Status:
No Longer Recruiting, Ongoing
Clinicaltrials.gov identifier:
Sponsor:
Hoffmann-La Roche
Enrollment:
300
Study Design:
The PASADENA study has two parts, both of which are randomized, double-blind and placebo controlled. The first part has three arms: ARM 1 – high dose Prasinezumab 4500mg for participants with body-weight greater than or equal to (>/=) 65kg or 3500 mg for participants with body-weight less than (<) 65 kg; ARM 2 – low dose Prasinezumab 1500mg; ARM 3 – placebo. All three arms will receive the relevant dose through IV infusion every 4 weeks for 52 weeks. At the end of part 1, patients who have been on placebo will be randomized to either high dose or low dose Prasinezumab, joining those patients who have already been on the high or low dose. Part 2 will therefore have 2 arms: HIGH DOSE ARM - high dose group participants and placebo group participants randomized to high dose level will receive Prasinezumab at high dose level as intravenous infusion every 4 weeks for additional 52 weeks; LOW DOSE ARM - low dose group participants and placebo group participants randomized to low dose level will receive Prasinezumab at low dose level as intravenous infusion every 4 weeks for additional 52 weeks.
Rationale:
Primary Outcome Measures: 1. Change From Baseline in Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52 [Time Frame: Baseline and Week 52]. Secondary Outcome Measures: 1. Change From Baseline in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Signal at Week 52 [Time Frame: Baseline and Week 52]. 2. Change From Baseline in the MDS-UPDRS Motor Subscale (Part III) Score [Time Frame: Baseline and Week 52]. 3. Clinical Global Impression of Improvement (CGI-I) Score at Weeks 24 and 52 [Time Frame: Week 24 and Week 52]. 4. Patient Global Impression of Change (PGIC) Score at Weeks 24 and 52 [Time Frame: Week 24 and Week 52]. 5. Time to Start of Dopaminergic Symptomatic Treatment [Time Frame: From Baseline to Week 52]. 6. Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [Time Frame: From Day 1 to Week 104]. 7. Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7046015 [Time Frame: Baseline, Pre-dose (0 hours) on Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)]. 8. Systemic Clearance (CL) of RO7046015 [ Time Frame: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Day 1, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)]. 9. Apparent Volume of Distribution (Vz/F) of RO7046015 [Time Frame: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Day 1, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)]. 10. Area Under the Serum Concentration-Time Curve (AUC) of RO7046015 [Time Frame: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Day 1, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)]. 11. Maximum Observed Serum Concentration (Cmax) of RO7046015 [Time Frame: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Day 1, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)]. 12. Minimum Observed Serum Trough Concentration (Ctrough) of RO7046015 [Time Frame: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Day 1, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)].
Comments:
This is a comprehensive phase 2 study assessing both efficacy and safety/tolerability at two active dose levels of Prasinezumab.
