jRCT2031240070进行中（未招募）不适用
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study to Evaluate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants with Severe Asthma (VALIANT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF).
- •Aged 18 to 80 years of age (inclusive) at the time of signing the ICF.
- •Physician-diagnosed asthma for at least 12 months prior to Visit
- •Participant has evidence of bronchodilator (BD) reversibility as documented by either historical reversibility (in the 12 months prior to Visit 1) or reversibility during screening.
- •Documented treatment with a total daily dose of either medium or high dose inhaled costicosteroids (ICS) for at least 3 months. Participants on medium dose ICS must also have been taking at least one additional maintenance asthma controller medication for at least 3 months.
- •Documented history of asthma exacerbation(s) within 12 months of Visit
- •Asthma Control Questionnaire-6 (ACQ-6) score >= 1.5 at Visit 1 and randomization.
- •Participant must have a pre-BD FEV1 value of >=30 % and <=80% predicted at screening.
- •Minimum compliance with daily diary and background asthma medication(s) as captured in the daily diary during the Run-in Period.
- •Agrees to follow the required contraceptive techniques/methods.
- •Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug intervention or at the Final Visit, whichever occurs last.
排除标准
- •Inpatient hospitalization due to asthma at any time within 4 weeks prior to Visit 1 or during the Screening/Run-in Period.
- •Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of its excipients.
- •Previous biologics, including those for asthma treatment, for which the appropriate washout period is not fulfilled prior to Visit
- •If the half-life is not known, a 24-week washout period prior to Visit 1 should be applied.
- •Allergen immunotherapy (unless maintenance dose) within 12 weeks prior to Visit 1 or plans to begin therapy or change dosing during the study.
- •For participants taking oral corticosteroids (OCS), the dose has not been stable for at least 2 weeks prior to Visit 1 and/or is >10 mg daily, or >20 mg every other day.
- •Evidence of active or suspected bacterial, viral, fungal, or parasitic infections within 2 weeks prior to Visit
- •History compatible with or diagnosis of a parasitic infection and has not been treated or has not responded to standard of care therapy.
- •Current tobacco smokers, nicotine vapers (including electronic cigarettes), snuff users or participants with a smoking history >=10 pack years. (Former nicotine smokers with a smoking history of <10 pack years, former nicotine vapers and former snuff users must have stopped for at least 6 months prior to Visit 1 to be eligible).
- •Positive coronavirus disease 2019 (COVID-19) test with lower respiratory tract symptoms within 28 days before Visit
- •Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active.
结局指标
主要结局
-
Annualized asthma exacerbation rate (AAER) over 60 weeks of treatment
次要结局
未报告次要终点
研究者
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