Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps
- Conditions
- Nasal Polyps
- Registration Number
- NCT05274750
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 277
<br><br> - Participants with 18 years of age and older inclusive, at the time of signing the<br> informed consent.<br><br> - Endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a<br> minimum score of 2 in each nasal cavity) assessed by the investigator.<br><br> - Participants who have had at least one of the following at Visit 1: Previous nasal<br> surgery for the removal of NP; have used at least three consecutive days of systemic<br> corticosteroids in the previous 2 years for the treatment of NP; medically<br> unsuitable or intolerant to systemic corticosteroid.<br><br> - Participants (except for those in Japan) must be on daily treatment with intranasal<br> corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at<br> least the 8 weeks immediately prior to screening.<br><br> - Participants presenting with severe NP symptoms defined as symptoms of nasal<br> congestion/blockade/obstruction with moderate or severe severity and loss of smell<br> or rhinorrhea (runny nose) based on clinical assessment by the investigator.<br><br> - Presence of symptoms of chronic rhinosinusitis as described by at least 2 different<br> symptoms for at least 12 weeks prior to Visit 1, one of which should be either nasal<br> blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip),<br> plus facial pain/pressure and/or reduction or loss of smell.<br><br> - Male or eligible female participants.<br><br>Exclusion criteria:<br><br>Exclusion criteria:<br><br> - As a result of medical interview, physical examination, or screening investigation<br> the physician responsible considers the participant unfit for the study.<br><br> - Cystic fibrosis.<br><br> - Antrochoanal polyps.<br><br> - Nasal cavity tumor (malignant or benign).<br><br> - Fungal rhinosinusitis.<br><br> - Severe nasal septal deviation occluding one nostril preventing full assessment of<br> nasal polyps in both nostrils<br><br> - Participants who had a sino-nasal or sinus surgery changing the lateral wall<br> structure of the nose making impossible the evaluation of nasal polyp score.<br><br> - Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2<br> weeks prior to screening.<br><br> - Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis).<br><br> - Participants who have had an asthma exacerbation requiring admission to hospital<br> within 4 weeks of screening.<br><br> - Participants who have undergone any intranasal and/or sinus surgery (for example<br> [e.g.], polypectomy, balloon dilatation or nasal stent insertion) within 6 months<br> prior to Visit 1; nasal biopsy prior to Visit 1 for diagnostic purposes only is<br> excepted.<br><br> - Participants where NP surgery is contraindicated in the opinion of the Investigator.<br><br> - Participants with other conditions that could lead to elevated eosinophils such as<br> hyper-eosinophilic syndromes including (but not limited to) Eosinophilic<br> granulomatosis with polyangiitis (EGPA) (formerly known as Churg-Strauss Syndrome)<br> or Eosinophilic Esophagitis.<br><br> - Participants with a known, pre-existing parasitic infestation within 6 months prior<br> to Visit 1.<br><br> - A known immunodeficiency (e.g. human immunodeficiency virus [HIV]), other than that<br> explained by the use of corticosteroids (CSs) taken as therapy for asthma.<br><br> - A current malignancy or previous history of cancer in remission for less than 12<br> months prior to screening.<br><br> - Liver Disease: Alanine aminotransferase (ALT) >2 times Upper limit of normal (ULN);<br> Total bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if<br> bilirubin is fractionated and direct bilirubin less than [<]35 percent [%]);<br> Cirrhosis or current unstable liver or biliary disease per investigator assessment<br> defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia,<br> esophageal or gastric varices, persistent jaundice.<br><br> - Participants who have known, pre-existing, clinically significant cardiac,<br> endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic,<br> hematological or any other system abnormalities that are uncontrolled with standard<br> treatment.<br><br> - Participants with current diagnosis of vasculitis. Participants with high clinical<br> suspicion of vasculitis at screening will be evaluated and current vasculitis must<br> be excluded prior to enrollment.<br><br> - Hypersensitivity: Participants with allergy/intolerance to the excipients of<br> depemokimab (GSK3511294) in a monoclonal antibody, or biologic.<br><br> - Participants that, according to the investigator's medical judgment, are likely to<br> have active Coronavirus Disease-2019 (COVID-19) infection must be excluded.<br> Participants with known COVID-19 positive contacts within the past 14 days must be<br> excluded for at least 14 days following the exposure during which the participant<br> should remain symptom-free. Reported smell/ taste complications from COVID-19 must<br> be used as exclusion.<br><br> - Participants that have been exposed to ionizing radiation in excess of 10<br> millisievert (mSv) above background over the previous 3-year period as a result of<br> occupational exposure or previous participation in research studies.<br><br> - Previously participated in any study with mepolizumab, reslizumab, or benralizumab<br> and received study intervention (including placebo) within 12 months prior to Visit<br> 1.<br><br> - Women who are pregnant or lactating or are planning on becoming pregnant during the<br> study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in total endoscopic Nasal polyps (NP) score at Week 52 (Scores on a scale);Change from Baseline in mean nasal obstruction score using verbal response scale (VRS) from Weeks 49 to 52 (Scores on a scale)
- Secondary Outcome Measures
Name Time Method