Multiple SclerosisPhase 1OCARINA 3NCT07667322
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis
A Phase 1 study testing Ocrelizumab Co-formulated With rHuPH20 in people with Multiple Sclerosis, run by Hoffmann-La Roche at 12 sites in 4 countries.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS). The study consists of two treatment phases: a dose-escalation and dose-continuation phase. 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?
- Ocrelizumab Co-formulated With rHuPH20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 17 Dec 2024to 1 Aug 2028
- 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
- Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)
- Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
Who cannot join
- Participants who have previously received anti-cluster of differentiation 20 (CD20s) (including ocrelizumab) less than 2 years before screening
- Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening
- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
- Immunocompromised state
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
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- Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
- Lack of peripheral venous access
- Previous treatment with cladribine, atacicept, and alemtuzumab
- Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline
- Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
- Any previous history of transplantation or anti-rejection therapy
- Positive screening tests for active, latent, or inadequately treated hepatitis B
- Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States6 sites
Shepherd Center Inc.
Atlanta, Georgia, 30309
John Hopkins University School of Medicine
Baltimore, Maryland, 21287
Profound Research, LLC
Carlsbad, California, 92011
Hope Neurology
Knoxville, Tennessee, 37922
Neurology Associates, PA
Maitland, Florida, 32751
University of South Florida
Tampa, Florida, 33612
Brazil2 sites
Instituto de Neurologia de Curitiba
Curitiba, Paraná, 81210-310
Centro de Pesquisas Clinicas
São Paulo, São Paulo, 01228-200
Mexico2 sites
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
Guadalajara, Jalisco, 44130
Inovacion y Desarrollo en ciencias de la salud
Mexico City, Mexico CITY (federal District), 14090
United Kingdom2 sites
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Morriston Hospital
Swansea, SA6 6NL
About this study
Official title: A Phase 1b Multicenter, Non-randomized, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Single Ascending Doses of a New Subcutaneous Formulation of Ocrelizumab in Patients With Multiple Sclerosis
The main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS). The study consists of two treatment phases: a dose-escalation and dose-continuation phase. Participants will receive single ascending doses of ocrelizumab SC during an initial dose-escalation phase, with the option to continue treatment with the selected dose of ocrelizumab SC in the dose-continuation phase.
- Conditions
- Multiple Sclerosis
- Being tested
- Ocrelizumab Co-formulated With rHuPH20
- Keywords
- Relapsing Remitting Multiple Sclerosis, Primary Progressive Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocrelizumab Co-formulated With rHuPH20Drug
Also called RO4964913; Ocrevus®
Participants will receive ocrelizumab co-formulated with rHuPH20, as a SC injection, per the schedule specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Ocrelizumab SC | Experimental | Participants will receive single ascending doses of ocrelizumab SC, co-formulated with recombinant human hyaluronidase (rHuPH20) on Day 1 of the 24 week dose-escalation phase. Participants who opt to continue treatment in the dose continuation phase will receive ocrelizumab SC at a dose determined in the dose escalation phase, every 24 weeks (Q24W) for 144 weeks. Receives: Drug: Ocrelizumab Co-formulated With rHuPH20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Measured: Up to 168 weeks
Secondary outcomes (3)
Ocrelizumab Serum Concentration at Specified Timepoints Following Single SC Administration
Measured: Up to 168 weeks
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Ocrelizumab
Measured: Up to 168 weeks
Number of Participants With Treatment-emergent ADAs to rHuPH20
Measured: Up to 168 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start17 Dec 2024
- Primary completion15 Feb 2028 (estimated)
- Study completion1 Aug 2028 (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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT07667322
- Sponsor's protocol ID
- WN45319
- Other IDs
- 2024-513639-26-00
- Acronym
- OCARINA 3
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Multicenter, Non-randomized, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Single Ascending Doses of a New Subcutaneous Formulation of Ocrelizumab in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07667322
- Acronym / sponsor ID
- OCARINA 3 / WN45319
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing Remitting Multiple Sclerosis, Primary Progressive Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 25 Jun 2026 (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 main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS). The study consists of two treatment phases: a dose-escalation and dose-continuation phase. Participants will receive single ascending doses of ocrelizumab SC during an initial dose-escalation phase, with the option to continue treatment with the selected dose of ocrelizumab SC in the dose-continuation phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ocrelizumab SC | Experimental | Drug: Ocrelizumab Co-formulated With rHuPH20Participants will receive single ascending doses of ocrelizumab SC, co-formulated with recombinant human hyaluronidase (rHuPH20) on Day 1 of the 24 week dose-escalation phase. Participants who opt to continue treatment in the dose continuation phase will receive ocrelizumab SC at a dose determined in the dose escalation phase, every 24 weeks (Q24W) for 144 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)
- Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
Key exclusion criteria (14 listed)
- Participants who have previously received anti-cluster of differentiation 20 (CD20s) (including ocrelizumab) less than 2 years before screening
- Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening
- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
- Immunocompromised state
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 |
|---|---|---|
| Ocrelizumab Co-formulated With rHuPH20Also: RO4964913; Ocrevus®Participants will receive ocrelizumab co-formulated with rHuPH20, as a SC injection, per the schedule specified in the treatment arm. | Drug | Ocrelizumab SC |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to 168 weeks
3 secondary outcomes
Ocrelizumab Serum Concentration at Specified Timepoints Following Single SC Administration
Time frame: Up to 168 weeks
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Ocrelizumab
Time frame: Up to 168 weeks
Number of Participants With Treatment-emergent ADAs to rHuPH20
Time frame: Up to 168 weeks
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 13 Aug 2026.
- Individual participant dataSharing planned: No
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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
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ocrelizumab Co-formulated With rHuPH20 in people with Multiple Sclerosis, run by Hoffmann-La Roche at 12 sites in 4 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 2 inclusion and 14 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Brazil, Mexico, United Kingdom. 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?
Number of Participants With Adverse Events (AEs) (time frame: Up to 168 weeks). 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 13 Aug 2026.