A Study to Demonstrate the Effect of REGN5713-5715 on Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Birch Pollen Allergy
- Conditions
- Allergic Conjunctivitis
- Interventions
- Registration Number
- NCT06602739
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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 tree pollen 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 54
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description REGN5713-5715 REGN5713 Participants will be randomized 1:1 REGN5713-5715 REGN5715 Participants will be randomized 1:1 Placebo Placebo Participants will be randomized 1:1
- Primary Outcome Measures
Name Time Method Ocular itch score in response to birch allergen challenge 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 Outcome Measures
Name Time Method Total ocular symptom score (TOSS) in response to birch allergen challenge 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.
Total redness score in response to birch allergen challenge 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)
Conjunctival redness score in response to birch allergen challenge At Day 8 post-CAC Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\] ciliary \[ciliary redness scale\], episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments
Percent change in birch titrated Skin Prick Test (tSPT) in response to birch allergen challenge Baseline and at Day 8 Tearing score in response to birch allergen challenge 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
Ciliary redness score in response to birch allergen challenge At Day 8 post-CAC Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\] ciliary \[ciliary redness scale\], episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments
Episcleral redness score At Day 8 post-CAC Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\] ciliary \[ciliary redness scale\], episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments
Change in birch tSPT Baseline and Day 113 AUC of the mean wheal diameters
Percent change in birch tSPT Baseline and Day 113 AUC of the mean wheal diameters
Change in oak tSPT Baseline and Day 8 AUC of the mean wheal diameter
Percent change in oak tSPT Baseline and Day 8 AUC of the mean wheal diameters
Incidence of Treatment-emergent adverse event (TEAEs) Up to Day 113 Incidence of serious TEAEs Up to Day 113 Incidence of Adverse Events of Special Interest (AESIs) Up to Day 113 Total REGN5713 concentrations in serum over time Up to Day 113 Total REGN5715 concentrations in serum over time Up to Day 113 Incidence of Anti-drug antibody (ADAs) to REGN5713 Up to Day 113 Titers of ADAs to REGN5713 Up to Day 113 Incidence of ADAs to REGN5715 Up to Day 113 Titers of ADAs to REGN5715 Up to Day 113
Trial Locations
- Locations (3)
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
Clinique de Specialisee en Allergie de la Capitale
🇨🇦Quebec, Canada