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Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous Ocrelizumab in Children and Adolescents with Relapsing‑Remitting Multiple Sclerosis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on children and adolescents who have Relapsing-Remitting Multiple Sclerosis, a disease where the immune system mistakenly attacks the nervous system, causing episodes of new symptoms that later improve. The medication being examined is ocrelizumab, which is given by a subcutaneous injection (placed just under the skin). The purpose is to learn how the drug travels through the body and to check its safety and how the body reacts to it.

Participants will receive a series of injections over several months and will attend regular study visits where blood samples are taken and simple health checks, such as measuring vital signs and a basic heart rhythm test (ECG), are performed. Throughout the study, researchers will watch for any side effects, observe changes in specific immune cells, and test for the body’s production of antibodies against the drug. The follow‑up period is designed to collect enough information to understand the treatment’s behavior in this young age group.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment visit

    You attend the first study visit after joining the trial. you sign the consent form and a study nurse records your medical history, current symptoms of relapsing‑remitting multiple sclerosis, vital signs, and performs an electrocardiogram (ecg).

    Baseline laboratory tests are taken, including blood work to measure cd19+ b cells and any existing anti‑drug antibodies.

  2. Step 2

    Baseline sample collection

    A blood sample is drawn to establish the initial level of ocrelizumab in your circulation and to assess baseline immune markers.

    The sample is also used to evaluate the presence of anti‑drug antibodies before any medication is given.

  3. Step 3

    First subcutaneous injection

    You receive a single dose of 920 mg of ocrelizumab as a subcutaneous injection (injection under the skin). the injection is administered by trained study staff according to the study protocol.

  4. Step 4

    Post‑injection monitoring

    After the injection you are observed for a short period for any immediate reactions. vital signs such as blood pressure and heart rate are checked.

  5. Step 5

    Regular follow‑up visits

    You attend scheduled follow‑up visits throughout the study period. at each visit blood samples are taken to measure pharmacokinetics (how the drug moves in your body), cd19+ b cell counts, and anti‑drug antibodies.

    Vital signs, ecg, and selected laboratory tests are repeated to monitor safety.

    Any symptoms you experience are recorded as potential adverse events.

  6. Step 6

    Safety assessments

    Throughout the trial you are asked to report any new or worsening symptoms. the study team grades each event using a standard severity scale.

    If an adverse event is severe, the study medication may be discontinued according to the protocol.

  7. Step 7

    Final assessment and study completion

    At the end of the study you undergo a final set of evaluations similar to the baseline visit, including a blood draw, vital signs, ecg, and laboratory tests.

    The collected data are used to evaluate the overall safety, tolerability, and pharmacokinetic profile of the subcutaneous ocrelizumab dose in children and adolescents with relapsing‑remitting multiple sclerosis.

Who can join the trial?

7 criteria

  • Must weigh at least 25 kilograms (about 55 pounds).
  • Must have a diagnosis of Relapsing‑Remitting Multiple Sclerosis (RRMS) confirmed by the pediatric MS guidelines (IPMSSG criteria 2012) or the adult MS guidelines (McDonald criteria 2017 or 2024).
  • Must have received all routine childhood vaccinations that are recommended in your country.
  • Must have an Expanded Disability Status Scale (EDSS) score between 0 and 5.5 at the screening visit; the EDSS is a simple scale that shows how much MS is affecting daily activities, with lower numbers meaning less disability.
  • Must agree to follow the study’s contraception (birth‑control) requirements to avoid pregnancy during the trial.
  • Must have been neurologically stable—meaning no new symptoms or worsening of existing symptoms—for at least 30 days before the screening visit and must stay stable between screening and the first treatment.
  • Must be a male or female child or adolescent; the study includes participants as young as 2 years old.

Who cannot join the trial?

9 criteria

  • Any known or suspected other brain or nerve disorders that can look like multiple sclerosis, such as acute disseminated encephalomyelitis (ADEM) (a sudden inflammation of the brain and spinal cord) or neuromyelitis optica (a disease that attacks the optic nerve and spinal cord), or any condition that could affect brain function or normal development.
  • Having a positive test for aquaporin‑4 (AQP4) or myelin oligodendrocyte glycoprotein (MOG) antibodies, which are proteins that the immune system makes and can indicate other diseases.
  • Having an infection that requires a stay in the hospital or treatment with medicines given through an IV (a tube placed into a vein).
  • Having a history of ongoing or repeated infections such as human immunodeficiency virus (HIV), syphilis, or tuberculosis (a lung infection).
  • Receiving a live or weakened live vaccine within the 6 weeks before the study starts. Live vaccines contain a weakened form of the germ.
  • Having been treated before with medicines that target B‑cells (a type of immune cell that helps fight infections).
  • Having a CD4 cell percentage (a type of immune cell) lower than 30% of the total white blood cells.
  • Having an absolute neutrophil count (another type of white blood cell) less than 1.5 × 10³ per microliter, which means a low level of these cells.
  • Having a lymphocyte count (a type of white blood cell) below the normal range for the child’s age and sex.
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Investigated drugs

Ocrevus is a medication that contains the active ingredient ocrelizumab. It is given as a solution that is injected under the skin (subcutaneously). In this study, Ocrevus is being tested in children and adolescents who have relapsing‑remitting multiple sclerosis. The drug works by targeting specific immune cells that are involved in the disease, helping to reduce attacks and slow the progression of symptoms. Researchers are closely monitoring how the medicine moves through the body, how safe it is, how well patients tolerate it, whether the body creates any immune response against it, and how it affects disease‑related markers.

What is already known about the treatment

Ocrevus - Ocrevus is given as a 920 mg solution for injection that is administered under the skin (subcutaneous injection). It is an approved medicine that has been studied widely for multiple sclerosis and is listed in medical references as a standard treatment. The drug is used mainly for relapsing‑remitting multiple sclerosis and also for primary progressive multiple sclerosis. It works by attaching to a protein called CD20 on certain immune cells, which leads to removal of those cells and reduces the immune attack on the nervous system; it belongs to the class of monoclonal antibody immunosuppressants.

Investigated diseases

Relapsing‑Remitting Multiple Sclerosis - Relapsing‑Remitting Multiple Sclerosis is a condition where the immune system attacks the protective coating of nerves in the brain and spinal cord. It causes periods of new or worsening neurological symptoms that are followed by times of partial or complete recovery. During a relapse, symptoms such as weakness, tingling, vision problems, or coordination difficulties may appear. After the relapse, many people experience a remission phase where symptoms improve or disappear for weeks, months, or longer. The pattern of relapses and remissions can change over time, with episodes sometimes becoming more frequent or less predictable. The disease can continue to cause new episodes as it progresses.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2025-524164-37-00Protocol codeBA45841Estimated enrolment21 patientsSponsorF. Hoffmann-La Roche AG

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