Trial Outcomes & Findings for Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) (NCT NCT04137224)
NCT ID: NCT04137224
Last Updated: 2024-02-05
Results Overview
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
COMPLETED
PHASE2
27 participants
From first dose of study drug through last follow-up visit (up to 36 weeks)
2024-02-05
Participant Flow
Participants were enrolled at study centers in Australia, Germany, Italy, Poland, and the United Kingdom from 19 September 2019 to 17 May 2022.
A total of 30 participants were screened, of which 27 participants were enrolled and randomized to Sequence A or Sequence B in this study.
Participant milestones
| Measure |
Sequence A (IgPro20/IgPro10)
Participants received IgPro20 of a total dose of 0.5 grams per kilogram (g/kg) over 2 sessions per week as a subcutaneous (SC) injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an intravenous (IV) infusion for up to 16 weeks in Treatment Period 2.
|
Sequence B (IgPro10/IgPro20)
Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Treatment Period 1 (Week 1 to Week 16)
STARTED
|
13
|
14
|
|
Treatment Period 1 (Week 1 to Week 16)
COMPLETED
|
12
|
13
|
|
Treatment Period 1 (Week 1 to Week 16)
NOT COMPLETED
|
1
|
1
|
|
Treatment Period 2 (Week 17 to Week 32)
STARTED
|
13
|
13
|
|
Treatment Period 2 (Week 17 to Week 32)
COMPLETED
|
13
|
12
|
|
Treatment Period 2 (Week 17 to Week 32)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sequence A (IgPro20/IgPro10)
Participants received IgPro20 of a total dose of 0.5 grams per kilogram (g/kg) over 2 sessions per week as a subcutaneous (SC) injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an intravenous (IV) infusion for up to 16 weeks in Treatment Period 2.
|
Sequence B (IgPro10/IgPro20)
Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Treatment Period 1 (Week 1 to Week 16)
Adverse Event
|
1
|
0
|
|
Treatment Period 1 (Week 1 to Week 16)
Withdrawal by Subject
|
0
|
1
|
|
Treatment Period 2 (Week 17 to Week 32)
Adverse Event
|
0
|
1
|
Baseline Characteristics
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
Baseline characteristics by cohort
| Measure |
Sequence A (IgPro20/IgPro10)
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as an SC injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2.
|
Sequence B (IgPro10/IgPro20)
n=14 Participants
Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 12.22 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 12.91 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 12.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow-up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With at Least One Adverse Event (AE) for IgPro20
|
9 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow-up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. The percentage of participants are rounded off to the single decimal point.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Percentage of Participants With at Least One AE for IgPro20
|
69.2 percentage of participants
|
69.2 percentage of participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow-up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) for IgPro20
|
9 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow-up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. The percentage of participants are rounded off to the single decimal point.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Percentage of Participants With at Least One TEAE for IgPro20
|
69.2 percentage of participants
|
69.2 percentage of participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow-up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed.
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With at Least One Serious Adverse Event (SAE) for IgPro20
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow-up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. The percentage of participants are rounded off to the single decimal point.
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Percentage of Participants With at Least One SAE for IgPro20
|
15.4 percentage of participants
|
23.1 percentage of participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow-up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With at Least One Adverse Event of Special Interest (AESI) for IgPro20
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. The percentage of participants are rounded off to the single decimal point.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Percentage of Participants With at Least One AESI for IgPro20
|
0 percentage of participants
|
7.7 percentage of participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed.
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With AEs Categorized as Infusion Site Reactions (ISRs) for IgPro20
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. The percentage of participants are rounded off to the single decimal point.
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Percentage of Participants With AEs Categorized as ISRs for IgPro20
|
15.4 percentage of participants
|
23.1 percentage of participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed.
ISR rate per infusion = total number of ISRs across all participants while on IgPro20 / total number of IgPro20 Infusions across all participants. ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions NEC', 'Infusion site reactions', or 'Injection site reactions'
Outcome measures
| Measure |
Sequence A: IgPro20
n=353 Infusions
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=333 Infusions
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Rate of ISRs Per Infusion for IgPro20
|
0.0057 ISRs per infusion
|
0.0360 ISRs per infusion
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 and with ISRs were analyzed.
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Time to onset of ISR since the start of the treatment period was reported.
Outcome measures
| Measure |
Sequence A: IgPro20
n=2 ISRs
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=12 ISRs
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Time to Onset of ISRs for IgPro20
|
2.0 days
Interval 1.0 to 3.0
|
15.0 days
Interval 1.0 to 64.0
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 and with ISRs were analyzed.
