Informations générales (source: ClinicalTrials.gov)
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 (OCEAN)
Interventional
Phase 3
GlaxoSmithKline (Voir sur ClinicalTrials)
juillet 2022
juin 2026
25 avril 2025
This study aims to investigate the efficacy and safety of depemokimab compared with
mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | JEAN-EMMANUEL KAHN | 05/05/2025 07:12:11 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| GSK Investigational Site - 29609 - Brest Cedex - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 31059 - Toulouse Cedex 9 - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 34295 - Montpellier cedex - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 44093 - Nantes Cedex 1 - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 59037 - Lille - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 75014 - Paris - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 85925 - La Roche Sur Yon - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 92150 - Suresnes - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.