Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04137224
Registration number
NCT04137224
Ethics application status
Date submitted
21/10/2019
Date registered
23/10/2019
Titles & IDs
Public title
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
Query!
Scientific title
A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) and IgPro10 (Intravenous Immunoglobulin, Privigen®) in Adults With Systemic Sclerosis (SSc)
Query!
Secondary ID [1]
0
0
2018-003149-41
Query!
Secondary ID [2]
0
0
IgPro20_2001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diffuse Cutaneous Systemic Sclerosis
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Autoimmune diseases
Query!
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - IgPro20
Treatment: Other - IgPro10
Experimental: 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.
Experimental: 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: Other: IgPro20
Human normal immunoglobulin for subcutaneous administration
Treatment: Other: IgPro10
Human normal immunoglobulin for intravenous administration
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With at Least One Adverse Event (AE) for IgPro20
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From first dose of study drug through last follow-up visit (up to 36 weeks)
Query!
Primary outcome [2]
0
0
Percentage of Participants With at Least One AE for IgPro20
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
From first dose of study drug through last follow-up visit (up to 36 weeks)
Query!
Primary outcome [3]
0
0
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) for IgPro20
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
From first dose of study drug through last follow-up visit (up to 36 weeks)
Query!
Primary outcome [4]
0
0
Percentage of Participants With at Least One TEAE for IgPro20
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
From first dose of study drug through last follow-up visit (up to 36 weeks)
Query!
Primary outcome [5]
0
0
Number of Participants With at Least One Serious Adverse Event (SAE) for IgPro20
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
From first dose of study drug through last follow-up visit (up to 36 weeks)
Query!
Primary outcome [6]
0
0
Percentage of Participants With at Least One SAE for IgPro20
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
From first dose of study drug through last follow-up visit (up to 36 weeks)
Query!
Primary outcome [7]
0
0
Number of Participants With at Least One Adverse Event of Special Interest (AESI) for IgPro20
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
From first dose of study drug through last follow-up visit (up to 36 weeks)
Query!
Primary outcome [8]
0
0
Percentage of Participants With at Least One AESI for IgPro20
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Primary outcome [9]
0
0
Number of Participants With AEs Categorized as Infusion Site Reactions (ISRs) for IgPro20
Query!
Assessment method [9]
0
0
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Query!
Timepoint [9]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Primary outcome [10]
0
0
Percentage of Participants With AEs Categorized as ISRs for IgPro20
Query!
Assessment method [10]
0
0
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Query!
Timepoint [10]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Primary outcome [11]
0
0
Rate of ISRs Per Infusion for IgPro20
Query!
Assessment method [11]
0
0
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'
Query!
Timepoint [11]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Primary outcome [12]
0
0
Time to Onset of ISRs for IgPro20
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Primary outcome [13]
0
0
Duration of ISRs for IgPro20
Query!
Assessment method [13]
0
0
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Query!
Timepoint [13]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Primary outcome [14]
0
0
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro20
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Primary outcome [15]
0
0
Number of Participants With Clinically Significant Changes in Vital Signs for IgPro20
Query!
Assessment method [15]
0
0
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).
Query!
Timepoint [15]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Primary outcome [16]
0
0
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters for IgPro20
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Primary outcome [17]
0
0
Number of Participants With Clinically Significant Abnormalities in Pulmonary Function Tests (PFTs) for IgPro20
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [1]
0
0
Relative Bioavailability (%F) of IgPro20
Query!
Assessment method [1]
0
0
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)).
Query!
Timepoint [1]
0
0
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)
Query!
Secondary outcome [2]
0
0
Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro20
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
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)
Query!
Secondary outcome [3]
0
0
Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro20
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
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)
Query!
Secondary outcome [4]
0
0
Maximum Plasma Drug Concentration (Cmax) for IgPro20
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
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)
Query!
Secondary outcome [5]
0
0
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Pre-injection at Weeks 5, 9, 13, and 14
Query!
Secondary outcome [6]
0
0
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Pre-injection at Weeks 21, 25, 29, and 30
Query!
Secondary outcome [7]
0
0
Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro10
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
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 32,16
Query!
Secondary outcome [8]
0
0
Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro10
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
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 32,16
Query!
Secondary outcome [9]
0
0
Maximum Plasma Drug Concentration (Cmax) for IgPro10
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
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 32,16
Query!
Secondary outcome [10]
0
0
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Pre-infusion at Weeks 21, 25 and 29
Query!
Secondary outcome [11]
0
0
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Pre-infusion at Weeks 5, 9 and 13
Query!
