Allergic Conjunctivitis
Conditions
Keywords
Birch Pollen Allergy, Ocular allergy symptoms, Ocular allergy signs
Brief summary
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: * What side effects may happen from taking the study drugs * How much of the study drugs is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
Interventions
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
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Positive SPT to birch allergen extract 2. Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1 3. Positive CAC criteria Key
Exclusion criteria
1. Significant and/or severe environmental allergies causing symptoms (outside of the challenge setting) that are expected to interfere with study assessments 2. Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or negatively impact participant safety 3. A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within prior 12 months or once within 3 months prior to screening visit 1 or has been hospitalized or has attended the Emergency Room/Urgent Care facility for asthma in the 12 months prior to screening Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular itch score in participants receiving REGN5713-5715 compared to placebo | At Day 8 post-Conjunctival Allergen Challenge (CAC) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Ciliary redness score in participants receiving REGN5713-5715 compared to placebo | At Day 8 and Day 57 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 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments |
| Episcleral redness score in participants receiving REGN5713-5715 compared to placebo | At Day 8 and Day 57 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 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments |
| Total redness score in participants receiving REGN5713-5715 compared to placebo | At Day 8 and Day 57 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) |
| 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 | — |
| 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 | — |
| 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 | At Day 57 post-CAC | — |
| Conjunctival redness score in participants receiving REGN5713-5715 compared to placebo | At Day 8 and Day 57 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 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments |
| 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 | At Day 8 post-CAC | 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. |
| 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 | — |
| Percent change in birch titrated Skin Prick Test (tSPT) in participants receiving REGN5713-5715 compared to placebo | Baseline and at Day 8 post-CAC | Area Under the Curve (AUC) of the mean wheal diameters |
| 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 | — |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed