Allergic Conjunctivitis
Conditions
Keywords
Cat allergy, Eye allergy, Cat-induced eye allergy, Ocular allergy signs/symptoms, Allergic conjunctivitis signs/symptoms
Brief summary
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: * 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) * How long the study drug effect lasts
Interventions
DRUGREGN-2Cat
Administered per the protocol
DRUGFreneslerbart
Administered per the protocol
DRUGMevonlerbart
Administered per the protocol
DRUGPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Part A: adult participants aged 18 years and older. For part B: pediatric participants ≥8 years and \<18 years, and adult participants aged 18 years and older. 2. Positive SPT to cat allergen extract 3. Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1 4. Positive CAC criteria Key
Exclusion criteria
1. Significant and/or severe environmental allergies causing symptoms (eg, ocular itching, ocular redness, etc) outside of the challenge setting that are expected to coincide or may interfere with study assessments 2. Presence of any ophthalmic disease/ abnormality/ condition that may interfere with study assessments, affect the study outcomes or participant safety 3. A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment as defined in the protocol Note: Other Protocol Defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular itch score in participants receiving REGN-2Cat as compared to placebo | At day 8, post-Conjunctival Allergen Challenge (CAC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | At day 8, post-CAC | Part A |
| 12. Conjunctival redness score in participants receiving mevonlerbart as compared to placebo | At day 8, post-CAC | Part A |
| 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 | At day 8, post-CAC | Part A |
| 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 | At day 8, post-CAC | Part A |
| 15. Ocular itch score in participants receiving REGN-2Cat as compared to mevonlerbart | At day 8, post-CAC | Part A |
| 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 | At day 8 | Part A |
| 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 | Up to day 85 | Part A |
| 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 | — |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed