Status:
COMPLETED
A Study to Demonstrate How Well REGN1908-1909 Works in Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Cat Allergy
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 allerg...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
November 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06602726
Start Date
November 6 2024
End Date
August 2 2025
Last Update
September 5 2025
Active Locations (4)
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1
Andover Eye Associates
Andover, Massachusetts, United States, 01810
2
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
3
Red Maple Trials Inc.
Ottawa, Ontario, Canada, K1H 1E4
4
Clinique de Specialisee en Allergie de la Capitale
Québec, Canada, G1V 4W2