Multiple SclerosisPhase 1NCT05704361
A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
A Phase 1 study testing RO7121932 IV and RO7121932 SC in people with Multiple Sclerosis, run by Hoffmann-La Roche at 26 sites in 12 countries.
Trial summary
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), and multiple-ascending SC doses following a single IV dose (Part 4) of RO7121932 in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- RO7121932 IV and RO7121932 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 26 sitesin 12 countries
- Study dates
- 11 Aug 2021to 8 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening
- Participants with relapsing multiple sclerosis (RMS) or progressive multiple sclerosis (PMS) who fulfil international panel criteria for diagnosis (McDonald 2017 criteria)
- Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including follow-up)
- Biological male and female participants
- Female participants must practice abstinence or otherwise use contraception
Who cannot join
- Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by >1 clinical relapse within 12 months prior to screening
- Evidence of brain magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new or enlarging T2 lesions in the screening scan as compared to a reference scan
- Participants who have active progressive multifocal leukoencephalopathy (PML), have had confirmed PML, or have a high degree of suspicion for PML
- Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum disease, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreated hypothyroidism
- Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Day 1
- Participants with a current diagnosis of epilepsy
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- Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, gastrointestinal or other major diseases
- History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy >1 year prior to screening is not exclusionary
- History of inflammatory bowel disease or other clinically significant gastrointestinal disorders
- Any concomitant disease that may require treatment with systemic corticosteroids or immunosuppressants during course of the study
- History of currently active primary or secondary (non-drug-related) immunodeficiency
- History of hypersensitivity to biologic agents or any of the excipients in the formulation
- Only for cohorts where CSF samples are planned to be collected: Participants with a history of spinal cord compression, raised intra-cerebral pressure, clinically significant vertebral joint pathology or any other current abnormalities in the lumbar region which could prevent the lumbar puncture procedure.
- 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-CD20 B-cell-depleting therapies (e.g., rituximab, ocrelizumab, or ofatumumab)
- <12 months prior to acquiring any screening laboratory tests,
- ≥12 months prior to acquiring any screening laboratory tests, if B-cells are outside the normal range, or not back to individual baseline ± 20% (if data are available),
- If discontinuation of a prior B-cell depletion therapy was motivated by safety reasons
- 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:
- Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, or hepatitis B
- Participants with SI or behavior within 6 months prior to Screening or participants who, in the Investigator's judgment, pose a suicidal or homicidal risk
- Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1
Trial locations and contacts
26 sites in 12 countries.
26 sites in 12 countries
Germany6 sites
Universitätsklinikum "Carl Gustav Carus"
Dresden, 01307
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, 37075
Klinikum rechts der Isar der TU Muenchen
München, 81675
Universitätsklinikum Münster Klinik u. Poliklinik f. Neurologie
Münster, 48149
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, 72076
Universitätsklinikum Ulm
Ulm, 89081
Poland4 sites
Regionalny Szpital Specjalistyczny im. W. Bieganskiego
Grudzi?dz, 86-300
MedPolonia
Poznan, 60-693
Osrodek Badan Klinicznych Euromedis
Szczecin, 70-111
SPSK nr 1
Zabrze, 41-800
Portugal3 sites
Hospital de Braga
Braga, 4710-243
Hospital Santo Antonio dos Capuchos
Lisbon, 1169-050
Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião
Santa Maria da Feira, 4520-211
United States2 sites
Yale University Multiple Sclerosis Center
New Haven, Connecticut, 06473
Stanford University Medical Center
Stanford, California, 94305
Belgium2 sites
Cliniques Universitaires St-Luc
Brussels, 1200
UZ Gent
Ghent, 9000
Italy2 sites
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, 20133
Romania2 sites
ARENSIA Exploratory Medicine SRL - Bucharest (Monza Medical Center)
Bucharest, 011658
ARENSIA Exploratory Medicine, County Emergency Hospital
Cluj-Napoca, 40006
Canada1 site
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
Moldova1 site
ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital
Chisinau, MD-2025
About this study
Official title: A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3), and Long-term Safety (Part 4), Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1 and 4) and Subcutaneous (Parts 2, 3 and 4) Administration in Participants With Multiple Sclerosis
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), and multiple-ascending SC doses following a single IV dose (Part 4) of RO7121932 in participants with multiple sclerosis (MS). Only Parts 1 and 2 of the study will be conducted in the United States, whereas Parts 1, 2, 3, and 4 will be conducted in all other participating countries outside the United States.
- Conditions
- Multiple Sclerosis
- Being tested
- RO7121932 IV, RO7121932 SC
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7121932 IVDrug
Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms.
