REGN1908
DrugAdministered per the protocol
NCT Number: NCT06602726
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)
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Kingston Health Sciences Centre, Kingston, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Administered per the protocol
Administered per the protocol
Administered per the protocol
Time frame: 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
Time frame: 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
Time frame: Baseline and day 8
Area under the curve (AUC) of the mean wheal diameters
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Baseline and day 8
AUC of the mean wheal diameters
Time frame: Baseline and day 113
AUC of the mean wheal diameters
Time frame: Baseline and day 113
AUC of the mean wheal diameters
Time frame: Up to Day 113
Time frame: Up to Day 113
Time frame: Up to Day 113
Time frame: Up to Day 113
Time frame: Up to Day 113
Time frame: Up to Day 113
Time frame: Up to Day 113
Time frame: Up to Day 113
Time frame: Up to Day 113
Time frame: Up to Day 113
Regeneron Pharmaceuticals
Industry
A Randomized, Double-masked, Placebo-controlled Study to Assess the Efficacy and Safety of REGN1908-1909 to Reduce Signs and Symptoms of Allergic Conjunctivitis in Participants With Cat Allergy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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