cataract
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Eye disorders
Chorioretinal disorder
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Eye disorders
Eye Inflammation
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
9.4%
3/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Gastrointestinal disorders
Dry Mouth
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
General disorders
Administration site bruise
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
General disorders
Application site rash
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
General disorders
Injection site pain
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
General disorders
Polyp
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
General disorders
Pyrexia
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Hepatobiliary disorders
Nonalcoholic fatty liver disease
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Immune system disorders
Multiple allergies
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Immune system disorders
Seasonal Allergy
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Acute sinusitis
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
COVID-19
|
6.1%
2/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
12.5%
4/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Helicobacter Gastritis
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Oesophageal candidiasis
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Oral candidiasis
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Paronychia
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Periodontitis
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Rhinitis
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Sinusitis
|
9.1%
3/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
12.5%
4/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
6.2%
2/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Injury, poisoning and procedural complications
Concussion
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Injury, poisoning and procedural complications
Traumatic iritis
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Investigations
Free Prostate-specific Antigen Increased
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Investigations
Low Density Lipoprotein Increased
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Investigations
SARS-CoV-2 Test Positive
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Metabolism and nutrition disorders
Hypoferritinaemia
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
2/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
6.2%
2/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Nervous system disorders
Headache
|
15.2%
5/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
15.6%
5/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Reproductive system and breast disorders
Prostatitis
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Mucosal Disorder
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pain
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
6.2%
2/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
3.1%
1/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
0.00%
0/32 • From first dose of study drug up to end of study (Up to Week 54)
The safety population included all participants who received any amount of study drug (IVIG-PEG and/or GC).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site may publish results from the Study, after providing Sponsor thirty days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsors' request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsors' request, delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor Inventions.
- Publication restrictions are in place
Restriction type: OTHER