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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003162-25 | EudraCT Number |
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Eosinophilic Granulomatosis with Polyangiitis (EGPA), also referred to as Churg-Strauss syndrome, is a rare hyper-eosinophilic syndrome. Eosinophilia is central to the pathophysiology of EGPA and interleukin-5 (IL-5) is a key cytokine regulating the life-cycle of the eosinophil. Neutralization of IL-5 with mepolizumab, an anti-IL5 monoclonal antibody, therefore offers a potential therapeutic option for EGPA. The objective of study MEA115921 was to investigate the efficacy and safety of mepolizumab compared with placebo wherein the subjects were randomized to receive either: 300 milligram (mg) mepolizumab or Placebo subcutaneous (SC) injection every 4 weeks in addition to their background standard-of-care therapy. Subjects were treated for a period of 52 weeks and then followed up for a further 8 weeks to study completion at Week 60. This is a LAP to support provision of open-label mepolizumab on an individual basis to eligible subjects who participated in clinical study MEA115921 and who require a dose of prednisolone (or equivalent) of >=5 milligrams per day (mg/day) for adequate control of their EGPA. Eligible subjects can initiate mepolizumab under this LAP within a 6-month period starting from completion of study MEA115921 (that is, at Week 60) or, in case of premature discontinuation from study MEA115921, the subjects will initiate mepolizumab at the time point that would have been Week 60 if the subject had completed the study. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks. Eligible subjects will continue to receive mepolizumab under this LAP until mepolizumab is commercially licensed for the treatment of EGPA in the relevant country or until GlaxoSmithKline (GSK) discontinues the program or until the subject meets any of the withdrawal/stopping criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects from clinical study MEA115921 | Experimental | Subjects who participated in clinical study MEA115921 and who require a dose of prednisolone (or equivalent) of 5 mg/day for adequate control of their EGPA will be included. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab | Drug | Mepolizumab will be available as lyophilized powder for injection to be reconstituted with sterile water for injection, prior to use. Subjects will be dosed with mepolizumab at a dose of 300 mg which will be administered as three separate 100 mg SC injections every 4 weeks. The injections will be administered into any of the upper arm, thigh or anterior abdominal wall. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events based on medical or scientific judgment; and is associated with liver injury and impaired liver function. Additionally, systemic (that is, allergic/hypersensitivity and non-allergic) reactions and local injection site reactions were recorded throughout the treatment and follow-up period. | Up to approximately 89 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Denver | Colorado | 80206 | United States | ||
| GSK Investigational Site |
A total of 100 participants entered the study and received mepolizumab.
Participants who participated in clinical study MEA115921 and required a dose of prednisolone (or equivalent) of greater than or equal to (>=) 5 milligrams per day (mg/day) for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) were included in this study based on their eligibility. Eligible participants received subcutaneous (SC) injection of mepolizumab 300 milligrams (mg) every 4 weeks.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mepolizumab 300 mg | Participants who participated in clinical study MEA115921, who required additional dose of >=5 milligrams per day (mg/day) prednisolone for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) received 300 milligrams (mg) mepolizumab subcutaneous (SC) injection every 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2021 | Feb 14, 2024 |
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Subjects who participated in clinical study MEA115921 and require a dose of prednisolone (or equivalent) of >=5 mg/day for adequate control of their EGPA will be included in this study based on the confirmation of their eligibility by GSK Medical Monitor. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks.
