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, 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: * What side effects may happen from taking the study drug * 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).
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Documented or participant-reported history of moderate to severe birch pollen allergy for at least 2 years with bothersome ocular symptoms during the birch season 2. Positive SPT to birch allergen extract, as described in the protocol 3. Positive allergen specific immunoglobulin E (sIgE) tests for birch and Bet v 1 (≥0.7 kUa/L) at screening visit 1 4. Must be able to complete birch screening CACs and meet the criteria, as described in the protocol Key
Exclusion criteria
1. Participation in a prior clinical study and received either REGN5713-5714-5715, REGN5713-5715, or REGN5715 antibodies, as described in the protocol 2. Inability to complete or termination of the screening or confirmatory CACs due to a safety concern (eg, anaphylaxis) per Principal Investigator (PI) judgement 3. Significant and/or severe allergies causing symptoms that are expected to coincide or potentially interfere with the study CAC assessments, as assessed by the investigator, as described in the protocol 4. Persistent chronic or recurring acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening visit 1, as described in the protocol 5. The presence of an active ocular infection (bacterial, viral, or fungal) or diagnosis by a physician within 30 days prior to screening visit 1, as described in the protocol Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular itch score in response to birch allergen challenge | At Day 8 post-Conjunctival Allergen Challenge (CAC) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival redness score in response to birch allergen challenge | At Day 8 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 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments |
| 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 | At Day 8 post-CAC | Assessed using the Ora Calibra® Conjunctival Allergen Challenge Tearing Scale, a 0-4 scale where 0 = none and 4 = very severe, 1 unit increments |
| Total ocular symptom score (TOSS) in response to birch allergen challenge | At Day 8 post-CAC | 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. |
| Total redness score in response to birch allergen challenge | At Day 8 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) |
| Ciliary redness score in response to birch allergen challenge | At Day 8 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 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments |
| Episcleral redness score | At Day 8 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 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments |
| Change in birch tSPT | Baseline and Day 8 | AUC of the mean wheal diameters |
| Percent change in birch tSPT | Baseline and Day 113 | AUC of the mean wheal diameters |
| Change in oak tSPT | Baseline and Day 8 | AUC of the mean wheal diameter |
| Percent change in oak tSPT | Baseline and Day 8 | AUC of the mean wheal diameters |
| 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 | — |
Countries
Canada, United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed