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

JRCT ID: jRCT2021220005

Registered date:23/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOGAD)
• Date of first enrollment: 06/01/2023
• Target sample size: 152
• Countries of recruitment: United States,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,China,Japan,France,Japan,Germany,Japan,Italy,Japan,Republic of Korea,Japan
• Study type: Interventional
• Intervention(s): Satralizumab: 120 mg SC injection every 4 weeks (Q4W)

Outcome(s)

Primary Outcome

Efficacy
Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC)

Secondary Outcome

Safety, Efficacy, Exploratory, Phamacokinetics, Other
To evaluate the efficacy of satralizumab compared with placebo
- Annualized rate of adjudicated MOGAD relapses
- Annualized rate of active lesions on MRI of the neuroaxis
- Proportion of participants receiving rescue therapy
- Annualized rate of inpatient hospitalizations

To evaluate the safety of satralizumab compared with placebo

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Participants who are capable of giving signed informed consent and are aged >=12 years at the time of signing Informed Consent Form
2. 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
3. Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
4. High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening
5. Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
6. 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

Exclude criteria

1. Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum
2. History of encephalitis unrelated to MOGAD
3. 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
4. Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
5. Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
6. Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
7. Participants with positive screening tests for hepatitis B and C
8. Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
9. History of severe allergic reaction to a biologic agent

Related Information

• Primary Sponsor: Ivana Vodopivec
• Secondary ID(s): NCT05271409