Diffuse Cutaneous Systemic Sclerosis

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

NCT04137224 | PHASE 2 | INTERVENTIONAL

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.

9 Sites

27 Participants

Recruiting

18 Years to 17 Years

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SUBMIT

Royal Adelaide Hospital

Adelaide,South Australia,Australia,5000

Charit Universittsmedizin Berlin

Berlin,Germany,10117

Uniklinik Kln, innere Medizin

Köln,Germany,50937

ASST Spedali Civili di Brescia

Brescia,Italy,25123

Azienda Ospedaliera Gaetano Pini

Milano,Italy,20122

Uniwersytecki Szpital Kliniczny W Bialymstoku

Bialystok,Poland,15-276

Szpital Kliniczny Jezus

Warsaw,Poland,02-008

Narodowy Instytut Geriatrii

Warsaw,Poland,02-637

The Royal Free Hospital

London,United Kingdom,NW32QG

Study 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov