Randomized, Double-Blind, Placebo-Controlled Trial of IL1-TRAP – A Phase I/II Biomarker Trial

Inclusion Criteria:

• Must meet the American College of Rheumatology criteria for systemic sclerosis with diffuse cutaneous involvement and <24 months since the onset of the first SSc manifestation other than Raynaud’s phenomenon or an and increase in MRSS by 5 or more in the past 6 months.
• Must have a MRSS of ≥ 15
• Male or female patient ≥18 years of age
• Able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria:

• Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
• Ongoing use of high dose steroids (>10mg/day prednisone or equivalent) or unstable steroid dose in the past 4 weeks
• Treatment with immunosuppressive (other than low dose steroids), cytotoxic or anti-fibrotic drug within 4 weeks of screening
• Patients must have a negative PPD tested within 6 months of the time of screening, or past positive PPD treated with appropriate antibiotic prophylaxis
• Moderately severe pulmonary disease with FVC <60%, or DLCO <50% predicted
• Positive viral hepatitis B, hepatitis C or HIV serologies
• Pregnancy (a negative pregnancy test will be performed for all women of childbearing potential on study day 0 and 42)
• Moderately severe cardiac disease with either a history of significant arrhythmia