RO7121932 SCDrug
Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) IV: RO7121932- Dose Escalation Cohorts 1 to 7 | 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. Receives: Drug: RO7121932 IV |
| 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. Receives: Drug: RO7121932 SC |
| 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. Receives: Drug: RO7121932 SC |
| Part 4: Long-term Safety: RO7121932- Dose Escalation Cohorts 1 to 2 | Experimental | Participants will receive a single IV dose of RO7121932 on treatment Day 1 followed by multiple SC maintenance doses of RO7121932. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data. Receives: Drug: RO7121932 IV; Drug: RO7121932 SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1, 2, 3, and 4: 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)
Measured: Day 1 to Day 169 for Part 1 and Part 2; Day 1 to Day 197 for Part 3; Day 1 to Day 253 for Part 4
Parts 1, 2, 3, and 4: 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.
Measured: Day 1 to Day 169 for Part 1 and Part 2; Day 1 to Day 197 for Part 3; Day 1 to Day 253 for Part 4
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.
Measured: 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.
Measured: Day 1,2, 5, 8 for Part 2; Day 1, 2, 5, 8, 15, 22, 29, 36 for Part 3
Part 4: Percentage of Participants With Local Injection-site Reactions
Measured: Day 1 to Day 253
Secondary outcomes (18)
Parts 1, 2 and 3 (Week 1 and Week 4): Time to Maximum Observed Concentration (Tmax) of RO7121932
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 1 to Day 169 for Part 1 and Part 2
Parts 1 and 2: AUC From Time 0 to Infinity (AUCinf)
Measured: Day 1 to Day 169 for Part 1 and Part 2
Part 1: Total Body Clearance (CL) Of RO7121932
Measured: Day 1 to Day 169
Parts 2 and 3 (Week 4): Apparent Clearance (CL/F) of RO7121932
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1, 2, 5 and 22
Part 4: Serum Concentrations of RO7121932
Measured: Day 1 to Day 253
Parts 1, 3 and 4: Cerebrospinal Fluid (CSF) Concentration of RO7121932
Measured: Screening, Day 2 to Day 169 for Part 1; Screening, Day 2 to Day 197 for Part 3; Screening, Day 85 and Day 169 for Part 4
Parts 1, 2, 3 and 4: Percentage of Participants With Anti-RO7121932 Antibodies
Measured: 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; Days 1 to 253 for Part 4
Parts 1, 2, 3, and 4: Time Course of B-cell Frequencies in Blood
Measured: 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; Screening up to Day 253 for Part 4
Parts 1 and 4: Time Course of B-cell Frequencies in CSF
Measured: Screening, Day 2 to 169; Screening, Day 85 and Day 169 for Part 4
Parts 1, 2, 3, and 4: Change From Baseline in B-cell Frequencies in Blood
Measured: 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; Screening up to Day 253 for Part 4
Parts 1, 3 and 4: Change From Baseline in B-cell Frequencies in CSF
Measured: Screening, Day 2 to 169 for Part 1; Screening, Day 2 to 197 for Part 3; Screening, Day 85 and Day 169 for Part 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start11 Aug 2021
- Primary completion8 Jul 2027 (estimated)
- Study completion8 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704361
- Sponsor's protocol ID
- BP42230
- Other IDs
- 2020-004122-33, 2023-509357-31-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3), and Long-term Safety (Part 4), Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1 and 4) and Subcutaneous (Parts 2, 3 and 4) Administration in Participants With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05704361
- Acronym / sponsor ID
- BP42230
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 8 Jul 2027 (estimated)
- Study completion
- 8 Jul 2027 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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), and multiple-ascending SC doses following a single IV dose (Part 4) of RO7121932 in participants with multiple sclerosis (MS). Only Parts 1 and 2 of the study will be conducted in the United States, whereas Parts 1, 2, 3, and 4 will be conducted in all other participating countries outside the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) IV: RO7121932- Dose Escalation Cohorts 1 to 7 | Experimental | Drug: RO7121932 IVParticipants 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. |
| Part 2: SAD SC: RO7121932- Dose Escalation Cohorts 1 to 2 | Experimental | Drug: RO7121932 SCParticipants 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. |
| Part 3: Multiple Ascending Dose (MAD) SC: RO7121932- Dose Escalation Cohorts 1 to 3 | Experimental | Drug: RO7121932 SCParticipants 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. |
| Part 4: Long-term Safety: RO7121932- Dose Escalation Cohorts 1 to 2 | Experimental | Drug: RO7121932 IV, Drug: RO7121932 SCParticipants will receive a single IV dose of RO7121932 on treatment Day 1 followed by multiple SC maintenance doses of RO7121932. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening
