EUCTR2016-000460-42-GB进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo Controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients are eligible for the study if all of the following criteria are met:
- •1. Written informed consent
- •2. Male and female patients aged =18 and =75 years at the time of Screening
- •3. SNOT-22 =30
- •4. At Screening, TPS of =5 for both nostrils with presence on endoscopy of nasal polyps of grade =2 in each nostril according to the polyp grading scale
- •Polyp grading scale for each nostril:
- •0=no nasal polyps
- •1=small polyps in the middle meatus not reaching below the inferior border of the middle turbinate
- •2=polyps reaching below the lower border of the middle turbinate
- •3=large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate
- •4=large polyps causing complete obstruction of the inferior nasal cavity
- •5. History of at least 2 of the following symptoms for more than 4 weeks prior to Screening:
- •a) Anterior nasal discharge
- •b) Posterior nasal discharge
- •c) Nasal congestion, blockade, or obstruction
- •d) Decreased sense of smell
- •e) Facial pain or pressure
- •6. Received continuous topical nasal steroids and/or leukotriene receptor antagonists for at least 8 weeks prior to Screening unless failure or no effect of prior nasal steroid or leukotriene receptor antagonist therapy is documented
- •7. At randomization, received =80% of doses of NASONEX scheduled during the Run-in period
- •8. At randomization, TPS of =5 for both nostrils with presence on endoscopy of nasal polyps of grade =2 in each nostril according to the polyp grading scale (see Inclusion Criterion #4) and despite prior INS treatment during the Run-in period
- •9. Female patients must be post-menopausal for =1 year with documented follicle-stimulating hormone (FSH) >30 IU/L, surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or, if of child-bearing potential, willing to use a highly effective method of contraception from Screening until at least 17 weeks after the last dose of the study drug was administered, which corresponds to approximately 5 half-lives of the study drug
- •10. Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from Screening until at least 17 weeks after the last dose of the study drug was administered, which corresponds to approximately 5 half-lives of the study drug. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
- •11. Negative Screening ova and parasite test
- •12. No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or urinalysis findings
- •13. Able to comply with all study procedures including recording scores of symptoms (i.e., anterior nasal discharge; posterior nasal discharge, nasal congestion, blockade, or obstruction; decreased sense of smell; facial pain or pressure) at clinic visits
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Use of systemic corticosteroids within 6 weeks prior to Screening (or 5 half-lives, whichever is longer) or scheduled to receive systemic corticosteroids
- •2. Chronic use of antibiotic therapy within 3 months prior to Screening
- •3. Receipt of short-term antibiotic therapy within 14 days prior to Screening or use of antibiotics during the Screening period
- •4. Acute infection that requires antibiotic, antiviral, or antifungal therapy within 30 days prior to Screening
- •5. Nasal surgery (including polypectomy) within 6 months prior to Screening
- •6. Significant mechanical nasal airway obstruction due to septal deviation based on Investigator assessment
- •7. Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives, whichever is longer, prior to Screening
- •8. Use of any medications that may interfere with the study, such as immunosuppressive drugs during the 2 weeks before Screening, or expected to require such medications through Day 168
- •9. Receipt of any live attenuated vaccines within 30 days or 5 half-lives, whichever is longer, prior to initiation of treatment in the study or expected to receive such a vaccine during the treatment period
- •10. Pregnancy or lactation in women
- •11. In patients with comorbid asthma, either of the following:
- •a) A FEV1 =60% at Screening
- •b) An asthma exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization for >24 hours for treatment of asthma within 30 days prior to Screening
- •12. History of human immunodeficiency virus infection (HIV) or other severe immunosuppressive disease or positive HIV test at Screening
- •13. Current diagnosis or prior history of allergic fungal sinusitis, cystic fibrosis, ciliary dyskinesia, Wegener’s Granulomatosis, or Churg-Strauss syndrome
- •14. Current diagnosis or prior history of any other condition likely to present with non-eosinophilic nasal polyps
- •15. History of hepatitis or active/chronic liver disease of any genesis or positive serology for hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody at Screening
- •16. Current diagnosis or history of cancer
- •17. A helminthic parasitic infestation, even if treated, within 6 months prior to Screening
- •18. History of or suspected history of cytokine release syndrome
- •19. Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, endocrine, autoimmune, gastrointestinal, hepatic, skeletal, or central nervous system; other conditions that might interfere with the absorption, distribution, metabolism or excretion of AK001 or would place the patient at increased risk
- •20. Known hypersensitivity to any constituent of the product
- •21. Legally institutionalized
研究者
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