A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)
- Conditions
- Soft growths inside the nosechronic inflammation of the mucous membranes in the nose or sinuses1002765610046304
- Registration Number
- NL-OMON56281
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method