A clinical trial to compare satralizumab to placebo, with or without background therapy, in people with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

  • MOG Antibody Disease
Trial Status:

Not yet recruiting

This trial runs in
Cities
  • Baltimore
  • Berlin
  • Bochum
  • Boston
  • Box Hill
  • Bunkyo City
  • cheng-du-shi
  • Chiba
  • Chicago
  • Cincinnati
  • Cleveland
  • Columbus
  • Concord
  • Dallas
  • datteln
  • Düsseldorf
  • Gainesville
  • Goyang-si
  • Greer
  • guang-zhou-shi
  • Hamilton
  • hang-zhou-shi
  • Jacksonville
  • Kiel
  • Koriyama
  • Milwaukee
  • Minato City
  • Montréal
  • München
  • New Lambton Heights
  • New York
  • Ottawa
  • Paraná
  • Parkville
  • Rio Grande do Sul
  • Rochester
  • Scottsdale
  • Sendai
  • Seoul
  • shang-hai-shi
  • St Leonards
  • Stanford
  • São Paulo
  • tai-yuan-shi
  • tian-jin-shi
  • Toronto
  • Washington
  • 横浜市
Trial Identifier:

NCT05271409 WN43194

      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

      The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT05271409 , WN43194 Trial Identifier
      All Gender
      ≥12 Years Age
      No Healthy Volunteers

      How does the Meteoroid (WN43194) clinical trial work?

      This clinical trial is recruiting people who have a type of disease called myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). In order to take part, patients must be at least 12 years old, with a confirmed diagnosis of MOGAD.

      The purpose of this clinical trial is to compare the effects, good or bad, of satralizumab with or without background therapy versus placebo with or without background therapy in patients with MOGAD. In this clinical trial, you will get either satralizumab with or without background therapy, or placebo with or without background therapy. Background therapy is the treatment you take regularly to prevent MOGAD attacks (relapses).

      How do I take part in this clinical trial?

      To be able to take part in this clinical trial, you must be at least 12 years old, have been diagnosed with MOGAD according to certain criteria, and weigh at least 20 kg. You must have had at least one attack in the last year, or at least two attacks in the last two years (this may include the first attack and at least one relapse).

      You must not have had a relapse within the 12 weeks before entering the clinical trial, unless you have fully recovered from this relapse. If you have certain other medical conditions or have previously taken certain medicines, you may not be able to take part in this clinical trial. You must not be pregnant, breastfeeding, or intending to become pregnant. Certain types of vaccinations (live and attenuated [weakened] vaccines) are not allowed within the six weeks before starting the clinical trial or during the clinical trial.

      If you think this clinical trial may be suitable for you 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, 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 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 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, and for at least three months after the final dose, women (if you are not currently pregnant but can become pregnant) 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?

      This clinical trial is split into two parts. In Part 1 (double-blind period), everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and given either:

      • Satralizumab as one or two injections under the skin (subcutaneous) every four weeks plus an extra dose at Week 2, with or without background therapy. The dose you are given will be dependent on your body weight
      • OR placebo, as one or two injections under the skin (subcutaneous) every four weeks plus an extra dose at Week 2, with or without background therapy. Placebo is a medicine with no active ingredients. A placebo is used to show that the doctor or the patient do not sway the results of the clinical trial.

      You will have a 1 in 2 chance of being placed in either treatment group. Neither you nor your clinical trial doctor can choose or know the group you are in during Part 1. However, your clinical trial doctor can find out which group you are in, if your safety is at risk.

      In both groups, you may continue to receive your regular (background) therapy prescribed to prevent MOGAD relapses.

      You will be given the clinical trial treatment, satralizumab OR placebo, with or without background therapy, until researchers have seen a certain number of MOGAD attacks (relapses) among the clinical trial participants. This could take up to 44 months (roughly four years).

      If you complete Part 1 (double-blind period) of the clinical trial, you may enter Part 2 (open-label period). If you decide to enter Part 2 of the clinical trial, you will be given satralizumab, with or without background therapy, for up to two years even if you received placebo in Part 1. Both you and your clinical trial doctor will know that you are receiving satralizumab treatment during this part of the clinical trial.

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

      During the clinical trial, your scheduled clinic visits will include checks to see how you are responding to the treatment and if you are experiencing any side effects. Clinical trial doctors will perform these checks. These will happen before you are given your next dose of clinical trial treatment.

      You are free to stop this treatment at any time. After your final dose, you will still have regular check-ups with your clinical trial doctor every four weeks. These check-ups will be done over the phone to check if you are experiencing any side effects. All participants will have a clinic visit for final tests after 12 weeks, and again after another 12 weeks if you are an adolescent.

      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/NCT05271409

      Trial-identifier: NCT05271409

      Trial Summary

      The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT05271409 , WN43194 Trial Identifier
      Satralizumab, Placebo Treatments
      Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) Condition
      Official Title

      A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab As Monotherapy Or In Addition To Baseline Therapy In Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

      Eligibility Criteria

      All Gender
      ≥12 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Participants who are aged >=12 years at the time of signing Informed Consent Form
      • Confirmed diagnosis of MOGAD with a history of >=1 MOGAD relapse in the 12 months prior to screening or >=2 attacks in the 24 months prior to screening
      • Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
      • Best corrected visual acuity (BCVA) better than 20/800 in both eyes at screening
      • Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
      • For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab
      Exclusion Criteria
      • Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum
      • History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
      • Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study
      • Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
      • Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
      • Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
      • Participants with positive screening tests for hepatitis B and C
      • Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
      • History of severe allergic reaction to a biologic agent

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