Recombinant human anti–transforming growth factor β1 antibody therapy in systemic sclerosis: A multicenter, randomized, placebo‐controlled phase I/II trial of CAT‐192

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Abstract
Objective To evaluate CAT‐192, a recombinant human antibody that neutralizes transforming growth factor β1 (TGFβ1), in the treatment of early‐stage diffuse cutaneous systemic sclerosis (dcSSc). Methods Patients with SSc duration of P = 0.0008). Changes in the PINP level from baseline correlated with changes in the MRSS (r = 0.37, P = 0.027). Conclusion We report the first evaluation of a systemically administered and repeatedly dosed anti‐TGFβ1 drug. In this pilot study, CAT‐192, in doses up to 10 mg/kg, showed no evidence of efficacy. The utility of clinical and biochemical outcome measures and the feasibility of multicenter trials of early dcSSc were confirmed.