A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
2026년 8월 10일 업데이트: Regeneron Pharmaceuticals
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
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
연구 개요
연구 유형
중재적
등록 (추정된)
570
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Clinical Trials Administrator
- 전화번호: 844-734-6643
- 이메일: clinicaltrials@regeneron.com
연구 장소
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Massachusetts
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Andover, Massachusetts, 미국, 01810
- 모병
- Andover Eye Associates
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: REGN-2Cat
Part A and B
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Administered per the protocol
다른 이름들:
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실험적: Freneslerbart
Part A and B
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Administered per the protocol
다른 이름들:
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실험적: Mevonlerbart
Part A
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Administered per the protocol
다른 이름들:
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위약 비교기: Matching placebo
Part A and B
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프로토콜에 따라 관리됨
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Ocular itch score in participants receiving REGN-2Cat as compared to placebo
기간: At day 8, post-Conjunctival Allergen Challenge (CAC)
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At day 8, post-Conjunctival Allergen Challenge (CAC)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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1. Ocular itch score in participants receiving REGN-2Cat as compared to placebo
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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2. Conjunctival redness score in participants receiving REGN-2Cat as compared to placebo
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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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
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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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
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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5. Percent change from baseline in cat titrated Skin Prick Test (tSPT) in participants receiving REGN-2Cat as compared to placebo
기간: Up to day 85
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Up to day 85
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6. Ocular itch score in participants receiving freneslerbart as compared to placebo
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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7. Conjunctival redness score in participants receiving freneslerbart as compared to placebo
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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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
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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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
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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10. Percent change from baseline in cat tSPT in participants receiving freneslerbart as compared to placebo
기간: Up to day 85
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Up to day 85
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11. Ocular itch score in participants receiving mevonlerbart as compared to placebo
기간: At day 8, post-CAC
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Part A
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At day 8, post-CAC
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12. Conjunctival redness score in participants receiving mevonlerbart as compared to placebo
기간: At day 8, post-CAC
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Part A
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At day 8, post-CAC
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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
기간: At day 8, post-CAC
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Part A
|
At day 8, post-CAC
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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
기간: At day 8, post-CAC
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Part A
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At day 8, post-CAC
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15. Ocular itch score in participants receiving REGN-2Cat as compared to mevonlerbart
기간: At day 8, post-CAC
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Part A
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At day 8, post-CAC
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16. Ocular itch score in participants receiving REGN-2Cat as compared to freneslerbart
기간: At day 8, post-CAC
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At day 8, post-CAC
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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
기간: At day 8, post-CAC
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At day 8, post-CAC
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18. Percent change from baseline in cat tSPT in participants receiving REGN-2Cat as compared to freneslerbart
기간: At day 8
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At day 8
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19. Percent change from baseline in cat tSPT in participants receiving REGN-2Cat as compared to mevonlerbart
기간: At day 8
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Part A
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At day 8
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20. Ciliary redness score in participants receiving REGN-2Cat as compared to placebo
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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21. Episcleral redness score in participants receiving REGN-2Cat as compared to placebo
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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22. Total redness score in participants receiving REGN-2Cat as compared to placebo
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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23. Ciliary redness score in participants receiving freneslerbart as compared to placebo
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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24. Episcleral redness score in participants receiving freneslerbart as compared to placebo
기간: Up to day 85, post-CAC
|
Up to day 85, post-CAC
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25. Total redness score in participants receiving freneslerbart as compared to placebo
기간: Up to day 85, post-CAC
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Up to day 85, post-CAC
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26. Percent change from baseline in cat tSPT in participants receiving mevonlerbart as compared to placebo
기간: Up to day 85
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Part A
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Up to day 85
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27. Occurrence of Treatment Emergent Adverse Events (TEAEs)
기간: Up to day 113
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Up to day 113
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28. Severity of TEAEs
기간: Up to day 113
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Up to day 113
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29. Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs)
기간: Up to day 113
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Up to day 113
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30. Concentrations of total freneslerbart in serum
기간: Up to day 113
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Up to day 113
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31. Concentrations of total mevonlerbart in serum
기간: Up to day 113
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Up to day 113
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32. Occurrence of Anti-Drug Antibodies (ADA) to freneslerbart
기간: Up to day 113
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Up to day 113
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33. Magnitude of ADA to freneslerbart
기간: Up to day 113
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Up to day 113
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34. Occurrence of ADA to mevonlerbart
기간: Up to day 113
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Up to day 113
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35. Magnitude of ADA to mevonlerbart
기간: Up to day 113
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Up to day 113
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Clinical Trial Management, Regeneron Pharmaceuticals
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 31일
기본 완료 (추정된)
2029년 5월 31일
연구 완료 (추정된)
2029년 9월 20일
연구 등록 날짜
최초 제출
2026년 6월 23일
QC 기준을 충족하는 최초 제출
2026년 6월 23일
처음 게시됨 (실제)
2026년 6월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 10일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- R1908-1909-ALG-2582
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD 공유 기간
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD 공유 액세스 기준
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli.
Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .