Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 20.0 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Hizentra
Product Name: Human normal immunoglobulin for subcutaneous administration
Product Code: IgPro20
Pharmaceutical Form: Solution for i
Sponsors
CSL Behring GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years (male or female) at time of providing written informed consent 2. 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). 3. mRSS = 15 and = 45 at screening 4. Disease duration = 5 years defined as the time from the first non-Raynaud’s phenomenon manifestation 5. A female who is not pregnant, not breastfeeding, and either is not a woman of childbearing potential or is a woman of childbearing potential who agrees to use acceptable methods of contraception 6. Capable of providing written informed consent and willing and able to adhere to all protocol requirements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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: Subjects with fibromyalgia, secondary Sjogren’s syndrome, and scleroderma-associated myopathy at screening are not excluded 2. Subject has mRSS > 2 at the potential subcutaneous (SC) infusion sites 3. 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) 4. Subject has clinical sign and symptoms of skin irritation (eg, pruritus, burning, erythema) or hypo/ hyperpigmentations (eg, scars, tattoos) at the potential SC infusion sites 5. Significant pulmonary arterial hypertension (PAH) as documented by mean pulmonary arterial pressure (PAP) > 30 mmHg on right heart catheterization requiring SC or IV prostacyclin or use of dual oral therapies 6. FVC < 50% predicted or a diffusing capacity of the lung for carbon dioxide (DLCO) = 40% predicted (corrected for hemoglobin) at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): - Number and percentage of subjects with adverse events (AEs) for IgPro20 - Number and percentage of patients with AEs categorized as injection site reactions (ISRs) for IgPro20 - Rate of ISRs per subject for IgPro20 - Rate of ISRs per infusion for IgPro10 - Onset of ISRs for IgPro20 - Duration of ISRs for IgPro20 ;Timepoint(s) of evaluation of this end point: Up to 16 weeks;Main Objective: The primary objective of the study is to evaluate the safety of IgPro20 in adults with dcSSc.; Secondary Objective: The secondary objectives of the study are to evaluate: • Relative bioavailability of IgPro20 • Pharmacokinetics of IgPro20 • Pharmacokinetics of IgPro10 • Safety of IgPro10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - IgPro20 relative bioavailability (%F) - Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro20 - Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro20 - Maximum [peak] plasma drug concentration (Cmax) for IgPro20 - Minimum plasma drug concentration (Ctrough) for IgPro20 -Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro10 -Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro10 -Maximum [peak] plasma drug concentration (Cmax) for IgPro10 -Minimum plasma drug concentration (Ctrough) for IgPro10 -Number and percentage of subjects with adverse events (AEs) for IgPro10 -Number and percentage of subjects with AEs categorized as ISRs for IgPro10 ; Timepoint(s) of evaluation of this end point: - Up to 16 weeks - Up to 240 hours after first infusion - Up to 240 hours after first infusion - Up to 240 hours after first infusion - Prior to infusion - Up to 672 hours after first infusion - Up to 672 hours after first infusion - Up to 672 hours after first infusion - Prior to infusion - Up to 16 weeks - Up to 16 weeks | — |
Countries
Australia, France, Germany, Italy, Poland, United Kingdom
Contacts
Public ContactTrial Registration Coordinator
CSLB
Outcome results
None listed