Soft growths inside the nose
Conditions
Interventions
The study will include an approximate 4 week run-in period followed by
randomization to a 52 week treatment period. Randomization will be stratified
based on occurrence of previous surgery for nasal
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Participant is >=18 years old 2. Participant has a 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 3. 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. 4. Participants must be on daily treatment with INCS (including intranasal liquid steroid wash/douching) for at least 8 weeks prior to screening. 5. Participants presenting with severe NP symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity and loss of smell or rhinorrhoea (runny nose) based on clinical assessment by the investigator. 6. 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 7. Male or eligible female participants: 8. Capable of giving signed informed consent
Exclusion criteria
Exclusion criteria: 1. As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study 2. Participants who have cystic fibrosis 3. Participants who have antrochoanal polyps 4. Nasal cavity tumor (malignant or benign) 5. Fungal rhinosinusitis 6. Participant has severe nasal septal deviation occluding one nostril preventing full assessment of nasal polyps in both nostrils 7. 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 8. Participants who have acute sinusitis or upper respiratory tract infection at screening or in 2 weeks prior to screening 9. Participants who have ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis) 10. Participants who have had an asthma exacerbation requiring admission to hospital within 4 weeks of Screening 11. Participants who have undergone any intranasal and/or sinus surgery within 6 months prior to Visit 1; nasal biopsy prior to Visit 1 for diagnostic purposes only is excepted. 12. Participants where NP surgery is contraindicated in the opinion of the Investigator 13. Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) EGPA (formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis 14. Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 15. Participants with a known immunodeficiency (e.g. human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma 16. Participants with a current malignancy or previous history of cancer in remission for less than 12 months prior to screening (NOTE: Participants that had localised carcinoma of the skin which was resected for cure will not be excluded). 17. Participant is ineligible if any of the following hepatic characteristics are present: • Alanine aminotransferase (ALT) >2x ULN • Total bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) • Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice. 18. Other Concurrent Medical Conditions: Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment. 19. Vasculitis: 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 enrolment. 20. Participants with allergy/intolerance to the excipients of depemokimab in Section 6.1, a monoclonal antibody, or biologic. 21. Participants that, according to the investigator's medical judgment, are likely to have active COVID-19 infection must be excluded. Participants with known COVID-19 positive contacts within the past 14 days must be excluded for at lea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| c) Change from baseline in total endoscopic NP score at Week 52 (centrally read) a) Change from baseline in mean nasal obstruction score (verbal response scale [VRS]) from Week 49 through to Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change from baseline in mean symptom score for rhinorrhoea (runny nose) (VRS) from Week 49 through to Week 52 • Change from baseline in mean symptom score for loss of smell (VRS) from Week 49 through to Week 52 • Change from baseline in Lund Mackay CT score at Week 52 • Change from baseline in SNOT-22 total score at Week 52 • Change from baseline in mean nasal obstruction score (VRS) from Week 21 through to Week 24 • Change from baseline in total endoscopic NP score at Week 26 | — |
Countries
Netherlands
Outcome results
None listed