NCT07675811招募中3 期
A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Cat Allergy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 570
- 试验地点
- 1
- 主要终点
- Ocular itch score in participants receiving REGN-2Cat as compared to placebo
研究概览
简要总结
This study is researching two experimental medicines, freneslerbart and mevonlerbart. Freneslerbart and mevonlerbart can be given alone or together. When given together, the medicine is called "REGN-2Cat". These medicines are also known as the "study drugs".
The aim of the study is to see what side effects freneslerbart, mevonlerbart, and REGN-2Cat may have and if they help reduce eye allergy symptoms caused by cat hair/dander compared with a placebo.
The study is looking at several other research questions, including:
- 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)
- How long the study drug effect lasts
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Part A: adult participants aged 18 years and older. For part B: pediatric participants ≥8 years and <18 years, and adult participants aged 18 years and older.
- •Positive SPT to cat allergen extract
- •Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1
- •Positive CAC criteria
排除标准
- •Significant and/or severe environmental allergies causing symptoms (eg, ocular itching, ocular redness, etc) outside of the challenge setting that are expected to coincide or may interfere with study assessments
- •Presence of any ophthalmic disease/ abnormality/ condition that may interfere with study assessments, affect the study outcomes or participant safety
- •A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment as defined in the protocol
- •Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
研究组 & 干预措施
REGN-2Cat
Experimental
Part A and B
干预措施: REGN-2Cat (Drug)
Mevonlerbart
Experimental
Part A
干预措施: Mevonlerbart (Drug)
Matching placebo
Placebo Comparator
Part A and B
干预措施: Placebo (Drug)
Freneslerbart
Experimental
Part A and B
干预措施: Freneslerbart (Drug)
结局指标
主要结局
Ocular itch score in participants receiving REGN-2Cat as compared to placebo
时间窗: At day 8, post-Conjunctival Allergen Challenge (CAC)
次要结局
- 28. Severity of TEAEs(Up to day 113)
- 30. Concentrations of total freneslerbart in serum(Up to day 113)
- 31. Concentrations of total mevonlerbart in serum(Up to day 113)
- 7. Conjunctival redness score in participants receiving freneslerbart as compared to placebo(Up to day 85, post-CAC)
- 3. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo(Up to day 85, post-CAC)
- 4. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo(Up to day 85, post-CAC)
- 29. Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs)(Up to day 113)
- 20. Ciliary redness score in participants receiving REGN-2Cat as compared to placebo(Up to day 85, post-CAC)
- 1. Ocular itch score in participants receiving REGN-2Cat as compared to placebo(Up to day 85, post-CAC)
- 2. Conjunctival redness score in participants receiving REGN-2Cat as compared to placebo(Up to day 85, post-CAC)
- 5. Percent change from baseline in cat titrated Skin Prick Test (tSPT) in participants receiving REGN-2Cat as compared to placebo(Up to day 85)
- 6. Ocular itch score in participants receiving freneslerbart as compared to placebo(Up to day 85, post-CAC)
- 8. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving freneslerbart as compared to placebo(Up to day 85, post-CAC)
- 9. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving freneslerbart as compared to placebo(Up to day 85, post-CAC)
- 10. Percent change from baseline in cat tSPT in participants receiving freneslerbart as compared to placebo(Up to day 85)
- 11. Ocular itch score in participants receiving mevonlerbart as compared to placebo(At day 8, post-CAC)
- 12. Conjunctival redness score in participants receiving mevonlerbart as compared to placebo(At day 8, post-CAC)
- 13. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving mevonlerbart as compared to placebo(At day 8, post-CAC)
- 14. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving mevonlerbart as compared to placebo(At day 8, post-CAC)
- 15. Ocular itch score in participants receiving REGN-2Cat as compared to mevonlerbart(At day 8, post-CAC)
- 16. Ocular itch score in participants receiving REGN-2Cat as compared to freneslerbart(At day 8, post-CAC)
- 17. Achievements of different degrees of clinical response, as measured by change from baseline in ocular itch score among participants receiving REGN-2Cat, freneslerbart, mevonlerbart or placebo(At day 8, post-CAC)
- 18. Percent change from baseline in cat tSPT in participants receiving REGN-2Cat as compared to freneslerbart(At day 8)
- 19. Percent change from baseline in cat tSPT in participants receiving REGN-2Cat as compared to mevonlerbart(At day 8)
- 21. Episcleral redness score in participants receiving REGN-2Cat as compared to placebo(Up to day 85, post-CAC)
- 22. Total redness score in participants receiving REGN-2Cat as compared to placebo(Up to day 85, post-CAC)
- 23. Ciliary redness score in participants receiving freneslerbart as compared to placebo(Up to day 85, post-CAC)
- 24. Episcleral redness score in participants receiving freneslerbart as compared to placebo(Up to day 85, post-CAC)
- 25. Total redness score in participants receiving freneslerbart as compared to placebo(Up to day 85, post-CAC)
- 26. Percent change from baseline in cat tSPT in participants receiving mevonlerbart as compared to placebo(Up to day 85)
- 27. Occurrence of Treatment Emergent Adverse Events (TEAEs)(Up to day 113)
- 32. Occurrence of Anti-Drug Antibodies (ADA) to freneslerbart(Up to day 113)
- 33. Magnitude of ADA to freneslerbart(Up to day 113)
- 34. Occurrence of ADA to mevonlerbart(Up to day 113)
- 35. Magnitude of ADA to mevonlerbart(Up to day 113)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A clinical trial to study the effects of Nutrition Powder in children with severe and moderate acute malnutritionCTRI/2024/12/078456Rediskovar Innovative Products LLP150
尚未招募
不适用
Oral bioavailability study of test product to evaluate the safety, tolerability, and Pharmacokinetics in healthy subjects.CTRI/2025/08/093831LipoSeuticals Inc.40
进行中（未招募）
2 期
Clinical trial study to investigate the safety of SucroSEB and SEB TG which affects the metabolism and gut health of diabetic adultsCTRI/2025/01/079413Advanced Enzymes Technologies Ltd.45
招募中
4 期
A study to assess the effect of Glucocil® on metabolic health in individuals with prediabetes and Type 2 Diabetes MellitusPrediabetesCTRI/2024/07/071682Vedic Lifesciences Pvt. Ltd100
已完成
4 期
A study to determine the safety and tolerability of a range of doses of investigational product in pre-diabetic individuals.CTRI/2024/04/066499Vedic Lifesciences Pvt. Ltd100