Informations générales (source: ClinicalTrials.gov)
A 52-week, Randomised, Double-blind, Double-dummy, Parallel Group, Multi-centre, Non-inferiority Study Assessing Exacerbation Rate, Additional Measures of Asthma Control and Safety in Adult and Adolescent Severe Asthmatic Participants With an Eosinophilic Phenotype Treated With GSK3511294 Compared With Mepolizumab or Benralizumab (NIMBLE)
Interventional
Phase 3
GlaxoSmithKline (Voir sur ClinicalTrials)
janvier 2021
octobre 2025
21 septembre 2024
This study will assess whether switching participants who have benefitted from
mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining
current treatment on the annualized rate of clinically significant exacerbations in
participants with severe asthma with an eosinophilic phenotype. Throughout the study, all
participants will continue their non-biologic Baseline standard of care (SoC) asthma
treatment.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | COLAS TCHERAKIAN | 21/10/2024 07:07:19 | Contacter | ||
| HOPITAL NOVO | BOITIAUX | 04/07/2024 11:05:03 | 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 - 06001 - Nice - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 06414 - Cannes - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 13003. - Marseille - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 13015 - Marseille - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 14033 - Caen cedex 9 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 25030 - BesanCon - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 29609 - Brest - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 29609 - Brest Cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 31059 - Toulouse cedex 9 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 34295 - Montpellier cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 37044 - Tours cedex 9 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 38700 - La Tronche - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 44093 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 49300 - Cholet - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 69317 - Lyon - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 72037 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 74011 - Annecy Cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 75012 - Paris cedex 12 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 75014 - Paris - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 75015 - Paris - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 75877 - Paris - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 76031 - Rouen cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 76290 - Montivilliers - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 80000 - Amiens - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 92150 - Suresnes - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 92160 - Antony Cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 93370 - Montfermeil - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 95303 - Pontoise - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Key inclusion criteria for study:
- Adult and adolescent participants more than or equal to (>=)12 years of age, at the
time of signing the informed consent/assent.
- Participants who have a documented physician diagnosis of asthma for >=2 years that
meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global
Initiative for Asthma (GINA) guidelines.
- Participants receiving either mepolizumab 100 milligrams (mg) or benralizumab 30 mg
for >=12 months prior to screening and have a documented benefit to therapy assessed
by either:
(i) >=50% reduction in exacerbation frequency since initiating treatment, or (ii)
>=50% reduction in maintenance OCS use since initiating treatment, or (iii) No
exacerbations in the past 6 months whilst receiving anti-IL-5/5R therapy and an
Asthma Control Questionnaire (ACQ)-5 score of less than or equal to (<=)1.5 at
screening.
- A well-documented requirement for regular treatment with medium to high dose ICS in
the 12 months prior to Visit 1 with or without maintenance OCS. The maintenance ICS
dose must be >=440 micrograms (mcg) fluticasone propionate (FP) hydrofluoroalkane
(HFA) product daily, or clinically comparable. Participants who are treated with
medium dose ICS will also need to be treated with a LABA to qualify for inclusion.
- Current treatment with at least one additional controller medication, besides ICS
[for example (e.g.), LABA, LAMA, leukotriene receptor antagonist (LTRA), or
theophylline].
Key exclusion criteria for study:
- Participants with presence of a known pre-existing, clinically important lung
condition other than asthma. This includes (but is not limited to) current
infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or
diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease
other than asthma) or a history of lung cancer.
- Participants with other conditions that could lead to elevated eosinophils such as
hyper-eosinophilic syndromes including (but not limited to) Eosinophilic
Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or
Eosinophilic Esophagitis.
- A current malignancy or previous history of cancer in remission for less than 12
months prior to screening (Participants that had localized carcinoma of the skin
which was resected for cure will not be excluded).
- Cirrhosis or current unstable liver or biliary disease per investigator assessment
defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia,
esophageal or gastric varices, persistent jaundice.
- Participants with current diagnosis of vasculitis. Participants with high clinical
suspicion of vasculitis at screening will be evaluated and current vasculitis
excluded prior to enrolment.
- Participants who have received Omalizumab (Xolair), dupilumab (Dupixent) or
reslizumab (Cinqair/Cinqaero) within 130 days prior to Visit 1.
- Participants who have received any Monoclonal antibody (mAb) within 5 half-lives of
Visit 1.
- Corrected QT interval using Fridericia's formula (QTcF) >=450 milliseconds (msec) or
QTcF >=480 msec for participants with Bundle Branch Block at screening Visit 1.
