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

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) - Meteoroid

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003192-34-DE

Enrollment

152

Registered

2021-10-21

Start date

2022-02-21

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) MedDRA version: 20.0 Level: PT Classification code 10075688 Term: Autoimmune demyelinating disease System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Enspryng Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Satralizumab Current Sponsor code: Ro 533-3787/F01- 04 Concentration unit: mg/ml milligram(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Participants who are aged >=12 years at the time of signing Informed Consent Form and 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 ? High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening ? Participants receiving either no ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening or receiving ongoing treatment with azathioprine (AZA), mycophenolate mofetil (MMF), oral corticosteroids (OCS) or a combination of OCS and AZA or MMF prior to and at the time of screening ? No contraindications to rescue treatments and no contraindications to MRI ? 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 Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 132 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

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 Exclusion Criteria Related to Previous or Concomitant Therapy ? Intravenous immunoglobulins (IVIg) or subcutaneous immunoglobulins (ScIg) within 4 weeks prior to screening ? Plasma exchange (PLEX) within 4 weeks prior to screening ? Systemic corticosteroids, AZA or MMF within 4 weeks prior to screening (if not continued as concomitant IST in the study)

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: ?To evaluate the efficacy of satralizumab compared with placebo based on rate of adjudicated MOGAD relapses, presence of active lesions on magnetic resonance imaging (MRI) of the neuroaxis, rescue therapy use, inpatient hospitalizations, and proportion of relapse-free participants at 6-month intervals ?To evaluate the safety of satralizumab compared with placebo ;Primary end point(s): 1. Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC);Timepoint(s) of evaluation of this end point: 1. Up to approximately 44 months	—

Measure

Time frame

Main Objective: 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;Secondary Objective: ?To evaluate the efficacy of satralizumab compared with placebo based on rate of adjudicated MOGAD relapses, presence of active lesions on magnetic resonance imaging (MRI) of the neuroaxis, rescue therapy use, inpatient hospitalizations, and proportion of relapse-free participants at 6-month intervals ?To evaluate the safety of satralizumab compared with placebo ;Primary end point(s): 1. Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC);Timepoint(s) of evaluation of this end point: 1. Up to approximately 44 months

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Secondary

Measure	Time frame
Secondary end point(s): 1. Rate of adjudicated MOGAD relapses 2. Active lesions on MRI of the neuroaxis (Gd-enhancing or new/enlarging T2 hyperintense lesions measured across the optic nerve, the spinal cord and the brain, including brainstem and cerebellum) 3. Proportion of participants receiving rescue therapy 4. Rate of inpatient hospitalizations (defined as more than an overnight stay, excluding those for elective procedures) 5. Proportion of relapse-free participants at 6-month intervals 6. Change from baseline in total Montreal cognitive assessment (MoCA) score (adolescents only) 7. Incidence, seriousness and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) 8. Change from baseline in targeted vital signs 9. Change from baseline in targeted electrocardiogram (ECG) parameters 10. Change from baseline in targeted clinical laboratory test results 11. Change from baseline in suicidality, as determined by Columbia-Suicide Severity Rating Scale 12. Change from baseline in weight;Timepoint(s) of evaluation of this end point: 1-12. Up to approximately 44 months	—

Measure

Time frame

Secondary end point(s): 1. Rate of adjudicated MOGAD relapses 2. Active lesions on MRI of the neuroaxis (Gd-enhancing or new/enlarging T2 hyperintense lesions measured across the optic nerve, the spinal cord and the brain, including brainstem and cerebellum) 3. Proportion of participants receiving rescue therapy 4. Rate of inpatient hospitalizations (defined as more than an overnight stay, excluding those for elective procedures) 5. Proportion of relapse-free participants at 6-month intervals 6. Change from baseline in total Montreal cognitive assessment (MoCA) score (adolescents only) 7. Incidence, seriousness and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) 8. Change from baseline in targeted vital signs 9. Change from baseline in targeted electrocardiogram (ECG) parameters 10. Change from baseline in targeted clinical laboratory test results 11. Change from baseline in suicidality, as determined by Columbia-Suicide Severity Rating Scale 12. Change from baseline in weight;Timepoint(s) of evaluation of this end point: 1-12. Up to approximately 44 months

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Countries

Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, Republic of, United States

Contacts

Public ContactTrial Information Support Line-TISL

Genentech Inc. c/o F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026