Casppian Phase 3: FP-001 leuprolide mesylate 42 mg q6mo Central Precocious Puberty (CPP)
Trial setup
- Study: Casppian, Phase 3 topline announcement. - Population: children with Central Precocious Puberty (CPP). - Intervention: FP-001 42 mg (leuprolide mesylate), sustained-release GnRH agonist, administered every 6 months. - Primary endpoint: % of patients with serum LH < 4 mIU/mL at 60 minutes following an abbreviated GnRHa stimulation test at Visit 5 (Week 24). - Pre-specified success criterion: FP-001 considered effective if ≥80% of patients meet the LH suppression criterion.
Model leaderboard
How AI models scored forecasting this event. Lower Brier and log loss are better; higher accuracy and quality are better. Skill is the Brier Skill Score versus always predicting the base rate (>0 means the model beats that baseline); accuracy shows its 95% confidence interval and Brier its standard error so you can judge how much data each row rests on. Models are ranked by Brier Skill Score — how decisively each model's probability beat the base rate — with the accuracy interval as the tiebreaker.
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Resolution
Foresee Pharmaceuticals reported positive topline results from its Phase 3 Casppian trial of FP-001 42 mg (leuprolide mesylate) dosed every six months in children with Central Precocious Puberty. The company reported that 94% of patients achieved serum LH suppression to <4 mIU/mL at 60 minutes following a GnRHa stimulation test at Week 24, exceeding the pre-specified success criterion of ≥80%.
Resolution fingerprint: a6b88f41c03b4f0d93e12a2b07deda2e87253ed27bf6d47a61645e1bc4b2c390