NCT06602739已完成3 期
A Randomized, Double-Masked, Placebo-Controlled Study to Assess the Efficacy and Safety of REGN5713-5715 to Reduce Signs and Symptoms of Allergic Conjunctivitis in Participants With Birch Pollen Allergy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Ocular itch score in response to birch allergen challenge
研究概览
简要总结
This study is researching 2 experimental drugs, REGN5713 and REGN5715, which are called REGN5713-5715 when mixed together (called "study drug") to reduce eye allergy signs and symptoms due to birch tree pollen allergy.
The aim of the study is to see how safe and effective the study drug is at lowering allergic eye signs and symptoms compared with placebo. A placebo looks like a treatment but does not contain any real medicine.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).
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
- 否
入选标准
- •Documented or participant-reported history of moderate to severe birch pollen allergy for at least 2 years with bothersome ocular symptoms during the birch season
- •Positive SPT to birch allergen extract, as described in the protocol
- •Positive allergen specific immunoglobulin E (sIgE) tests for birch and Bet v 1 (≥0.7 kUa/L) at screening visit 1
- •Must be able to complete birch screening CACs and meet the criteria, as described in the protocol
排除标准
- •Participation in a prior clinical study and received either REGN5713-5714-5715, REGN5713-5715, or REGN5715 antibodies, as described in the protocol
- •Inability to complete or termination of the screening or confirmatory CACs due to a safety concern (eg, anaphylaxis) per Principal Investigator (PI) judgement
- •Significant and/or severe allergies causing symptoms that are expected to coincide or potentially interfere with the study CAC assessments, as assessed by the investigator, as described in the protocol
- •Persistent chronic or recurring acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening visit 1, as described in the protocol
- •The presence of an active ocular infection (bacterial, viral, or fungal) or diagnosis by a physician within 30 days prior to screening visit 1, as described in the protocol
- •Note: Other protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
REGN5713-5715
Experimental
Participants will be randomized 1:1
干预措施: REGN5713 (Drug)
Placebo
Placebo Comparator
Participants will be randomized 1:1
干预措施: Placebo (Drug)
REGN5713-5715
Experimental
Participants will be randomized 1:1
干预措施: REGN5715 (Drug)
结局指标
主要结局
Ocular itch score in response to birch allergen challenge
时间窗: At Day 8 post-Conjunctival Allergen Challenge (CAC)
Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 point scale where 0 = none and 4= incapacitating itch, 0.5 unit increments
次要结局
- Total ocular symptom score (TOSS) in response to birch allergen challenge(At Day 8 post-CAC)
- Total redness score in response to birch allergen challenge(At Day 8 post-CAC)
- Conjunctival redness score in response to birch allergen challenge(At Day 8 post-CAC)
- Percent change in birch titrated Skin Prick Test (tSPT) in response to birch allergen challenge(Baseline and at Day 8)
- Tearing score in response to birch allergen challenge(At Day 8 post-CAC)
- Ciliary redness score in response to birch allergen challenge(At Day 8 post-CAC)
- Episcleral redness score(At Day 8 post-CAC)
- Change in birch tSPT(Baseline and Day 113)
- Percent change in birch tSPT(Baseline and Day 113)
- Change in oak tSPT(Baseline and Day 8)
- Percent change in oak tSPT(Baseline and Day 8)
- Incidence of Treatment-emergent adverse event (TEAEs)(Up to Day 113)
- Incidence of serious TEAEs(Up to Day 113)
- Incidence of Adverse Events of Special Interest (AESIs)(Up to Day 113)
- Total REGN5713 concentrations in serum over time(Up to Day 113)
- Total REGN5715 concentrations in serum over time(Up to Day 113)
- Incidence of Anti-drug antibody (ADAs) to REGN5713(Up to Day 113)
- Titers of ADAs to REGN5713(Up to Day 113)
- Incidence of ADAs to REGN5715(Up to Day 113)
- Titers of ADAs to REGN5715(Up to Day 113)
- Change in birch tSPT(Baseline and Day 8)
研究者
研究点 (6)
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