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Outcome measures
| Measure |
Sequence A: IgPro20
n=2 ISRs
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=12 ISRs
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Duration of ISRs for IgPro20
|
162.0 minutes
Interval 162.0 to 162.0
|
220.0 minutes
Interval 180.0 to 1170.0
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed.
Abnormality criteria:Hematology-Hemoglobin:\<10 g/dL;Platelet count:\<75x10\^9/L or \>500x10\^9/L;White Blood Cell Count:\<3x10\^9/L or \>16x10\^9/L;Neutrophils:absolute \<1.5x10\^9/L,differential \<40%;Lymphocytes:absolute \<0.8x10\^9/L,differential \<10 or \>50%; Biochemistry-Bilirubin:\>1.5xupper limit of normal (ULN);Alkaline phosphatase:\>2.5xULN;Serum Glutamic-oxalacetic transaminase(SGOT), Aspartate transaminase(AST):\>3xULN;Serum glutamic-pyruvic transaminase(SGPT), Alanine transaminase(ALT):\>3xULN;Screening:AST/ALT \>3xULN and Total Bilirubin \>2xULN;Urea nitrogen:\>2.5xULN; Creatinine, serum\>1.5xbaseline assessment or change \>0.3mg/dL since last visit;Glucose,blood (non-fasting):\<55/\>160mg/dL;Calcium:\<7/\>11.5mg/dL;Total protein: \<5/\>9g/dL; Albumin:\<3g/dL;Sodium:\<130/\>150mmol/L;Potassium:\<3/\>5.5mmol/L; Uric acid,serum:\>10mg/dL Males,\>8mg/dL Females;Gamma Glutamyl Transpeptidase:\>2.5xULN; Phosphorus,inorganic:\<2.5/\>5mg/dL;Lactate dehydrogenase:\>3xULN;Urinalysis-Protein:\>20mg/dL.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro20
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed.
Clinically significant abnormality criteria for vital signs included Systolic blood pressure (BP): \<100 millimeters of mercury (mmHg) or ≥140 mmHg or ≥140 mmHg and increase \>10 from reference visit; Diastolic BP: \<50 mmHg or ≥90 mmHg or ≥90 mmHg and increase \>10 from reference visit; Pulse rate: \<50 beats/minute or ≥120 beats/minute or ≥120 beats/minute and increase \>15 from reference visit; Weight (kilograms) ≥10% change (increase and decrease) from baseline assessment; Body temperature: \> 39-degree Celsius (°C ) or \<35°C (oral, tympanic, axilla or forehead).
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs for IgPro20
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed.
Clinically significant abnormality criteria for ECG parameters included Heart rate: ≤50 or ≥100 beats/minute; PR Interval: ≥200 millisecond (msec); QRS Interval: ≥120 msec; QT: ≥480 msec; QT interval corrected using Bazett' s formula (QTcB): ≤ 500 msec; QT interval corrected using Fridericia's formula (QTcF): \>500 msec; QT: increase from baseline ≥ 30; QTcB: increase from baseline \< 60 msec; QTcF: increase from baseline ≥ 60.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters for IgPro20
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed.
PFTs include Spirometry which included forced vital capacity (FVC) % Predicted, considered as clinically significant abnormality when decrease is greater than10 percentage points from the reference visit.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Pulmonary Function Tests (PFTs) for IgPro20
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro20 and with data available for outcome measure analysis.
Relative bioavailability was calculated using Mixed Model Repeated Measures on Log-transformed Dose-normalized area under the curve to the end of the dosing period \[AUC0-tau\] following administration of the first dose of IgPro20 in the last week of dosing for Sequence A and / or Sequence B. Relative Bioavailability= (AUCtau IgPro20 (SC)/dose of IgPro20 (SC) / (AUCtau of IgPro10 (IV)/dose of IgPro10 (IV)).
Outcome measures
| Measure |
Sequence A: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Relative Bioavailability (%F) of IgPro20
|
0.831 percentage bioavailability
Interval 0.7343 to 0.9396
|
0.698 percentage bioavailability
Interval 0.6235 to 0.7804
|
SECONDARY outcome
Timeframe: Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro20 and with data available for outcome measure analysis.
Outcome measures
| Measure |
Sequence A: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=11 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro20
|
3835.68 hours*grams per liter (h*g/L)
Interval 3394.749 to 4333.883
|
3581.08 hours*grams per liter (h*g/L)
Interval 3326.635 to 3854.997
|
SECONDARY outcome
Timeframe: Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro20 and with data available for outcome measure analysis.
