EUCTR2017-003675-61-AT进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients with Severe Nasal Polyposis - OSTRO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol.
- •2. Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable EU guidelines.
- •3. Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis.
- •4. Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF.
- •5. Patients with bilateral sinonasal polyposis that, despite treatment
- •with a stable dose of intranasal corticosteroids (INCS) for at least 4
- •weeks prior to V1, in addition to a history of treatment with systemic
- •corticosteroids (SCS -oral, parenteral) or prior surgery for nasal
- •polyposis (NP), have severity consistent with a need for surgery as
- •described by:
- •- A minimum total Nasal Polyp Score (NPS) of 5 out of a maximum score
- •of 8 (with a unilateral score of at least 2 for each nostril) at V1 and
- •continuously maintained at V2 to meet the randomization criterion, as
- •determined by the study Imaging Core Lab;
- •- Ongoing symptoms for at least 12 weeks prior to V1;
- •- Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3
- •over the 2-weeks prior to V1 (2-week recall assessment of symptoms,
- •scores 0-none to 3-severe).
- •6. SNOT-22 total score = 30 at enrolment (V1).
- •Patient must meet the following criteria (points 7-10) at the
- •randomization visit (V3):
- •7. At least 8 days of evaluable daily diary data in the 14-day period prior
- •to randomization (baseline bi-weekly mean score collected from study
- •Day -13 to study Day 0).
- •8. At randomization, a bi-weekly mean NBS = 1.5.
- •9. SNOT-22 total score = 30 at randomization (V3).
- •10. At least 70% compliance with INCS during the run-in period based
- •on daily diary.
- •11. Patients with a minimum weight of 40kg.
- •12. Negative serum pregnancy test result at V1 and a negative urine
- •pregnancy test at randomization for female patients of childbearing
- •13. Women of childbearing potential (WOCBP) must use an effective
- •form of birth control (confirmed by the Investigator) eg, total sexual
- •abstinence, a vasectomized sexual partner, Implanon. Female
- •sterilization by tubal occlusion, any effective IUD intrauterine
- •device/IUS levonorgestrel Intrauterine system, Depo-ProveraTM
- •injections, oral contraceptive, Evra PatchTM, or NuvaringTM. Women of
- •childbearing potential must agree to use highly effective method of birth
- •control, as defined above, from enrolment, throughout the study
- •duration and for 16 weeks after the last dose of investigational product
- •14. Women not of childbearing potential are defined as women who are
- •either permanently sterilized (hysterectomy, bilateral oophorectomy, or
- •bilateral salpingectomy), or who are postmenopausal. Women will be
- •considerd postmenopausal if they have been amenorrheic for 12 months
- •prior to the planned date of the randomization without alternative
- •medical cause. The following age specific requirements apply:
- •- Women <50 years old are considered postmenopausal if they have
- •been amenorrheic for 12 months or more following cessation of
- •exogenous hormonal treatment and if follicle stimulating hormone (FSH)
- •levels are in the postmenopausal range;
- 另有 1 项未显示
排除标准
- •1. Patients who have undergone any nasal and/or sinus surgery within 3months prior to V1
- •2. Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as:
- •- Unilateral antrochoanal polyps;
- •- Nasal septal deviation that occludes at least one nostril;
- •- Acute sinusitis, nasal infection, or upper respiratory infection at
- •screening or in the 2 weeks before screening;
- •- Current rhinitis medicamentosa;
- •- Allergic fungal rhinosinusitis (AFRS) or Allergic fungal sinusitis (AFS);
- •- Nasal cavity tumors
- •3. Clinically important comorbidities that could confound Interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (eg, allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegener's granulomatosis), Young's syndrome, etc.
- •4. Any disorder, including but not limited to: cardiovascular,
- •gastrointestinal, hepatic, renal, neurological, musculoskeletal,
- •infectious, endocrine, metabolic, haematological, psychiatric, or Major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could:
- •- Affect the safety of the patient throughout the study;
- •- Influence the findings of the studies or their interpretations;
- •- Impede the patient's ability to complete the entire duration of study
- •5. Patients experiencing an asthma exacerbation requiring systemic
- •(oral and/or parenteral) corticosteroids treatment or hospitalization
- •(>24hrs) for treatment of asthma within 4 weeks prior to V1
- •6. History of anaphylaxis to any biologic therapy or vaccine
- •7. Known history of allergy or reaction to any component of the IP
- •formulation
- •8. History of Guillain-Barré syndrome
- •9. A helminth parasitic infection diagnosed within 24 weeks prior to V1 and has not been treated with, or has failed to respond to standard of care therapy
- •10. Current malignancy, or history of malignancy with specific
- •11. Any clinically significant cardiac disease or any electrocardiogram
- •(ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments
- •12. Positive hepatitis B surface antigen, or hepatitis C virus antibody
- •serology (confirmed by additional testing, e.g. hepatitis C RNA test, if
- •indicated), or a positive medical history for hepatitis B or C. (Note:
- •Patients with history of hepatitis B vaccination without history of
- •hepatitis B are allowed to enrol)
- •13. History of known immunodeficiency disorder, including a positive
- •human immunodeficiency virus (HIV) test
- •14. Infection requiring systemic antibiotics (Ab) within 14 days prior to V1
- •15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any
- •experimental anti-inflammatory therapy) within 3 months prior to V1
- •16. Receipt of any marketed or investigational biologic products
- •(monoclonal or polyclonal antibody) within 6 months or 5 half-lives,
- •whichever is longer, prior to V1. This also applies to patients who
- •previously participated in clinical studies and were treated with
- •monoclonal antibodies (e.g. mepolizumab, reslizumab, dupilumab,
- •omalizumab). Note that this restriction do not apply to patients, who are confirmed to h
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