- Current smokers or former smokers with a smoking history of >=10 pack years (number
of pack years equal to [number of cigarettes per day/20] times number of years
smoked). A former smoker is defined as a participant who quit smoking at least 6
months prior to Visit 1.
- Participants with allergy/intolerance to a mAb or biologic.
Key exclusion criteria for randomization:
- Evidence of a clinically significant abnormality in the 12-lead electrocardiogram
(ECG) over-read conducted at Screening Visit 1, based on the evaluation of the
investigator, or QTcF >=450 msec or QTcF >=480 msec for participants with Bundle
Branch Block, at randomization Visit 2.
- Participants with a clinically significant asthma exacerbation in the 7 days prior
to randomization should have their randomization visit delayed until the
investigator considers the participant's asthma to be stable. If the 8-week
screening period has elapsed, then the participant should be considered a run-in
failure.
- Any changes in the dose or regimen of Baseline ICS and/or additional controller
medication (except for treatment of an exacerbation) during the run-in period.
- Adult and adolescent participants more than or equal to (>=)12 years of age, at the
time of signing the informed consent/assent.
- Participants who have a documented physician diagnosis of asthma for >=2 years that
meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global
Initiative for Asthma (GINA) guidelines.
- Participants receiving either mepolizumab 100 milligrams (mg) or benralizumab 30 mg
for >=12 months prior to screening and have a documented benefit to therapy assessed
by either:
(i) >=50% reduction in exacerbation frequency since initiating treatment, or (ii)
>=50% reduction in maintenance OCS use since initiating treatment, or (iii) No
exacerbations in the past 6 months whilst receiving anti-IL-5/5R therapy and an
Asthma Control Questionnaire (ACQ)-5 score of less than or equal to (<=)1.5 at
screening.
- A well-documented requirement for regular treatment with medium to high dose ICS in
the 12 months prior to Visit 1 with or without maintenance OCS. The maintenance ICS
dose must be >=440 micrograms (mcg) fluticasone propionate (FP) hydrofluoroalkane
(HFA) product daily, or clinically comparable. Participants who are treated with
medium dose ICS will also need to be treated with a LABA to qualify for inclusion.
- Current treatment with at least one additional controller medication, besides ICS
[for example (e.g.), LABA, LAMA, leukotriene receptor antagonist (LTRA), or
theophylline].
Key exclusion criteria for study:
- Participants with presence of a known pre-existing, clinically important lung
condition other than asthma. This includes (but is not limited to) current
infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or
diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease
other than asthma) or a history of lung cancer.
- Participants with other conditions that could lead to elevated eosinophils such as
hyper-eosinophilic syndromes including (but not limited to) Eosinophilic
Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or
Eosinophilic Esophagitis.
- A current malignancy or previous history of cancer in remission for less than 12
months prior to screening (Participants that had localized carcinoma of the skin
which was resected for cure will not be excluded).
- Cirrhosis or current unstable liver or biliary disease per investigator assessment
defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia,
esophageal or gastric varices, persistent jaundice.
- Participants with current diagnosis of vasculitis. Participants with high clinical
suspicion of vasculitis at screening will be evaluated and current vasculitis
excluded prior to enrolment.
- Participants who have received Omalizumab (Xolair), dupilumab (Dupixent) or
reslizumab (Cinqair/Cinqaero) within 130 days prior to Visit 1.
- Participants who have received any Monoclonal antibody (mAb) within 5 half-lives of
Visit 1.
- Corrected QT interval using Fridericia's formula (QTcF) >=450 milliseconds (msec) or
QTcF >=480 msec for participants with Bundle Branch Block at screening Visit 1.
- Current smokers or former smokers with a smoking history of >=10 pack years (number
of pack years equal to [number of cigarettes per day/20] times number of years
smoked). A former smoker is defined as a participant who quit smoking at least 6
months prior to Visit 1.
- Participants with allergy/intolerance to a mAb or biologic.
Key exclusion criteria for randomization:
- Evidence of a clinically significant abnormality in the 12-lead electrocardiogram
(ECG) over-read conducted at Screening Visit 1, based on the evaluation of the
investigator, or QTcF >=450 msec or QTcF >=480 msec for participants with Bundle
Branch Block, at randomization Visit 2.
- Participants with a clinically significant asthma exacerbation in the 7 days prior
to randomization should have their randomization visit delayed until the
investigator considers the participant's asthma to be stable. If the 8-week
screening period has elapsed, then the participant should be considered a run-in
failure.
- Any changes in the dose or regimen of Baseline ICS and/or additional controller
medication (except for treatment of an exacerbation) during the run-in period.