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Rozanolixizumab

Clinical trials are studying Rozanolixizumab in people with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and generalized myasthenia gravis. These studies look at long-term safety, how well the treatment works, and how the body handles it in adults and children. The trials include Phase 3 and Phase 4 studies.

Table of Contents

Trial overview

The clinical trial data for Rozanolixizumab include three interventional studies, all marked as authorised.[1][2][3] One study is in adults with relapsing myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), and two studies are in children and teenagers with generalized myasthenia gravis.[1][2][3]

These studies are looking at both efficacy and safety, which means they aim to learn whether the treatment works and whether it can be used safely in the study groups.[1][2][3]

Study in relapsing MOGAD

NCT05063162 is a Phase 3 study with 110 participants, and it is designed to learn if Rozanolixizumab works and is safe over a long period in adults with relapsing MOGAD.[1] The brief summary says the study is evaluating the efficacy of Rozanolixizumab for participants with MOGAD.[1]

The main endpoint for Part A is the time from randomization to first independently centrally adjudicated relapse during the double-blind treatment period.[1] In simple words, the study checks how long it takes before a relapse happens after people are assigned to a study group, and the relapse is reviewed by an independent central team.[1]

Part B focuses on safety during the open-label extension period, including treatment-emergent adverse events and adverse events that lead to permanent withdrawal of the investigational medicinal product.[1]

Pediatric study in generalized myasthenia gravis

NCT06149559 is a Phase 4 interventional study with 12 participants, and it is designed to learn if Rozanolixizumab is safe, how it moves through the body, and if it works in children with myasthenia gravis.[2] The brief summary says it is assessing the safety and tolerability of subcutaneous administration in pediatric participants aged 2 to under 18 years with generalized myasthenia gravis.[2]

The primary outcomes are serious treatment-emergent adverse events, treatment-emergent adverse events that lead to permanent withdrawal of the investigational medicinal product, and adverse events of special monitoring, all measured up to the end of study visit, which is up to 18 weeks.[2]

This study is important because it focuses on children and teenagers, a group that often needs age-specific research before a treatment can be better understood in that population.[2]

Extension study in pediatric generalized myasthenia gravis

NCT06540144 is a Phase 3 extension study with 12 participants, and it looks at whether multiple treatment cycles of Rozanolixizumab are safe and work in children with myasthenia gravis.[3] The brief summary says the study is assessing the long-term safety and tolerability of additional 6-week treatment cycles in pediatric participants with generalized myasthenia gravis aged 2 years and older at the screening visit of MG0006.[3]

Its main safety outcomes are the same type of measures used in the other pediatric study: serious treatment-emergent adverse events, events that lead to permanent withdrawal of the study drug, and adverse events of special monitoring.[3]

Because it is an extension study, it is meant to add more follow-up time and more information about longer-term use in children with generalized myasthenia gravis.[3]

Main endpoints and what they mean

Primary endpoints are the main results that a trial is designed to measure.[1][2][3] In these studies, the endpoints are mostly about relapse timing and safety events.[1][2][3]

  • Time to first relapse in the MOGAD study means how long it takes before the disease comes back after randomization.[1]
  • Serious treatment-emergent adverse events are serious health problems that start after treatment begins and are watched closely in the pediatric studies.[2][3]
  • Permanent withdrawal of investigational medicinal product means the study treatment is stopped for good because of a problem or safety concern.[2][3]
  • Adverse events of special monitoring are side effects or health problems that need extra attention from the study team.[2][3]

Who may participate

The adult study is for people with relapsing MOGAD.[1] The pediatric studies are for children and teenagers with generalized myasthenia gravis, with ages given as 2 to under 18 years in one study and 2 years and older at screening in the extension study.[2][3]

The trial data do not give full eligibility rules such as exact medical test results or prior treatment limits, so the main known participation details are the condition and age group.[1][2][3]

Key trial terms

Randomization means people are assigned by chance to a study group.[1] Double blind means the participant and the study team do not know which treatment is being given during that part of the study.[1]

Open-label extension means a later study period where treatment is known and researchers can collect longer-term data.[1] Subcutaneous use means the treatment is given under the skin.[2][3]

Investigational medicinal product is the study treatment being tested in the trial.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
NCT05063162 Phase 3 Relapsing myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) Authorised 110
NCT06149559 Phase 4 Generalized myasthenia gravis Authorised 12
NCT06540144 Phase 3 Generalized myasthenia gravis Authorised 12

FAQ

  • What conditions are being studied in Rozanolixizumab trials? The trials are studying myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and generalized myasthenia gravis. One study focuses on adults with relapsing MOGAD, and two studies focus on children with generalized myasthenia gravis.
  • Who can take part in these trials? One trial is for adults with relapsing MOGAD. The pediatric studies are for children and teenagers aged 2 to under 18 years, with one extension study starting from age 2 at screening.
  • What are the trials trying to find out? The trials aim to see if Rozanolixizumab is safe and whether it works over time. They also measure relapse timing in MOGAD and several safety outcomes in children with myasthenia gravis.
  • What trial phases are included? The data include a Phase 3 study in adults with MOGAD, a Phase 4 study in children with generalized myasthenia gravis, and another Phase 3 extension study in children with generalized myasthenia gravis.
  • What kinds of results are the studies measuring? The studies measure time to first relapse, serious treatment-emergent adverse events, events that lead to stopping the study treatment, and adverse events that need special monitoring. These are used to judge both benefit and safety.

Ongoing Clinical Trials on Rozanolixizumab

  • Study on the Safety and Effectiveness of Rozanolixizumab in Children with Generalized Myasthenia Gravis

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Poland

  • Study on the Safety and Effectiveness of Rozanolixizumab and Immunoglobulins in Children with Generalized Myasthenia Gravis

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Poland

  • Study on the Effectiveness and Safety of Rozanolixizumab for Adults with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOG-AD)

    Not recruiting

    3 1 1
    Investigated drugs:
    Belgium Czechia France Germany Greece Italy +4

Glossary

  • Clinical trial: A planned research study in people that checks whether a treatment is safe, helpful, or both.
  • Interventional study: A study where researchers give a treatment or compare treatments to see what happens.
  • Phase 3: A later-stage trial that usually tests how well a treatment works and keeps checking safety in a larger group.
  • Phase 4: A study done after a treatment is already being used, to learn more about safety, use, or benefit in real-world settings.
  • MOGAD: Short for myelin oligodendrocyte glycoprotein antibody-associated disease, a condition studied in one of the trials.
  • Generalized myasthenia gravis: A condition studied in the pediatric trials; it affects muscle strength in more than one part of the body.
  • Relapsing: A pattern where symptoms come back after a period of improvement.
  • Randomization: A process that assigns people to study groups by chance.
  • Double blind: A study setup where the participant and the study team do not know who gets which treatment during a period of the trial.
  • Open-label extension: A follow-up study period where everyone knows what treatment is being given, often used to collect longer-term safety data.
  • Treatment-emergent adverse event (TEAE): A health problem that appears or gets worse after a person starts the study treatment.
  • Adverse event of special monitoring (AESM): A side effect or health problem that the study team watches closely because it may be especially important.

References