A Study to Identify and Characterize Adults and Pediatric Participants With Cat and/or Birch Allergy

Patient Identification and Characterization (PIC) Study: A Prospective, Multicenter, Non-Interventional Study to Identify and Characterize Participants With Allergic Conjunctivitis With or Without Allergic Rhinitis Due to Cat and/or Birch Allergy

The purpose of this Patient Identification and Characterization (PIC) study is to collect information and perform limited allergy-related procedures to determine if participants can qualify for cat and/or birch tree pollen allergy clinical research studies in the future. The study is also looking at how cat and/or birch tree pollen allergies have affected overall health.

Study Overview

• Status: Not yet recruiting
• Conditions: Conjunctivitis Allergic
• Intervention / Treatment: Other: Noninterventional

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study will enroll adult and pediatric (aged ≥5 to <18 years) participants with cat and/or birch allergen induced allergic conjunctivitis with or without allergic rhinitis

Description

Key Inclusion Criteria:

1. Adults or pediatric participants, ≥5 years of age inclusive (pediatric participants ≥5 years and <18 years and weighing ≥10 kg, to be enrolled where permitted per local regulations/approvals), at the time of signing the informed consent
2. Participant-reported (and/or caregiver-reported for pediatric participants) and/or documented allergic history as described in the protocol
3. Positive Skin Prick Test (SPT) at screening: to cat allergen (Part A) and/or to birch allergen (Part B)
4. Must not currently live with a cat(s) or have lived with a cat(s) in the home for the past 1 year (Part A)
5. Willing and able to comply with clinic visit(s) and study-related assessments

Key Exclusion Criteria:

1. Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or participant safety as described in the protocol
2. History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures
3. Active, chronic infections requiring long-term use of systemic antibiotics, antivirals, or anti-fungal treatments

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Part A; Cat allergy	Other: Noninterventional; No investigational medicinal products will be administered in this study.
Part B; Birch allergy	Other: Noninterventional; No investigational medicinal products will be administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with moderate-to-severe allergic conjunctivitis due to cat allergy who report "very bothered" or "extremely bothered" by allergic symptoms upon exposure to cat and/or cat hair/dander	Part A	At visit 1, up to 30 days
Proportion of participants with moderate-to-severe allergic conjunctivitis due to birch tree pollen allergy who report "very bothered" or "extremely bothered" by allergic symptoms	Part B	At visit 1, up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who report "very bothered" or "extremely bothered" by allergic symptoms upon exposure to cat and/or cat hair/dander	Part A	At visit 1, up to 30 days
Proportions of participants who report "very bothered" or "extremely bothered" by allergic symptoms due to birch tree pollen	Part B	At visit 1, up to 30 days

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): January 10, 2028

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cat allergy; Birch pollen allergy; Eye allergy; Cat-induced eye allergy; Ocular allergy signs/symptoms; Allergic conjunctivitis signs/symptoms; Cat and/or birch allergen induced allergic conjunctivitis
• Additional Relevant MeSH Terms: Immune System Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Conjunctivitis; Conjunctival Diseases; Conjunctivitis, Allergic
• Other Study ID Numbers: R1908-1909-ALG-25126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No