Allergic Conjunctivitis
Conditions
Keywords
Cat allergy, Eye allergy, Ocular allergy, Ocular allergy symptoms, Ocular allergy signs
Brief summary
This study is researching 2 experimental drugs, REGN1908 and REGN1909, which are called REGN1908-1909 when mixed together (called "study drug") to reduce eye allergy signs and symptoms from cat 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
DRUGREGN1908
Administered per the protocol
DRUGREGN1909
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Documented or participant-reported history of moderate to severe cat allergy for at least 2 years with bothersome ocular symptoms being near cat(s) 2. Positive SPT with cat allergen extract (mean wheal diameter at least 5 mm greater than the negative control) at screening visit 1 3. Positive Allergen-specific Immunoglobulin E (sIgE) tests for cat allergen and Fel d 1 (both ≥0.7 kUa/L) at screening visit 1 4. Must be able to complete the screening CACs to confirm moderate to severe cat allergen-induced allergic conjunctivitis as described in the protocol 5. Must not have lived with a cat(s) in the home for the past 3 years and must be willing to have no exposure to cat(s) at home throughout the study duration as described in the protocol Key
Exclusion criteria
1. Participation in a prior clinical study and received either REGN1908-1909, REGN1908, or REGN1909 antibodies as described in the protocol 2. Inability to complete or termination of the screening or confirmatory CAC (where applicable) due to a safety concern (eg, anaphylaxis), per PI judgement 3. Significant and/or severe allergies, ocular, nasal, or systemic disease causing symptoms (eg, ocular itching, ocular redness, etc) that are expected to coincide or potentially interfere with the study CAC assessments, 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. Presence of ocular conditions associated with acute or chronic vision loss, or any other ophthalmic disease or abnormality that may affect the study outcomes or participant safety, per Principal Investigator (PI) judgement as described in the protocol 6. Uncontrolled asthma or on Global Initiative for Asthma (GINA) steps 4 to 5 as described in the protocol 7. Abnormal lung function as judged by the investigator with Forced expiratory volume in 1 second (FEV1) \<70% of predicted at screening 8. History of cat immunotherapy (eg, subcutaneous immunotherapy or any other route) in the 3 years prior to screening visit 1 9. Ongoing Allergen immunotherapy (AIT) with any allergen other than cat at screening visit 1 as described in the protocol Note: Other Protocol Defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular itch score | 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 | At day 8 post-CAC | Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\], ciliary \[ciliary redness scale\] and 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 cat titrated Skin prick test (tSPT) | Baseline and day 8 | Area under the curve (AUC) of the mean wheal diameters |
| Tearing score | 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) | 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 | 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 | At day 8 post-CAC | Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\], ciliary \[ciliary redness scale\] and 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 \[ciliary redness scale\] and 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 cat tSPT | Baseline and day 8 | AUC of the mean wheal diameters |
| Percent change in cat tSPT | Baseline and day 113 | AUC of the mean wheal diameters |
| Incidence of Treatment-emergent adverse events (TEAEs) | Up to Day 113 | — |
| Severity of TEAEs | Up to Day 113 | — |
| Incidence of serious TEAEs | Up to Day 113 | — |
| Incidence of Adverse event of special interest (AESIs) | Up to Day 113 | — |
| Total REGN1908 concentrations in serum over time | Up to Day 113 | — |
| Total REGN1909 concentrations in serum over time | Up to Day 113 | — |
| Incidence of Anti-drug antibodies (ADAs) to REGN1908 | Up to Day 113 | — |
| Titers of ADAs to REGN1908 | Up to Day 113 | — |
| Incidence of ADAs to REGN1909 | Up to Day 113 | — |
| Titers of ADAs to REGN1909 | Up to Day 113 | — |
Countries
Canada, United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed