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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 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

570

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Andover, Massachusetts, Forenede Stater, 01810
        • Rekruttering
        • Andover Eye Associates

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: REGN-2Cat
Part A and B
Medicin: REGN-2Cat
Administered per the protocol
Andre navne:
  • REGN1908-REGN1909
Eksperimentel: Freneslerbart
Part A and B
Medicin: Freneslerbart
Administered per the protocol
Andre navne:
  • REGN1908
Eksperimentel: Mevonlerbart
Part A
Medicin: Mevonlerbart
Administered per the protocol
Andre navne:
  • REGN1909
Placebo komparator: Matching placebo
Part A and B
Medicin: Placebo
Administreret i henhold til protokollen

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regeneron Pharmaceuticals

Efterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. juli 2026

Primær færdiggørelse (Anslået)

31. maj 2029

Studieafslutning (Anslået)

20. september 2029

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

23. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R1908-1909-ALG-2582

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner