EUCTR2008-007844-33-GB进行中（未招募）不适用
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Fully Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults with Uncontrolled, Moderate-to-severe, Persistent Asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 192
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)Male or female subjects.
- •2)Age 18 to 65 years at the time of screening.
- •3)Subjects must have a body mass index (BMI) between 18 and 40 kg/m2.
- •4)Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- •5)Physician-diagnosed moderate-to-severe, persistent asthma requiring treatment with appropriate asthma controller medication
- •6)Shows FEV1 reversibility postbronchodilator of = 12% and = 200 mL or have shown such values in a previous test within the last year, or have a positive AHR test result in the last year.
- •7)Pre-bronchodilator FEV1 value = 40% of individual predicted value at Visits 1 and 3
- •8)Uncontrolled, moderate-to-severe, persistent asthma consistent with Expert Panel Report (EPR)-3. In the 2 to 4 weeks preceding the screening visit, subjects should have a history of one or more of the following: i) Daytime asthma symptoms = 2 days/week ii)Nighttime awakening = 1 night/week iii)Salbutamol use = 2 days/week.
- •9) An ACQ score = 1.5 at Visits 1 and 3
- •10)At least one occurrence of asthma exacerbation in the past year that required an unscheduled medical encounter.
- •11)Women of child-bearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years postmenopausal must have a negative pregnancy test prior to the first dose of investigational product, and must agree to use 2 effective methods of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, use of condom by male sexual partner); or abstinence or sterile sexual partner from screening through Study Day 169. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study.
- •12)Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide) and must use such precautions from Study Day 1 through Study Day 169.
- •13)Otherwise healthy by medical history and physical examination for that age group.
- •14)A chest x-ray or CT scan within the previous 12 months before entering the study with no findings suggestive of acute or chronic respiratory pathology other than asthma.
- •15)Ability and willingness to complete the follow-up period until Study Day 169 as required by the protocol.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Known history of allergy or reaction to any component of the investigational product formulation.
- •2)Acute illness other than asthma at the start of the study.
- •3)History of an active infection within 4 weeks prior to screening, or evidence of clinically significant active infection, including ongoing chronic infection.
- •4)History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or a diagnosis of parasitic infection within 6 months prior to screening.
- •5)Use of immunosuppressive medication (except oral prednisone up to 10 mg/day and inhaled and topical corticosteroids) within 30 days before randomization into the study.
- •6)Receipt of immunoglobulin or blood products within 30 days before randomization into the study.
- •7)Receipt of any investigational drug therapy or use of any biologicals including omalizumab within 6 months before the first dose of investigational product in this study or within 5 half-lives of an investigational agent or biologic, whichever is longer.
- •8)History of any known immunodeficiency disorder.
- •9)A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject’s verbal report.
- •10)A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject’s verbal report.
- •11)A live or attenuated vaccination received within 4 weeks prior to screening
- •12)Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study.
- •13)History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator.
- •14)Lactation (women)
- •15)History of treatment for alcohol or drug abuse within the past year.
- •16)History suggestive of chronic obstructive pulmonary disease (COPD) and of cigarette smoking = 10 pack-years.
- •17)Evidence of any systemic disease on physical examination.
- •18)History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy = 1 year prior to Study Day 1 or other malignancies treated with apparent success with curative therapy = 5 years prior to entry.
- •19)Known exposure to inhaled occupational agents or fumes.
- •20)Any condition (eg, cystic fibrosis [CF] or COPD) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results.
- •21)Individuals who are legally institutionalized
- •22)Employees of the clinical study site or any other individuals involved with the conduct of the study, or family members of such individuals.
研究者
相似试验
进行中（未招募）
1 期
A study to assess if a new antiviral drug called FF-3 is safe and can protect healthy volunteers against infection with a type of flu virus.EUCTR2015-001103-31-GBAutoimmune Technologies, LLC79
进行中（未招募）
1 期
Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)MedDRA version: 20.0 Level: LLT Classification code 10071166 Term: Bladder pain syndrome System Organ Class: 100000004857EUCTR2016-004138-12-BEAstellas Pharma Europe B.V.163
进行中（未招募）
1 期
Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)MedDRA version: 20.0 Level: LLT Classification code 10071166 Term: Bladder pain syndrome System Organ Class: 100000004857EUCTR2016-004138-12-NLAstellas Pharma Europe B.V.163
进行中（未招募）
1 期
A clinical study to evaluate safety, tolerability, Pharmacokinetics and Pharmacodynamis of Belcesiran in patients with PiZZ Alpha-1 Antitrypsin Deficiency.PiZZAlpha-1 Antitrypsin Deficiency Associated Liver DiseaseMedDRA version: 23.1Level: LLTClassification code 10001806Term: Alpha-1 anti-trypsin deficiencySystem Organ Class: 100000004850EUCTR2020-003313-35-ESDicerna Pharmaceuticals, Inc.54
进行中（未招募）
不适用
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Fully Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults with Uncontrolled, Moderate-to-severe, Persistent AsthmaAsthmaMedDRA version: 8.1Level: PTClassification code 10003553Term: AsthmaEUCTR2008-007844-33-DEMedImmune Limited192