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Also known as RO7046015
Prasinezumab · 3 trials · 2 indications
Time to confirmed motor progression event was the first time point of a worsening event defined as either \>= 5 points increase in MDS-UPDRS Part III score (assessed in "OFF" medication state) from baseline sustained over 2 consecutive assessments or a change in medication after first occurrence of \>= 5 points increase in MDS-UPDRS Part III score from baseline \& before follow-up assessment. MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. The total MDS-UPDRS Part III score (ranging from 0 to 132) is calculated by summing these 33 individual ratings, with higher scores indicating severe impairment.
The MDS-UPDRS is a multimodal scale consisting of four parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contains 6 questions and are assessed by the examiner (Range 0-24). Part IB contains 7 questions on non-motor experiences of daily living which was completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of Parkinson's Disease (PD) and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. The MDS-UPDRS Total Score equals the sum of Parts I,II, and III (Range: 0-236). A higher score indicated more severe symptoms of Parkinson's disease.
| Arm | Type | Description |
|---|---|---|
| Prasinezumab | EXPERIMENTAL | Participants will receive Prasinezumab as an IV infusion in the double blind treatment period. Upon completion, eligible participants will enter into the Open Label Extension (OLE) phase. |
| Placebo | EXPERIMENTAL | Participants will receive placebo as an IV Infusion. |
| Part 1: RO7046015 High Dose | EXPERIMENTAL | Participants will receive RO7046015 at high dose level as intravenous (IV) infusion every 4 weeks (Q4W) up to 52 weeks in Part 1. |
| Part 1: RO7046015 Low Dose | EXPERIMENTAL | Participants will receive RO7046015 at low dose level as IV infusion Q4W up to 52 weeks in Part 1. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as IV infusion Q4W up to 52 weeks in Part 1. |
| Part 2: RO7046015 High Dose | EXPERIMENTAL | Part 1 RO7046015 high dose group participants and placebo group participants randomized to high dose level will receive RO7046015 at high dose level as IV infusion Q4W for additional 52 weeks in Part 2. |
| Part 2: RO7046015 Low Dose | EXPERIMENTAL | Part 1 RO7046015 low dose group participants and placebo group participants randomized to low dose level will receive RO7046015 at low dose level as IV infusion Q4W for additional 52 weeks in Part 2. |
| Part 3: RO7046015 Low Dose | EXPERIMENTAL | All participants who complete Part 1 and Part 2 will receive monthly IV infusions of RO7046015. |
| Name | Type | Description |
|---|---|---|
| Prasinezumab | DRUG | Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol. |
| Placebo | DRUG | Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol |
| RO7046015 | DRUG | RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (\>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (\<) 65 kg. |
Inclusion Criteria: * Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2 * Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria * Has received monotherapy treatment * An MDS-UPDRS Part IV score of 0 at screenin...
Prasinezumab is an investigational monoclonal antibody being developed for the treatment of early-stage Parkinson's disease. It is designed to target alpha-synuclein, a protein implicated in the disease, and is currently in Phase 3 clinical development. It has not been approved for any indication.
Prasinezumab targets SNCA, the gene encoding alpha-synuclein. As a monoclonal antibody, it binds to alpha-synuclein, which is a key component of Lewy bodies in Parkinson's disease. This mechanism is intended to reduce the spread of pathological alpha-synuclein in the brain.
Prasinezumab is being developed by Prothena Corporation plc, which trades on the Nasdaq under the ticker PRTA. Prothena is a clinical-stage biotechnology company focused on protein dysregulation diseases.
Prasinezumab is in Phase 3 clinical development for early-stage Parkinson's disease. It is also being studied in Phase 2 trials. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
Prasinezumab is being evaluated in three clinical trials: NCT07174310, a Phase 3 study in early-stage Parkinson's disease that is currently recruiting; NCT04777331, a Phase 2 trial that is active but not recruiting; and NCT03100149, a Phase 2 trial that is also active but not recruiting.
Yes, Prasinezumab is also known as RO7046015. RO7046015 is an alternative designation used in some clinical trial listings and development documentation. Both names refer to the same monoclonal antibody candidate for Parkinson's disease.