Secondary outcome [12]
0
0
Number of Participants With at Least One AE for IgPro10
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [13]
0
0
Percentage of Participants With at Least One AE for IgPro10
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [14]
0
0
Number of Participants With at Least One TEAE for IgPro10
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [15]
0
0
Percentage of Participants With at Least One TEAE for IgPro10
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [16]
0
0
Number of Participants With at Least One SAE for IgPro10
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [17]
0
0
Percentage of Participants With at Least One SAE for IgPro10
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [18]
0
0
Number of Participants With at Least One AESI for IgPro10
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [19]
0
0
Percentage of Participants With at Least One AESI for IgPro10
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [20]
0
0
Number of Participants With AEs Categorized as ISRs for IgPro10
Query!
Assessment method [20]
0
0
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Query!
Timepoint [20]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [21]
0
0
Percentage of Participants With AEs Categorized as ISRs for IgPro10
Query!
Assessment method [21]
0
0
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Query!
Timepoint [21]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [22]
0
0
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro10
Query!
Assessment method [22]
0
0
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.
Query!
Timepoint [22]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [23]
0
0
Number of Participants With Clinically Significant Changes in Vital Signs for IgPro10
Query!
Assessment method [23]
0
0
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).
Query!
Timepoint [23]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [24]
0
0
Number of Participants With Clinically Significant Abnormalities in ECG Parameters for IgPro10
Query!
Assessment method [24]
0
0
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.
Query!
Timepoint [24]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Secondary outcome [25]
0
0
Number of Participants With Clinically Significant Abnormalities in PFTs for IgPro10
Query!
Assessment method [25]
0
0
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.
Query!
Timepoint [25]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
Query!
Eligibility
Key inclusion criteria
* Age = 18 years (male or female) at time of providing written informed consent
* Documented diagnosis of systemic sclerosis (scleroderma) according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria 2013 (diffuse cutaneous form of SSc).
* Modified Rodnan Skin Score (mRSS) = 15 and = 45 at screening
* Disease duration = 5 years defined as the time from the first non-Raynaud's phenomenon manifestation
* Capable of providing written informed consent and willing and able to adhere to all protocol requirements
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, dermatomyositis, as determined by the investigator. Note: Participants with fibromyalgia, secondary Sjogren's syndrome, and scleroderma-associated myopathy at screening are not excluded
* Participants has mRSS > 2 at the potential subcutaneous (SC) injection sites
* History of skin condition precluding SC infusion, or clinical signs and symptoms of a chronic skin disease other than systemic sclerosis or skin manifestation of an allergic disease or other dermatological conditions that would interfere with trial assessments or compromise safety (eg, dermatitis, eczema, psoriasis)
* Participants has clinical signs and symptoms of skin irritation (eg, pruritus, burning, erythema) or hypo/ hyperpigmentation (eg, scars, tattoos) at the potential SC injection sites
* Significant pulmonary arterial hypertension as documented by mean pulmonary arterial pressure > 30 mmHg on right heart catheterization requiring SC or IV prostacyclin or use of dual oral therapies
* Forced vital capacity < 50% predicted or a diffusing capacity of the lung for carbon dioxide (DLCO) = 40% predicted (corrected for hemoglobin)
* A female who is pregnant, breastfeeding, or is a woman of childbearing potential who does not agree to use acceptable methods of contraception; a male who does agree to use acceptable methods of contraception.
* Evidence of chronic kidney disease with an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2 or if participants are receiving dialysis. Participants with current confirmed diagnosis of diabetes mellitus requiring medication with an eGFR < 90 ml/min/1.73m2
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
19/09/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
17/05/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
27
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment hospital [1]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Recruitment outside Australia
Country [1]
0
0
Germany
Query!
State/province [1]
0
0
Berlin
Query!
Country [2]
0
0
Germany
Query!
State/province [2]
0
0
Köln
Query!
Country [3]
0
0
Italy
Query!
State/province [3]
0
0
Brescia
Query!
Country [4]
0
0
Italy
Query!
State/province [4]
0
0
Milano
Query!
Country [5]
0
0
Poland
Query!
State/province [5]
0
0
Bialystok
Query!
Country [6]
0
0
Poland
Query!
State/province [6]
0
0
Warsaw
Query!
Country [7]
0
0
United Kingdom
Query!
State/province [7]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
CSL Behring
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc). The pharmacokinetic study aims to evaluate the relative bioavailability of IgPro20, and characterize pharmacokinetics of IgPro20 and IgPro10, respectively, in participants with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10 will also be evaluated.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04137224
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Study Director
Query!
Address
0
0
CSL Behring
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at
[email protected]
.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
Query!
Available to whom?
Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.
An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.
The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/24/NCT04137224/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/24/NCT04137224/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04137224