A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (Meteoroid)
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ClinicalTrials.gov Identifier: NCT05271409 |
Recruitment Status :
Recruiting
First Posted : March 9, 2022
Last Update Posted : May 1, 2024
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Condition or disease | Intervention/treatment | Phase |
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Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) | Drug: Satralizumab Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 152 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | August 30, 2022 |
Estimated Primary Completion Date : | July 31, 2026 |
Estimated Study Completion Date : | December 31, 2028 |
Arm | Intervention/treatment |
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Experimental: Group A: Satralizumab
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.
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Drug: Satralizumab
Study drug will be administered by SC injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit. |
Placebo Comparator: Group B: Placebo
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.
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Other: Placebo
Placebo will be administered by SC injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit. |
- Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC) [ Time Frame: Up to approximately 44 months ]
- Annualized rate of adjudicated MOGAD relapses [ Time Frame: Up to approximately 44 months ]
- Annualized rate of active lesions on MRI of the neuroaxis [ Time Frame: Up to approximately 44 months ]
- Proportion of participants receiving rescue therapy [ Time Frame: Up to approximately 44 months ]
- Annualized rate of inpatient hospitalizations [ Time Frame: Up to approximately 44 months ]
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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05271409
Contact: Reference Study ID Number: WN43194, https://forpatients.roche.com/ | 888-662-6728 (U.S.) | global-roche-genentech-trials@gene.com |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT05271409 |
Other Study ID Numbers: |
WN43194 |
First Posted: | March 9, 2022 Key Record Dates |
Last Update Posted: | May 1, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |