Status:
COMPLETED
A Study to Demonstrate the Effect of REGN5713-5715 on Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Birch Pollen Allergy
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is researching 2 experimental drugs, REGN5713 and REGN5715, which are called REGN5713-5715 when mixed together (called "study drug") to reduce eye allergy signs and symptoms due to birch tr...
Eligibility Criteria
Inclusion
- Key
- Documented or participant-reported history of moderate to severe birch pollen allergy 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 (≥0.7 kUa/L) at screening visit 1
- Must be able to complete birch screening CACs and meet the criteria, as described in the protocol
- Key
Exclusion
- 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 a safety concern (eg, anaphylaxis) per Principal Investigator (PI) judgement
- Significant and/or severe allergies causing symptoms that are expected to coincide or potentially interfere with the study CAC assessments, as assessed by the investigator, 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
- The presence of an active ocular infection (bacterial, viral, or fungal) or diagnosis by a physician within 30 days prior to screening visit 1, as described in the protocol
- Note: Other protocol defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
November 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06602739
Start Date
November 19 2024
End Date
August 2 2025
Last Update
September 3 2025
Active Locations (3)
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1
Andover Eye Associates
Andover, Massachusetts, United States, 01810
2
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
3
Clinique de Specialisee en Allergie de la Capitale
Québec, Canada, G1V 4W2