Trial record 15 of 57 for:
Churg Strauss
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 : February 2, 2023
|
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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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 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
MedlinePlus Genetics related topics:
Granulomatosis with polyangiitis
MedlinePlus related topics:
Granulomatosis with Polyangiitis
Drug Information available for:
Mepolizumab
| 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. |
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) [ Time Frame: Up to Week 52 ]Participants must be in remission at both Weeks 36 and 52.
Secondary Outcome Measures :
- 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.
- 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.
- 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.
- 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).
- 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 ]
- 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 ]
- 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.
- 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.
- 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 ]
Information from the National Library of Medicine
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| 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.
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
| 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
| United States, Colorado | |
| GSK Investigational Site | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Michael Wechsler | |
| United States, Minnesota | |
| GSK Investigational Site | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Ulrich Specks | |
| United States, Oklahoma | |
| GSK Investigational Site | Recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Iftikhar Hussain | |
| United States, Pennsylvania | |
| GSK Investigational Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Peter Merkel | |
| United States, Tennessee | |
| GSK Investigational Site | Recruiting |
| Nashville, Tennessee, United States, 37208 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Basil Kahwash | |
| United States, Virginia | |
| GSK Investigational Site | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Joseph Han | |
| Austria | |
| GSK Investigational Site | Recruiting |
| Graz, Austria, 8036 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Jens Thiel | |
| Belgium | |
| GSK Investigational Site | Recruiting |
| Bruxelles, Belgium, 1070 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Florence Roufosse | |
| GSK Investigational Site | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Daniël Blockmans | |
| Canada, Ontario | |
| GSK Investigational Site | Recruiting |
| Toronto, Ontario, Canada, M5T 3A9 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Kenneth Chapman | |
| China, Liaoning | |
| GSK Investigational Site | Recruiting |
| Shenyang, Liaoning, China, 110004 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Li Zhao | |
| China, Shandong | |
| GSK Investigational Site | Recruiting |
| Qingdao, Shandong, China, 266071 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Wei Han | |
| China | |
| GSK Investigational Site | Recruiting |
| Guangzhou, China, 510163 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Qingling Zhang | |
| Czechia | |
| GSK Investigational Site | Recruiting |
| Praha, Czechia, 14059 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Lucie Heribanova | |
| France | |
| GSK Investigational Site | Recruiting |
| Suresnes, France, 92150 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Jean-Emmanuel Kahn | |
| Hungary | |
| GSK Investigational Site | Recruiting |
| Budapest, Hungary, 1023 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Judit Majnik | |
| Italy | |
| GSK Investigational Site | Recruiting |
| Firenze, Toscana, Italy, 50134 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Giacomo Emmi | |
| Japan | |
| GSK Investigational Site | Recruiting |
| Kanagawa, Japan, 247-8533 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Masami Taniguchi | |
| GSK Investigational Site | Recruiting |
| Kanagawa, Japan, 252-0392 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Kiyoshi Sekiya | |
| GSK Investigational Site | Recruiting |
| Saitama, Japan, 350-8550 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Koichi Amano | |
| Korea, Republic of | |
| GSK Investigational Site | Recruiting |
| Chonju, Korea, Republic of, 561-712 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Yong Chul Lee | |
| GSK Investigational Site | Recruiting |
| Gwangju, Korea, Republic of, 61469 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Young-Il Koh | |
| GSK Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 05505 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Tae-Bum Kim | |
| GSK Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 06351 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Byung-Jae Lee | |
| GSK Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 06591 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Chin Kook Rhee | |
| Spain | |
| GSK Investigational Site | Recruiting |
| Badalona, Spain, 08036 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Georgina Espigol Frigole | |
| GSK Investigational Site | Recruiting |
| Badalona, Spain, 08930 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Ivette Casafont Solé | |
| GSK Investigational Site | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Roser Solans Laqué | |
| GSK Investigational Site | Recruiting |
| Granada, Spain, 18014 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Concepción Morales García | |
| GSK Investigational Site | Recruiting |
| Granada, Spain, 18016 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: José Luis Callejas Rubio | |
| GSK Investigational Site | Recruiting |
| Pamplona, Spain, 31008 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Patricia Fanlo Mateo | |
| GSK Investigational Site | Recruiting |
| Valencia, Spain, 46026 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: José Antonio Román Ivorra | |
| GSK Investigational Site | Recruiting |
| Zaragoza, Spain, 50009 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Adela Marín Ballvé | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT05263934 |
| Other Study ID Numbers: |
217102 |
| First Posted: | March 3, 2022 Key Record Dates |
| Last Update Posted: | February 2, 2023 |
| Last Verified: | January 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 |
| 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:
|
Churg-Strauss Syndrome Granulomatosis with Polyangiitis Systemic Vasculitis Vasculitis Vascular Diseases Cardiovascular Diseases Lung Diseases, Interstitial Lung Diseases |
Respiratory Tract Diseases Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Immune System Diseases Granuloma Lymphoproliferative Disorders Lymphatic Diseases |