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

• Status: Not yet recruiting
• Trial end date: 2025-01-06
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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 with severe NP symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity (VRS score of 2 or 3) and loss of smell or rhinorrhea (runny nose).

• 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.

• 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 0 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.