NCT06602726已完成3 期
A Randomized, Double-masked, Placebo-controlled Study to Assess the Efficacy and Safety of REGN1908-1909 to Reduce Signs and Symptoms of Allergic Conjunctivitis in Participants With Cat 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
- 64
- 试验地点
- 8
- 主要终点
- Ocular itch score
研究概览
简要总结
This study is researching 2 experimental drugs, REGN1908 and REGN1909, which are called REGN1908-1909 when mixed together (called "study drug") to reduce eye allergy signs and symptoms from cat 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 cat allergy for at least 2 years with bothersome ocular symptoms being near cat(s)
- •Positive SPT with cat allergen extract (mean wheal diameter at least 5 mm greater than the negative control) at screening visit 1
- •Positive Allergen-specific Immunoglobulin E (sIgE) tests for cat allergen and Fel d 1 (both ≥0.7 kUa/L) at screening visit 1
- •Must be able to complete the screening CACs to confirm moderate to severe cat allergen-induced allergic conjunctivitis as described in the protocol
- •Must not have lived with a cat(s) in the home for the past 3 years and must be willing to have no exposure to cat(s) at home throughout the study duration as described in the protocol
排除标准
- •Participation in a prior clinical study and received either REGN1908-1909, REGN1908, or REGN1909 antibodies as described in the protocol
- •Inability to complete or termination of the screening or confirmatory CAC (where applicable) due to a safety concern (eg, anaphylaxis), per PI judgement
- •Significant and/or severe allergies, ocular, nasal, or systemic disease causing symptoms (eg, ocular itching, ocular redness, etc) that are expected to coincide or potentially interfere with the study CAC assessments, 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
- •Presence of ocular conditions associated with acute or chronic vision loss, or any other ophthalmic disease or abnormality that may affect the study outcomes or participant safety, per Principal Investigator (PI) judgement as described in the protocol
- •Uncontrolled asthma or on Global Initiative for Asthma (GINA) steps 4 to 5 as described in the protocol
- •Abnormal lung function as judged by the investigator with Forced expiratory volume in 1 second (FEV1) <70% of predicted at screening
- •History of cat immunotherapy (eg, subcutaneous immunotherapy or any other route) in the 3 years prior to screening visit 1
- •Ongoing Allergen immunotherapy (AIT) with any allergen other than cat at screening visit 1 as described in the protocol
- •Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
研究组 & 干预措施
REGN1908-1909
Experimental
干预措施: REGN1908 (Drug)
REGN1908-1909
Experimental
干预措施: REGN1909 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular itch score
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
- Conjunctival redness score(At day 8 post-CAC)
- Percent change in cat titrated Skin prick test (tSPT)(Baseline and day 8)
- Tearing score(At day 8 post-CAC)
- Total Ocular Symptom Score (TOSS)(At day 8 post-CAC)
- Total redness score(At day 8 post-CAC)
- Ciliary redness score(At day 8 post-CAC)
- Episcleral redness score(At day 8 post-CAC)
- Change in cat tSPT(Baseline and day 113)
- Percent change in cat tSPT(Baseline and day 113)
- Incidence of Treatment-emergent adverse events (TEAEs)(Up to Day 113)
- Severity of TEAEs(Up to Day 113)
- Incidence of serious TEAEs(Up to Day 113)
- Incidence of ADAs to REGN1909(Up to Day 113)
- Titers of ADAs to REGN1909(Up to Day 113)
- Incidence of Adverse event of special interest (AESIs)(Up to Day 113)
- Total REGN1908 concentrations in serum over time(Up to Day 113)
- Total REGN1909 concentrations in serum over time(Up to Day 113)
- Incidence of Anti-drug antibodies (ADAs) to REGN1908(Up to Day 113)
- Titers of ADAs to REGN1908(Up to Day 113)
研究者
研究点 (8)
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