Phase
Condition
Allergy (Pediatric)
Allergies & Asthma
Eye Disorders/infections
Treatment
REGN5715
Placebo
REGN5713
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Documented or participant-reported history of moderate to severe birch pollenallergy for at least 2 years with bothersome ocular symptoms during the birch season
Positive SPT to birch allergen extract, as described in the protocol
Positive allergen specific immunoglobulin E (sIgE) tests for birch and Bet v 1 (≥0.7kUa/L) at screening visit 1
Must be able to complete birch screening CACs and meet the criteria, as described inthe protocol
Exclusion
Key Exclusion Criteria:
Participation in a prior clinical study and received either REGN5713-5714-5715,REGN5713-5715, or REGN5715 antibodies, as described in the protocol
Inability to complete or termination of the screening or confirmatory CACs due to asafety concern (eg, anaphylaxis) per Principal Investigator (PI) judgement
Significant and/or severe allergies causing symptoms that are expected to coincideor potentially interfere with the study CAC assessments, as assessed by theinvestigator, 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
The presence of an active ocular infection (bacterial, viral, or fungal) ordiagnosis by a physician within 30 days prior to screening visit 1, as described inthe 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
Clinique de Specialisee en Allergie de la Capitale
Quebec, G1V 4W2
CanadaSite Not Available
Andover Eye Associates
Andover, Massachusetts 01810
United StatesSite Not Available
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