Clinical Trials Resource Center

New Medical Therapies™

Scleroderma

October 17, 2011

Daval International issued results from a phase IIa trial of AIMSPRO for diffuse scleroderma. This double-blind, randomized, placebo-controlled study enrolled 20 subjects who received either AIMSPRO or placebo, 4.5mg/ml subcutaneously, twice weekly for 26 weeks. The results for the Modified Rodnan Skin Score, a measure of disease severity, showed a worsening in the subjects receiving placebo (changes: -27.07%, p≡0.29) while the subjects on AIMSPRO treatment remained stable. There was also an improvement in the overall SF-36 scores (changes: +41.6%, p≡0.184) for the subjects receiving AIMSPRO. AIMSPRO was determined to be safe and well-tolerated.

February 16, 2004

Centocor reported positive results from a retrospective analysis of a phase II trial investigating Remicade (infliximab), a monoclonal antibody for the treatment of psoriasis from psoriatic arthritis. Results showed that subjects treated with Remicade showed a greater than or equal to 75% improvement from baseline to week 10 in the Psoriasis Area and Severity Index score (PASI 75 response) compared to placebo-treated subjects. At week 10, 75% and 86% of subjects treated with Remicade 3mg/kg and 5 mg/kg, respectively, achieved a PASI 75 response compared to 0% in the placebo group. The data presented were from a retrospective analysis in a subset of 78 subjects who also had psoriatic arthritis (PsA). Results were presented at the annual meeting of the American Academy of Dermatology (AAD) in Washington, DC.

Genzyme and Cambridge Antibody Technology reported preliminary results from a phase I/II trial of CAT-192, a human anti-TGFß1 monoclonal antibody for the treatment of scleroderma. Results showed that the primary objective was met and the drug was safe and well tolerated at each dose level. There were no treatment-related serious adverse events observed. Four subject’s deaths occurred during the trial but were unrelated to treatment. The double-blind, placebo-controlled trial enrolled 45 subjects at 12 sites in the U.S. and Europe. The primary objective of the trial was to assess the safety, tolerability and pharmacokinetics of CAT-192 in patients with diffuse systemic sclerosis. Subjects were randomized to receive one of three dose levels of CAT-192 (0.5mg/kg, 5 mg/kg or 10 mg/kg) or matching placebo, as an intravenous infusion every six weeks for four doses.

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