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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 aktualisiert von: 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

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

570

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Massachusetts
      • Andover, Massachusetts, Vereinigte Staaten, 01810
        • Rekrutierung
        • Andover Eye Associates

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: REGN-2Cat
Part A and B
Arzneimittel: REGN-2Cat
Administered per the protocol
Andere Namen:
  • REGN1908-REGN1909
Experimental: Freneslerbart
Part A and B
Arzneimittel: Freneslerbart
Administered per the protocol
Andere Namen:
  • REGN1908
Experimental: Mevonlerbart
Part A
Arzneimittel: Mevonlerbart
Administered per the protocol
Andere Namen:
  • REGN1909
Placebo-Komparator: Matching placebo
Part A and B
Arzneimittel: Placebo
Wird gemäß Protokoll verabreicht

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Regeneron Pharmaceuticals

Ermittler

  • Studienleiter: Clinical Trial Management, Regeneron Pharmaceuticals

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

31. Juli 2026

Primärer Abschluss (Geschätzt)

31. Mai 2029

Studienabschluss (Geschätzt)

20. September 2029

Studienanmeldedaten

Zuerst eingereicht

23. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juni 2026

Zuerst gepostet (Tatsächlich)

30. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • R1908-1909-ALG-2582

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

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-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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