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An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety,and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients with Central (Gonadotropin-Dependent) Precocious Puberty
Study ID: STU-2023-0726
Summary
This will be a multicenter, Phase iii, open-label, single-arm 12-month study. Pediatric patients who have been diagnosed with CPP but have not yet received GnRHa therapy (drugnaive) will be eligible (see inclusion/exclusion Criteria). all patients will have a GnRHa stimulation test to confirm a diagnosis of CPP prior to receiving study drug treatment. Pediatric patients will receive their first study drug injection at their baseline visit on Day 0 and the second injection at the Week 24 visit with periodic evaluations and monitoring for up to a total of 12 months following the first injection. Patients will return to the clinic as indicated in the Schedule of assessments (Soa) periodically for 12 months from start of dosing for efficacy, safety and pharmacokinetic (PK) assessments.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- PERRIN C WHITE
QPS HOLDINGS, LLC
1. Primary objective: To determine the efficacy of subcutaneous FP-001 42 mg in suppressing GnRH stimulated LH to [Less Than] 4 miu/mL at 24 weeks for treatment of children with Central Precocious Puberty (CPP). FP-001 42 mg will be considered effective for the treatment of children with CPP if [GreaterThanorequalTo] 80% of patients exhibit LH suppression [Less Than] 4 miu/mL at Week 24 of treatment. 2. Secondary objectives: * To evaluate the safety and tolerability of FP-001 42 mg in children with CPP. * To characterize the burst kinetics of FP-001 42 mg after the first administration. * To characterize the pharmacodynamic (PD) relationship of leuprolide serum concentrations to concentrations of serum luteinizing hormone (LH), follicle stimulating hormone (FSH) and to testosterone/estradiol. * To assess change in height velocity and bone age progression at 48 weeks post first injection. * To assess changes in physical signs of puberty as measured by Tanner stages or in changes to or onset of menses. * To measure the dosing interval (6 months) for which the leuprolide formulation is able to suppress LH concentration to [Less Than]4 miu/mL * To measure the 'acute-on-chronic' phenomenon 48 hours after the second dose of FP-001 Rationale Fensolvi (Sanofi-aventis uS, LLC.) is a novel formulation incorporating leuprolide acetate with a biodegradable polymer matrix (atrigel[RegisteredTM] delivery system). it is designed to deliver 45 mg of leuprolide acetate at a controlled rate over a 6-month period of time.
