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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN5713-5715 | Experimental | Participants will be randomized 1:1 |
|
| Placebo | Placebo Comparator | Participants will be randomized 1:1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN5713 | Drug | Administered per protocol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular itch score in response to birch allergen challenge | 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 | At Day 8 post-Conjunctival Allergen Challenge (CAC) |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival redness score in response to birch allergen challenge | 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 | At Day 8 post-CAC |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States | ||
| Kingston Health Sciences Centre |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| REGN5715 | Drug | Administered per protocol |
|
|
| Placebo | Drug | Administered per protocol |
|
| 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 | Assessed using the Ora Calibra® Conjunctival Allergen Challenge Tearing Scale, a 0-4 scale where 0 = none and 4 = very severe, 1 unit increments | At Day 8 post-CAC |
| Total ocular symptom score (TOSS) in response to birch allergen challenge | 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. | At Day 8 post-CAC |
| Total redness score in response to birch allergen challenge | 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) | At Day 8 post-CAC |
| Ciliary redness score in response to birch allergen challenge | 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 | At Day 8 post-CAC |
| Episcleral redness score | 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 | At Day 8 post-CAC |
| Change in birch tSPT | AUC of the mean wheal diameters | Baseline and Day 8 |
| Change in birch tSPT | AUC of the mean wheal diameters | Baseline and Day 113 |
| Percent change in birch tSPT | AUC of the mean wheal diameters | Baseline and Day 113 |
| Change in oak tSPT | AUC of the mean wheal diameter | Baseline and Day 8 |
| Percent change in oak tSPT | AUC of the mean wheal diameters | Baseline and Day 8 |
| 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 |
| Kingston |
| Ontario |
| K7L 2V7 |
| Canada |
| Clinique de Specialisee en Allergie de la Capitale | Québec | G1V 4W2 | Canada |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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