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|
| Prednisolone | Drug | Subjects who require a dose of prednisolone (or equivalent) of 5 mg/day for adequate control of their EGPA will be included. |
|
| Bethesda |
| Maryland |
| 20892 |
| United States |
| GSK Investigational Site | Boston | Massachusetts | 02118-2307 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44195 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73131 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| GSK Investigational Site | Mempis | Tennessee | 38119 | United States |
| GSK Investigational Site | Murray | Utah | 84107 | United States |
| GSK Investigational Site | St. George | Utah | 84770 | United States |
| GSK Investigational Site | Abingdon | Virginia | 24210 | United States |
| GSK Investigational Site | Bellevue | Washington | 98004 | United States |
| GSK Investigational Site | Brussels | 1070 | Belgium |
| GSK Investigational Site | Hamilton | Ontario | L8N 4A6 | Canada |
| GSK Investigational Site | Bron | 69677 | France |
| GSK Investigational Site | Marseille | 13915 | France |
| GSK Investigational Site | Montpellier | 34295 | France |
| GSK Investigational Site | Paris | 75014 | France |
| GSK Investigational Site | Saint-Priest-en-Jarez | 42270 | France |
| GSK Investigational Site | Suresnes | 92151 | France |
| GSK Investigational Site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| GSK Investigational Site | Kirchheim -Teck | Baden-Wurttemberg | 73230 | Germany |
| GSK Investigational Site | Fulda | Hesse | 36043 | Germany |
| GSK Investigational Site | Bad Bramstedt | Schleswig-Holstein | 24576 | Germany |
| GSK Investigational Site | Jena | Thuringia | 07740 | Germany |
| GSK Investigational Site | Kanagawa | 252-0392 | Japan |
| GSK Investigational Site | Miyagi | 980-8574 | Japan |
| GSK Investigational Site | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
| GSK Investigational Site | Cambridge | CB2 0QQ | United Kingdom |
| GSK Investigational Site | Leicester | LE3 9QP | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mepolizumab 300 mg | Participants who participated in clinical study MEA115921, who required additional dose of >=5 milligrams per day (mg/day) prednisolone for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) received 300 milligrams (mg) mepolizumab subcutaneous (SC) injection every 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events based on medical or scientific judgment; and is associated with liver injury and impaired liver function. Additionally, systemic (that is, allergic/hypersensitivity and non-allergic) reactions and local injection site reactions were recorded throughout the treatment and follow-up period. | Safety Population consisted of all participants who received at least one dose of open label mepolizumab. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days. | Posted | Count of Participants | Participants | Up to approximately 89 Months |
|
|
|
Up to approximately 89 Months
Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mepolizumab 300 mg | Participants who participated in clinical study MEA115921, who required additional dose of >=5 milligrams per day (mg/day) prednisolone for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) received 300 milligrams (mg) mepolizumab subcutaneous (SC) injection every 4 weeks. | 1 | 100 | 38 | 100 | 97 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | v25.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | v25.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | v25.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | v25.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | v25.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | v25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Rectal ulcer | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Chest pain | General disorders | v25.1 | Systematic Assessment |
| |
| Eosinophilic granulomatosis with polyangiitis | Immune system disorders | v25.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | v25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Salpingitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Post procedural fever | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | v25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | v25.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | v25.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.1 | Systematic Assessment |
| |
| Cervical cord compression | Nervous system disorders | v25.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | v25.1 | Systematic Assessment |
| |
| Stress | Psychiatric disorders | v25.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | v25.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | v25.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | v25.1 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | v25.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Vocal cord dysfunction | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | v25.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | v25.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | v25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | v25.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | v25.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | v25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | v25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | v25.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | v25.1 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | v25.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | v25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | v25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | v25.1 | Systematic Assessment |
| |
| Eosinophilic granulomatosis with polyangiitis | Immune system disorders | v25.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | v25.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | v25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | v25.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | v25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | v25.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | v25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | v25.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | v25.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | v25.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | v25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | v25.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | v25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | v25.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | v25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | v25.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | v25.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | v25.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | v25.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | v25.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | v25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | v25.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | v25.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | v25.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | v25.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | v25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | v25.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2019 | Feb 14, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015267 | Churg-Strauss Syndrome |
| D056647 | Systemic Vasculitis |
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006099 | Granuloma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C434107 | mepolizumab |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| ASIAN - SOUTH EAST ASIAN HERITAGE |
|
| WHITE - ARABIC/NORTH AFRICAN HERITAGE |
|
| WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE |
|