Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000087-15 | EudraCT Number | ||
| 2023-504472-24-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Prothena Biosciences Limited | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be offered participation in Part 3 open-label extension (all-participants-on-RO7046015-treatment) for an additional 520 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | From baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the MDS-UPDRS Part IA, Part IB, Part I Total, Part II Total, Part III Total and Part III Subscores | 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. There are 4 subscores in Part III: Bradykinesia, Rigidity, Resting tremors and Axial symptoms. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. 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. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uab Medicine | Birmingham | Alabama | 35233 | United States | ||
| Barrow Neurology Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40523921 | Derived | Taylor KI, Lipsmeier F, Scelsi MA, Volkova-Volkmar E, Rukina D, Popp W, Lambrecht S, Anzures-Cabrera J, Summers D, Abt M, Monnet A, Kilchenmann T, Schjodt-Eriksen J, Essioux L, Kustermann T, Zago W, Svoboda H, Nikolcheva T, Postuma RB, Pagano G, Lindemann M; PASADENA Investigators; Prasinezumab Study Group. Exploratory digital outcome measures of motor sign progression in Parkinson's disease patients treated with prasinezumab. NPJ Digit Med. 2025 Jun 16;8(1):365. doi: 10.1038/s41746-025-01572-8. | |
| 39379705 |
| Label | URL |
|---|---|
| Pasadenastudy.com provides information about the Roche clinical trial NCT03100149 and molecule being investigated in Parkinson's Disease | View source |
Not provided
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Not provided
Not provided
Not provided
Not provided
A total of 316 participants were randomized with a 1:1:1 allocation between the treatment groups (Placebo, Low-Dose prasinezumab and High-Dose prasinezumab)
Participants were enrolled at 57 sites in 5 different countries. 1 site had only 1 screen failure and no active participants were enrolled there.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Placebo | Participants received placebo as intravenous (IV) infusion every four weeks (Q4W) up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to placebo during Part 1 of the study will be rerandomized to one of the two active doses using a 1:1 allocation ratio. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2020 | Nov 26, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Part 3: RO7046015 Low Dose | Experimental | All participants who complete Part 1 and Part 2 will receive monthly IV infusions of RO7046015. |
|
|
| RO7046015 | Drug | RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm. |
|
|
| Placebo | Drug | RO7046015 placebo will be administered to all participants in the indicated arm. |
|
| From baseline to Week 52 |
| Change From Baseline in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Striatal Binding Ratio (SBR) in the Putamen Ipsilateral to the Clinically Most Affected Side | DaT-SPECT (dopamine transporter imaging with single photon emission computed tomography) is a dopamine transporter SPECT imaging that uses a radioactive agent called 123^I-ioflupane to quantify the density of the dopamine transporters in the striatum. Changes from baseline to week 52 in DaT-SPECT striatal binding ratios (SBRs; reference region: occipital cortex) in the putamen ipsilateral to the clinically most affected side were analyzed. | From baseline to Week 52 |
| Change From Baseline in Montreal Cognition Assessment (MoCA) Total Score | The Montreal Cognitive Assessment (MoCA) is a rapid screening that was developed to be more sensitive to participants presenting with mild cognitive complaints. It briefly assesses short term and working memory, visuospatial abilities, executive function, attention, concentration, language and orientation. Scores on the MoCA test range from 0-30. Higher scores are associated with better cognitive function. | From baseline to Week 52 |
| Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Score | The CGI-I was intended as a measure of change in health status. CGI-I scores ranged from 1 (very much improved) through to 7 (very much worse). For the CGI-I, participants were divided into one of two groups, Responders or Progressors. Responders were scored on a scale of 1-4 which was rated as "no change", "minimally improved", "much improved" or "very much improved." Progressors were scored on a scale of 5-7 which was rated as "minimally worse", "much worse" or "very much worse." The percentage of participants rated by CGI-I Scale grouping at week 52 was analyzed using a logistic regression model. | From baseline to Week 52 |
