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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04137224
Registration number
NCT04137224
Ethics application status
Date submitted
21/10/2019
Date registered
23/10/2019
Date last updated
5/02/2024
Titles & IDs
Public title
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
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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)
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Secondary ID [1]
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2018-003149-41
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Secondary ID [2]
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IgPro20_2001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Cutaneous Systemic Sclerosis
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - IgPro20
Other interventions - 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.
Other interventions: IgPro20
Human normal immunoglobulin for subcutaneous administration
Other interventions: IgPro10
Human normal immunoglobulin for intravenous administration
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With at Least One Adverse Event (AE) for IgPro20
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose of study drug through last follow-up visit (up to 36 weeks)
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Primary outcome [2]
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Percentage of Participants With at Least One AE for IgPro20
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Assessment method [2]
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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.
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Timepoint [2]
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From first dose of study drug through last follow-up visit (up to 36 weeks)
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Primary outcome [3]
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Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) for IgPro20
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Assessment method [3]
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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.
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Timepoint [3]
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From first dose of study drug through last follow-up visit (up to 36 weeks)
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Primary outcome [4]
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Percentage of Participants With at Least One TEAE for IgPro20
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Assessment method [4]
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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.
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Timepoint [4]
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From first dose of study drug through last follow-up visit (up to 36 weeks)
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Primary outcome [5]
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Number of Participants With at Least One Serious Adverse Event (SAE) for IgPro20
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Assessment method [5]
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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.
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Timepoint [5]
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From first dose of study drug through last follow-up visit (up to 36 weeks)
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Primary outcome [6]
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Percentage of Participants With at Least One SAE for IgPro20
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Assessment method [6]
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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.
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Timepoint [6]
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From first dose of study drug through last follow-up visit (up to 36 weeks)
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Primary outcome [7]
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Number of Participants With at Least One Adverse Event of Special Interest (AESI) for IgPro20
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Assessment method [7]
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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.
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Timepoint [7]
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From first dose of study drug through last follow-up visit (up to 36 weeks)
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Primary outcome [8]
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Percentage of Participants With at Least One AESI for IgPro20
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Assessment method [8]
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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.
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Timepoint [8]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Primary outcome [9]
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Number of Participants With AEs Categorized as Infusion Site Reactions (ISRs) for IgPro20
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Assessment method [9]
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ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
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Timepoint [9]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Primary outcome [10]
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Percentage of Participants With AEs Categorized as ISRs for IgPro20
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Assessment method [10]
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ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
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Timepoint [10]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Primary outcome [11]
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Rate of ISRs Per Infusion for IgPro20
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Assessment method [11]
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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'
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Timepoint [11]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Primary outcome [12]
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Time to Onset of ISRs for IgPro20
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Assessment method [12]
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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.
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Timepoint [12]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Primary outcome [13]
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Duration of ISRs for IgPro20
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Assessment method [13]
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ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
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Timepoint [13]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Primary outcome [14]
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Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro20
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Assessment method [14]
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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.
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Timepoint [14]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Primary outcome [15]
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Number of Participants With Clinically Significant Changes in Vital Signs for IgPro20
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Assessment method [15]
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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).
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Timepoint [15]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Primary outcome [16]
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Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters for IgPro20
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Assessment method [16]
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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.
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Timepoint [16]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Primary outcome [17]
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Number of Participants With Clinically Significant Abnormalities in Pulmonary Function Tests (PFTs) for IgPro20
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Assessment method [17]
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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.
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Timepoint [17]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [1]
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Relative Bioavailability (%F) of IgPro20
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Assessment method [1]
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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)).
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Timepoint [1]
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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)
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Secondary outcome [2]
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Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro20
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Assessment method [2]
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Timepoint [2]
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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)
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Secondary outcome [3]
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Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro20
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Assessment method [3]
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Timepoint [3]
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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)
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Secondary outcome [4]
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Maximum Plasma Drug Concentration (Cmax) for IgPro20
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Assessment method [4]
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Timepoint [4]
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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)
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Secondary outcome [5]
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Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A
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Assessment method [5]
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Timepoint [5]
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Pre-injection at Weeks 5, 9, 13, and 14
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Secondary outcome [6]
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Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B
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Assessment method [6]
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0
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Timepoint [6]
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Pre-injection at Weeks 21, 25, 29, and 30
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Secondary outcome [7]
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Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro10
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Assessment method [7]
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Timepoint [7]
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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
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Secondary outcome [8]
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Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro10
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Assessment method [8]
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0
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Timepoint [8]
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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
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Secondary outcome [9]
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Maximum Plasma Drug Concentration (Cmax) for IgPro10
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Assessment method [9]
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0
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Timepoint [9]
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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
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Secondary outcome [10]
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0
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A
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Assessment method [10]
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0
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Timepoint [10]
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Pre-infusion at Weeks 21, 25 and 29
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Secondary outcome [11]
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Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B
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Assessment method [11]
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0
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Timepoint [11]
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Pre-infusion at Weeks 5, 9 and 13
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Secondary outcome [12]
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Number of Participants With at Least One AE for IgPro10
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Assessment method [12]
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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.
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Timepoint [12]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [13]
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Percentage of Participants With at Least One AE for IgPro10
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Assessment method [13]
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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.
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Timepoint [13]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [14]
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Number of Participants With at Least One TEAE for IgPro10
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Assessment method [14]
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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.
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Timepoint [14]
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0
From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [15]
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Percentage of Participants With at Least One TEAE for IgPro10
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Assessment method [15]
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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.
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Timepoint [15]
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0
From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [16]
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Number of Participants With at Least One SAE for IgPro10
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Assessment method [16]
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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.
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Timepoint [16]
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From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [17]
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0
Percentage of Participants With at Least One SAE for IgPro10
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Assessment method [17]
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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.
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Timepoint [17]
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0
From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [18]
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Number of Participants With at Least One AESI for IgPro10
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Assessment method [18]
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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]
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0
From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [19]
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0
Percentage of Participants With at Least One AESI for IgPro10
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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]
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0
From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [20]
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0
Number of Participants With AEs Categorized as ISRs for IgPro10
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Assessment method [20]
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0
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
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Timepoint [20]
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0
From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [21]
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0
Percentage of Participants With AEs Categorized as ISRs for IgPro10
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Assessment method [21]
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0
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
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Timepoint [21]
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0
From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [22]
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0
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro10
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Assessment method [22]
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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.
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Timepoint [22]
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0
From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [23]
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0
Number of Participants With Clinically Significant Changes in Vital Signs for IgPro10
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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).
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Timepoint [23]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [24]
0
0
Number of Participants With Clinically Significant Abnormalities in ECG Parameters for IgPro10
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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.
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Timepoint [24]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
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Secondary outcome [25]
0
0
Number of Participants With Clinically Significant Abnormalities in PFTs for IgPro10
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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.
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Timepoint [25]
0
0
From first dose of study drug through last follow up visit (up to 36 weeks)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/09/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/05/2022
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Sample size
Target
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
0
0
Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
0
0
5000 - Adelaide
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Recruitment outside Australia
Country [1]
0
0
Germany
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State/province [1]
0
0
Berlin
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Country [2]
0
0
Germany
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State/province [2]
0
0
Köln
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Country [3]
0
0
Italy
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State/province [3]
0
0
Brescia
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Country [4]
0
0
Italy
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State/province [4]
0
0
Milano
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Country [5]
0
0
Poland
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State/province [5]
0
0
Bialystok
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Country [6]
0
0
Poland
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State/province [6]
0
0
Warsaw
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Country [7]
0
0
United Kingdom
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State/province [7]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CSL Behring
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04137224
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Study Director
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Address
0
0
CSL Behring
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04137224
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