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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

10 de agosto de 2026 atualizado por: 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

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

570

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Massachusetts
      • Andover, Massachusetts, Estados Unidos, 01810
        • Recrutamento
        • Andover Eye Associates

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Key Inclusion Criteria:

  1. 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.
  2. Positive SPT to cat allergen extract
  3. Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1
  4. Positive CAC criteria

Key Exclusion Criteria:

  1. 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
  2. Presence of any ophthalmic disease/ abnormality/ condition that may interfere with study assessments, affect the study outcomes or participant safety
  3. 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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: REGN-2Cat
Part A and B
Medicamento: REGN-2Cat
Administered per the protocol
Outros nomes:
  • REGN1908-REGN1909
Experimental: Freneslerbart
Part A and B
Medicamento: Freneslerbart
Administered per the protocol
Outros nomes:
  • REGN1908
Experimental: Mevonlerbart
Part A
Medicamento: Mevonlerbart
Administered per the protocol
Outros nomes:
  • REGN1909
Comparador de Placebo: Matching placebo
Part A and B
Medicamento: Placebo
Administrado de acordo com o protocolo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Ocular itch score in participants receiving REGN-2Cat as compared to placebo
Prazo: At day 8, post-Conjunctival Allergen Challenge (CAC)
At day 8, post-Conjunctival Allergen Challenge (CAC)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
1. Ocular itch score in participants receiving REGN-2Cat as compared to placebo
Prazo: Up to day 85, post-CAC
Up to day 85, post-CAC
2. Conjunctival redness score in participants receiving REGN-2Cat as compared to placebo
Prazo: Up to day 85, post-CAC
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
Prazo: Up to day 85, post-CAC
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
Prazo: Up to day 85, post-CAC
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
Prazo: Up to day 85
Up to day 85
6. Ocular itch score in participants receiving freneslerbart as compared to placebo
Prazo: Up to day 85, post-CAC
Up to day 85, post-CAC
7. Conjunctival redness score in participants receiving freneslerbart as compared to placebo
Prazo: Up to day 85, post-CAC
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
Prazo: Up to day 85, post-CAC
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
Prazo: Up to day 85, post-CAC
Up to day 85, post-CAC
10. Percent change from baseline in cat tSPT in participants receiving freneslerbart as compared to placebo
Prazo: Up to day 85
Up to day 85
11. Ocular itch score in participants receiving mevonlerbart as compared to placebo
Prazo: At day 8, post-CAC
Part A
At day 8, post-CAC
12. Conjunctival redness score in participants receiving mevonlerbart as compared to placebo
Prazo: At day 8, post-CAC
Part A
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
Prazo: At day 8, post-CAC
Part A
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
Prazo: At day 8, post-CAC
Part A
At day 8, post-CAC
15. Ocular itch score in participants receiving REGN-2Cat as compared to mevonlerbart
Prazo: At day 8, post-CAC
Part A
At day 8, post-CAC
16. Ocular itch score in participants receiving REGN-2Cat as compared to freneslerbart
Prazo: At day 8, post-CAC
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
Prazo: At day 8, post-CAC
At day 8, post-CAC
18. Percent change from baseline in cat tSPT in participants receiving REGN-2Cat as compared to freneslerbart
Prazo: At day 8
At day 8
19. Percent change from baseline in cat tSPT in participants receiving REGN-2Cat as compared to mevonlerbart
Prazo: At day 8
Part A
At day 8
20. Ciliary redness score in participants receiving REGN-2Cat as compared to placebo
Prazo: Up to day 85, post-CAC
Up to day 85, post-CAC
21. Episcleral redness score in participants receiving REGN-2Cat as compared to placebo
Prazo: Up to day 85, post-CAC
Up to day 85, post-CAC
22. Total redness score in participants receiving REGN-2Cat as compared to placebo
Prazo: Up to day 85, post-CAC
Up to day 85, post-CAC
23. Ciliary redness score in participants receiving freneslerbart as compared to placebo
Prazo: Up to day 85, post-CAC
Up to day 85, post-CAC
24. Episcleral redness score in participants receiving freneslerbart as compared to placebo
Prazo: Up to day 85, post-CAC
Up to day 85, post-CAC
25. Total redness score in participants receiving freneslerbart as compared to placebo
Prazo: Up to day 85, post-CAC
Up to day 85, post-CAC
26. Percent change from baseline in cat tSPT in participants receiving mevonlerbart as compared to placebo
Prazo: Up to day 85
Part A
Up to day 85
27. Occurrence of Treatment Emergent Adverse Events (TEAEs)
Prazo: Up to day 113
Up to day 113
28. Severity of TEAEs
Prazo: Up to day 113
Up to day 113
29. Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs)
Prazo: Up to day 113
Up to day 113
30. Concentrations of total freneslerbart in serum
Prazo: Up to day 113
Up to day 113
31. Concentrations of total mevonlerbart in serum
Prazo: Up to day 113
Up to day 113
32. Occurrence of Anti-Drug Antibodies (ADA) to freneslerbart
Prazo: Up to day 113
Up to day 113
33. Magnitude of ADA to freneslerbart
Prazo: Up to day 113
Up to day 113
34. Occurrence of ADA to mevonlerbart
Prazo: Up to day 113
Up to day 113
35. Magnitude of ADA to mevonlerbart
Prazo: Up to day 113
Up to day 113

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Regeneron Pharmaceuticals

Investigadores

  • Diretor de estudo: Clinical Trial Management, Regeneron Pharmaceuticals

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

31 de julho de 2026

Conclusão Primária (Estimado)

31 de maio de 2029

Conclusão do estudo (Estimado)

20 de setembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

23 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de junho de 2026

Primeira postagem (Real)

30 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • R1908-1909-ALG-2582

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento IPD

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

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • ANALYTIC_CODE
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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