Health TrialsbyHealthPanel

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

ConditionAllergic Conjunctivitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age8+
SponsorRegeneron Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • REGN-2Cat

    Drug

    Administered per the protocol

  • Freneslerbart

    Drug

    Administered per the protocol

  • Mevonlerbart

    Drug

    Administered per the protocol

  • Placebo

    Drug

    Administered per the protocol

Treatment groups

570 Participants
are divided into 4 treatment groups
Group A: REGN-2CatExperimental treatment 1 intervention
Group B: FreneslerbartExperimental treatment 1 intervention
Group C: MevonlerbartExperimental treatment 1 intervention
Group D: Matching placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ocular itch score in participants receiving REGN-2Cat as compared to placebo

Time frame
At day 8, post-Conjunctival Allergen Challenge (CAC)

Secondary outcomes

1

1. Ocular itch score in participants receiving REGN-2Cat as compared to placebo

Time frame
Up to day 85, post-CAC
2

2. Conjunctival redness score in participants receiving REGN-2Cat as compared to placebo

Time frame
Up to day 85, post-CAC
3

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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