Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
Condition: Diffuse Cutaneous Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: IgPro20; IgPro10
Intervention description: Human normal immunoglobulin for subcutaneous administration; Human normal immunoglobulin for intravenous administration
Intervention MeSH terms: Immunoglobulins, Intravenous
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: scleroderma

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.
    

Eligibility criteria:

        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