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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 26

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. Modified Rodnan Skin Score (mRSS) = 15 and = 45 at screening
4. Disease duration = 5 years defined as the time from the first non- Raynaud's phenomenon manifestation
5. 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

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 signs and symptoms of skin irritation (eg, pruritus, burning, erythema) or hypo/ hyperpigmentation (eg, scars, tattoos) at the potential SC infusion sites
5. 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
6. Forced vital capacity < 50% predicted or a diffusing capacity of the lung for carbon dioxide (DLCO) = 40% predicted (corrected for hemoglobin)
7. 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 not agree to use acceptable methods of contraception.
8. Evidence of chronic kidney disease with an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2 or if subject is receiving dialysis. Subjects with current confirmed diagnosis of diabetes mellitus requiring medication with an eGFR < 90 ml/min/1.73m2

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>• Relative bioavailability of IgPro20<br>• Pharmacokinetics of IgPro20 <br>• Pharmacokinetics of IgPro10 <br>• Safety of IgPro10;Primary end point(s): - Number and percentage of subjects with adverse events (AEs) for IgPro20<br>- Number and percentage of subjects with treatment emergent adverse events (TEAEs) for IgPro20<br>- Number and percentage of subjects with serious adverse events (SAEs) for IgPro20<br>- Number and percentage of subjects with adverse events of Special interest (AESIs) for IgPro20<br>- Number and percentage of patients with AEs categorized as infusion site reactions (ISRs) for IgPro20<br>- Rate of ISRs per subject for IgPro20<br>- Rate of ISRs per infusion for IgPro20<br>- Onset of ISRs for IgPro20<br>- Duration of ISRs for IgPro20;Timepoint(s) of evaluation of this end point: Up to 16 weeks

Secondary Outcome Measures

Name	Time	Method

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