NCT05430919已完成2 期
A Two-Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of the Anti-Bet v 1 Monoclonal Antibodies to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 3
- 主要终点
- Mean Total Nasal Symptom Score (TNSS) (2 to 6 Hours) During Out-of-season Birch Allergen Environmental Exposure Unit (EEU) Challenge (REGN5713-5714-5715 vs. Placebo) at Day 29
研究概览
简要总结
Primary objective: To assess the efficacy of a single dose of the anti- Bet v 1 monoclonal antibodies (mAb(s ) in the reduction of allergic nasal symptoms during an out-of-season birch allergen environmental exposure unit (EEU) challenge in participants receiving REGN5713-5714-5715 versus placebo (Part A)
详细描述
The study consists of Part A and Part B. All participants will be asked to complete both Part A and Part B of the study. The study lasts for a total duration of up to approximately 46 weeks (including up to a 10-week screening period). Part A of the study lasts up to approximately 28 weeks (including the screening period). Part B of the study starts after completion of Part A and lasts up to approximately 18 weeks (including an approximately 4-week follow-up period after end of birch pollen season (BPS)), dependent on the start and end times of the natural BPS.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented or participant-reported history of birch tree pollen-triggered allergic-rhinitis (AR) symptoms with or without conjunctivitis (for at least 2 seasons)
- •Positive Skin prick test (SPT) with birch tree pollen extract (mean wheal diameter at least 5 mm greater than a negative control) in screening period
- •Positive allergen-specific immunoglobulin E (sIgE) tests for birch tree pollen and Bet v 1 (≥0.7 kUa/L) in screening period
- •Demonstrated TNSS ≥ 6 out of 12 on at least 2 time points during the birch EEU exposure challenge in screening period
排除标准
- •Participation in a prior REGN5713-5714-5715 clinical trial and received REGN5713-5714-5715 antibodies (receipt of placebo in a previous trial is allowed)
- •Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season, or due to daily contact with other non-birch related allergens causing symptoms that are expected to coincide or potentially interfere with the study EEU assessments or with the birch pollen season, as assessed by the investigator
- •Participants who anticipate major changes in allergen exposure during the birch pollen season that are expected to coincide with study assessments or planned travel that is expected to interfere with the study assessments, as assessed by the investigator (eg. anticipated travel during planned EEU sessions or birch pollen season)
- •Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening visit
- •Patients may be re-evaluated for eligibility after resolution of symptoms and specified duration.
- •History of significant, recurrent sinusitis, defined as at least 3 episodes requiring antibiotic treatment per year for the last 2 years
- •Abnormal lung function as judged by the investigator with Forced Expiratory Volume (FEV1) <75% of predicted at screening or randomization
- •A clinical history of moderate to severe asthma, uncontrolled asthma, global initiative for asthma [GINA] steps 3 to 5, history of life-threatening asthma, asthma exacerbations due to tree pollen allergy within 2 prior seasons, >2 asthma exacerbations requiring systemic steroids in past 12 months, asthma related emergency care or hospitalization within 12 months prior to screening, as defined in the protocol.
- •History of birch or other tree allergen immunotherapy in the 3 years prior to screening.
- •Use of anti-IgE or other biological therapy (including but not limited to anti IL-5, anti IL-4) that interferes with type 2 disease within 6 months prior to screening visit
- •Allergen-specific immunotherapy with any allergen other than birch or other trees at screening.
- •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease,
- •Any malignancy within the past 5 years, except for basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus that have been resected, with no evidence of local recurrence or metastatic disease for 3 years.
