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

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-003149-41-FR
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• 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. 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified