Overview

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.