A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants With Allergic Asthma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- To evaluate the safety and tolerability of briquilimab in mild-to-moderate asthmatic participants
研究概览
简要总结
Study JSP-CP-012 is designed as a proof of concept, parallel-group, single dose, double blind, placebo-controlled study using an allergen challenge model. A single dose proof of concept approach at a dose level shown to be biologically active should inform the impact of briquilimab on allergic asthma as compared to placebo while minimizing exposure to participants, in a new indication.
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
- •Men and women 18 to 65 years of age; stable, allergic asthma; history of episodic wheeze and shortness of breath; forced expiratory volume in 1 second (FEV1) at baseline at least 70% of the predicted value; able to comprehend and follow all required study procedures; willing and able to sign an informed consent form; positive methacholine challenge at baseline (concentration of methacholine causing 20% decrease in FEV1 [PC20] PC20 ≤ 16 mg/mL or PD20 equivalent to ≤400µg); and positive skin-prick test and positive allergen-induced early and late airway bronchoconstriction to common aeroallergens.
排除标准
- •Worsening of asthma or respiratory infection in the preceding 6 weeks; lung disease other than allergic asthma; prior treatment with a c-Kit inhibiting therapy; anaphylaxis to any parenterally administered biologics; use of asthma medications (note: intermittent doses of short-acting β2-agonist are allowed once weekly for relief of symptoms but prophylactic use for exercise is allowed as-needed); pregnant or lactating women; and women actively seeking pregnancy or who are not using adequate contraception.
研究组 & 干预措施
Placebo
干预措施: Placebo Comparator (Other)
Briquilimab
干预措施: Briquilimab (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of briquilimab in mild-to-moderate asthmatic participants
时间窗: From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 4.5 months)
Incidence and/or severity of AEs, treatmentemergent adverse events (TEAEs), SAEs, AEIs, and AEs leading to discontinuation. Incidence of clinically significant abnormal laboratory values and vital signs.
To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR
时间窗: 3-7 hours after allergen challenge between Briquilimab and Placebo at week 6
Allergen-induced LAR will be measured by area under the FEV1 time-response curve \[AUC\] during the period 3-7 hours after the allergen challenge and compared between briquilimab and placebo at week 6.
次要结局
- To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo.(0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6)
- Comparison of allergen-induced inflammatory mediators at 7h and 24h post allergen, between briquilimab and placebo(7 hours and 24 hours after the allergen challenge, compared between briquilimab and placebo at week 6.)
- Comparison of the allergen-induced shift in AHR to methacholine at 24 hours after the allergen challenge, between briquilimab and placebo.(24 hours after the allergen challenge compared between briquilimab and placebo at week 6.)
- Comparison of the allergen-induced changes in sputum leukocytes at 7h and 24h post allergen challenge, between the briquilimab and placebo.(7 hours and 24 hours after the allergen challenge, compared between briquilimab at week 6. and placebo.)