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(352) 733-0111

Meteoroid

  • Status
    Accepting Candidates
  • Age
    12 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
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Objective

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

Details

Full study 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)
Protocol number OCR41512
ClinicalTrials.gov ID NCT05271409
Phase Phase 3

Eligibility

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 (HCVA) better than 20/800 in each eye 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

Lead researcher

  • Torge Rempe, MD, PhD
    Neurologist
    Languages: Spanish, German
    Torge Rempe

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.