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Monoclonal Antibodies
Depemokimab vs Mepolizumab for Granulomatosis with Polyangiitis (OCEAN Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 49 to 52
Awards & highlights
OCEAN Trial Summary
This trial will compare the effectiveness and safety of two different drugs in treating a rare autoimmune disease.
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.Check my eligibility
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.See study design
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.
OCEAN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
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My condition has come back or hasn't responded to treatment.
OCEAN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 49 to 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 49 to 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Number of participants achieving remission (BVAS = 0 and OCS <= 4mg/day) within the first 24 weeks with continued remission until Week 52
Collagen Diseases
Number of participants in each category of accrued duration of remission
+6 moreOCEAN 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
Placebo matching mepolizumab
2017
Completed Phase 3
~110
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,312 Total Patients Enrolled
8 Trials studying Churg-Strauss Syndrome
1,326 Patients Enrolled for Churg-Strauss Syndrome
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,770 Total Patients Enrolled
4 Trials studying Churg-Strauss Syndrome
656 Patients Enrolled for Churg-Strauss Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and sign the consent form.I am currently being treated for a long-term infection.My liver tests are within acceptable ranges for the study, and I don't have severe liver or biliary disease.Your heart's electrical activity, as measured by a test called ECG, is outside the normal range.You have a weakened immune system, such as from HIV.I have been diagnosed with granulomatosis with polyangiitis or microscopic polyangiitis.I have had a parasitic infestation in the last 6 months.I have been diagnosed with EGPA for at least 6 months and meet the specific criteria.I am not pregnant or breastfeeding and either cannot have children or am using effective birth control.I am allergic to certain monoclonal antibodies or biologic therapies.You have been taking certain medications, such as corticosteroids or specific treatments for immune system conditions, within a certain time period before the study.I am 18 years old or older.My condition is severe EGPA as defined by EULAR.My heart condition is severe and not controlled by standard treatments.My cancer has been in remission for less than a year.I weigh at least 40 kilograms.My immunosuppressive medication dose has been stable for the last 4 weeks.My EGPA condition has been life-threatening in the last 3 months.My condition has come back or hasn't responded to treatment.I have other health issues not related to my EGPA that aren't well-managed with treatment.You have a major abnormality in your blood, urine, or other test results at the first visit.You might have COVID-19, or you have been in close contact with someone who has COVID-19 in the last 14 days.I have been taking a stable dose of prednisolone or prednisone between 7.5 and 50 mg/day for at least 4 weeks.I have tried and not responded to anti-IL5/IL5R therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving depemokimab+placebo matching mepolizumab
- Group 2: Participants receiving mepolizumab+placebo matching depemokimab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there different versions of this trial happening in different places?
"5 different research sites are conducting this study in major cities including Denver, Toronto, and Tulsa. Additionally, there are 5 other locations conducting this study. To limit travel requirements, please select the nearest location to you."
Answered by AI
Are patients being accepted into this experiment right now?
"The most recent information on clinicaltrials.gov suggests that this clinical trial is still recruiting patients. The trial was initially posted on 7/14/2022, with the most recent update being on 11/4/2022."
Answered by AI
Has the FDA cleared Depemokimab for therapeutic use?
"Depemokimab has undergone Phase 3 trials, meaning that there is both evidence of efficacy and safety. Consequently, our team rates it as a 3 on the Power scale."
Answered by AI
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