Safety, Efficacy and pharmacokinetics of T1h, a humanized anti-CD6 monoclonal antibody, in moderate to severe chronic plaque psoriasis - Results from a randomized phase II trial. (96.13)

Abstract T1h, a novel humanized monoclonal antibody targeting CD6, a co-stimulatory receptor present on T cells, was evaluated as a potential therapy for psoriasis. In this multi-centric phase II, dose finding, single-blind study, 40 patients with moderate-to-severe psoriasis were randomized to receive T1h intravenously at 3 different doses across weekly, two-weekly and four-weekly schedules (n=5 per dose cohort) for 8 weeks, and followed for further 24 weeks. Safety and PK were the primary endpoints. Efficacy of T1h was evaluated using PASI and PGA. SF-36 and DLQI questionnaires were used to assess changes in quality of life. T1h was well tolerated. The most common adverse events were chills and pyrexia. Only 2 serious adverse events (both related to psoriasis) were ascribed to T1h therapy. T1h was weakly immunogenic with one patient developing an immune response. T1/2 of T1h ranged from 11.72 days to 18.51 days across different dose-schedules. Significant reductions in mean PASI score from baseline were observed at week 12 (22.32 to 6.23, P< 0.0001) with the best response observed in cohort receiving 1.6 mg/kg T1h administered every 2 weeks. Overall, the proportion of patients with PASI50 and 75 responses were 72.5% and 45% respectively. 26 patients (65%) achieved a PGA score of clear or minimum at 12 weeks. A significant improvement in DLQI, SF36 and epidermal thickness was also noted. T1h exhibited a favourable safety profile in the treatment of moderate to severe psoriasis.