NCT02481856已完成2 期
A Dose-response Evaluation of the SQ Tree SLIT-tablet in Subjects With Moderate to Severe Allergic Rhinoconjunctivitis Induced by Pollens From the Birch Group During Controlled Exposure in an Environmental Exposure Chamber
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Average total rhinoconjunctivitis symptom score
研究概览
简要总结
The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled multi-site trial conducted in Canada. Before the start of treatment, the subjects will undergo baseline birch and oak Environmental Exposure Chamber sessions. The treatment duration is 24 weeks. The subjects will undergo birch Environmental Exposure Chamber sessions after 8, 16 and 24 weeks of treatment and an oak Environmental Exposure Chamber session after 24 weeks of treatment.
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
- •Written informed consent obtained before any trial related procedures are performed
- •Male or female aged 18 to 65 years
- •Female subjects of child-bearing potential must have a negative urine pregnancy test and be willing to practise contraceptive methods
- •History of moderate-to-severe rhinoconjunctivitis induced by pollens from the birch group with or without asthma despite having received treatment with symptom relieving medication during the previous 2 tree pollen seasons
- •Positive SPT response (wheal diameter ≥ 3 mm) to Betula verrucosa
- •Positive specific IgE against Bet v1 (≥ IgE Class 2; ≥0.70 kU/L)
- •Willing and able to comply with the trial protocol
- •Minimum level of rhinoconjunctivitis symptoms, defined as a TSS of at least 7 (of 18), at one timepoint during birch baseline EEC session.
排除标准
- •Symptoms induced by interfering allergens that are expected to be present during the periods where the subject attends the EEC sessions
- •Rhinoconjunctivitis caused by animal hair and dander to which the subject is regularly exposed.
- •Allergic symptoms induced by perennial allergens such as house dust mites, and moulds
- •A clinical history of uncontrolled asthma within 3 months prior to screening
- •Reduced lung function FEV1 (< 70% of predicted value after adequate pharmacological treatment)
- •Asthma requiring treatment with inhaled corticosteroid within the past 3 months prior to screening
- •Previous treatment with any allergy immunotherapy product with tree pollen allergens or a cross-reacting allergen within the past 5 years
- •Ongoing treatment with any allergy immunotherapy product
- •Immunosuppressive treatment within 3 months prior to the screening visit
- •Treatment with tricyclic antidepressants, catecholamine-O-methyltransferase inhibitors, mono amine oxidase inhibitors and beta-blockers
- •Treatment with antidepressant medication with antihistaminic effect
- •Treatment with antipsychotic medications with antihistaminic effect
- •Treatment with anti-IgE drugs within 130 days/5 half-lives of the drug (which ever longest)
- •Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
- •Severe oral inflammation or oral wounds at randomisation
- •Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infections that have not resolved 1-week prior to the baseline birch and oak Environmental Exposure Chamber sessions and at the randomisation visit
- •Clinically relevant nasal polyps
- •A history of paranasal sinus surgery
- •A history of surgery of nasal turbinates
- •A history of anaphylaxis with cardiorespiratory symptoms
- •A history of recurrent (defined as two or more episodes) generalised urticaria during the last 2 years
- •A history of drug-induced (incl. Allergy Immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema
- •Any clinically relevant chronic disease (≥3 months duration) that in the opinion of the investigator would interfere with the trial assessments or the safety of the subject
- •An uncontrolled systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not)
- •A history of allergy, hypersensitivity or intolerance to the investigational medicinal product (except Betula verrucosa) or any of the symptomatic medications provided in this trial
- •Being immediate family of the investigator or trial staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild.
研究组 & 干预措施
12 DU SQ tree SLIT-tablet
Experimental
Betula verrucosa, allergen extract, Oral lyophilisate
干预措施: SQ tree SLIT-tablet (Drug)
7 DU SQ tree SLIT-tablet
Experimental
Betula verrucosa, allergen extract, Oral lyophilisate
干预措施: SQ tree SLIT-tablet (Drug)
2 DU SQ tree SLIT-tablet
Experimental
Betula verrucosa, allergen extract, Oral lyophilisate
干预措施: SQ tree SLIT-tablet (Drug)
Placebo
Placebo Comparator
No active ingredient, Oral lyophilisate
干预措施: Placebo (Drug)
结局指标
主要结局
Average total rhinoconjunctivitis symptom score
时间窗: After 24 weeks of treatment
The total rhinoconjunctivitis symptom score will measured during a birch pollen challenge in the Inflamax Environmental Exposure Chamber
次要结局
- Average total rhinoconjunctivitis symptom score(After 24 weeks of treatment)
- Adverse events(During the 24-weeks treatment period)
- Vital signs(During the 24-weeks treatment period)
- Lung function measures(During the 24-weeks treatment period)
- Changes in significant clinical safety laboratory values(Before and after the 24-weeks treatment period)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Evaluate the Efficacy and Safety of SHR-1918 in Patients With HyperlipidemicHyperlipidemicNCT06109831Beijing Suncadia Pharmaceuticals Co., Ltd335
撤回
1 期
A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Repeated-dose SC Injection in Patients With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT06055374Brexogen Inc.
已完成
1 期
A Single-And Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of WD-890 Tablets in Healthy Chinese SubjectsHealthy ParticipantsNCT06506591Zhejiang Wenda Medical Technology Co., Ltd.106
已完成
2 期
GB001 in Adult Subjects With Moderate to Severe AsthmaAsthmaNCT03683576GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.481
已完成
1 期
A Phase Ia/Ib, SAD and MAD Study of of KL1333 in Healthy Subjects and Patients With Primary Mitochondrial DiseaseMitochondrial DiseasesMitochondrial Respiratory Chain DeficienciesMELAS SyndromeMitochondrial MyopathiesNCT03888716Abliva AB72