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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. august 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

570

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Massachusetts
      • Andover, Massachusetts, Forente stater, 01810
        • Rekruttering
        • Andover Eye Associates

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: REGN-2Cat
Part A and B
Legemiddel: REGN-2Cat
Administered per the protocol
Andre navn:
  • REGN1908-REGN1909
Eksperimentell: Freneslerbart
Part A and B
Legemiddel: Freneslerbart
Administered per the protocol
Andre navn:
  • REGN1908
Eksperimentell: Mevonlerbart
Part A
Legemiddel: Mevonlerbart
Administered per the protocol
Andre navn:
  • REGN1909
Placebo komparator: Matching placebo
Part A and B
Legemiddel: Placebo
Administrert i henhold til protokollen

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Regeneron Pharmaceuticals

Etterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. juli 2026

Primær fullføring (Antatt)

31. mai 2029

Studiet fullført (Antatt)

20. september 2029

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

23. juni 2026

Først lagt ut (Faktiske)

30. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R1908-1909-ALG-2582

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere