NCT07254871已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Investigate the Safety and Efficacy in Reducing Nasal Allergen Challenge Provoked Symptoms of Treatment With DM-101PX in Adults With Birch Pollen Allergic Rhinitis or Rhinoconjunctivitis
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Desentum Oy
- 入组人数
- 97
- 试验地点
- 3
- 主要终点
- Change in Total Nasal Symptom Score (TNSS) after treatment
研究概览
简要总结
Randomized, double-blind placebo-controlled phase 2 trial with the aim to investigate safety and efficacy of DM-101-PX in reducing allergic symptoms provoked by nasal allergen challenge in birch pollen allergic adults. Expanded access to the study treatment is not available.
详细描述
The study will be carried out in two study sites located in Canada
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
- 是
入选标准
- •Participant of either sex and any race, aged 18 to 65 years inclusive.
- •Documented clinical history of birch pollen-induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over, at least, 2 previous allergy seasons.
- •Bet v 1 specific serum IgE ≥ 0.7 kAU/L.
- •Positive Skin Prick Test to birch pollen allergen, with a wheal diameter ≥ 5 mm.
- •Body weight ≥ 50 kg and body mass index (BMI) within the range 18-35 kg/m2 inclusive.
排除标准
- •History or findings on physical examination at screening visit of any significant disease or disorder which, in the opinion of the Investigator, could put the participant at risk because of participation in the study, influence the results of the study or the participant's ability to participate in the study.
- •History of significant rhinitis, sinusitis, and/or presence of significant symptoms of respiratory allergy due to regular contact with other allergens, not associated with the birch pollen season, that are expected to coincide or potentially interfere with the study allergen challenge assessments, as assessed by the Investigator.
- •History of nasal polyps or other nasal oropharyngeal conditions that in the judgement of the Investigator may interfere with study outcome assessments.
- •History of chronic obstructive pulmonary disease requiring regular treatment.
- •Current diagnosis of uncontrolled, partially controlled or persistent asthma requiring regular (> 6 weeks per year) maintenance use of inhaled corticosteroids. History of severe asthma during the pollen season. History of asthma deterioration that resulted in emergency treatment or hospitalization in the 12 months before screening, or a life-threatening asthma attack at any time in the past.
- •Forced Expiratory Volume in one second (FEV1) < 75% of predicted. History of severe drug allergy, severe angioedema or systemic allergic reaction of Grade 3 or greater, according to the World Allergy Organization (WAO) scale, due to any cause.
- •History of intolerance to the Investigational Product, rescue medications used for systemic allergic reactions (i.e., adrenaline, antihistamine, glucocorticoids, and beta-2 agonists such as salbutamol), or their excipients.
- •History of acute hypersensitivity and/or anaphylaxis to protein therapeutics or components of formulation.
研究组 & 干预措施
Placebo
Placebo Comparator
weekly subcutaneous administration of Placebo for 10 weeks
干预措施: Placebo (Biological)
DM-101PX
Experimental
weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks
干预措施: DM-101PX (Biological)
结局指标
主要结局
Change in Total Nasal Symptom Score (TNSS) after treatment
时间窗: From baseline to 3 weeks after the last dose
Change in AUC for TNSS from baseline to post-treatment visit. TNSS is a symptom score consisting of 4 nasal symptoms, each symptom is rated as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). TNSS score can very between 0-12.
次要结局
- Adverse events (AEs)(from the start of treatment to 3 weeks after the last dose)
- Laboratory safety evaluations(from the start of treatment to 3 weeks after the last dose)
- Vital signs(From the start of treatment to 3 weeks after the last dose)
- Adverse Events of Special Interest (AESIs)(From the start of treatment to 3 weeks after the last dose)
- Change in TNSS after follow-up period(from baseline to 20-30 weeks after the last dose)
- Change in Total Symptom Score (TSS)(From baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose)
- Change in Peak Nasal Inspiratory Flow (PNIF)(from baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose)
- Change in blood allergy biomarker levels(From baseline to the 7th injection, the 10th injection, 3 weeks after the last dose, and 20-30 weeks after the last dose.)
研究者
研究点 (3)
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