| Change From Baseline in Patient Global Impression of Change (PGIC) Score | The PGIC was intended as a measure of change in health state from the participants perspective. PGIC scores ranged from 1 (very much improved) through to 7 (very much worse). For the PGIC, participants were divided into one of two groups, Responders or Progressors. Responders were scored on a scale of 1-4 which was rated as "no change", "minimally improved", "much improved" or "very much improved." Progressors were scored on a scale of 5-7 which was rated as "minimally worse", "much worse" or "very much worse." The percentage of participants rated by PGIC Scale grouping at week 52 was analyzed using a logistic regression model. | From baseline to Week 52 |
| Change From Baseline in Schwab and England Activity of Daily Living (SE-ADL) Score | The SE-ADL is a single item scale assessing Activities of Daily Living on a scale ranging from 0% (bedridden) to 100% (completely independent), using 10% intervals. | From baseline to Week 52 |
| Time to Worsening in Motor or Non-Motor Symptoms | This outcome measure is defined as the time to between first dose of study medication and the date when the particiapnt increases in MDS-UPDRS Part I (Range 0-52) of 3 or more points, or in MDS-UPDRS Part II (Range 0-52) of 3 or more points, whichever comes first. A higher score indicated more severe motor signs of Parkinson's disease. | From baseline to Week 52 |
| Time to Start of Dopaminergic Parkinson's Disease Treatment | This endpoint is defined as the time between first dose of study medication and the date when the participant starts dopaminergic treatment. | From baseline to Week 52 |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was any AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | From baseline to Week 52 |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7046015 | Samples of the participant's blood was taken to evaluate anti-drug antibodies (ADA). The number of ADA positive participants, Treatment-induced and Treatment-enhanced was reported. Treatment-induced = participants with ADA negative or missing data at baseline but develop an ADA response following exposure to the study drug. Treatment-enhanced = participants with ADA positive at baseline and the titre of one or more post-baseline samples is at least >=4 fold increase greater than the baseline titre sample. | 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) |
| Systemic Clearance (CL) of RO7046015 | Clearance is a measure of the rate at which a drug is removed from the body. | Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Baseline, 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) |
| Apparent Volume of Distribution (Vz/F) of RO7046015 | Volume of distribution is defined as the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Baseline, 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) |
| Area Under the Serum Concentration-Time Curve (AUC) of RO7046015 Over the Dosing Interval | AUC is defined as the measure of RO7046015 plasma concentration over time. | Baseline over the duration of the study |
| Maximum Observed Serum Concentration (Cmax) of RO7046015 at Steady-state | Cmax is the maximum observed plasma concentration of RO7046015. | Baseline over the duration of the study |
| Minimum Observed Serum Concentration (Ctrough) of RO7046015 at Steady-state | Cmin is the minimum observed plasma concentration of RO7046015. | Baseline over the duration of the study |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Neurology Center of North Orange County | Fullerton | California | 92835 | United States |
| USC Keck Medical Center of USC | Los Angeles | California | 90033 | United States |
| University of California at San Francisco | San Francisco | California | 94115 | United States |
| CenExel Rocky Mountain Clinical Research, LLC | Englewood | Colorado | 80113 | United States |
| Associated Neurologists of Southern CT PC | Fairfield | Connecticut | 06824 | United States |
| Molecular Neurolmaging | New Haven | Connecticut | 06510 | United States |
| Aventura Neurologic Associates | Aventura | Florida | 33180 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| USF Parkinsons Disease and Movement Disorders Center | Tampa | Florida | 33613 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Corewell Health Neurology and Epilepsy - Beltline | Grand Rapids | Michigan | 49525 | United States |
| Henry Ford Health System | West Bloomfield | Michigan | 48322 | United States |
| Columbia University | New York | New York | 10032 | United States |
| University of Rochester Medical Center | Rochester | New York | 14618 | United States |
| The Movement Disorder Clinic of Oklahoma | Tulsa | Oklahoma | 74136 | United States |
| Oregon Health & Science Uni | Portland | Oregon | 97239 | United States |
| UNIVERSITY of PENNSYLVANIA | Philadelphia | Pennsylvania | 19107 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Baylor College | Houston | Texas | 77030 | United States |
| Central Texas Neurology Consultants | Round Rock | Texas | 78681 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Medizinische Universität Innsbruck | Innsbruck | 6020 | Austria |
| Groupe Hospitalier Pellegrin | Bordeaux | 33000 | France |
| Hopital Gabriel Montpied | Clermont-Ferrand | 63003 | France |
| Hopital Henri Mondor | Créteil | 94010 | France |
| Hôpital Michallon - Centre d'Investigation Clinique | Grenoble | 38043 | France |
| hopital de la Timone | Marseille | 13385 | France |
| CHU de Nice Hopital Pasteur | Nice | 06002 | France |
| Hopital Pitie-Salpetriere APHP | Paris | 75013 | France |
| CHU Poitiers | Poitiers | 86021 | France |
| CHU Rouen Charles Nicolle | Rouen | 76031 | France |
| CHU de Nantes - Hopital Laennec | Saint-Herblain | 44800 | France |
| CIC - Hôpital Purpan | Toulouse | 31059 | France |
| Klinik fur Neurologie | Berlin | 10117 | Germany |
| Heinrich-Heine Universitätsklinik Düsseldorf | Düsseldorf | 40225 | Germany |
| Paracelsus Elena Klinik Kassel | Kassel | 34128 | Germany |
| Klinik und Poliklinik für Neurologie Universitätsklinikum | Leipzig | 04103 | Germany |
| Philipps Universität Marburg | Marburg | 35043 | Germany |
| DZNE Clinical Trial Unit | München | 81377 | Germany |
| Universitaettsklinikum Tübingen | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Hospital General de Catalunya | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| PoliclÃnica Guipuzcoa | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Fundacion Hospital de Alcorcon | Alcorcón | Madrid | 28922 | Spain |
| Clinica Universidad de Navarra | Pamplona/iruña | Navarre | 31008 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Derived |
| Pagano G, Monnet A, Reyes A, Ribba B, Svoboda H, Kustermann T, Simuni T, Postuma RB, Pavese N, Stocchi F, Brockmann K, Smigorski K, Gerbaldo V, Fontoura P, Doody R, Kerchner GA, Brundin P, Marek K, Bonni A, Nikolcheva T; PASADENA Investigators; Prasinezumab Study Group. Sustained effect of prasinezumab on Parkinson's disease motor progression in the open-label extension of the PASADENA trial. Nat Med. 2024 Dec;30(12):3669-3675. doi: 10.1038/s41591-024-03270-6. Epub 2024 Oct 8. |
| 35921451 | Derived | Pagano G, Taylor KI, Anzures-Cabrera J, Marchesi M, Simuni T, Marek K, Postuma RB, Pavese N, Stocchi F, Azulay JP, Mollenhauer B, Lopez-Manzanares L, Russell DS, Boyd JT, Nicholas AP, Luquin MR, Hauser RA, Gasser T, Poewe W, Ricci B, Boulay A, Vogt A, Boess FG, Dukart J, D'Urso G, Finch R, Zanigni S, Monnet A, Pross N, Hahn A, Svoboda H, Britschgi M, Lipsmeier F, Volkova-Volkmar E, Lindemann M, Dziadek S, Holiga S, Rukina D, Kustermann T, Kerchner GA, Fontoura P, Umbricht D, Doody R, Nikolcheva T, Bonni A; PASADENA Investigators; Prasinezumab Study Group. Trial of Prasinezumab in Early-Stage Parkinson's Disease. N Engl J Med. 2022 Aug 4;387(5):421-432. doi: 10.1056/NEJMoa2202867. |
| 35840753 | Derived | Lipsmeier F, Taylor KI, Postuma RB, Volkova-Volkmar E, Kilchenmann T, Mollenhauer B, Bamdadian A, Popp WL, Cheng WY, Zhang YP, Wolf D, Schjodt-Eriksen J, Boulay A, Svoboda H, Zago W, Pagano G, Lindemann M. Reliability and validity of the Roche PD Mobile Application for remote monitoring of early Parkinson's disease. Sci Rep. 2022 Jul 15;12(1):12081. doi: 10.1038/s41598-022-15874-4. |
| 34659081 | Derived | Pagano G, Boess FG, Taylor KI, Ricci B, Mollenhauer B, Poewe W, Boulay A, Anzures-Cabrera J, Vogt A, Marchesi M, Post A, Nikolcheva T, Kinney GG, Zago WM, Ness DK, Svoboda H, Britschgi M, Ostrowitzki S, Simuni T, Marek K, Koller M, Sevigny J, Doody R, Fontoura P, Umbricht D, Bonni A; PASADENA Investigators; Prasinezumab Study Group. A Phase II Study to Evaluate the Safety and Efficacy of Prasinezumab in Early Parkinson's Disease (PASADENA): Rationale, Design, and Baseline Data. Front Neurol. 2021 Oct 1;12:705407. doi: 10.3389/fneur.2021.705407. eCollection 2021. |
| 29913017 | Derived | Jankovic J, Goodman I, Safirstein B, Marmon TK, Schenk DB, Koller M, Zago W, Ness DK, Griffith SG, Grundman M, Soto J, Ostrowitzki S, Boess FG, Martin-Facklam M, Quinn JF, Isaacson SH, Omidvar O, Ellenbogen A, Kinney GG. Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-alpha-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1206-1214. doi: 10.1001/jamaneurol.2018.1487. |
