Status:
COMPLETED
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
Lead Sponsor:
CSL Behring
Conditions:
Diffuse Cutaneous Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 scl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04137224
Start Date
September 19 2019
End Date
May 17 2022
Last Update
February 5 2024
Active Locations (9)
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1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
3
Uniklinik Köln, innere Medizin
Cologne, Germany, 50937
4
ASST Spedali Civili di Brescia
Brescia, Italy, 25123