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

Overview

About this study

The purpose of this study is to evaluate the effectiveness, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo as monotherapy or in addition (add-on) to baseline/background ISTs for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) relapse prevention.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/2/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Eoin Flanagan, M.B., B.Ch.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Carol Larson

(507) 422-9337

Denny.Carol@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Cristina Valencia Sanchez, M.D., Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Neil Santos

(480) 301-4252

Santos.Neil@mayo.edu

More information

Publications

Publications are currently not available