Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)

Launched by GLAXOSMITHKLINE · Mar 7, 2022

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Eligibility criteria

• Inclusion 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 8 weeks 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 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 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 ionising 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.