NCT01673672终止2 期
A Randomized, Placebo-Controlled, Phase IIb Dose-Finding Study of CYT003-QbG10, a TLR9-Agonist, in Patients With Moderate to Severe Allergic Asthma Not Sufficiently Controlled on Current Standard Therapy (GINA Steps 3+4)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 365
- 试验地点
- 34
- 主要终点
- Asthma Control Questionnaire
研究概览
简要总结
The purpose of this study is to assess the therapeutic potential and safety/tolerability of study drug (CYT003) at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard controller therapy.
Altogether 360 patients randomized to 4 treatment groups will be included. The study compares three dose strength with placebo. Each patient receives 7 injections of study drug or undistinguishable placebo. Key outcome measures are patient reported parameters on their asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide written informed consent
- •Able and willing to complete all protocol requirements
- •Between 18 to 65 years of age
- •Presence of persistent asthma for at least 6 months according to GINA 2011 guidelines at step 3 or 4 of treatment who has been on stable controller therapy for at least 4 weeks, and symptoms are not sufficiently controlled with medium to high doses of inhaled corticosteroid (ICS) (>250 to ≤1000 µg/day fluticasone or equivalent) in combination with or without long acting beta agonist (LABA), insufficient control will be based on asthma control questionnaire (ACQ) score ≥1.5 points. Use of stable doses of other controller therapies according to GINA steps 3 and 4 (leukotriene modifiers, sustained release theophylline) are also acceptable, but NOT treatment with anti immunoglobulin E (IgE) antibodies within the past 6 months
- •Stable but insufficiently controlled baseline conditions as documented by ACQ ≥1.5 at the screening and the baseline visits.
- •Positive skin prick test (SPT) or radioallergosorbent test (RAST) to at least 1 aero-allergen during the screening period
- •Forced expiratory volume in one second (FEV1)≥40 to ≤90% of predicted value
- •Reversibility of airway obstruction as demonstrated by:
- •FEV1 improvement by >12% , and
- •By ≥200 mL after inhaled β2-agonist (400 µg salbutamol or equivalent). If a subject does not meet reversibility criteria at the screening visit, reversibility may be retested once prior to run-in as long as the test is performed at least 5 days prior to the beginning of the run-in phase
排除标准
- •Failure to meet at least 80% compliance with completion of asthma symptoms and medication diaries at the baseline visit, after initial instruction at the screening visit and where necessary additional training at the 2-weeks run-in visit. . An additional maximum 2-weeks training period may be added in such patients.
- •Treatment or hospitalization for asthma exacerbation within past 2 months.
- •Current use or use of systemic corticosteroids within past 2 months.
- •Current smokers.
- •Ex-smokers with a smoking history of >10 pack years (1 package per day for 10 years).
- •Pregnancy or female planning to become pregnant during the study period.
- •Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
- •Treatment with IgE antibodies (Xolair®) within past 6 months.
- •Use of investigational unapproved drugs within 30 days or within 5 half-lives of the investigational drug, whichever is longer, or planned use during the whole study period.
- •Use of investigational biologics within the last 6 months.
- •Previous participation in a clinical study with a virus like particle (VLP) Qb-based vaccine.
- •Possible dependency of the patient on sponsor and/or investigator.
- •Women of child bearing potential
研究组 & 干预措施
Placebo
Placebo Comparator
7 weekly/biweekly injections of a placebo buffer
干预措施: Placebo (Biological)
CYT003 high dose
Experimental
7 weekly/biweekly injections of CYT003 high dose
干预措施: CYT003 (Biological)
CYT003 medium dose
Experimental
7 weekly/biweekly injections of CYT003 medium dose
干预措施: CYT003 (Biological)
CYT003 low dose
Experimental
7 weekly/biweekly injections of CYT003 low dose
干预措施: CYT003 (Biological)
结局指标
主要结局
Asthma Control Questionnaire
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (34)
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