EUCTR2012-003070-39-PL进行中（未招募）不适用
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) - CYT003-QbG1012
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
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
- •Each patient must meet the following criteria to be enrolled in this study. Note: All potential patients will sign an informed consent form (ICF) (Visit Scr/R1) before performing any study procedures.
- •1.Able and willing to provide written informed consent
- •2.Able and willing to complete all protocol requirements
- •3.Between 18 to 65 years of age
- •4.Persistent asthma with all of the following:
- •Present for at least 6 months according to GINA 2011 guidelines at Step 3 or 4 of treatment
- •Stable doses of controller therapy for at least 4 weeks prior to signing the ICF
- •Symptoms are not sufficiently controlled with medium to high doses of ICS (>250 to =1000 µg/day fluticasone or equivalent) in combination with or without LABA.
- •Asthma control questionnaire (ACQ) score =1.5.
- •Note: Use of stable doses of other controller therapies according to GINA Steps 3 and 4 (leukotriene modifiers, sustained-release theophylline) are also acceptable provided doses are stable for 4 weeks prior to signing the ICF. Treatment with anti immunoglobulin E (IgE) antibodies (Xolair®) within the past 6 months will not be allowed (see exclusion criterion 18)
- •5.Stable but insufficiently controlled baseline conditions as documented by ACQ =1.5 at the screening and the baseline visits.
- •6.Positive skin prick test (SPT) or radioallergosorbent test (RAST) to at least 1 aero-allergen during the screening visit
- •7.Forced expiratory volume in one second (FEV1) =40 to =90% of predicted value
- •8.Reversibility of airway obstruction as demonstrated by:
- •FEV1 improvement of =12% , and
- •FEV1 improvement of =200 mL after inhaled ß2-agonist (400 µg salbutamol or equivalent).
- •If a patient does not meet reversibility criteria at the screening visit, reversibility can be retested once prior to run-in visit R2. Reversibility testing should occur after at least 6 hours of short-acting ß2-agonist (SABA) withhold and at least 12 hours of LABA withhold. Reversibility can be performed after a longer LABA withhold at the discretion of the principal investigator.
- •9.Patients meeting the contraception requirements detailed in the contraception requirements section.
- •Contraception Requirements
- •Male patients who can father a child & Female patients of childbearing potential must agree to use 2 highly effective methods of contraception with their female partners. Contraception must include at least 1 barrier method
- •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 360
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following criteria will be excluded from the study. Note: Any patient who fails during the screening visit may rescreen once with approval of the medical monitor.
- •1.Failure to meet at least 80% compliance of use of the patient e-diary/PEF meter (AM3) at baseline visit, after initial instructions at the screening visit and, where necessary, additional training at the R2 run-in visit. The 80% AM3 compliance will be calculated over the 10 days prior to and including the morning session of BL/T1. A scheduled AM3 session will be considered to be compliant if a complete set of answers and at least 1 PEF measurement is available.
- •2.Treatment or hospitalization for asthma exacerbation within past 2 months prior to signing the ICF. Patients who have an exacerbation during the screening visit/run-in period will be considered screen failures.
- •3.Current use or use of systemic corticosteroids within past 2 months prior to signing the ICF.
- •4.Current smokers.
- •5.Ex-smokers with a smoking history of >10 pack years (e.g., 1 pack per day for 10 years).
- •6.Major surgery within 4 weeks prior to enrollment or anticipated within the 12-week treatment period that might impact study procedures (e.g., spirometry)
- •7.Presence or history of clinically relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, dermatological, neurological, psychiatric, or ocular disease as judged by the investigator.
- •8.Any malignancy within the previous 5 years except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or squamous cell carcinoma
- •9.Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
- •10.Confirmed or suspected current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- •11.Presence of active infectious disease as judged by the investigator.
- •12.Active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus, and colitis ulcerosa.
- •13.Pregnancy (based on positive urine test at screening visit) or lactation.
- •14.Female planning to become pregnant during the study period.
- •15.Patients with any history of abuse of alcohol or other recreational drugs.
- •16.Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
- •17.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.
- •18.Use of investigational or approved biologics including IgE antibodies (Xolair®) within the last 6 months.
- •19.Previous participation in a clinical study with a virus-like particle (VLP) recombinantly expressed virus capsid shell (Qb)-based vaccine.
- •20.Possible dependency of the patient on sponsor and/or investigator.
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