2:1 randomization
Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks

Placebo

2:1 randomization
Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks

Rilonacept

Total

Sex: Female, Male

Region of Enrollment

To investigate the effect of rilonacept on 2-gene biomarker expression in skin after treatment with rilonacept compared to pre-treatment 2-gene biomarker expression. These were measured at visit 3 (Day 42) and visit 1 (Day 0). This was calculated using a previously validated equation (MRSS = -27.6844 + [4.46(baseline THBS1)] + [5.31(ΔMS4A4A) + 4.96(ΔTHBS1)]). In this equation the expression of two genes (THBS1 and MS4A4) in collected samples are measured via nanostring, and then the expression levels of each gene are inserted into the equation in order to obtain the 2- gene biomarker score. A high biomarker score is equivalent to a high skin score, suggesting a higher severity of the disease.

Change in 2- Gene Biomarker

Change in Modified Rodnan Skin Score over time. The fully validated modified version of the Rodnan skin thickness score was used. On this scale, a total of 17 skin sites are evaluated, including the face, upper arms, forearms, dorsum of the hands, fingers, chest, abdomen, thighs, forearms and feet. The total score can range from 0 to 51, with higher scores indicating greater severity of skin thickening and involvement (MRSS-51). Each of the 17 skin sites are scored from 0 to 3, where the following criteria apply: 0, normal skin; 1, thickened skin; 2, thickened and unable to pinch; and 3, thickened and unable to move. Scores from visit 3 (Day 42) and visit 1 (Day 0) were compared.

Change in Modified Rodnan Skin Score

Overall Study

Eric A Stratton, Sr. Clinical Research Manager

Scleroderma

Systemic Sclerosis

Diffuse Scleroderma

Diffuse Systemic Sclerosis

Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks

Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks

silica/infarto

IL1-TRAP, Rilonacept, in Systemic Sclerosis

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