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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004122-33 | EudraCT Number | ||
| 2023-509357-31-00 | EU Trial (CTIS) Number |
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The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3) of RO7121932 in participants with multiple sclerosis (MS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Ascending Dose (SAD) IV: RO7121932- Dose Escalation Cohorts 1 to 6 and Later Cohorts | Experimental | Participants will receive a single IV dose of RO7121932 on treatment Day 1. The planned starting dose of RO7121932 is 7 milligrams (mg) and will be escalated up to 2000 mg. The maximum dose will not exceed 4000 mg . Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data. |
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| Part 2: SAD SC: RO7121932- Dose Escalation Cohorts 1 to 2 | Experimental | Participants will receive a single SC dose of RO7121932 on treatment Day 1. The planned starting dose of RO7121932 is 70 mg and will be escalated up to 200 mg. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data. |
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| Part 3: Multiple Ascending Dose (MAD) SC: RO7121932- Dose Escalation Cohorts 1 to 3 | Experimental | Participants will receive multiple SC doses of RO7121932, once weekly on treatment Day 1 through Day 22. The planned starting dose of RO7121932 is 70 mg and will be escalated up to 700 mg. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7121932 IV | Drug | Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1, 2, and 3: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) With Severity of AEs Measured According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE V5) | Day 1 to Day 169 for Part 1 and Part 2; Day 1 to Day 197 for Part 3 | |
| Parts 1, 2, and 3: Change From Baseline in Suicide Risk as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is an interview-based instrument used to assess baseline incidence of suicidal ideation (SI) and behavior. The assessment includes "yes" or "no" responses for 5 questions, each related to SI (wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent, active SI with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings are provided for severity of ideation (if present), from 0 to 5. A score of 0 is assigned if no suicide risk is present. A score of 1 or higher indicates SI or behavior, with 5 being the most severe. | Day 1 to Day 169 for Part 1 and Part 2; Day 1 to Day 197 for Part 3 |
| Parts 2 and 3: Percentage of Participants With Local Pain at the Site of Injection Assessed Using the Visual Analog Scale (VAS) | VAS is a 100 millimetre (mm) horizontal visual analog scale with values 0 to 100 mm to indicate pain. The following cutpoints on the VAS will be considered in the interpretation of the pain data: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). A higher score indicates greater pain intensity. | Day 1, 2, 5, 8 for Part 2; Day 1, 2, 5, 8, 15, 22, 29, 36 for Part 3 |
| Parts 2 and 3: Percentage of Participants With Local Injection-site Reaction Using Local Injection-site Symptom Assessment (LISSA) | LISSA form will be used to assess the participant's injection site for the following categories of reactions: Burning, Itching, Bruising, Erythema (redness), Hive formation, Induration, Swelling, Ecchymosis, Sensitivity, Papules, Stinging, Blister, Cold sensation, and Other. These reactions will be described using the following scale: Unable to assess, less than a dime (<18 mm/<0.7 inches), a dime (18 mm/0.7 inches), a nickel (21 mm/0.8 inches), a quarter (24 mm/1 inch), a half dollar (31 mm/1.2 inches), larger than a half dollar (>31 mm/>1.2 inches). A higher score indicates high injection site reactions. |
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1, 2 and 3 (Week 1 and Week 4): Time to Maximum Observed Concentration (Tmax) of RO7121932 | Day 1 to Day 169 for Part 1 and Part 2; Days 1, 2, 5 and, 22 for Part 3 | |
| Parts 1, 2 and 3 (Week 1 and Week 4): Maximum Observed Serum Concentration (Cmax) of RO7121932 |
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Inclusion Criteria:
Exclusion Criteria:
Prior/Concomitant Therapy:
Treatment with any approved MS treatment at Screening. Participants may become eligible after completion of a washout period prior to acquiring any screening laboratory tests but should not be withdrawn from therapies for the sole purpose of meeting eligibility for the trial
Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous treatment with daclizumab
Previous treatment with anti-cluster of differentiation 20 (CD20) B-cell-depleting therapies (e.g., rituximab, ocrelizumab, or ofatumumab)
Current or prior treatment with natalizumab (if <24 months prior to acquiring any screening laboratory tests)
Prior/Concurrent Clinical Study Experience:
- Participation in an investigational drug medicinal product or medical device study within 30 days before Screening or within five times the pharmacodynamic (PD) or pharmacokinetic (PK) half-life (if known), whichever is longer
Diagnostic Assessments:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BP42230 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Completed | Stanford | California | 94305 | United States | |
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
