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Multiple Sclerosis (MS)Phase 1NCT03972306

A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis

A Phase 1 study testing Ocrelizumab and rHuPH20 in people with Multiple Sclerosis (MS), run by Hoffmann-La Roche at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (MS). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis (MS)
What is being tested?
Ocrelizumab and rHuPH20
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
18 sitesUnited States
Study dates
12 Aug 2019to 3 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

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
  • Absence of relapses for 30 days prior to the screening visit
  • For the dose escalation phase for participants pretreated with ocrelizumab (Group A):
  • treatment with IV ocrelizumab for at least 1 year prior to screening (i.e., at least two 600-mg doses of ocrelizumab separated by 24 weeks)
  • For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab.
  • For female perticipants without reproductive potential:
  • Women may be enrolled if post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy).

Who cannot join

  • MS disease duration of more than 15 years for participants with an Expanded Disability Status Scale (EDSS) score <2.0 at screening.
  • Known presence of other neurologic disorders that may mimic MS, including, but not limited to, the following:
  • History of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or ischemia of the spinal cord
  • History or known presence of Central Nervous System (CNS) or spinal cord tumor (e.g., meningioma,glioma)
  • History or known presence of potential metabolic causes of myelopathy (e.g., untreated vitamin B12 deficiency)
  • History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-lymphotropic virus 1, herpes zoster and myelopathy.
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  • History of genetically inherited progressive CNS degenerative disorder (e.g., hereditary paraparesis and mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke syndrome)
  • Neuromyelitis optica
  • History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjögren syndrome, Behçet disease, sarcoidosis).
  • History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • The NeuroMedical Clinic of Central Louisiana

    Alexandria, Louisiana, 71301

  • University of Colorado

    Aurora, Colorado, 80045

  • John Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Cleveland Clinic Mellen Center

    Cleveland, Ohio, 44195

  • Neurology Clinic PC

    Cordova, Tennessee, 38018

  • UC Health Neurology

    Dayton, Ohio, 45417

  • Wayne State University

    Detroit, Michigan, 48201

  • University of Texas at Houston

    Houston, Texas, 77030

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

    Owosso, Michigan, 48867

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Swedish Neuroscience Institute

    Seattle, Washington, 98122

  • Washington Univ School of Med

    St Louis, Missouri, 63110

  • MultiCare Health System Institute for Research and Innovation

    Tacoma, Washington, 98405

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple Sclerosis

This study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (MS).

Being tested
Ocrelizumab, rHuPH20
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OcrelizumabDrug

    Administered by subcutaneous Injection

  • OcrelizumabDrug

    Administered by Intravenous (IV) Injection

  • rHuPH20Drug

    Administered in a 2-mL glass vial as a sterile, single-use, injectable liquid to be manually mixed with SC ocrelizumab

Study groups in NCT03972306
Study groupRoleWhat they receive
Group A: Cohorts A1-A4ExperimentalParticipants (participants pretreated with ocrelizumab) will receive a single injection of subcutaneous (SC) ocrelizumab co-mixed with rHuPH20 in the abdomen. For every new dose level, recruitment will be staggered by enrolling 1 participant in each cohort followed by a 48-hour waiting period to review safety and tolerability data by the Safety Monitoring Committee (SMC) prior to enrolling subsequent participants in the same cohort. Currently, the planned dose escalation steps for patients who enroll in Group A are as follows: * Cohort A1: 40 mg of SC ocrelizumab * Cohort A2: 200 mg of SC ocrelizumab * Cohort A3: 600 mg of SC ocrelizumab * Cohort A4: 1200 mg of SC ocrelizumab
Receives: Drug: Ocrelizumab; Drug: rHuPH20
Group A: Cohort A5ExperimentalIn the non-randomized subphase, participants will receive a single SC injection of ocrelizumab co-mixed with rHuPH20 in the abdomen.
Receives: Drug: Ocrelizumab; Drug: rHuPH20
Group A: Cohort AAExperimentalParticipants will receive a single 600-mg dose ocrelizumab by intravenous (IV) infusion
Receives: Drug: Ocrelizumab
Group B: Cohorts B1-B4ExperimentalOcrelizumab treatment- naive participants will receive a minimum of 3 patients in Cohort B will receive a single SC injection of ocrelizumab co-mixed with rHuPH20 in the abdomen. * Cohort B1: 40 mg of SC ocrelizumab * Cohort B2: 200 mg of SC ocrelizumab * Cohort B3: 600 mg of SC ocrelizumab * Cohort B4: 1200 mg of SC ocrelizumab
Receives: Drug: Ocrelizumab; Drug: rHuPH20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab following subcutaneous (SC) administration

    Measured: At predefined intervals from baseline through end of study (approximately 5 years)

  2. Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab following single IV (intravenous Infusion)administration

    Measured: At predefined intervals from baseline through end of study (approximately 5 years)

  3. Percentage of participants with adverse events

    Measured: Baseline to end of study (approximately 5 years)

  4. Percentage of participants with change from baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters

    Measured: Baseline to end of study (approximately 5 years)

  5. Incidence of local pain at site of injection assessed using Visual Analog Scale (VAS

    Measured: Baseline to end of study (approximately 5 years)

  6. Incidence of local-injection reaction (ISR) assessed using Local Injection-Site Symptom Assessment (LISSA)

    Measured: Baseline to end of study (approximately 5 years)

Secondary outcomes (2)

  1. Percentage of Participants with Anti-Drug Antibodies (ADAs) to ocrelizumab

    Measured: Baseline to end of study (approximately 5 years)

  2. Percentage of Participants with Anti-Drug Antibodies (ADAs) to rHuPH20

    Measured: Baseline to end of study (approximately 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2019
  2. Study start12 Aug 2019
  3. Primary completion3 Jun 2025
  4. Study completion3 Jun 2025

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03972306
Sponsor's protocol ID
CN41144
Status last verified
Jul 2025
First submitted
29 May 2019
Last updated
8 Jul 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Newsome SD, Goldstick L, Robertson DS, Bowen JD, Naismith RT, Townsend B, Figueiredo C, Kletzl H, Giraudon M, Bortolami O, Zecevic D, Giacobino C, Clinch S, Shen YA, Deol-Bhullar G, Bermel RA. Subcutaneous ocrelizumab in multiple sclerosis: Results of the Phase 1b OCARINA I study. Ann Clin Transl Neurol. 2024 Dec;11(12):3215-3226. doi: 10.1002/acn3.52229. Epub 2024 Oct 26.

    PubMed 39460719

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ocrelizumab and rHuPH20 in people with Multiple Sclerosis (MS), run by Hoffmann-La Roche at 18 sites in United States.

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 8 inclusion and 10 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: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab following subcutaneous (SC) administration (time frame: At predefined intervals from baseline through end of study (approximately 5 years)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03972306, which also lists 1 linked publication.

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 8 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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