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Completed

NCT Number: NCT06602726

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

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kingston Health Sciences Centre, Kingston, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Documented or participant-reported history of moderate to severe cat allergy for at least 2 years with bothersome ocular symptoms being near cat(s)
  • Positive SPT with cat allergen extract (mean wheal diameter at least 5 mm greater than the negative control) at screening visit 1
  • Positive Allergen-specific Immunoglobulin E (sIgE) tests for cat allergen and Fel d 1 (both ≥0.7 kUa/L) at screening visit 1
  • Must be able to complete the screening CACs to confirm moderate to severe cat allergen-induced allergic conjunctivitis as described in the protocol
  • Must not have lived with a cat(s) in the home for the past 3 years and must be willing to have no exposure to cat(s) at home throughout the study duration as described in the protocol

Key Exclusion Criteria:

  • Participation in a prior clinical study and received either REGN1908-1909, REGN1908, or REGN1909 antibodies as described in the protocol
  • Inability to complete or termination of the screening or confirmatory CAC (where applicable) due to a safety concern (eg, anaphylaxis), per PI judgement
  • Significant and/or severe allergies, ocular, nasal, or systemic disease causing symptoms (eg, ocular itching, ocular redness, etc) that are expected to coincide or potentially interfere with the study CAC assessments, as described in the protocol
  • Persistent chronic or recurring acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening visit 1 as described in the protocol
  • Presence of ocular conditions associated with acute or chronic vision loss, or any other ophthalmic disease or abnormality that may affect the study outcomes or participant safety, per Principal Investigator (PI) judgement as described in the protocol
  • Uncontrolled asthma or on Global Initiative for Asthma (GINA) steps 4 to 5 as described in the protocol
  • Abnormal lung function as judged by the investigator with Forced expiratory volume in 1 second (FEV1) <70% of predicted at screening
  • History of cat immunotherapy (eg, subcutaneous immunotherapy or any other route) in the 3 years prior to screening visit 1
  • Ongoing Allergen immunotherapy (AIT) with any allergen other than cat at screening visit 1 as described in the protocol

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Treatment and study plan

REGN1908

Drug

Administered per the protocol

REGN1909

Drug

Administered per the protocol

Placebo

Drug

Administered per the protocol

Primary outcomes

  1. Ocular itch score

    Time frame: At day 8 post-Conjunctival Allergen Challenge (CAC)

    Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 point scale where 0= none and 4= incapacitating itch, 0.5 unit increments

Secondary outcomes

  1. Conjunctival redness score

    Time frame: At day 8 post-CAC

    Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival [conjunctival redness scale], ciliary [ciliary redness scale] and episcleral [episcleral redness scale] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

  2. Percent change in cat titrated Skin prick test (tSPT)

    Time frame: Baseline and day 8

    Area under the curve (AUC) of the mean wheal diameters

  3. Tearing score

    Time frame: At day 8 post-CAC

    Assessed using the Ora Calibra® Conjunctival Allergen Challenge Tearing Scale, a 0-4 scale where 0 = none and 4 = very severe, 1 unit increments

  4. Total Ocular Symptom Score (TOSS)

    Time frame: At day 8 post-CAC

    TOSS is a summed score of ocular itch score (graded 0 = none to 4 = incapacitating itch), conjunctival redness score (graded 0 = none to 4 = extremely severe), and tearing score (graded 0 = none to 4 = very severe) for a total range from 0 to 12, where higher scores indicate worse responses

  5. Total redness score

    Time frame: At day 8 post-CAC

    The total redness score is calculated for CAC: range 0 to 12, where higher scores indicate worse responses (calculated as a sum of the bilateral averages for conjunctival redness score, graded 0 = none to 4 = extremely severe + ciliary redness score, graded 0 = none and 4 = extremely severe + episcleral redness score, graded 0 = none and 4 = extremely severe)

  6. Ciliary redness score

    Time frame: At day 8 post-CAC

    Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival [conjunctival redness scale], ciliary [ciliary redness scale] and episcleral [episcleral redness scale] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

  7. Episcleral redness score

    Time frame: At day 8 post-CAC

    Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival [conjunctival redness scale], ciliary [ciliary redness scale] and episcleral [episcleral redness scale] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

  8. Change in cat tSPT

    Time frame: Baseline and day 8

    AUC of the mean wheal diameters

  9. Change in cat tSPT

    Time frame: Baseline and day 113

    AUC of the mean wheal diameters

  10. Percent change in cat tSPT

    Time frame: Baseline and day 113

    AUC of the mean wheal diameters

  11. Incidence of Treatment-emergent adverse events (TEAEs)

    Time frame: Up to Day 113

  12. Severity of TEAEs

    Time frame: Up to Day 113

  13. Incidence of serious TEAEs

    Time frame: Up to Day 113

  14. Incidence of Adverse event of special interest (AESIs)

    Time frame: Up to Day 113

  15. Total REGN1908 concentrations in serum over time

    Time frame: Up to Day 113

  16. Total REGN1909 concentrations in serum over time

    Time frame: Up to Day 113

  17. Incidence of Anti-drug antibodies (ADAs) to REGN1908

    Time frame: Up to Day 113

  18. Titers of ADAs to REGN1908

    Time frame: Up to Day 113

  19. Incidence of ADAs to REGN1909

    Time frame: Up to Day 113

  20. Titers of ADAs to REGN1909

    Time frame: Up to Day 113

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-masked, Placebo-controlled Study to Assess the Efficacy and Safety of REGN1908-1909 to Reduce Signs and Symptoms of Allergic Conjunctivitis in Participants With Cat Allergy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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