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Not yet recruiting NCT07675811

A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy

Phase III Interventional Allergic Conjunctivitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REGN-2Cat, Freneslerbart, Mevonlerbart, Placebo.
Who it may be relevant to
Registry conditions: Allergic Conjunctivitis. Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Cat Allergy

Overview

This study is researching two experimental medicines, freneslerbart and mevonlerbart. Freneslerbart and mevonlerbart can be given alone or together. When given together, the medicine is called "REGN-2Cat". These medicines are also known as the "study drugs". The aim of the study is to see what side effects freneslerbart, mevonlerbart, and REGN-2Cat may have and if they help reduce eye allergy symptoms caused by cat hair/dander compared with a placebo. The study is looking at several other research questions, including: * 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) * How long the study drug effect lasts

Interventions

  • Drug REGN-2Cat
    Administered per the protocol
  • Drug Freneslerbart
    Administered per the protocol
  • Drug Mevonlerbart
    Administered per the protocol
  • Drug Placebo
    Administered per the protocol

Primary outcome measures

  • Ocular itch score in participants receiving REGN-2Cat as compared to placebo [Time frame: At day 8, post-Conjunctival Allergen Challenge (CAC)]
Secondary outcome measures (12)
  • 1. Ocular itch score in participants receiving REGN-2Cat as compared to placebo [Time frame: Up to day 85, post-CAC]
  • 2. Conjunctival redness score in participants receiving REGN-2Cat as compared to placebo [Time frame: Up to day 85, post-CAC]
  • 3. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo [Time frame: Up to day 85, post-CAC]
  • 4. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo [Time frame: Up to day 85, post-CAC]
  • 5. Percent change from baseline in cat titrated Skin Prick Test (tSPT) in participants receiving REGN-2Cat as compared to placebo [Time frame: Up to day 85]
  • 6. Ocular itch score in participants receiving freneslerbart as compared to placebo [Time frame: Up to day 85, post-CAC]
  • 7. Conjunctival redness score in participants receiving freneslerbart as compared to placebo [Time frame: Up to day 85, post-CAC]
  • 8. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving freneslerbart as compared to placebo [Time frame: Up to day 85, post-CAC]
  • 9. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving freneslerbart as compared to placebo [Time frame: Up to day 85, post-CAC]
  • 10. Percent change from baseline in cat tSPT in participants receiving freneslerbart as compared to placebo [Time frame: Up to day 85]
  • 11. Ocular itch score in participants receiving mevonlerbart as compared to placebo [Time frame: At day 8, post-CAC]
  • 12. Conjunctival redness score in participants receiving mevonlerbart as compared to placebo [Time frame: At day 8, post-CAC]

Eligibility criteria

Inclusion criteria

  • Part A: adult participants aged 18 years and older. For part B: pediatric participants ≥8 years and <18 years, and adult participants aged 18 years and older.
  • Positive SPT to cat allergen extract
  • Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1
  • Positive CAC criteria

Exclusion criteria

  • Significant and/or severe environmental allergies causing symptoms (eg, ocular itching, ocular redness, etc) outside of the challenge setting that are expected to coincide or may interfere with study assessments
  • Presence of any ophthalmic disease/ abnormality/ condition that may interfere with study assessments, affect the study outcomes or participant safety
  • A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment as defined in the protocol

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07675811 · R1908-1909-ALG-2582

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