Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is researching 2 experimental drugs, REGN5713 and REGN5715. The study drugs will be either of these drugs given alone (either REGN5713 or REGN5715) or given together (REGN5713 and REGN5715) 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 drugs are at lowering eye allergy signs and symptoms compared with placebo.
The study will also evaluate whether the combination (REGN5713-5715) has different effectiveness than REGN5713 or REGN5715 alone.
The study is looking at several other research questions, including:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN5713-5715 | Experimental |
| |
| REGN5713 | Experimental |
| |
| REGN5715 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN5713 | Drug | Administered per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular itch score in participants receiving REGN5713-5715 compared to placebo | Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 scale where 0 = none and 4= incapacitating itch, 0.5 unit increments | At Day 8 post-Conjunctival Allergen Challenge (CAC) |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo | Baseline to Day 8 post-CAC | |
| Ocular itch score in participants receiving REGN5713-5715 compared to placebo |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Recruiting | Andover | Massachusetts | 01810 | United States | |
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
Not provided
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| REGN5715 | Drug | Administered per protocol |
|
|
| Placebo | Drug | Administered per protocol |
|
| At Day 57 post-CAC |
| Conjunctival redness score in participants receiving REGN5713-5715 compared to placebo | 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 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments | At Day 8 and Day 57 post-CAC |
| Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo | Baseline to Day 8 post-CAC |
| Total Nasal Symptom Score (TNSS) in participants receiving REGN5713-5715 compared to placebo | The TNSS ranges from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a verbal rating scale ranging from 0 (none) to 3 (severe) for nasal congestion, nasal itching, rhinorrhea, and sneezing. | At Day 8 post-CAC |
| Ocular itch score in participants receiving REGN5715 compared to placebo | At Day 8 and Day 57 post-CAC |
| Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5715 compared to placebo | Baseline to Day 8 post-CAC |
| Conjunctival redness score in participants receiving REGN5715 compared to placebo | At Day 8 post-CAC |
| Achievement of at least a 1-point reduction in conjunctival redness score in for at least 2 out of 3 post-CAC time points participants receiving REGN5715 compared to placebo | Baseline to Day 8 post-CAC |
| Ocular itch score in participants receiving REGN5713 compared to placebo | At Day 8 and Day 57 post-CAC |
| Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713 compared to placebo | Baseline to Day 8 post-CAC |
| Conjunctival redness score in participants receiving REGN5713 compared to placebo | At Day 8 post-CAC |
| Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713 compared to placebo | Baseline to Day 8 post-CAC |
| Percent change in birch titrated Skin Prick Test (tSPT) in participants receiving REGN5713-5715 compared to placebo | Area Under the Curve (AUC) of the mean wheal diameters | Baseline and at Day 8 post-CAC |
| Ocular itch score in participants receiving REGN5713-5715 compared to REGN5713 | Baseline to Day 8 post-CAC |
| Ocular itch score in participants receiving REGN5713-5715 compared to REGN5715 | Baseline to Day 8 post-CAC |
| Achievements of different response thresholds for the ocular itch score among participants receiving REGN5713-5715, REGN5713, REGN5715 or placebo | Baseline to Day 8 post-CAC |
| Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo | Baseline to Day 57 post-CAC |
| Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo | Baseline to Day 57 post-CAC |
| Ciliary redness score in participants receiving REGN5713-5715 compared to placebo | 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 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments | At Day 8 and Day 57 post-CAC |
| Episcleral redness score in participants receiving REGN5713-5715 compared to placebo | 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 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments | At Day 8 and Day 57 post-CAC |
| Total redness score in participants receiving REGN5713-5715 compared to placebo | 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 and Day 57 post-CAC |
| Percent change in birch tSPT in participants receiving REGN5713-5715 compared to placebo | Baseline and at Day 57 post-CAC |
| Percent change in birch tSPT in participants receiving REGN5715 compared to placebo | Baseline, at Day 8 and at Day 57 post-CAC |
| Percent change in birch tSPT in participants receiving REGN5713 compared to placebo | Baseline, at Day 8 and at Day 57 post-CAC |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to Day 113 |
| Severity of TEAEs | Up to Day 113 |
| Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs) | Up to Day 113 |
| Concentrations of total REGN5713 is serum over time | Up to Day 113 |
| Concentrations of total REGN5715 is serum over time | Up to Day 113 |
| Occurrence of Anti-Drug Antibodies (ADA) responses to REGN5713 | Up to Day 113 |
| Magnitude of ADA to REGN5713 | Up to Day 113 |
| Occurrence of ADA responses to REGN5715 | Up to Day 113 |
| Magnitude of ADA to REGN5715 | Up to Day 113 |
| Somnos Clinical Research |
| Recruiting |
| Lincoln |
| Nebraska |
| 68510 |
| United States |
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |