A clinical trial to compare the safety and effectiveness of ocrelizumab with fingolimod in children and young people with relapsing-remitting multiple sclerosis (RRMS)

A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

  • Multiple Sclerosis (MS)
Trial Status:

Recruiting

This trial runs in
Countries
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • France
  • Greece
  • Hungary
  • Italy
  • Poland
  • Spain
  • Ukraine
  • United States
Trial Identifier:

NCT05123703 2020-004128-41 WN42086

      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 double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT05123703 , WN42086 , 2020-004128-41 Trial Identifier
      All Gender
      ≥10 Years & ≤ 17 Years Age
      No Healthy Volunteers

      How does the OPERETTA 2 clinial 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 compare the effects, good or bad, of ocrelizumab versus fingolimod in children and young people with RRMS. If you take part in this clinical trial, you will receive either ocrelizumab or fingolimod. 

      How do I take part in this clinical trial?

      To be able to take part in this clinical trial, you must have been diagnosed with RRMS according to specific criteria, be 10 to 17 years old and weigh at least 25 kg.

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

      If you and your caregiver think this clinical trial may be suitable for you and you 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, he/she 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. If you have had some of the tests recently, they may not need to be done again.

      Before starting the clinical trial, you and your caregiver will be told about any 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 a female patient and can become pregnant, you will need to either not have heterosexual intercourse or take reliable birth control for safety reasons. 

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

      Everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and given:

      • Ocrelizumab as an infusion into the vein every six months (for at least four doses) as well as a fingolimod ‘dummy’ capsule by mouth once a day
      • OR fingolimod as a capsule by mouth once a day, as well as an ocrelizumab ‘dummy’ infusion into the vein every six months (for at least four doses).

      Before each infusion you will also receive medicine to help reduce the risk of side effects from the infusion.

      You will have an equal chance of being placed in either group.

      This is a ‘double-dummy’ clinical trial, which means that both groups will be given treatments that look exactly the same. ‘Dummy’ treatments are used so that doctors and patients/caregivers do not know which treatment each group is receiving. This means that all patients will have an infusion every six months and a capsule to take once a day, regardless of which group they are in.

      Neither you, your caregiver nor your clinical trial doctor can choose or know the group you are in. However, your clinical trial doctor can find out which group you are in if your safety is at risk. 

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

      You will be given the clinical trial treatment ocrelizumab OR fingolimod for at least two years (96 weeks), but this might be longer, as all patients will be given the treatment until the last patient has had two years of treatment. This is the double-blind treatment (DBT) phase of the clinical trial and you are free to stop this treatment at any time and for any reason.

      During the DBT phase, you will be seen by the clinical trial doctor about every three months. These hospital visits will include checks to see how you are responding to the treatment and any side effects that you may be having. These will include:

      • Scans of your brain (magnetic resonance imaging [MRI] scans)
      • Tests to measure the activity of your heart
      • Tests to check how well your brain processes information and how your RRMS is progressing (assessing factors like your balance and how well you can see and hear)
      • Blood sample collection
      • Questionnaires for you and your caregiver to complete

      There will be a shorter visit about two weeks before each infusion of ocrelizumab (or the dummy infusion) for blood and urine sample collection. You will also have a phone or video call with the clinical trial team the day after each infusion and every month between clinical visits, to check how you are doing.

      Once the DBT phase of the clinical trial is complete, you may be given the option to take part in a further open-label extension (OLE) phase of the trial. All patients who take part in the OLE phase will receive ocrelizumab as an infusion into the vein every six months for at least three years. This part of the trial will not be double dummy, so you won’t be given the capsule by mouth once a day. You will know that you are getting ocrelizumab, as will the clinical trial doctors.

      As part of the OLE phase, you will still be seen regularly by the clinical trial doctor. As in the first part of the trial, these visits will also include checks to see how you are responding to treatment and any side effects that you may be having.

      After stopping treatment (either after the DBT phase or the OLE phase), you will still be seen by the clinical trial doctor every three months for roughly one year. You may continue to be monitored by the clinical trial doctor for longer than one year, depending on the results of your blood tests.

      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/NCT05123703

      Trial-identifier: NCT05123703

      Trial Summary

      This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT05123703 , WN42086 , 2020-004128-41 Trial Identifier
      Ocrelizumab, Ocrelizumab Placebo, Fingolimod, Fingolimod Placebo Treatments
      Relapsing-Remitting Multiple Sclerosis Condition
      Official Title

      A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

      Eligibility Criteria

      All Gender
      ≥10 Years & ≤ 17 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Body weight ≥ 50 kg
      • Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017
      • EDSS at screening: 0-5.5, inclusive
      • Neurologic stability for ≥ 30 days prior to screening, and between screening and Day 1
      • At least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 months
      Exclusion Criteria
      • Known presence or suspicion of other neurologic disorders that may mimic MS
      • Significant uncontrolled somatic diseases, known active infection or any other significant condition that may preclude patient from participating in the study
      • Patient with severe cardiac disease or significant findings on the screening ECG

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