152 Participants Needed

Satralizumab for MOG Antibody Disease

(Meteoroid Trial)

Recruiting at 95 trial locations
RS
Overseen ByReference Study ID Number: WN43194, https://forpatients.roche.com/
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Hoffmann-La Roche
Must be taking: Immunosuppressants
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing satralizumab, a medication that helps prevent relapses in patients with MOGAD by reducing inflammation and stopping the immune system from attacking the nervous system.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on ongoing chronic immunosuppressant treatment for MOGAD at the time of screening.

How is the drug Satralizumab unique for treating MOG Antibody Disease?

Satralizumab is unique because it targets the interleukin-6 receptor, which is different from other treatments that may target different pathways or use broader immunosuppressive strategies. It is administered as a subcutaneous injection, which can be more convenient compared to intravenous treatments.12345

Who Is on the Research Team?

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for people aged 12 and older with confirmed MOGAD who've had at least one relapse in the past year or two in the last two years. Participants must not be pregnant, agree to use contraception, have a certain level of disability (EDSS score 0-6.5), and good vision (BCVA better than 20/800). They can't join if they have other antibodies, infections, hepatitis B/C, are pregnant/breastfeeding, recently vaccinated with live vaccines, severe allergies to biologics or need high doses of steroids.

Inclusion Criteria

I have MOGAD and had at least one relapse in the last year or two attacks in the last two years.
I agree to use birth control or remain abstinent during and for 3 months after my treatment.
I am not on or am currently taking long-term immune system suppression medication for MOGAD.
See 3 more

Exclusion Criteria

Participants with positive screening tests for hepatitis B and C
History of severe allergic reaction to a biologic agent
I don't have any other illness needing strong steroids for more than 3 weeks.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive satralizumab or placebo at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks thereafter

Variable, based on time to first MOGAD relapse
Visits at Weeks 0, 2, 4, and every 4 weeks thereafter

Open-label Extension

All participants receive open label treatment with satralizumab

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • Satralizumab
Trial Overview The study tests whether Satralizumab is more effective than a placebo in preventing relapses in patients with MOGAD. It measures the time until a participant has their first relapse after starting treatment during a double-blind period where neither doctors nor participants know who's getting Satralizumab or placebo.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: SatralizumabExperimental Treatment1 Intervention
Group II: Group B: PlaceboPlacebo Group1 Intervention

Satralizumab is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:

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Approved in United States as Enspryng for:
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Approved in European Union as Enspryng for:
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Approved in Canada as Enspryng for:
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Approved in Japan as Enspryng for:
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Approved in Switzerland as Enspryng for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Chugai Pharmaceutical

Industry Sponsor

Trials
105
Recruited
25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical University

Published Research Related to This Trial

Mepolizumab (MPZ) demonstrated a 100% retention rate in patients with severe eosinophilic granulomatosis with polyangiitis (EGPA), indicating strong adherence and effectiveness as a remission induction therapy compared to intravenous cyclophosphamide (IVCY), which had a completion rate of only 61.5%.
Patients treated with MPZ experienced fewer adverse events (28.6%) compared to those receiving IVCY (53.8%), and the MPZ group showed a significantly greater reduction in corticosteroid doses after 3 months, suggesting MPZ may be a safer and more effective option for managing EGPA.
Safety and effectiveness of mepolizumab therapy in remission induction therapy for eosinophilic granulomatosis with polyangiitis: a retrospective study.Ueno, M., Miyagawa, I., Aritomi, T., et al.[2022]
In a phase III trial, mepolizumab significantly improved clinical outcomes in patients with eosinophilic granulomatosis with polyangiitis (EGPA), with 78% achieving a comprehensive definition of clinical benefit compared to 32% in the placebo group.
The treatment was particularly effective in patients with lower baseline eosinophil counts and those weighing more than 85 kg, indicating that mepolizumab can provide substantial benefits in managing EGPA symptoms and reducing glucocorticoid dependency.
Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis.Steinfeld, J., Bradford, ES., Brown, J., et al.[2021]
In a 40-week pilot study involving 10 patients with eosinophilic granulomatosis with polyangiitis (EGPA), benralizumab was well tolerated and significantly reduced the median oral corticosteroid dose from 15 mg to 2 mg by the end of treatment.
Benralizumab also decreased the mean annualized exacerbation rate from 4.6 to 1.5 during treatment, indicating its potential efficacy in managing EGPA symptoms.
Benralizumab as a Steroid-Sparing Treatment Option in Eosinophilic Granulomatosis with Polyangiitis.Guntur, VP., Manka, LA., Denson, JL., et al.[2022]

Citations

Safety and effectiveness of mepolizumab therapy in remission induction therapy for eosinophilic granulomatosis with polyangiitis: a retrospective study. [2022]
Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis. [2021]
Benralizumab as a Steroid-Sparing Treatment Option in Eosinophilic Granulomatosis with Polyangiitis. [2022]
Effectiveness and safety of mepolizumab in combination with corticosteroids in patients with eosinophilic granulomatosis with polyangiitis. [2021]
Successful benralizumab for eosinophilic myocarditis in eosinophilic granulomatosis with polyangiitis. [2022]
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