What side effects are associated with this type of intervention?

Common treatments for Churg-Strauss Syndrome, particularly those targeting IL-5 like mepolizumab and depemokimab, generally have a favorable safety profile. The most frequently reported side effects include injection site reactions (e.g., pain, erythema, and swelling), headache, and nasopharyngitis. Serious adverse events are rare but can include hypersensitivity reactions such as rash, pruritus, and urticaria. Overall, these treatments are well-tolerated, with most side effects being mild to moderate in severity.

What prior FDA approvals exist?

Mepolizumab, a monoclonal antibody targeting IL-5, has been approved by the FDA for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA). Mepolizumab works by reducing eosinophil levels and inflammation, similar to the mechanism being studied for Depemokimab. Other related treatments include biologics like benralizumab and reslizumab, which also target eosinophils but are not specifically approved for EGPA.

What other types of research exist?

Promising alternatives to Depemokimab for Churg-Strauss Syndrome (EGPA) patients include Mepolizumab, which is another anti-IL-5 monoclonal antibody that has shown success in treating EGPA. Other potential treatments include Benralizumab, an anti-IL-5 receptor monoclonal antibody, and Dupilumab, which targets IL-4 and IL-13 pathways and has shown efficacy in other eosinophilic conditions. These alternatives offer different mechanisms of action that may be beneficial for managing EGPA.

← Back to Search

Monoclonal Antibodies

Depemokimab vs Mepolizumab for Granulomatosis with Polyangiitis (OCEAN Trial)

Q: What is the mechanism of action of this treatment?

Churg-Strauss Syndrome (Eosinophilic Granulomatosis with Polyangiitis) is commonly treated with corticosteroids and immunosuppressive agents to reduce inflammation and suppress the immune system. Monoclonal antibodies such as mepolizumab and depemokimab target interleukin-5 (IL-5), a cytokine essential for eosinophil growth and activation. By inhibiting IL-5, these treatments lower eosinophil levels and inflammation, which is vital for controlling EGPA symptoms and preventing relapses.

Phase 3

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with a documented diagnosis of EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia defined as >1.0*10^9/Liter (L) and/or >10 percentage (%) of leucocytes plus at least 2 of the following additional features of EGPA: a biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation, neuropathy, mono or poly (motor deficit or nerve conduction abnormality), pulmonary infiltrates, non-fixed, sino-nasal abnormality, cardiomyopathy (established by echocardiography or magnetic resonance imaging), glomerulonephritis (hematuria, red cell casts, proteinuria), alveolar hemorrhage (by bronchoalveolar lavage), palpable purpura, anti-neutrophil cytoplasmic antibodies positive Myeloperoxidase or Proteinase 3

Participant (male or female) must be 18 years of age or older at the time of signing the informed consent

Must not have

Chronic or ongoing active infectious disease requiring systemic treatment

Participants diagnosed with granulomatosis with polyangiitis; previously known as Wegener's granulomatosis or microscopic polyangiitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 49 to 52

Awards & highlights

Pivotal Trial

Summary

This trial is testing two medications, depemokimab and mepolizumab, to see if they can help adults with a difficult-to-treat inflammatory condition called EGPA by reducing inflammation. Mepolizumab was previously approved for the treatment of EGPA.

Who is the study for?

Adults with relapsing or refractory EGPA who are at least 18 years old, weigh more than 40 kg, and can consent to the study. They must have stable immunosuppressive therapy doses (excluding cyclophosphamide), a non-pregnant/non-breastfeeding status with effective contraception if of childbearing potential, and be on a steady oral steroid dose. Participants should not have severe organ-threatening conditions or recent cancer remission.

What is being tested?

The trial is testing the effectiveness and safety of depemokimab versus mepolizumab in adults with EGPA alongside standard care. It involves comparing these drugs to their respective placebos to see which one better controls the disease symptoms.

What are the potential side effects?

Potential side effects may include allergic reactions to monoclonal antibodies, issues from immune system suppression such as increased infection risk, and possible abnormalities in liver function tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with EGPA for at least 6 months and meet the specific criteria.

Select...

I am 18 years old or older.

Select...

I weigh at least 40 kilograms.

Select...

My immunosuppressive medication dose has been stable for the last 4 weeks.

Select...

My condition has come back or hasn't responded to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently being treated for a long-term infection.

Select...

I have been diagnosed with granulomatosis with polyangiitis or microscopic polyangiitis.

Select...

I have had a parasitic infestation in the last 6 months.

Select...

I am allergic to certain monoclonal antibodies or biologic therapies.

Select...

My condition is severe EGPA as defined by EULAR.

Select...

My heart condition is severe and not controlled by standard treatments.

Select...

My cancer has been in remission for less than a year.

Select...

My EGPA condition has been life-threatening in the last 3 months.

Select...

I have other health issues not related to my EGPA that aren't well-managed with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 49 to 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 49 to 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 49 to 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with remission (Birmingham Vasculitis Activity Score [BVAS] =0 and a dose of oral corticosteroid [OCS] less than or equal to [<=] 4 milligram [mg] per day)

Secondary study objectives

Number of participants in each category of accrued duration of remission

Number of participants in each category of accrued duration of remission according to the EULAR definition of remission (BVAS = 0 plus OCS <=7.5 mg/day) over 52-week intervention period

Number of participants receiving in each category of mean OCS dose during the last 4 weeks of study treatment period (Weeks 49 to 52)

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Participants receiving depemokimab+placebo matching mepolizumabExperimental Treatment2 Interventions

Group II: Participants receiving mepolizumab+placebo matching depemokimabActive Control2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Depemokimab

2022

Completed Phase 1

~140

Placebo matching mepolizumab

2017

Completed Phase 3

~110

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Churg-Strauss Syndrome (Eosinophilic Granulomatosis with Polyangiitis) is commonly treated with corticosteroids and immunosuppressive agents to reduce inflammation and suppress the immune system. Monoclonal antibodies such as mepolizumab and depemokimab target interleukin-5 (IL-5), a cytokine essential for eosinophil growth and activation. By inhibiting IL-5, these treatments lower eosinophil levels and inflammation, which is vital for controlling EGPA symptoms and preventing relapses.

Mechanisms of endothelial cell injury in vasculitis.A Pediatric Case of Relapsing Eosinophilic Granulomatosis with Polyangiitis Successfully Treated with Mepolizumab.Targeted biologic approaches to the treatment of systemic vasculitis.