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| RO7121932 SC | Drug | Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms. |
|
| Day 1,2, 5, 8 for Part 2; Day 1, 2, 5, 8, 15, 22, 29, 36 for Part 3 |
| Day 1 to Day 169 for Part 1 and Part 2; Days 1, 2, 5 and, 22 for Part 3 |
| Parts 1, 2 and 3 (Week 1 and Week 4): Area Under the Serum Concentration-time Curve From Time 0 to 168 Hours (h) (AUC0-168h) Postdose | Day 1 (predose) to Day 8 (168 hours post-dose) for Parts 1, 2, and 3 (Week 1) and Day 22 (predose) to Day 29 (168 hours post-dose) for Part 3 (Week 4) |
| Parts 1 and 2: Area Under the Serum Concentration-time Curve up to the Last Measurable Concentration (AUClast) | Day 1 to Day 169 for Part 1 and Part 2 |
| Parts 1 and 2: AUC From Time 0 to Infinity (AUCinf) | Day 1 to Day 169 for Part 1 and Part 2 |
| Part 1: Total Body Clearance (CL) Of RO7121932 | Day 1 to Day 169 |
| Parts 2 and 3 (Week 4): Apparent Clearance (CL/F) of RO7121932 | Day 1 to Day 169 for Part 2; Day 22 to Day 29 for Part 3 |
| Parts 1, 2 and 3: Terminal Rate Constant of RO7121932 | Day 1 to Day 169 for Part 1 and Part 2; Day 22 to Day 197 for Part 3 |
| Parts 1, 2 and 3: Apparent Terminal Half-Life (T1/2) of RO7121932 | Day 1 to Day 169 for Part 1 and Part 2; Day 22 to Day 197 for Part 3 |
| Part 3: Trough Concentrations (Ctrough) of RO7121932 | Day 1 to Day 197 |
| Part 3 (Week 1 and Week 4): Area Under the Concentration-time Curve Over One Dosing Interval (AUCtau) of RO7121932 | Day 1, 2, 5 and 22 |
| Parts 1 and 3: Cerebrospinal Fluid (CSF) Concentration of RO7121932 | Screening, Day 2 to Day 169 for Part 1; Screening, Day 2 to Day 197 for Part 3 |
| Parts 1, 2, and 3: Percentage of Participants With Anti-RO7121932 Antibodies | Days 1, 8, 22, 29, 57, 85,169 for Part 1; Days 1, 8, 22, 57, 85, 169 for Part 2; Days 1, 8, 15, 22, 29, 57, 85, 120 & 197 for Part 3 |
| Parts 1, 2, and 3: Time Course of B-cell Frequencies in Blood | Screening, Days 1, 2, 8, 22, 57, 85, 169 for Part 1; Screening, Days 1, 2, 8, 22, 57, 85, 169 for Part 2; Screening, Days 1, 2, 8, 15, 22, 57, 85, 120, 197 for Part 3 |
| Part 1: Time Course of B-cell Frequencies in CSF | Screening, Day 2 to 169 |
| Parts 1, 2, and 3: Change From Baseline in B-cell Frequencies in Blood | Screening, Days 1, 2, 8, 22, 57, 85, 169 for Part 1; Screening, Days 1, 2, 8, 22, 57, 85, 169 for Part 2; Screening, Days 1, 2, 8, 15, 22, 57, 85, 120, 197 for Part 3 |
| Parts 1 and 3: Change From Baseline in B-cell Frequencies in CSF | Screening, Day 2 to 169 for Part 1; Screening, Day 2 to 197 for Part 3 |
| Yale University Multiple Sclerosis Center |
| Completed |
| New Haven |
| Connecticut |
| 06473 |
| United States |
| University of South Florida | Withdrawn | Tampa | Florida | 33612 | United States |
| University of Massachusetts Medical School | Withdrawn | Worcester | Massachusetts | 01655 | United States |
| UC Health, LLC. | Withdrawn | Cincinnati | Ohio | 45267 | United States |
| Cliniques Universitaires St-Luc | Recruiting | Brussels | 1200 | Belgium |
| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
| Montreal Neurological Institute and Hospital | Recruiting | Montreal | Quebec | H3A 2B4 | Canada |
| Universitätsklinikum "Carl Gustav Carus" | Active, not recruiting | Dresden | 01307 | Germany |
| Universitätsmedizin Göttingen Georg-August-Universität | Completed | Göttingen | 37075 | Germany |
| Klinikum rechts der Isar der TU Muenchen | Completed | München | 81675 | Germany |
| Universitätsklinikum Münster Klinik u. Poliklinik f. Neurologie | Recruiting | Münster | 48149 | Germany |
| Universitätsklinikum Tübingen, Zentrum für Neurologie | Recruiting | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm | Recruiting | Ulm | 89081 | Germany |
| Hadassah University Hospital - Ein Kerem | Recruiting | Jerusalem | 9112001 | Israel |
| Tel Aviv Sourasky Medical Center | Withdrawn | Tel Aviv | 6423906 | Israel |
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Lombardy | 20132 | Italy |
| Fond. Istituto Neurologico C.Besta | Recruiting | Milan | Lombardy | 20133 | Italy |
| ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital | Completed | Chisinau | MD-2025 | Moldova |
| Uniwersyteckie Centrum Kliniczne | Withdrawn | Gda?sk | 80-214 | Poland |
| Regionalny Szpital Specjalistyczny im. W. Bieganskiego | Completed | Grudzi?dz | 86-300 | Poland |
| MedPolonia | Recruiting | Poznan | 60-693 | Poland |
| Osrodek Badan Klinicznych Euromedis | Recruiting | Szczecin | 70-111 | Poland |
| Instytut Psychiatrii i Neurologii II Klinika Neurologiczna | Withdrawn | Warsaw | 02-957 | Poland |
| SPSK nr 1 | Completed | Zabrze | 41-800 | Poland |
| Hospital de Braga | Recruiting | Braga | 4710-243 | Portugal |
| Hospital Santo Antonio dos Capuchos | Recruiting | Lisbon | 1169-050 | Portugal |
| Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião | Recruiting | Santa Maria da Feira | 4520-211 | Portugal |
| ARENSIA Exploratory Medicine SRL - Bucharest (Monza Medical Center) | Recruiting | Bucharest | 011658 | Romania |
| ARENSIA Exploratory Medicine, County Emergency Hospital | Recruiting | Cluj-Napoca | 40006 | Romania |
| University Clinical Center of Serbia | Recruiting | Belgrade | 11000 | Serbia |
| Hospital Universitari Vall dHebron (CEMCAT) | Recruiting | Barcelona | 08035 | Spain |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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