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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 augustus 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

570

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Andover, Massachusetts, Verenigde Staten, 01810
        • Werving
        • Andover Eye Associates

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: REGN-2Cat
Part A and B
Geneesmiddel: REGN-2Cat
Administered per the protocol
Andere namen:
  • REGN1908-REGN1909
Experimenteel: Freneslerbart
Part A and B
Geneesmiddel: Freneslerbart
Administered per the protocol
Andere namen:
  • REGN1908
Experimenteel: Mevonlerbart
Part A
Geneesmiddel: Mevonlerbart
Administered per the protocol
Andere namen:
  • REGN1909
Placebo-vergelijker: Matching placebo
Part A and B
Geneesmiddel: Placebo
Toegediend volgens het protocol

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Regeneron Pharmaceuticals

Onderzoekers

  • Studie directeur: Clinical Trial Management, Regeneron Pharmaceuticals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 juli 2026

Primaire voltooiing (Geschat)

31 mei 2029

Studie voltooiing (Geschat)

20 september 2029

Studieregistratiedata

Eerst ingediend

23 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2026

Eerst geplaatst (Werkelijk)

30 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

10 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R1908-1909-ALG-2582

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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