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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorRegeneron Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Participant-reported (and/or caregiver-reported for pediatric participants) and/or documented allergic history as described in the protocol

Positive Skin Prick Test (SPT) at screening: to cat allergen (Part A) and/or to birch allergen (Part B)

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)

Disqualifiers

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

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

Active, chronic infections requiring long-term use of systemic antibiotics, antivirals, or anti-fungal treatments

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Noninterventional

    Other intervention

    No investigational medicinal products will be administered in this study.

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: Part A1 intervention
Group B: Part B1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
At visit 1, up to 30 days
2

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

Time frame
At visit 1, up to 30 days

Secondary outcomes

1

Proportion of participants who report "very bothered" or "extremely bothered" by allergic symptoms upon exposure to cat and/or cat hair/dander

Part A

Time frame
At visit 1, up to 30 days
2

Proportions of participants who report "very bothered" or "extremely bothered" by allergic symptoms due to birch tree pollen

Part B

Time frame
At visit 1, up to 30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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