This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) (OCEAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05263934
Recruitment Status : Recruiting
First Posted : March 3, 2022
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.

Condition or disease Intervention/treatment Phase
Eosinophilic Granulomatosis With Polyangiitis Biological: Depemokimab Biological: Mepolizumab Drug: Placebo matching mepolizumab Drug: Placebo matching depemokimab Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will receive either depemokimab plus placebo matching mepolizumab or mepolizumab plus placebo matching depemokimab
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind study.
Primary Purpose: Treatment
Official Title: A 52-week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-centre, Non-inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) Receiving Standard of Care (SoC) Therapy
Actual Study Start Date : July 14, 2022
Estimated Primary Completion Date : October 10, 2025
Estimated Study Completion Date : November 7, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Mepolizumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Participants receiving depemokimab+placebo matching mepolizumab Biological: Depemokimab
Depemokimab will be administered

Drug: Placebo matching mepolizumab
Placebo matching to mepolizumab will be administered.
Active Comparator: Participants receiving mepolizumab+placebo matching depemokimab Biological: Mepolizumab
Mepolizumab will be administered

Drug: Placebo matching depemokimab
Placebo matching to depemokimab will be administered.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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) [ Time Frame: Up to Week 52 ]
    Participants must be in remission at both Weeks 36 and 52.


Secondary Outcome Measures :
  1. Number of participants in each category of accrued duration of remission [ Time Frame: Up to Week 52 ]
    Total accrued duration of remission is the accrued number of weeks where BVAS = 0 plus OCS dose <= 4 mg/day over the 52-week intervention period. The accrued duration was categorized into zero, >0 to <12 weeks, 12 to <24 weeks, 24 to <36 weeks or more than or equal to (>=) 36 weeks.

  2. Number of participants with total accrued duration of remission [ Time Frame: Up to Week 52 ]
    Total accrued duration of remission is the accrued number of weeks where BVAS = 0 plus OCS dose <= 4 mg/day over the 52-week intervention period.

  3. Time to first EGPA relapse [ Time Frame: Up to Week 52 ]
    The time to first EGPA relapse will be calculated from the date of first dose of study intervention and start date of the EGPA relapse.

  4. Number of participants receiving in each category of mean OCS dose during the last 4 weeks of study treatment period (Weeks 49 to 52) [ Time Frame: Weeks 49 to 52 ]
    Number of participants receiving the mean OCS dose (categorized as 0, >0 to <=4, >4 to <=7.5 or >7.5 mg/day) will be assessed during the last 4 weeks of the study treatment period (Weeks 49 to 52).

  5. Number of participants achieving remission (BVAS = 0 and OCS <= 4mg/day) within the first 24 weeks with continued remission until Week 52 [ Time Frame: Up to Week 52 ]
  6. Number of participants achieving remission using the European League against Rheumatism (EULAR) definition (BVAS = 0 and OCS <=7.5 mg/day) at Weeks 36 and 52 [ Time Frame: At Weeks 36 and 52 ]
  7. 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 [ Time Frame: Up to Week 52 ]
    Total accrued duration of remission according to the EULAR definition of remission is the accrued number of weeks where BVAS = 0 plus OCS dose <=7.5 mg/day over the 52 week intervention period categorized as zero weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks or >= 36 weeks.

  8. Number of participants with total accrued duration of remission according to the EULAR definition of remission [ Time Frame: Up to Week 52 ]
    Total accrued duration of remission according to the EULAR definition of remission is the accrued number of weeks where BVAS=0 plus OCS <=7.5 mg/day over the 52-week intervention period.