| FG001 | Part 1: RO7046015 Low Dose | Participants received RO7046015 at a low dose level (1500 mg; for all body weights) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the low dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose. |
| FG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. |
| COMPLETED | Completed Part 1 |
|
| NOT COMPLETED |
|
|
The modified intent-to-treat (mITT) population includes all participants randomized in the study who received any amount of study drug treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Placebo | Participants received placebo as intravenous (IV) infusion every four weeks (Q4W) up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to placebo during Part 1 of the study will be rerandomized to one of the two active doses using a 1:1 allocation ratio. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose. |
| BG001 | Part 1: RO7046015 Low Dose | Participants received RO7046015 at a low dose level (1500 mg; for all body weights) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the low dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose. |
| BG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | The modified intent-to-treat (mITT) population includes all participants randomized in the study who received any amount of study drug treatment. Assessments of participants who started symptomatic therapy were included in the analysis up to the day before symptomatic treatment started. | Posted | Least Squares Mean | Standard Error | Units on a scale | From baseline to Week 52 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the MDS-UPDRS Part IA, Part IB, Part I Total, Part II Total, Part III Total and Part III Subscores | 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. There are 4 subscores in Part III: Bradykinesia, Rigidity, Resting tremors and Axial symptoms. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. 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. | The modified intent-to-treat (mITT) population includes all participants randomized in the study who received any amount of study drug treatment. Assessments of participants who started symptomatic therapy were included in the analysis up to the day before symptomatic treatment started. | Posted | Least Squares Mean | Standard Error | Units on a scale | From baseline to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Striatal Binding Ratio (SBR) in the Putamen Ipsilateral to the Clinically Most Affected Side | DaT-SPECT (dopamine transporter imaging with single photon emission computed tomography) is a dopamine transporter SPECT imaging that uses a radioactive agent called 123^I-ioflupane to quantify the density of the dopamine transporters in the striatum. Changes from baseline to week 52 in DaT-SPECT striatal binding ratios (SBRs; reference region: occipital cortex) in the putamen ipsilateral to the clinically most affected side were analyzed. | The mITT population includes all participants randomized in the study who received any amount of study drug treatment and had no symptomatic PD treatment. The analysis included all assessments regardless of symptomatic treatment intake. | Posted | Least Squares Mean | Standard Error | Striatal Binding Ratio (SBR) | From baseline to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Montreal Cognition Assessment (MoCA) Total Score | The Montreal Cognitive Assessment (MoCA) is a rapid screening that was developed to be more sensitive to participants presenting with mild cognitive complaints. It briefly assesses short term and working memory, visuospatial abilities, executive function, attention, concentration, language and orientation. Scores on the MoCA test range from 0-30. Higher scores are associated with better cognitive function. | The mITT population includes all participants randomized in the study who received any amount of study drug treatment and had no symptomatic PD treatment. The analysis included all assessments regardless of symptomatic treatment intake. | Posted | Least Squares Mean | Standard Error | Units on a scale | From baseline to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Score | The CGI-I was intended as a measure of change in health status. CGI-I scores ranged from 1 (very much improved) through to 7 (very much worse). For the CGI-I, participants were divided into one of two groups, Responders or Progressors. Responders were scored on a scale of 1-4 which was rated as "no change", "minimally improved", "much improved" or "very much improved." Progressors were scored on a scale of 5-7 which was rated as "minimally worse", "much worse" or "very much worse." The percentage of participants rated by CGI-I Scale grouping at week 52 was analyzed using a logistic regression model. | The mITT population includes all participants randomized in the study who received any amount of study drug treatment. Assessments of participants who started symptomatic therapy were included in the analysis up to the day before symptomatic treatment started. | Posted | Number | Percentage of participants | From baseline to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient Global Impression of Change (PGIC) Score | The PGIC was intended as a measure of change in health state from the participants perspective. PGIC scores ranged from 1 (very much improved) through to 7 (very much worse). For the PGIC, participants were divided into one of two groups, Responders or Progressors. Responders were scored on a scale of 1-4 which was rated as "no change", "minimally improved", "much improved" or "very much improved." Progressors were scored on a scale of 5-7 which was rated as "minimally worse", "much worse" or "very much worse." The percentage of participants rated by PGIC Scale grouping at week 52 was analyzed using a logistic regression model. | The mITT population includes all participants randomized in the study who received any amount of study drug treatment. Assessments of participants who started symptomatic therapy were included in the analysis up to the day before symptomatic treatment started. | Posted | Number | Percentage of participants | From baseline to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Schwab and England Activity of Daily Living (SE-ADL) Score | The SE-ADL is a single item scale assessing Activities of Daily Living on a scale ranging from 0% (bedridden) to 100% (completely independent), using 10% intervals. | The mITT population includes all participants randomized in the study who received any amount of study drug treatment and had no symptomatic PD treatment. The analysis included all assessments regardless of symptomatic treatment intake. | Posted | Least Squares Mean | Standard Error | Units on a scale | From baseline to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Worsening in Motor or Non-Motor Symptoms | This outcome measure is defined as the time to between first dose of study medication and the date when the particiapnt increases in MDS-UPDRS Part I (Range 0-52) of 3 or more points, or in MDS-UPDRS Part II (Range 0-52) of 3 or more points, whichever comes first. A higher score indicated more severe motor signs of Parkinson's disease. | The mITT population includes all participants randomized in the study who received any amount of study drug treatment and had no symptomatic PD treatment. The analysis included all assessments regardless of symptomatic treatment intake. | Posted | Median | 80% Confidence Interval | Days | From baseline to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Start of Dopaminergic Parkinson's Disease Treatment | This endpoint is defined as the time between first dose of study medication and the date when the participant starts dopaminergic treatment. | The mITT population includes all participants randomized in the study who received any amount of study drug treatment and had no symptomatic PD treatment. The analysis included all assessments regardless of symptomatic treatment intake. | Posted | Median | 80% Confidence Interval | Days | From baseline to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was any AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | All randomized participants receiving any dose of the study drug were included in the safety analysis. | Posted | Number | Percentage of participants | From baseline to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7046015 | Samples of the participant's blood was taken to evaluate anti-drug antibodies (ADA). The number of ADA positive participants, Treatment-induced and Treatment-enhanced was reported. Treatment-induced = participants with ADA negative or missing data at baseline but develop an ADA response following exposure to the study drug. Treatment-enhanced = participants with ADA positive at baseline and the titre of one or more post-baseline samples is at least >=4 fold increase greater than the baseline titre sample. | Not Posted | Apr 2027 | 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) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Systemic Clearance (CL) of RO7046015 | Clearance is a measure of the rate at which a drug is removed from the body. | Not