A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD)

Overview

About this study

The purpose of the study is to evalute the effectiveness, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD).

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:

- Participant must be ≥18 to ≤89 years of age, at the time of signing the informed
consent

- Confirmed diagnosis of MOG-AD, which entails that the participant must have:

1. History of any of the following core clinical demyelinating events:

- Optic neuritis (single, recurrent, or simultaneous bilateral)

- Transverse myelitis (including Longitudinally extensive spinal cord lesion
(LETM))

- Acute disseminated encephalomyelitis or MOG antibody-associated
encephalitis, brain stem encephalitis

- Combined presentations

2. Positive serum MOG-IgG antibody test using cell-based assay at Screening

- Participant has history of relapsing MOG-AD with at least 1 documented relapse over
the last 12 months prior to randomization

- Participant must be clinically stable at the time of the Screening Visit and during
the Screening Period

Exclusion Criteria:

- Participant has been diagnosed with a neurological autoimmune disease (including
multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum
disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the
investigator can interfere with the safety of the participant

- Participant has a clinically relevant active infection (eg, sepsis, pneumonia, or
abscess), or has had a serious infection (resulting in hospitalization or requiring
parenteral antibiotic treatment) within 6 weeks prior to the first dose of
investigational medicinal product (IMP)

- Participant has a current or medical history of primary immunodeficiency

- Participant has a current or medical history of IgA deficiency

- Participant tests positive for aquaporin-4 antibodies at Screening

- Participant has a serum total IgG level ≤ 5.5g/L

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

Eligibility last updated 12/22/22. 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:

Melissa Bush

Bush.Melissa1@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Alfonso Lopez Chiriboga, M.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:

Pamela Desaro CCRP

Desaro.Pamela@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Nicholas Zalewski, M.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
.
CLS-20535974

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