NL-OMON56281招募中3 期
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) - 217095 - ANCHOR-1
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •reduction or loss of smell
- •7. Male or eligible female participants:
- •8. Capable of giving signed informed consent
排除标准
- •1. As a result of medical interview, physical examination, or screening
- •investigation the physician responsible considers the participant unfit for the
- •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
- •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
- 另有 2 项未显示
研究者
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