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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05263934




Registration number
NCT05263934
Ethics application status
Date submitted
28/02/2022
Date registered
3/03/2022

Titles & IDs
Public title
Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Scientific 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
Secondary ID [1] 0 0
217102
Universal Trial Number (UTN)
Trial acronym
OCEAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Granulomatosis With Polyangiitis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Depemokimab
Treatment: Other - Mepolizumab
Treatment: Drugs - Placebo matching mepolizumab
Treatment: Drugs - Placebo matching depemokimab

Experimental: Participants receiving depemokimab+placebo matching mepolizumab -

Active comparator: Participants receiving mepolizumab+placebo matching depemokimab -


Treatment: Other: Depemokimab
Depemokimab will be administered

Treatment: Other: Mepolizumab
Mepolizumab will be administered

Treatment: Drugs: Placebo matching mepolizumab
Placebo matching to mepolizumab will be administered.

Treatment: Drugs: Placebo matching depemokimab
Placebo matching to depemokimab will be administered.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [1] 0 0
Number of participants in each category of accrued duration of remission
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [2] 0 0
Number of participants with total accrued duration of remission
Timepoint [2] 0 0
Up to Week 52
Secondary outcome [3] 0 0
Time to first EGPA relapse
Timepoint [3] 0 0
Up to Week 52
Secondary outcome [4] 0 0
Number of participants receiving in each category of mean OCS dose during the last 4 weeks of study treatment period (Weeks 49 to 52)
Timepoint [4] 0 0
Weeks 49 to 52
Secondary outcome [5] 0 0
Number of participants achieving remission (BVAS = 0 and OCS <= 4mg/day) within the first 24 weeks with continued remission until Week 52
Timepoint [5] 0 0
Up to Week 52
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
At Weeks 36 and 52
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Up to Week 52
Secondary outcome [8] 0 0
Number of participants with total accrued duration of remission according to the EULAR definition of remission
Timepoint [8] 0 0
Up to Week 52
Secondary outcome [9] 0 0
Number of participants with remission (BVAS=0 and OCS <=7.5 mg/day) within the first 24 weeks with continued remission until Week 52
Timepoint [9] 0 0
Up to Week 52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/11/2025
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 0 0
GSK Investigational Site - Canberra
Recruitment postcode(s) [1] 0 0
2606 - Canberra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oklahoma
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Tucumán
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Brazil
State/province [14] 0 0
São Paulo
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
China
State/province [16] 0 0
Guangdong
Country [17] 0 0
China
State/province [17] 0 0
Jiangsu
Country [18] 0 0
China
State/province [18] 0 0
Liaoning
Country [19] 0 0
China
State/province [19] 0 0
Shandong
Country [20] 0 0
China
State/province [20] 0 0
Yunnan
Country [21] 0 0
China
State/province [21] 0 0
Beijing
Country [22] 0 0
China
State/province [22] 0 0
Guangzhou
Country [23] 0 0
China
State/province [23] 0 0
Hefei
Country [24] 0 0
China
State/province [24] 0 0
Shanghai
Country [25] 0 0
China
State/province [25] 0 0
Wenzhou
Country [26] 0 0
Czechia
State/province [26] 0 0
Liben
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha
Country [28] 0 0
France
State/province [28] 0 0
Angers Cedex 09
Country [29] 0 0
France
State/province [29] 0 0
Brest Cedex
Country [30] 0 0
France
State/province [30] 0 0
La Roche sur Yon Cedex 9
Country [31] 0 0
France
State/province [31] 0 0
Lille Cedex
Country [32] 0 0
France
State/province [32] 0 0
Montpellier cedex 5
Country [33] 0 0
France
State/province [33] 0 0
Nantes Cedex 1
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Pessac
Country [36] 0 0
France
State/province [36] 0 0
Suresnes
Country [37] 0 0
France
State/province [37] 0 0
Toulouse
Country [38] 0 0
Germany
State/province [38] 0 0
Baden-Wuerttemberg
Country [39] 0 0
Hungary
State/province [39] 0 0
Budapest
Country [40] 0 0
Israel
State/province [40] 0 0
Kfar Saba
Country [41] 0 0
Israel
State/province [41] 0 0
Ramat-Gan
Country [42] 0 0
Italy
State/province [42] 0 0
Lazio
Country [43] 0 0
Italy
State/province [43] 0 0
Lombardia
Country [44] 0 0
Italy
State/province [44] 0 0
Marche
Country [45] 0 0
Italy
State/province [45] 0 0
Puglia
Country [46] 0 0
Italy
State/province [46] 0 0
Toscana
Country [47] 0 0
Italy
State/province [47] 0 0
Veneto
Country [48] 0 0
Italy
State/province [48] 0 0
Torino
Country [49] 0 0
Japan
State/province [49] 0 0
Kanagawa
Country [50] 0 0
Japan
State/province [50] 0 0
Saitama
Country [51] 0 0
Japan
State/province [51] 0 0
Tokyo
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Chonju
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Gwangju
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seoul
Country [55] 0 0
Netherlands
State/province [55] 0 0
Groningen
Country [56] 0 0
Netherlands
State/province [56] 0 0
Leiden, RC
Country [57] 0 0
Poland
State/province [57] 0 0
Gdansk
Country [58] 0 0
Poland
State/province [58] 0 0
Lodz
Country [59] 0 0
Poland
State/province [59] 0 0
Warszawa
Country [60] 0 0
Portugal
State/province [60] 0 0
Lisboa
Country [61] 0 0
Portugal
State/province [61] 0 0
Porto
Country [62] 0 0
Spain
State/province [62] 0 0
Badalona
Country [63] 0 0
Spain
State/province [63] 0 0
Barcelona
Country [64] 0 0
Spain
State/province [64] 0 0
Granada
Country [65] 0 0
Spain
State/province [65] 0 0
Pamplona
Country [66] 0 0
Spain
State/province [66] 0 0
Valencia
Country [67] 0 0
Spain
State/province [67] 0 0
Zaragoza
Country [68] 0 0
Sweden
State/province [68] 0 0
Malmö
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Birmingham
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Cambridge
Country [71] 0 0
United Kingdom
State/province [71] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05263934