Satralizumab for MOG Antibody Disease

(Meteoroid Trial)

Recruiting at 113 trial locations

Overseen By Reference 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

Must not be taking: Corticosteroids, others

Disqualifiers: AQP4-IgG, NMDAR encephalitis, infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests satralizumab, an immunotherapy, to determine its effectiveness for people with MOG Antibody Disease (MOGAD), a condition causing relapses or flare-ups in the brain, optic nerves, and spinal cord. Researchers aim to discover if satralizumab can delay the time until the next relapse compared to a placebo. The trial consists of two parts: initially, participants receive either the drug or a placebo, and later, all can receive the actual drug. Individuals aged 12 or older who have experienced at least one MOGAD relapse in the past year may qualify for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that satralizumab is likely to be safe for humans?

Research shows that satralizumab is generally safe for people. In earlier studies, researchers tested it on individuals with neuromyelitis optica spectrum disorder (NMOSD), which is similar to MOG antibody disease. The results indicated that satralizumab is well-tolerated, with most people not experiencing serious side effects.

Some participants reported mild to moderate side effects, such as headaches, joint pain, and colds. These side effects are common with many medications and usually do not last long.

The FDA has already approved satralizumab for treating NMOSD, meaning experts have reviewed and approved its use for similar conditions. This approval adds confidence in its safety for people with MOG antibody disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Satralizumab is unique because it targets the interleukin-6 (IL-6) receptor, which plays a key role in the inflammatory process of MOG antibody disease. Unlike standard treatments that may focus on general immunosuppression, satralizumab specifically inhibits IL-6 signaling, potentially offering more targeted control of the disease. Researchers are excited about this treatment because it could lead to fewer side effects and better disease management compared to broader immunosuppressive therapies. Additionally, its dosing schedule, with maintenance doses every four weeks, offers convenience for patients compared to more frequent treatments.

What evidence suggests that satralizumab might be an effective treatment for MOG antibody disease?

Research has shown that satralizumab, which participants in this trial may receive, can help reduce relapses in people with MOGAD, a condition affecting the nervous system. In earlier studies, satralizumab proved safe and effective for treating a similar condition known as NMOSD. This suggests that satralizumab might also benefit people with MOGAD. Specifically, some high-risk MOGAD patients experienced positive results when satralizumab was added to their treatment. Overall, these findings support the potential of satralizumab to help manage MOGAD. ^{1 2 4 6 7}

Who Is on the Research Team?

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.

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.

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?

Group I: Satralizumab Experimental Treatment 1 Intervention

In the DB 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. Additional adolescent participants will be directly enrolled in the OLE period to receive satralizumab.

Group II: Placebo Placebo Group 1 Intervention

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

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

Approved in United States as Enspryng for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Approved in European Union as Enspryng for:

• Neuromyelitis optica spectrum disorder (NMOSD)

Approved in Canada as Enspryng for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Approved in Japan as Enspryng for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Approved in Switzerland as Enspryng for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

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

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benralizumab as a Steroid-Sparing Treatment Option in Eosinophilic Granulomatosis with Polyangiitis. Guntur, VP., Manka, LA., Denson, JL., et al.[2022]

In a real-world study of 16 patients with relapsing/refractory eosinophilic granulomatosis with polyangiitis (EGPA), mepolizumab (MPZ) showed a 75% remission rate after one year, indicating its effectiveness in managing this condition.

MPZ treatment led to significant reductions in disease activity, as measured by the Birmingham vasculitis activity score (BVAS) and eosinophil counts, while also allowing for a decrease in corticosteroid use, demonstrating its safety and a corticosteroid-sparing effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of mepolizumab in combination with corticosteroids in patients with eosinophilic granulomatosis with polyangiitis. Ueno, M., Miyagawa, I., Nakano, K., et al.[2021]

Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, has shown to be both highly effective and safe in treating eosinophilic granulomatosis with polyangiitis (EGPA), particularly in cases with severe symptoms like myocarditis.

The case report highlights the potential of benralizumab to manage relapses in EGPA, suggesting that this biotherapy could be a valuable treatment option for patients with different phenotypes of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful benralizumab for eosinophilic myocarditis in eosinophilic granulomatosis with polyangiitis. Belfeki, N., Abroug, S., Ghriss, N., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis. Steinfeld, J., Bradford, ES., Brown, J., et al.[2021]

Citations

1. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/autoimmune-disorder/mog-antibody-disease/a-study-to-evaluate-the-efficacy--safety--pharmacokinet-94806.html

Clinical Trial - Myelin Oligodendrocyte Glycoprotein Anti... A clinical trial to compare satralizumab with placebo, with or without background therapy, in people with myelin oligodendrocyte glycoprotein antibody- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11648988/

Satralizumab as an adjunctive therapy for AQP-4 antibody and ... The serological tests for common pathogens, including the aquaporin-4 antibody (AQP-4 Ab), myelin oligodendrocyte glycoprotein antibody (MOG-Ab) ...

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000208464

Satralizumab as An Add-on Treatment in Refractory ... Satralizumab may be effective and safe as adjuvant therapy in patients with MOGAD at high risk of relapse.

4. mogproject.org mogproject.org/wp-content/uploads/2024/02/METEOROID-Overview-FINAL01172024.pdf

METEOROID Two clinical trials showed that satralizumab is safe and works as a treatment for neuromyelitis optica spectrum disorder. (NMOSD). Satralizumab has already been.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1044532325000168

Myelin oligodendrocyte glycoprotein antibody-associated ... This review explores recent insights in the understanding of MOGAD pathogenesis as well as advances in prognostic biomarkers of relapsing course and disease ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12429651/

Myelin Oligodendrocyte Glycoprotein Antibody-Associated ... Clinically, MOGAD manifests as diverse phenotypes, including optic neuritis (ON), transverse myelitis (TM), acute disseminated encephalomyelitis (ADEM), and ...

7. chugai-pharm.co.jp chugai-pharm.co.jp/english/news/detail/20230324150001_976.html

Chugai Receives Forerunner Designation for Enspryng in ... Chugai received forerunner designation for the expected indication for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) ...