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Clinical Trials associated with WP-1302A Double-blind, Placebo-controlled, Phase 2 Dose-range Study to Assess the Efficacy and Safety of WP1302 in Preventing Disease Relapse Following Methimazole Withdrawal in Subjects With Graves' Disease
This is a Phase 2, double-blind, placebo controlled, Methimazole (MMI) withdrawal study in subjects with Graves' disease. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with Methimazole period of 12 weeks; a Full dose of WP1302 or placebo with Methimazole tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months.
After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of Methimazole with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of Methimazole with placebo.
All the subjects will subsequently be enrolled in an extended safety follow-up period for an additional 6 months. Subjects who remain euthyroid will continue to be monitored for efficacy during the long-term follow-up.
100 Clinical Results associated with WP-1302
100 Translational Medicine associated with WP-1302
100 Patents (Medical) associated with WP-1302
100 Deals associated with WP-1302