Phase
Condition
Allergy (Pediatric)
Eye Disorders/infections
Allergy
Treatment
Placebo
REGN1908
REGN1909
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Documented or participant-reported history of moderate to severe cat allergy for atleast 2 years with bothersome ocular symptoms being near cat(s)
Positive SPT with cat allergen extract (mean wheal diameter at least 5 mm greaterthan 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 catallergen-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 bewilling to have no exposure to cat(s) at home throughout the study duration asdescribed in the protocol
Exclusion
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 (whereapplicable) due to a safety concern (eg, anaphylaxis), per PI judgement
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
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
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
Uncontrolled asthma or on Global Initiative for Asthma (GINA) steps 4 to 5 asdescribed in the protocol
Abnormal lung function as judged by the investigator with Forced expiratory volumein 1 second (FEV1) <70% of predicted at screening
History of cat immunotherapy (eg, subcutaneous immunotherapy or any other route) inthe 3 years prior to screening visit 1
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
Connect with a study center
Kingston Health Sciences Centre
Kingston, Ontario K7L 2V7
CanadaSite Not Available
Red Maple Trials Inc.
Ottawa, Ontario K1H 1E4
CanadaSite Not Available
Kingston Health Sciences Centre
Kingston 5992500, Ontario 6093943 K7L 2V7
CanadaSite Not Available
Red Maple Trials Inc.
Ottawa 6094817, Ontario 6093943 K1H 1E4
CanadaSite Not Available
Clinique de Specialisee en Allergie de la Capitale
Quebec, G1V 4W2
CanadaSite Not Available
Clinique de Specialisee en Allergie de la Capitale
Québec 6325494, G1V 4W2
CanadaSite Not Available
Andover Eye Associates
Andover, Massachusetts 01810
United StatesSite Not Available
Andover Eye Associates
Andover 4929055, Massachusetts 6254926 01810
United StatesSite Not Available
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