A clinical trial to find a safe and suitable dose of ocrelizumab in children and adolescents with relapsing-remitting multiple sclerosis

A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

  • Multiple Sclerosis (MS)
Trial Status:

Recruiting

This trial runs in
Cities
  • Aurora
  • Boston
  • Catania
  • Cleveland
  • Gdańsk
  • Genova
  • Lazio
  • Lombardy
  • Philadelphia
  • Poznań
  • Roma
  • San Francisco
  • St. Louis
  • Warszawa
  • Washington
Trial Identifier:

NCT04075266 2016-002667-34 WA39085

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT04075266 , WA39085 , 2016-002667-34 Trial Identifier
      All Gender
      ≥10 Years & ≤ 18 Years Age
      No Healthy Volunteers

       

      How does the OPERETTA 1 clinical trial work?
      This clinical trial is recruiting children and young people who have a type of disease called relapsing-remitting multiple sclerosis (RRMS).

      The purpose of this clinical trial is to test the safety of ocrelizumab at certain doses and to understand the way your body processes ocrelizumab. It will also identify the dose of ocrelizumab that is most appropriate to use for children and adolescents in further trials.

      How do I take part in this clinical trial?
      To be able to take part in this clinical trial, you must have a diagnosis of RRMS, be aged 10 to 17 years, and have a body weight of at least 25 kg.

      You must not have received previous B-cell targeted therapy. If you have certain other medical conditions or have received certain other medications, you may not be able to take part in this clinical trial.

      If you think this clinical trial may be suitable for you (or your child) and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, they may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

      You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial.

      Before starting the clinical trial, you will be told about the risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.

      While taking part in the clinical trial, if you are not currently pregnant but can become pregnant, you will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons. 

      What treatment will I be given if I join this clinical trial?

      Everyone who joins this clinical trial will enter a 2-month screening period to check that they are suitable to enter the clinical trial.  All suitable patients will then be split into two groups depending on their body weight:

      • Group 1: patients who weigh between 25 and 39 kg will be given 300 mg ocrelizumab. This will be given as two separate 150 mg infusions (drug given into your vein) at least two weeks apart. You will only be given these two infusions as the treatment will last for six months.
      • Group 2: patients who weigh at least 40 kg will be given 600 mg ocrelizumab. This will be given as two separate 300 mg infusions (drug given into your vein) at least two weeks apart. You will only be given these two infusions as the treatment will last for six months.

      Patients in both groups will be monitored over six months to check how the medicine is affecting the body and to check side effects. During this time, you will have to visit the hospital every month to have blood tests.

      If you complete the first six months of treatment, you can choose to continue treatment over roughly three years with additional doses of ocrelizumab given as single infusions every six months (using the same dose you received in the first part of the trial until a preferred final dose is selected by the clinical trial team).

      How often will I be seen in follow-up appointments and for how long?

      You will be given the ocrelizumab treatment as described above, depending on your weight. If you choose to receive the additional doses, you will continue into the 3-year extension period of the trial. You are free to stop this treatment at any time. During treatment, you will be seen regularly by the clinical trial doctor. Hospital visits will include tests (such as blood tests and MRI scans) and checks to see how you are responding to the treatment and any side effects that you may be having.

      After stopping treatment, you will still be seen by the clinical trial doctor every three months, and contacted by phone every month, for around 48 weeks (roughly one year). If your B-cell counts are still low after this time, you will continue to be seen by the clinical trial doctor every six months, and contacted by phone every three months, until your B-cell count reaches an acceptable level.

       

      What happens if I am unable to take part in this clinical trial?
      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04075266

      Trial-identifier: NCT04075266

      Trial Summary

      This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT04075266 , WA39085 , 2016-002667-34 Trial Identifier
      Ocrelizumab Treatments
      Multiple Sclerosis Condition
      Official Title

      An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

      Eligibility Criteria

      All Gender
      ≥10 Years & ≤ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Body weight >/= 25 kg
      • Children and adolescents must have received all childhood required vaccinations
      • Female participants of childbearing potential must agree to either remain completely abstinent or to use reliable means of contraception
      • Diagnosis of relapsing-remitting multiple sclerosis (RRMS)
      • Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive
      • Neurologic stability for >/= 30 days prior to screening, and between screening and baseline
      • Participants naive to prior disease-modifying therapy (DMT)
      • Participants who have had at least 6 contiguous months of DMT within the past 1 year must have evidence of disease activity occurring after the full 6-month course of treatment, that is, at least one relapse or >/= 1 Gd-enhancing lesion(s) on a T1-weighted brain MRI
      Exclusion Criteria
      • Known presence or suspicion of other neurologic disorders that may mimic MS, including, but not limited to, acute disseminated encephalomyelitis, neuromyelitis optica or neuromyelitis optica spectrum disorders and any neurologic, somatic, or metabolic condition that could interfere with brain function or normal cognitive or neurological development
      • Patients that are aquaporin 4 positive and myelin oligodendrocyte glycoprotein (MOG) antibody positive are not eligible to participate in the study.
      • In case of an ADEM-like appearance of the first MS attack, a second attack with clear MS-like features is required.
      • Infection requiring hospitalization or treatment with IV anti-infective agents
      • History or known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis)
      • Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation
      • History or laboratory evidence of coagulation disorders
      • Peripheral venous access that precludes IV administration and venous blood sampling
      • Inability to complete a magnetic resonance imaging (MRI) scan
      • History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ
      • History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody (mAbs) or known hypersensitivity to any component of ocrelizumab solution
      • Previous treatment with B-cell-targeted therapies
      • Percentage of CD4 < 30%
      • Absolute Neutrophil Count < 1.5x1000/microliter
      • Lymphocyte count below the lower limit of normal (LLN) for age- and sex-specific reference range

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