EUCTR2020-001217-20-PT进行中（未招募）1 期
A phase 4, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of the effect of dupilumab on sleep disturbance in patients with uncontrolled persistent asthma - MORPHEO
Sanofi Aventis Recherche & Developpement0 个研究点目标入组 578 人开始时间: 2020年8月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 578
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
- •- Physician diagnosis of asthma based on the Global Initiative for Asthma (GINA) 2020 Guidelines for =12 months treated with medium to high dose inhaled corticosteroid (ICS) and a second controller (ie, long-acting beta agonist, leukotriene receptor antagonist). A third controller is allowed but not mandatory. The dose regimen should be stable for at least 1 month before the study and during the screening period
- •- History of at least one asthma exacerbation within 1 year prior to screening. Exacerbation is defined as deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids (oral or injectable)
- •- Eosinophils =150 cells/µL and fractional exhaled nitric oxide (FeNO) =25 ppb during screening, prior to randomization
- •*Historical values of blood eosinophil count meeting the eligibility criterion measured within 6 months prior to screening Visit 1 in the absence of oral corticosteroid (OCS) treatment are allowed.
- •*FeNO value to be checked for eligibility at Visit 2 as well.
- •- Asthma control questionnaire (ACQ)-5 =2.5 at screening Visit 1 and Visit 2, prior to randomization
- •- Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) = 80% of predicted normal during screening, prior to randomization
- •- Exhibit bronchodilator reversibility (=12% and 200 mL improvement in FEV1 post short-acting beta agonist administration) during screening period, prior to randomization, unless reversibility test meeting the inclusion criteria was done within 6 months prior to screening Visit 1
- •- Weekly average nocturnal awakenings due to asthma symptoms in the week prior to screening Visit 1 is =1
- •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 578
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Current smoker
- •- Former smoker for 10 years with a smoking history of >10 pack-years
- •- Asthma exacerbation during screening, prior to randomization
- •- History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome)
- •- History of or current evidence of clinically significant non-respiratory diseases that in the opinion of the investigator may interfere with the aims of the study or put the participant at undue risk
- •- Active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing would be performed on a country by country basis, according to local guidelines if required by Regulatory Authorities or ethics boards
- •- Diagnosed active endoparasitic infection; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization
- •- History of human immunodeficiency (HIV) infection or positive HIV test at screening Visit 1
- •- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before screening
- •- Known or suspected immunodeficiency including history of invasive opportunistic infections, despite infection resolution
- •- Current evidence of clinically significant oncological disease
- •- History of systemic hypersensitivity or anaphylaxis to any biologic therapy
- •- Severe uncontrolled depression
- •- Sleep disturbances not related to asthma, including sleep apnea, hypersomnia, or insomnia secondary to chronic pain, atopic dermatitis (AD), COPD or other conditions
- •- Participant who works night shift (ie, any work between 8 pm and 6 am)
- •- Erratic sleep habits, as determined by the Investigator
- •- Restless leg syndrome or periodic limb movement disorder
- •- Chronic treatment with OCS for more than 2 weeks before screening Visit 1
- •- Participant taking sedative, anxiolytic, or hypnotic treatments, including melatonin, within 3 months before randomization
- •- Participant taking systemic sedative antihistamines (excluding newer generations of antihistamines) or theophylline
- •- Current treatment with antidepressants, lipophilic beta blockers, clonidine, opioids, or other medications known to interfere with sleep and may confound the study assessments, as determined by the Investigator
- •-Participant who has taken biologic therapy (including
- •dupilumab)/systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc) within 2 months or 5 half-lives before screening Visit 1, whichever is longer.
- •- Treatment with live (attenuated) vaccine within 4 weeks before screening Visit 1
- •For participants who have vaccination with live, attenuated vaccines planned during the course of the study (based on national vaccination schedule/local guidelines), it will be determined, after consultation with a physician
研究者
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已完成
4 期
A Phase 4, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of the effect of dupilumab on sleep disturbance in patients with uncontrolled persistent asthmasleep disturbance1000170810010613asthmaNL-OMON52410Genzyme Europe BV16