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

Roche

Status and phase: Enrolling; Phase 3

Conditions: Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Treatments: Other: Placebo; Drug: Satralizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05271409

WN43194

Details and patient eligibility

About

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

Enrollment: 152 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups, including a placebo group

Group A: Satralizumab

Experimental group

Description:

In the double-blind treatment period, participants will receive satralizumab at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.

Treatment:

Drug: Satralizumab

Group B: Placebo

Placebo Comparator group

Description:

In the double-blind treatment period, participants will receive satralizumab matching placebo at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.

Treatment:

Other: Placebo