A Study to Demonstrate How Well REGN1908-1909 Works in Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Cat Allergy

Last updated: September 4, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Allergy (Pediatric)

Eye Disorders/infections

Allergy

Treatment

Placebo

REGN1908

REGN1909

Clinical Study ID

NCT06602726
R1908-1909-ALG-2416
  • Ages > 18
  • All Genders

Study Summary

This study is researching 2 experimental drugs, REGN1908 and REGN1909, which are called REGN1908-1909 when mixed together (called "study drug") to reduce eye allergy signs and symptoms from cat allergy.

The aim of the study is to see how safe and effective the study drug is at lowering allergic eye signs and symptoms compared with placebo. A placebo looks like a treatment but does not contain any real medicine.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug

  • 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)

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Documented or participant-reported history of moderate to severe cat allergy for atleast 2 years with bothersome ocular symptoms being near cat(s)

  2. Positive SPT with cat allergen extract (mean wheal diameter at least 5 mm greaterthan the negative control) at screening visit 1

  3. Positive Allergen-specific Immunoglobulin E (sIgE) tests for cat allergen and Fel d 1 (both ≥0.7 kUa/L) at screening visit 1

  4. Must be able to complete the screening CACs to confirm moderate to severe catallergen-induced allergic conjunctivitis as described in the protocol

  5. Must not have lived with a cat(s) in the home for the past 3 years and must bewilling to have no exposure to cat(s) at home throughout the study duration asdescribed in the protocol

Exclusion

Key Exclusion Criteria:

  1. Participation in a prior clinical study and received either REGN1908-1909, REGN1908,or REGN1909 antibodies as described in the protocol

  2. Inability to complete or termination of the screening or confirmatory CAC (whereapplicable) due to a safety concern (eg, anaphylaxis), per PI judgement

  3. Significant and/or severe allergies, ocular, nasal, or systemic disease causingsymptoms (eg, ocular itching, ocular redness, etc) that are expected to coincide orpotentially interfere with the study CAC assessments, as described in the protocol

  4. Persistent chronic or recurring acute infection requiring treatment with systemicantibiotics, antivirals, or antifungals, or any untreated respiratory infectionswithin 4 weeks prior to screening visit 1 as described in the protocol

  5. Presence of ocular conditions associated with acute or chronic vision loss, or anyother ophthalmic disease or abnormality that may affect the study outcomes orparticipant safety, per Principal Investigator (PI) judgement as described in theprotocol

  6. Uncontrolled asthma or on Global Initiative for Asthma (GINA) steps 4 to 5 asdescribed in the protocol

  7. Abnormal lung function as judged by the investigator with Forced expiratory volumein 1 second (FEV1) <70% of predicted at screening

  8. History of cat immunotherapy (eg, subcutaneous immunotherapy or any other route) inthe 3 years prior to screening visit 1

  9. Ongoing Allergen immunotherapy (AIT) with any allergen other than cat at screeningvisit 1 as described in the protocol

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Study Design

Total Participants: 64
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 06, 2024
Estimated Completion Date:
August 02, 2025

Connect with a study center

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Red Maple Trials Inc.

    Ottawa, Ontario K1H 1E4
    Canada

    Site Not Available

  • Kingston Health Sciences Centre

    Kingston 5992500, Ontario 6093943 K7L 2V7
    Canada

    Site Not Available

  • Red Maple Trials Inc.

    Ottawa 6094817, Ontario 6093943 K1H 1E4
    Canada

    Site Not Available

  • Clinique de Specialisee en Allergie de la Capitale

    Quebec, G1V 4W2
    Canada

    Site Not Available

  • Clinique de Specialisee en Allergie de la Capitale

    Québec 6325494, G1V 4W2
    Canada

    Site Not Available

  • Andover Eye Associates

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • Andover Eye Associates

    Andover 4929055, Massachusetts 6254926 01810
    United States

    Site Not Available

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