Posted | Apr 2027 | Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Baseline, 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) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vz/F) of RO7046015 | Volume of distribution is defined as the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | Not Posted | Apr 2027 | Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Baseline, 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) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-Time Curve (AUC) of RO7046015 Over the Dosing Interval | AUC is defined as the measure of RO7046015 plasma concentration over time. | Not Posted | Apr 2027 | Baseline over the duration of the study | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Serum Concentration (Cmax) of RO7046015 at Steady-state | Cmax is the maximum observed plasma concentration of RO7046015. | Not Posted | Apr 2027 | Baseline over the duration of the study | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimum Observed Serum Concentration (Ctrough) of RO7046015 at Steady-state | Cmin is the minimum observed plasma concentration of RO7046015. | Not Posted | Apr 2027 | Baseline over the duration of the study | Participants |
Baseline up to Week 52
AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Placebo | Participants received placebo as intravenous (IV) infusion every four weeks (Q4W) up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to placebo during Part 1 of the study will be rerandomized to one of the two active doses using a 1:1 allocation ratio. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose. | 0 | 105 | 5 | 105 | 57 | 105 |
| EG001 | Part 1: RO7046015 Low Dose | Participants received RO7046015 at a low dose level (1500 mg; for all body weights) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the low dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose. | 0 | 105 | 7 | 105 | 67 | 105 |
| EG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. | 0 | 106 | 8 | 106 | 69 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Ligament disorder | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.1 | Systematic Assessment |
| |
| Large intestine benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Behaviour disorder | Psychiatric disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2019 | Nov 26, 2020 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| White |
|
| Unknown |
|
| 0.7169 |
| Difference in Adjusted Means |
| -0.62 |
| Standard Error of the Mean |
| 1.71 |
| 2-Sided |
| 80 |
| -2.82 |
| 1.58 |
| Superiority |
| OG001 | Part 1: RO7046015 Low Dose | Participants received RO7046015 at a low dose level (1500 mg; for all body weights) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the low dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose. |
| OG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. |
|
|
|
| Part 1: RO7046015 Low Dose |
Participants received RO7046015 at a low dose level (1500 mg; for all body weights) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the low dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose. |
| OG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. |
|
|
|
| OG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. |
|
|
|
| Part 1: RO7046015 Low Dose |
Participants received RO7046015 at a low dose level (1500 mg; for all body weights) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the low dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose. |
| OG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. |
|
|
|
| Part 1: RO7046015 Low Dose |
Participants received RO7046015 at a low dose level (1500 mg; for all body weights) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the low dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the low dose. |
| OG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. |
|
|
|
| OG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. |
|
|
|
| OG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. |
|
|
|
| OG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. |
|
|
|
| OG002 | Part 1: RO7046015 High Dose | Participants received RO7046015 at a high dose level (3500 mg for body weight <65 kilogram (kg) or 4500 mg for body weight >=65 kg) as an IV infusion Q4W up to 52 weeks in Part 1. Part 2 of the study occurs from Weeks 56 to 104. Participants initially randomized to the high dose group will remain on their dose as assigned in Part 1. Part 2 is followed by 12 week termination follow-up safety visit and then by Part 3. Part 3 will last 260 weeks plus 12 weeks termination follow-up safety visit in which all participants will receive the high dose. |
|
|