efficacy and safety of depemokimab (gsk3511294) in participants with chronic rhinosinusitis with nasal polyps

Conditions: Nasal Polyps

Summary: this study will evaluate the efficacy and safety of depemokimab (gsk3511294) in participants with chronic rhinosinusitis with nasal polyps (crswnp).


Eligibility criteria:
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. exclusion criteria: 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.

Keywords: depemokimab gsk3511294 chronic rhinosinusitis verbal response scale asthma control questionnaire lund mackay computed tomography nasal polyps score nasal endoscopy