This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, Argentina

GSK Investigational Site

Florida, Argentina

GSK Investigational Site

La Plata, Argentina

GSK Investigational Site

Mar del Plata, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

Rosario, Argentina

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)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Depemokimab (GSK3511294)

Placebo

Ubicaciones

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Patrocinadores