  9. Number of participants with remission (BVAS=0 and OCS <=7.5 mg/day) within the first 24 weeks with continued remission until Week 52 [ Time Frame: Up to Week 52 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant (male or female) must be 18 years of age or older at the time of signing the informed consent.
  • Participants who are >=40 kilogram at Screening Visit 1.
  • 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.
  • History of relapsing OR refractory disease.
  • Participants must be on a stable dose of oral prednisolone or prednisone of >=7.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to Baseline (Visit 2).
  • If participants receiving immunosuppressive therapy (excluding cyclophosphamide) the dosage must be stable for the 4 weeks prior to Baseline (Visit 2) and during the study.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%.
  • Capable of giving signed informed consent

Exclusion Criteria:

  • Participants diagnosed with granulomatosis with polyangiitis; previously known as Wegener's granulomatosis or microscopic polyangiitis.
  • Participants with organ-threatening EGPA as per EULAR criteria,
  • Imminently life-threatening EGPA disease within 3 months prior to Screening (Visit 1).
  • A current malignancy or previous history of cancer in remission for less than 12 months prior to Screening.
  • Participants with alanine aminotransferase >2*upper limit of normal (ULN) or if participant is on background methotrexate or azathioprine >3*ULN, aspartate aminotransferase >2*ULN or if participant is on background methotrexate or azathioprine >3*ULN, alkaline phosphatase >=2.0*ULN, total bilirubin >1.5*ULN (isolated bilirubin >1.5*ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), Cirrhosis or current unstable liver or biliary disease per investigator assessment.
  • Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment.
  • Participants who have known, pre-existing, clinically significant system abnormalities that are not associated with EGPA and are uncontrolled with standard treatment.
  • Clinically significant abnormality in the hematological, biochemical or urinalysis screen at Visit 1.
  • Chronic or ongoing active infectious disease requiring systemic treatment.
  • Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening Visit 1.
  • A known immunodeficiency (e.g. human immunodeficiency virus [HIV]).
  • Participants that, according to the investigator's medical judgment, are likely to have active coronavirus disease 2019 (COVID-19) infection. Participants with known COVID-19 positive contacts within the past 14 days must be excluded for at least 14 days following the exposure during which the participant must remain symptom-free.
  • Participants with a known allergy or intolerance to a monoclonal antibody or biologic therapy or any of the excipients of the investigational products.
  • Participants who have a previous documented failure with anti-Interleukin-5 /Interleukin-5 receptor therapy. Participants who have received monoclonal antibodies (mAb) and who have not undergone the required washout periods, prior to Visit 1.
  • Participants receiving any of the following: Oral corticosteroids: Participant requires an oral corticosteroid dose of >50 mg/day prednisolone/prednisone in the 4-week period prior to Baseline (Visit 2), Intravenous (IV), intramuscular or subcutaneous (SC) corticosteroids in the 4-week period prior to Baseline (Visit 2), Omalizumab within 130 days prior to Screening (Visit 1), Cyclophosphamide (CYC): oral CYC within 4 weeks prior to Baseline (Visit 2) and IV CYC within 3 weeks prior to Baseline (Visit 2), if their total white blood cells is >=4*10^9/L (measured using the local laboratory if necessary), Rituximab within 12 months prior to Screening (Visit 1); in addition, the Participant must have shown recovery of peripheral B-cell count to within the normal range, Tezepelumab and Dupilumab with a washout period of 5 half-lives prior to Screening Visit 1, IV or SC immunoglobulin within 6 months prior to Screening (Visit 1); For China and Japan only within 12 weeks prior to Screening (Visit 1), Interferon-alpha within 6 months prior to Screening Visit 1, Anti-tumor necrosis factor therapy within 12 weeks prior to Screening Visit 1, Anti-CD52 (alemtuzumab) within 6 months prior to Screening Visit 1.
  • Participants with QT interval corrected for heart rate according to Fridericia's formula (QTcF) >=450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from at Screening Visit 1.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT05263934


Contacts
Layout table for location contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
Show Show 86 study locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT05263934    
Other Study ID Numbers: 217102
First Posted: March 3, 2022    Key Record Dates
Last Update Posted: November 7, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Depemokimab
Mepolizumab
Eosinophilic Granulomatosis with Polyangiitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Granulomatosis with Polyangiitis
Systemic Vasculitis
Churg-Strauss Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases