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

November 6, 2023 updated by: GlaxoSmithKline

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

This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1900
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastian Juan Magri
    • Tucumán
      • San Miguel de Tucuman, Tucumán, Argentina, T4000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hector Hugo Altieri
  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2606
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wei-I Lee
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jens Thiel
  • Belgium
      • Bruxelles, Belgium, 1070
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florence Roufosse
      • Leuven, Belgium, 3000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Daniël Blockmans
        • Contact:
        • Contact:
  • Brazil
      • São Paulo, Brazil, 4023900
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexandre Wagner Souza
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-870
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joao Antonio Correa
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 3A9
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kenneth Chapman
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5T 3L9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Pagnoux
  • China
      • Beijing, China, 100005
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Xinping Tian
        • Contact:
        • Contact:
      • Guangzhou, China, 510163
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Qingling Zhang
        • Contact:
        • Contact:
      • Guangzhou, China, 510000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lie Dai
      • Hefei, China, 230001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaomei Li
      • Shanghai, China, 200032
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Meiling Jin
        • Contact:
        • Contact:
      • Wenzhou, China, 325000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yuanrong Dai
        • Contact:
        • Contact:
    • Guangdong
      • Shen Zhen, Guangdong, China, 518020
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lingwei Wang
        • Contact:
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Wei Gu
        • Contact:
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Li Zhao
        • Contact:
        • Contact:
    • Shandong
      • Qingdao, Shandong, China, 266071
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Wei Han
        • Contact:
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jianqing Zhang
  • Czechia
      • Liben, Czechia, 180 81
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Norbert Pauk
      • Praha, Czechia, 14059
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucie Heribanova
  • France
      • Angers Cedex 09, France, 49933
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carole Lacout
      • Brest Cedex, France, 29609
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Claire de Moreuil
        • Contact:
        • Contact:
      • La Roche sur Yon Cedex 9, France, 85925
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Bruno Villemagne
        • Contact:
        • Contact:
      • Lille Cedex, France, 59037
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guillaume Lefevre
      • Montpellier cedex 5, France, 34295
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arnaud Bourdin
      • Nantes Cedex 1, France, 44093
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoine Neel
      • Paris, France, 75014
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Benjamin Terrier
        • Contact:
        • Contact:
      • Pessac, France, 33600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-François Viallard
      • Suresnes, France, 92150
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Emmanuel Kahn
      • Toulouse, France, 31059
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • stanislas faguer
  • Germany
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephanie Finzel
  • Hungary
      • Budapest, Hungary, 1023
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Judit Majnik
        • Contact:
        • Contact:
  • Israel
      • Kfar Saba, Israel, 44281
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yossi Rosman
      • Ramat-Gan, Israel, 52621
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nancy Agmon Levin
  • Italy
      • Torino, Italy, 10154
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dario Roccatello
    • Lazio
      • Roma, Lazio, Italy, 00128
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roberto Giacomelli
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marco Taglietti
      • Milan, Lombardia, Italy, 20132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorenzo Dagna
      • Milano, Lombardia, Italy, 20162
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jan Schroeder
        • Contact:
        • Contact:
      • Pavia, Lombardia, Italy, 27100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sara Monti
    • Marche
      • Torrette, Marche, Italy, 60126
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gianluca Moroncini
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Angelo Vacca
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giacomo Emmi
      • Pisa, Toscana, Italy, 56126
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chiara Baldini
    • Veneto
      • Treviso, Veneto, Italy, 31100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Cinetto
  • Japan
      • Kanagawa, Japan, 247-8533
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Masami Taniguchi
        • Contact:
        • Contact:
      • Kanagawa, Japan, 252-0392
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kiyoshi Sekiya
        • Contact:
        • Contact:
      • Saitama, Japan, 350-8550
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Koichi Amano
        • Contact:
        • Contact:
      • Tokyo, Japan, 181-8611
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yoshinori Komagata
      • Tokyo, Japan, 162-8666
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomoaki Higuchi
  • Korea, Republic of
      • Chonju, Korea, Republic of, 561-712
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yong Chul Lee
        • Contact:
        • Contact:
      • Gwangju, Korea, Republic of, 61469
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Young-Il Koh
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tae-Bum Kim
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Chin Kook Rhee
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Byung-Jae Lee
      • Seoul, Korea, Republic of, 3080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hye-Ryun Kang
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Abraham Rutgers
        • Contact:
        • Contact:
      • Leiden, RC, Netherlands, 2333 ZA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miranda Geelhoed
  • Poland
      • Gdansk, Poland, 80-952
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Iwona Damps-Kostanska
      • Lodz, Poland, 90-153
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Izabela Kuprys-Lipinska
      • Warszawa, Poland, 01-138
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dariusz Gawryluk
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nikita Khmelinskii
      • Porto, Portugal, 4099-001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomas Fonseca
  • Spain
      • Badalona, Spain, 08930
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ivette Casafont Solé
        • Contact:
        • Contact:
      • Badalona, Spain, ?08036
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Georgina Espigol Frigole
        • Contact:
        • Contact:
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roser Solans Laqué
      • Granada, Spain, 18014
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Concepción Morales García
        • Contact:
        • Contact:
      • Granada, Spain, 18016
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jose Luis Callejas Rubio
        • Contact:
        • Contact:
      • Pamplona, Spain, 31008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Patricia Fanlo Mateo
        • Contact:
        • Contact:
      • Valencia, Spain, 46026
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • José Andrés Román Ivorra
      • Zaragoza, Spain, 50009
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Adela Marín Ballvé
        • Contact:
        • Contact:
  • Sweden
      • Malmö, Sweden, SE-205 02
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giovanni Cagnotto
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin Sutton
      • Cambridge, United Kingdom, CB2 2QQ
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • David Jayne
        • Contact:
        • Contact:
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • David Jackson
        • Contact:
        • Contact:
  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michael Wechsler
        • Contact:
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Bubb
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ulrich Specks
        • Contact:
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lindsay Lally
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Iftikhar Hussain
        • Contact:
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Merkel
    • Tennessee
      • Nashville, Tennessee, United States, 37208
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Basil Kahwash
        • Contact:
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Joseph Han
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to Week 52
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.
Up to Week 52
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.
Up to Week 52
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).
Weeks 49 to 52
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
Up to Week 52
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
At Weeks 36 and 52
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.
Up to Week 52
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.
Up to Week 52
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
Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2022

Primary Completion (Estimated)

October 10, 2025

Study Completion (Estimated)

November 7, 2025

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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