Outcome measures
| Measure |
Sequence A: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro20
|
5361.61 h*g/L
Interval 4729.962 to 6077.619
|
4898.02 h*g/L
Interval 4437.732 to 5406.046
|
SECONDARY outcome
Timeframe: Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro20 and with data available for outcome measure analysis.
Outcome measures
| Measure |
Sequence A: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Maximum Plasma Drug Concentration (Cmax) for IgPro20
|
24.237 g/L
Interval 21.6041 to 27.1898
|
23.203 g/L
Interval 21.7278 to 24.7782
|
SECONDARY outcome
Timeframe: Pre-injection at Weeks 5, 9, 13, and 14Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro20 were analyzed. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A
Week 5
|
22.046 g/L
Interval 16.69 to 63.7
|
—
|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A
Week 9
|
21.950 g/L
Interval 14.71 to 30.51
|
—
|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A
Week 13
|
22.354 g/L
Interval 16.98 to 31.36
|
—
|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A
Week 14
|
21.814 g/L
Interval 14.49 to 27.93
|
—
|
SECONDARY outcome
Timeframe: Pre-injection at Weeks 21, 25, 29, and 30Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro20 and with data available for outcome measure analysis.
Outcome measures
| Measure |
Sequence A: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B
Week 21
|
20.427 g/L
Interval 12.82 to 25.48
|
—
|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B
Week 25
|
21.603 g/L
Interval 16.92 to 30.49
|
—
|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B
Week 29
|
21.903 g/L
Interval 18.89 to 28.47
|
—
|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B
Week 30
|
20.497 g/L
Interval 18.15 to 23.59
|
—
|
SECONDARY outcome
Timeframe: Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro10 and with data available for outcome measure analysis.
Outcome measures
| Measure |
Sequence A: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro10
|
16942.66 h*g/L
Interval 15097.493 to 19013.345
|
17672.03 h*g/L
Interval 16402.479 to 19039.837
|
SECONDARY outcome
Timeframe: Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro10 and with data available for outcome measure analysis.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro10
|
16520.48 h*g/L
Interval 14742.232 to 18513.218
|
17349.72 h*g/L
Interval 15917.101 to 18911.275
|
SECONDARY outcome
Timeframe: Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro10 and with data available for outcome measure analysis.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=12 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Maximum Plasma Drug Concentration (Cmax) for IgPro10
|
47.142 g/L
Interval 41.2538 to 53.8713
|
44.996 g/L
Interval 39.211 to 51.634
|
SECONDARY outcome
Timeframe: Pre-infusion at Weeks 21, 25 and 29Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A
Week 21
|
16.123 g/L
Interval 9.69 to 34.7
|
—
|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A
Week 25
|
17.497 g/L
Interval 8.8 to 54.96
|
—
|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A
Week 29
|
16.838 g/L
Interval 8.51 to 58.16
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion at Weeks 5, 9 and 13Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. 'Overall number of participants analyzed' indicates the number of participants who received IgPro10 and with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B
Week 5
|
17.104 g/L
Interval 12.77 to 24.04
|
—
|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B
Week 9
|
17.744 g/L
Interval 13.92 to 23.36
|
—
|
|
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B
Week 13
|
17.113 g/L
Interval 12.89 to 25.43
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With at Least One AE for IgPro10
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. The percentage of participants are rounded off to the single decimal point.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Percentage of Participants With at Least One AE for IgPro10
|
38.5 percentage of participants
|
57.1 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With at Least One TEAE for IgPro10
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. The percentage of participants are rounded off to the single decimal point.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Percentage of Participants With at Least One TEAE for IgPro10
|
38.5 percentage of participants
|
57.1 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed.
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With at Least One SAE for IgPro10
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. The percentage of participants are rounded off to the single decimal point.
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Percentage of Participants With at Least One SAE for IgPro10
|
7.7 percentage of participants
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With at Least One AESI for IgPro10
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed. The percentage of participants are rounded off to the single decimal point.
AE is any untoward medical occurrence in a patient or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Percentage of Participants With at Least One AESI for IgPro10
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed.
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With AEs Categorized as ISRs for IgPro10
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed.
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Percentage of Participants With AEs Categorized as ISRs for IgPro10
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed.
Abnormality criteria:Hematology-Hemoglobin:\<10 g/dL;Platelet count:\<75x10\^9/L or \>500x10\^9/L;White Blood Cell Count:\<3x10\^9/L or \>16x10\^9/L;Neutrophils:absolute \<1.5x10\^9/L,differential \<40%;Lymphocytes:absolute \<0.8x10\^9/L,differential \<10 or \>50%; Biochemistry-Bilirubin:\>1.5xupper limit of normal (ULN);Alkaline phosphatase:\>2.5xULN;Serum Glutamic-oxalacetic transaminase(SGOT), Aspartate transaminase(AST):\>3xULN;Serum glutamic-pyruvic transaminase(SGPT), Alanine transaminase(ALT):\>3xULN;Screening:AST/ALT \>3xULN and Total Bilirubin \>2xULN;Urea nitrogen:\>2.5xULN; Creatinine, serum\>1.5xbaseline assessment or change \>0.3mg/dL since last visit;Glucose,blood (non-fasting):\<55/\>160mg/dL;Calcium:\<7/\>11.5mg/dL;Total protein: \<5/\>9g/dL; Albumin:\<3g/dL;Sodium:\<130/\>150mmol/L;Potassium:\<3/\>5.5mmol/L; Uric acid,serum:\>10mg/dL Males,\>8mg/dL Females;Gamma Glutamyl Transpeptidase:\>2.5xULN; Phosphorus,inorganic:\<2.5/\>5mg/dL;Lactate dehydrogenase:\>3xULN;Urinalysis-Protein:\>20mg/dL.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro10
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed.
Clinically significant abnormality criteria for vital signs included Systolic blood pressure (BP): \<100 millimeters of mercury (mmHg) or ≥140 mmHg or ≥140 mmHg and increase \>10 from reference visit; Diastolic BP: \<50 mmHg or ≥90 mmHg or ≥90 mmHg and increase \>10 from reference visit; Pulse rate: \<50 beats/minute or ≥120 beats/minute or ≥120 beats/minute and increase \>15 from reference visit; Weight (kilograms) ≥10% change (increase and decrease) from baseline assessment; Body temperature: \> 39-degree Celsius (°C ) or \<35°C (oral, tympanic, axilla or forehead).
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs for IgPro10
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed.
Clinically significant abnormality criteria for ECG parameters included Heart rate: ≤50 or ≥100 beats/minute; PR Interval: ≥200 millisecond (msec); QRS Interval: ≥120 msec; QT: ≥480 msec; QT interval corrected using Bazett' s formula (QTcB): ≤ 500 msec; QT interval corrected using Fridericia's formula (QTcF): \>500 msec; QT: increase from baseline ≥ 30; QTcB: increase from baseline \< 60 msec; QTcF: increase from baseline ≥ 60.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in ECG Parameters for IgPro10
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Population: Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10. Participants who received IgPro10 were analyzed.
PFTs include Spirometry which included forced vital capacity (FVC) % Predicted, considered as clinically significant abnormality when decrease is greater than10 percentage points from the reference visit.
Outcome measures
| Measure |
Sequence A: IgPro20
n=13 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=14 Participants
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in PFTs for IgPro10
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first dose of study drug through last follow up visit (up to 36 weeks)Outcome measures
Outcome data not reported
Adverse Events
Sequence A: IgPro20
Sequence A: IgPro10
Sequence B: IgPro10
Sequence B: IgPro20
Serious adverse events
| Measure |
Sequence A: IgPro20
n=13 participants at risk
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence A: IgPro10
n=13 participants at risk
Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2.
|
Sequence B: IgPro10
n=14 participants at risk
Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 participants at risk
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|---|---|
|
Infections and infestations
Viral Infection
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Chest pain
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
Other adverse events
| Measure |
Sequence A: IgPro20
n=13 participants at risk
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1.
|
Sequence A: IgPro10
n=13 participants at risk
Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2.
|
Sequence B: IgPro10
n=14 participants at risk
Participants received IgPro10 of a total dose of 2 g/kg over 2 to 5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1.
|
Sequence B: IgPro20
n=13 participants at risk
Participants received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
14.3%
2/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
14.3%
2/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Gastrointestinal disorders
Saliva altered
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
35.7%
5/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Nervous system disorders
Anosmia
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Nervous system disorders
Sciatica
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Nervous system disorders
Somnolence
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
14.3%
2/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Skin and subcutaneous tissue disorders
Scleroderma associated digital ulcer
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Skin and subcutaneous tissue disorders
Umbilical erythema
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Infusion site pain
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Infusion site swelling
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
15.4%
2/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Fatigue
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Infusion site discharge
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Infusion site erosion
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Infusion site erythema
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Infusion site reaction
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Infusion site vesicles
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Injection site hypersensitivity
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Injection site mass
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Peripheral swelling
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Infections and infestations
COVID-19
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
15.4%
2/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Eye disorders
Dry eye
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.7%
1/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
7.1%
1/14 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
0.00%
0/13 • From first dose of study drug through last follow up visit (up to 36 weeks)
Safety analysis set included all participants who received at least 1 infusion of IgPro20 or IgPro10.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER