Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)

Phase 2

Completed

Conditions: Diffuse Cutaneous Systemic Sclerosis

Interventions: Biological: IgPro20
Biological: IgPro10

Registration Number: NCT04137224

Lead Sponsor: CSL Behring

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

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

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

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A (IgPro20/IgPro10)	IgPro20	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)	IgPro10	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.
Sequence A (IgPro20/IgPro10)	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)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Serious Adverse Event (SAE) for IgPro20	From first dose of study drug through last follow-up visit (up to 36 weeks)	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.
Number of Participants With at Least One Adverse Event of Special Interest (AESI) for IgPro20	From first dose of study drug through last follow-up visit (up to 36 weeks)	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.
Percentage of Participants With AEs Categorized as ISRs for IgPro20	From first dose of study drug through last follow up visit (up to 36 weeks)	ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters for IgPro20	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Time to Onset of ISRs for IgPro20	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Number of Participants With at Least One Adverse Event (AE) for IgPro20	From first dose of study drug through last follow-up visit (up to 36 weeks)	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.
Percentage of Participants With at Least One AE for IgPro20	From first dose of study drug through last follow-up visit (up to 36 weeks)	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.
Rate of ISRs Per Infusion for IgPro20	From first dose of study drug through last follow up visit (up to 36 weeks)	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'
Duration of ISRs for IgPro20	From first dose of study drug through last follow up visit (up to 36 weeks)	ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro20	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Number of Participants With Clinically Significant Abnormalities in Pulmonary Function Tests (PFTs) for IgPro20	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Percentage of Participants With at Least One AESI for IgPro20	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Number of Participants With AEs Categorized as Infusion Site Reactions (ISRs) for IgPro20	From first dose of study drug through last follow up visit (up to 36 weeks)	ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) for IgPro20	From first dose of study drug through last follow-up visit (up to 36 weeks)	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.
Percentage of Participants With at Least One TEAE for IgPro20	From first dose of study drug through last follow-up visit (up to 36 weeks)	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.
Percentage of Participants With at Least One SAE for IgPro20	From first dose of study drug through last follow-up visit (up to 36 weeks)	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.
Number of Participants With Clinically Significant Changes in Vital Signs for IgPro20	From first dose of study drug through last follow up visit (up to 36 weeks)	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).

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro20	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)
Number of Participants With at Least One AE for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro10	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
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B	Pre-infusion at Weeks 5, 9 and 13
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A	Pre-injection at Weeks 5, 9, 13, and 14
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B	Pre-injection at Weeks 21, 25, 29, and 30
Number of Participants With at Least One AESI for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Percentage of Participants With at Least One AESI for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro20	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)
Maximum Plasma Drug Concentration (Cmax) for IgPro10	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
Number of Participants With at Least One TEAE for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Maximum Plasma Drug Concentration (Cmax) for IgPro20	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)
Percentage of Participants With at Least One AE for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Number of Participants With AEs Categorized as ISRs for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Relative Bioavailability (%F) of IgPro20	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)	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)).
Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro10	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
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A	Pre-infusion at Weeks 21, 25 and 29
Percentage of Participants With at Least One TEAE for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Number of Participants With at Least One SAE for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Percentage of Participants With AEs Categorized as ISRs for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Percentage of Participants With at Least One SAE for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Number of Participants With Clinically Significant Abnormalities in PFTs for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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.
Number of Participants With Clinically Significant Changes in Vital Signs for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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).
Number of Participants With Clinically Significant Abnormalities in ECG Parameters for IgPro10	From first dose of study drug through last follow up visit (up to 36 weeks)	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.

Trial Locations

Locations (9): Szpital Kliniczny Jezus
🇵🇱
Warsaw, Poland
Charité Universitätsmedizin Berlin
🇩🇪
Berlin, Germany
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
Uniklinik Köln, innere Medizin
🇩🇪
Köln, Germany
Azienda Ospedaliera Gaetano Pini
🇮🇹
Milano, Italy
ASST Spedali Civili di Brescia
🇮🇹
Brescia, Italy
Uniwersytecki Szpital Kliniczny W Bialymstoku
🇵🇱
Bialystok, Poland
The Royal Free Hospital
🇬🇧
London, United Kingdom
Narodowy Instytut Geriatrii
🇵🇱
Warsaw, Poland

Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)

Recruitment & Eligibility

Study & Design

Trial Locations

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