- Participants with relapsing multiple sclerosis (RMS) or progressive multiple sclerosis (PMS) who fulfil international panel criteria for diagnosis (McDonald 2017 criteria)
- Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including follow-up)
- Biological male and female participants
- Female participants must practice abstinence or otherwise use contraception
Key exclusion criteria (27 listed)
- Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by >1 clinical relapse within 12 months prior to screening
- Evidence of brain magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new or enlarging T2 lesions in the screening scan as compared to a reference scan
- Participants who have active progressive multifocal leukoencephalopathy (PML), have had confirmed PML, or have a high degree of suspicion for PML
- Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum disease, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreated hypothyroidism
- Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Day 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7121932 IVParticipants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms. | Drug | Part 1: Single Ascending Dose (SAD) IV: RO7121932- Dose Escalation Cohorts 1 to 7, Part 4: Long-term Safety: RO7121932- Dose Escalation Cohorts 1 to 2 |
| RO7121932 SCParticipants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms. | Drug | Part 2: SAD SC: RO7121932- Dose Escalation Cohorts 1 to 2, Part 3: Multiple Ascending Dose (MAD) SC: RO7121932- Dose Escalation Cohorts 1 to 3, Part 4: Long-term Safety: RO7121932- Dose Escalation Cohorts 1 to 2 |
Primary outcome
Parts 1, 2, 3, and 4: 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)
Time frame: Day 1 to Day 169 for Part 1 and Part 2; Day 1 to Day 197 for Part 3; Day 1 to Day 253 for Part 4
Parts 1, 2, 3, and 4: Change From Baseline in Suicide Risk as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 1 to Day 169 for Part 1 and Part 2; Day 1 to Day 197 for Part 3; Day 1 to Day 253 for Part 4
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.
Parts 2 and 3: Percentage of Participants With Local Pain at the Site of Injection Assessed Using the Visual Analog Scale (VAS)
Time frame: Day 1, 2, 5, 8 for Part 2; Day 1, 2, 5, 8, 15, 22, 29, 36 for Part 3
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.
Parts 2 and 3: Percentage of Participants With Local Injection-site Reaction Using Local Injection-site Symptom Assessment (LISSA)
Time frame: Day 1,2, 5, 8 for Part 2; Day 1, 2, 5, 8, 15, 22, 29, 36 for Part 3
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.
Part 4: Percentage of Participants With Local Injection-site Reactions
Time frame: Day 1 to Day 253
18 secondary outcomes
Parts 1, 2 and 3 (Week 1 and Week 4): Time to Maximum Observed Concentration (Tmax) of RO7121932
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Day 1 to Day 169 for Part 1 and Part 2
Parts 1 and 2: AUC From Time 0 to Infinity (AUCinf)
Time frame: Day 1 to Day 169 for Part 1 and Part 2
Part 1: Total Body Clearance (CL) Of RO7121932
Time frame: Day 1 to Day 169
Parts 2 and 3 (Week 4): Apparent Clearance (CL/F) of RO7121932
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1, 2, 5 and 22
Part 4: Serum Concentrations of RO7121932
Time frame: Day 1 to Day 253
Parts 1, 3 and 4: Cerebrospinal Fluid (CSF) Concentration of RO7121932
Time frame: Screening, Day 2 to Day 169 for Part 1; Screening, Day 2 to Day 197 for Part 3; Screening, Day 85 and Day 169 for Part 4
Parts 1, 2, 3 and 4: Percentage of Participants With Anti-RO7121932 Antibodies
Time frame: 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; Days 1 to 253 for Part 4
Parts 1, 2, 3, and 4: Time Course of B-cell Frequencies in Blood
Time frame: 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; Screening up to Day 253 for Part 4
Parts 1 and 4: Time Course of B-cell Frequencies in CSF
Time frame: Screening, Day 2 to 169; Screening, Day 85 and Day 169 for Part 4
Parts 1, 2, 3, and 4: Change From Baseline in B-cell Frequencies in Blood
Time frame: 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; Screening up to Day 253 for Part 4
Parts 1, 3 and 4: Change From Baseline in B-cell Frequencies in CSF
Time frame: Screening, Day 2 to 169 for Part 1; Screening, Day 2 to 197 for Part 3; Screening, Day 85 and Day 169 for Part 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
26 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7121932 IV and RO7121932 SC in people with Multiple Sclerosis, run by Hoffmann-La Roche at 26 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Poland, Portugal, United States, Belgium and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts 1, 2, 3, and 4: 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) (time frame: Day 1 to Day 169 for Part 1 and Part 2; Day 1 to Day 197 for Part 3; Day 1 to Day 253 for Part 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.