- •NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
研究组 & 干预措施
REGN5713-5715
Experimental
2-mAb
干预措施: Placebo (Other)
REGN5713-5714-5715
Experimental
3-mAb
干预措施: REGN5713 (Drug)
REGN5713-5714-5715
Experimental
3-mAb
干预措施: REGN5714 (Drug)
REGN5713-5714-5715
Experimental
3-mAb
干预措施: REGN5715 (Drug)
REGN5713-5715
Experimental
2-mAb
干预措施: REGN5713 (Drug)
REGN5713-5715
Experimental
2-mAb
干预措施: REGN5715 (Drug)
REGN5715
Experimental
1-mAb
干预措施: REGN5715 (Drug)
REGN5715
Experimental
1-mAb
干预措施: Placebo (Other)
Matching Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Mean Total Nasal Symptom Score (TNSS) (2 to 6 Hours) During Out-of-season Birch Allergen Environmental Exposure Unit (EEU) Challenge (REGN5713-5714-5715 vs. Placebo) at Day 29
时间窗: Day 29 from randomization (Out-of-season)
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
次要结局
- Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29(Day 29 from randomization (Out-of-season))
- Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85(Day 57 and Day 85, from randomization (Out-of-season))
- Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29(Day 29 from randomization (Out-of-season))
- Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85(Day 57 and Day 85, from randomization (Out-of-season))
- Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29(Day 29 from randomization (Out-of-season))
- Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85(Day 57 and Day 85, from randomization (Out-of-season))
- Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85(Day 29, Day 57 and Day 85, from randomization (Out-of-season))
- Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85(Day 29, Day 57 and Day 85, from randomization (Out-of-season))
- Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85(Day 29, Day 57 and Day 85, from randomization (Out-of-season))
- Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85(Day 29, Day 57 and Day 85, from randomization (Out-of-season))
- Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85(Day 29, Day 57 and Day 85, from randomization (Out-of-season))
- Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85(Day 29, Day 57 and Day 85, from randomization (Out-of-season))
- Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29(Day 29 from randomization (Out-of-season))
- Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85(Day 57 and Day 85, from randomization (Out-of-season))
- Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127(Day 127 from randomization)
- Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253(Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study))
- Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29(Day 29 from randomization (Out-of-season))
- Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85(Day 57 and Day 85, from randomization (Out-of-season))
- Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127(Day 127 from randomization)
- Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253(Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study))
- Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36(Day 36 from randomization (Out-of-season))
- Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36(Day 36 from randomization (Out-of-season))
- Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36(Day 36 from randomization (Out-of-season))
- Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds(Day 29, Day 57 and Day 85, from randomization (Out-of-season))
- Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds(Day 29, Day 57 and Day 85, from randomization (Out-of-season))
- Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds(Day 29, Day 57 and Day 85, from randomization (Out-of-season))
- Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds(Day 29, Day 57 and Day 85, from randomization (Out-of-season))
- Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190(Day 190 from randomization (In-season); Timing may vary based on local season)
- Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)(Up to 253 days from randomization (during BPS))
- Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS(Up to 253 days from randomization (during peak BPS))
- Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS(Up to 253 days from randomization (during BPS))
- Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS(Up to 253 days from randomization (during peak BPS))
- Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS(Up to 253 days from randomization (during BPS))
- Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS(Up to 253 days from randomization (during peak BPS))
- Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS(Up to 253 days from randomization (during BPS))
- Standardized RQLQ(S) Score Averaged During Peak BPS(Up to 253 days from randomization (during peak BPS))
- Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS(Up to 253 days from randomization (during BPS))
- Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS(Up to 253 days from randomization (during peak BPS))
- Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS(Up to 253 days from randomization (during BPS))
- Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS(Up to 253 days from randomization (during peak BPS))
- Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration(Up to 253 Days)
- Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration(Up to 253 Days)
- Serum Concentration of REGN5713 Over the Study Duration(Up to Week 36)
- Serum Concentration of REGN5714 Over the Study Duration(Up to Week 36)
- Serum Concentration of REGN5715 Over the Study Duration(Up to Week 36)
- Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time(Up to Week 36)
- Number of Participants With ADA to REGN5714 Over Time(Up to Week 36)
- Number of Participants With ADA to REGN5715 Over Time(Up to Week 36)
研究者
研究点 (3)
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