Informations générales (source: ClinicalTrials.gov)
A Randomised, Double-blind, Parallel Group Phase III Study to Assess the Efficacy and Safety of 100 mg SC Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis) (ANCHOR-1)
Interventional
Phase 3
GlaxoSmithKline (Voir sur ClinicalTrials)
avril 2022
août 2024
22 août 2024
This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in
participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Emilie BEQUIGNON | 29/03/2024 01:29:59 | Contacter | ||
| HOPITAL NOVO | FAUCON | 04/07/2024 11:04:58 | 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 - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 17019 - La Rochelle Cedex 1 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 31059 - Toulouse cedex 9 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 38043 - Grenoble Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 44093 - Nantes Cedex 1 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 59322 - Valenciennes Cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 63003 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 85925 - La Roche-Sur-Yon - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 94010 - CrEteil cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 95300 - Pontoise - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion criteria:
- Participants with 18 years of age and older inclusive, at the time of signing the
informed consent.
- Endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a
minimum score of 2 in each nasal cavity) assessed by the investigator.
- Participants who have had at least one of the following at Visit 1: Previous nasal
surgery for the removal of NP; have used at least three consecutive days of systemic
corticosteroids in the previous 2 years for the treatment of NP; medically
unsuitable or intolerant to systemic corticosteroid.
- Participants (except for those in Japan) must be on daily treatment with intranasal
corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at
least the 8 weeks immediately prior to screening.
- Participants presenting with severe NP symptoms defined as symptoms of nasal
congestion/blockade/obstruction with moderate or severe severity and loss of smell
or rhinorrhea (runny nose) based on clinical assessment by the investigator.
- Presence of symptoms of chronic rhinosinusitis as described by at least 2 different
symptoms for at least 12 weeks prior to Visit 1, one of which should be either nasal
blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip),
plus facial pain/pressure and/or reduction or loss of smell.
- Male or eligible female participants.
- Participants with 18 years of age and older inclusive, at the time of signing the
informed consent.
- Endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a
minimum score of 2 in each nasal cavity) assessed by the investigator.
- Participants who have had at least one of the following at Visit 1: Previous nasal
surgery for the removal of NP; have used at least three consecutive days of systemic
corticosteroids in the previous 2 years for the treatment of NP; medically
unsuitable or intolerant to systemic corticosteroid.
- Participants (except for those in Japan) must be on daily treatment with intranasal
corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at
least the 8 weeks immediately prior to screening.
- Participants presenting with severe NP symptoms defined as symptoms of nasal
congestion/blockade/obstruction with moderate or severe severity and loss of smell
or rhinorrhea (runny nose) based on clinical assessment by the investigator.
- Presence of symptoms of chronic rhinosinusitis as described by at least 2 different
symptoms for at least 12 weeks prior to Visit 1, one of which should be either nasal
blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip),
plus facial pain/pressure and/or reduction or loss of smell.
- Male or eligible female participants.
Exclusion criteria:
- As a result of medical interview, physical examination, or screening investigation
the physician responsible considers the participant unfit for the study.
- Cystic fibrosis.
- Antrochoanal polyps.
- Nasal cavity tumor (malignant or benign).
- Fungal rhinosinusitis.
- Severe nasal septal deviation occluding one nostril preventing full assessment of
nasal polyps in both nostrils
- Participants who had a sino-nasal or sinus surgery changing the lateral wall
structure of the nose making impossible the evaluation of nasal polyp score.
- Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2
weeks prior to screening.
- Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis).
- Participants who have had an asthma exacerbation requiring admission to hospital
within 4 weeks of screening.
- Participants who have undergone any intranasal and/or sinus surgery (for example
[e.g.], polypectomy, balloon dilatation or nasal stent insertion) within 6 months
prior to Visit 1; nasal biopsy prior to Visit 1 for diagnostic purposes only is
excepted.
- Participants where NP surgery is contraindicated in the opinion of the Investigator.
- 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.
- Participants with a known, pre-existing parasitic infestation within 6 months prior
to Visit 1.
- A known immunodeficiency (e.g. human immunodeficiency virus [HIV]), other than that
explained by the use of corticosteroids (CSs) taken as therapy for asthma.
- A current malignancy or previous history of cancer in remission for less than 12
months prior to screening.
- Liver Disease: Alanine aminotransferase (ALT) >2 times Upper limit of normal (ULN);
Total bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if
bilirubin is fractionated and direct bilirubin less than [<]35 percent [%]);
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 who have known, pre-existing, clinically significant cardiac,
endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic,
hematological or any other system abnormalities that are uncontrolled with standard
treatment.
- Participants with current diagnosis of vasculitis. Participants with high clinical
suspicion of vasculitis at screening will be evaluated and current vasculitis must
be excluded prior to enrollment.
- Hypersensitivity: Participants with allergy/intolerance to the excipients of
depemokimab (GSK3511294) in a monoclonal antibody, or biologic.
- Participants that, according to the investigator's medical judgment, are likely to
have active Coronavirus Disease-2019 (COVID-19) infection must be excluded.
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
should remain symptom-free. Reported smell/ taste complications from COVID-19 must
be used as exclusion.
- Participants that have been exposed to ionizing radiation in excess of 10
millisievert (mSv) above background over the previous 3-year period as a result of
occupational exposure or previous participation in research studies.
- Previously participated in any study with mepolizumab, reslizumab, or benralizumab
and received study intervention (including placebo) within 12 months prior to Visit
1.
- Women who are pregnant or lactating or are planning on becoming pregnant during the
study.