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This study is researching two experimental medicines, freneslerbart and mevonlerbart. Freneslerbart and mevonlerbart can be given alone or together. When given together, the medicine is called "REGN-2Cat". These medicines are also known as the "study drugs".
The aim of the study is to see what side effects freneslerbart, mevonlerbart, and REGN-2Cat may have and if they help reduce eye allergy symptoms caused by cat hair/dander compared with a placebo.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN-2Cat | Experimental | Part A and B |
|
| Freneslerbart | Experimental | Part A and B |
|
| Mevonlerbart | Experimental | Part A |
|
| Matching placebo | Placebo Comparator | Part A and B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN-2Cat | Drug | Administered per the protocol |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Ocular itch score in participants receiving REGN-2Cat as compared to placebo | At day 8, post-Conjunctival Allergen Challenge (CAC) |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Ocular itch score in participants receiving REGN-2Cat as compared to placebo | Up to day 85, post-CAC | |
| 2. Conjunctival redness score in participants receiving REGN-2Cat as compared to placebo | Up to day 85, 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
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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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| Freneslerbart | Drug | Administered per the protocol |
|
|
| Mevonlerbart | Drug | Administered per the protocol |
|
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| Placebo | Drug | Administered per the protocol |
|
| 3. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo | Up to day 85, post-CAC |
| 4. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo | Up to day 85, post-CAC |
| 5. Percent change from baseline in cat titrated Skin Prick Test (tSPT) in participants receiving REGN-2Cat as compared to placebo | Up to day 85 |
| 6. Ocular itch score in participants receiving freneslerbart as compared to placebo | Up to day 85, post-CAC |
| 7. Conjunctival redness score in participants receiving freneslerbart as compared to placebo | Up to day 85, post-CAC |
| 8. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving freneslerbart as compared to placebo | Up to day 85, post-CAC |
| 9. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving freneslerbart as compared to placebo | Up to day 85, post-CAC |
| 10. Percent change from baseline in cat tSPT in participants receiving freneslerbart as compared to placebo | Up to day 85 |
| 11. Ocular itch score in participants receiving mevonlerbart as compared to placebo | Part A | At day 8, post-CAC |
| 12. Conjunctival redness score in participants receiving mevonlerbart as compared to placebo | Part A | At day 8, post-CAC |
| 13. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving mevonlerbart as compared to placebo | Part A | At day 8, post-CAC |
| 14. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving mevonlerbart as compared to placebo | Part A | At day 8, post-CAC |
| 15. Ocular itch score in participants receiving REGN-2Cat as compared to mevonlerbart | Part A | At day 8, post-CAC |
| 16. Ocular itch score in participants receiving REGN-2Cat as compared to freneslerbart | At day 8, post-CAC |
| 17. Achievements of different degrees of clinical response, as measured by change from baseline in ocular itch score among participants receiving REGN-2Cat, freneslerbart, mevonlerbart or placebo | At day 8, post-CAC |
| 18. Percent change from baseline in cat tSPT in participants receiving REGN-2Cat as compared to freneslerbart | At day 8 |
| 19. Percent change from baseline in cat tSPT in participants receiving REGN-2Cat as compared to mevonlerbart | Part A | At day 8 |
| 20. Ciliary redness score in participants receiving REGN-2Cat as compared to placebo | Up to day 85, post-CAC |
| 21. Episcleral redness score in participants receiving REGN-2Cat as compared to placebo | Up to day 85, post-CAC |
| 22. Total redness score in participants receiving REGN-2Cat as compared to placebo | Up to day 85, post-CAC |
| 23. Ciliary redness score in participants receiving freneslerbart as compared to placebo | Up to day 85, post-CAC |
| 24. Episcleral redness score in participants receiving freneslerbart as compared to placebo | Up to day 85, post-CAC |
| 25. Total redness score in participants receiving freneslerbart as compared to placebo | Up to day 85, post-CAC |
| 26. Percent change from baseline in cat tSPT in participants receiving mevonlerbart as compared to placebo | Part A | Up to day 85 |
| 27. Occurrence of Treatment Emergent Adverse Events (TEAEs) | Up to day 113 |
| 28. Severity of TEAEs | Up to day 113 |
| 29. Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs) | Up to day 113 |
| 30. Concentrations of total freneslerbart in serum | Up to day 113 |
| 31. Concentrations of total mevonlerbart in serum | Up to day 113 |
| 32. Occurrence of Anti-Drug Antibodies (ADA) to freneslerbart | Up to day 113 |
| 33. Magnitude of ADA to freneslerbart | Up to day 113 |
| 34. Occurrence of ADA to mevonlerbart | Up to day 113 |
| 35. Magnitude of ADA to mevonlerbart | Up to day 113 |
| 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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