64 Participants Needed

REGN1908-1909 for Allergic Eye

Recruiting at 3 trial locations
CT
Overseen ByClinical Trials Administrator
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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)

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have ongoing allergen immunotherapy with any allergen other than cat, you may be excluded from participating.

What data supports the idea that REGN1908-1909 for Allergic Eye is an effective treatment?

The available research does not provide specific data on the effectiveness of REGN1908-1909 for Allergic Eye. Instead, it discusses other treatments for ocular allergies, such as anti-histamines, mast cell stabilizers, and steroids, which are used to manage symptoms. These treatments vary in potency and side effects, with steroids being very potent but having serious side effects. Without specific data on REGN1908-1909, we cannot compare its effectiveness to these alternatives.12345

What safety data is available for REGN1908-1909 treatment?

The provided research does not contain specific safety data for REGN1908-1909 or its variants. The studies focus on other treatments and allergens, such as cetirizine ophthalmic solution, 5-grass pollen tablet, and ragweed allergy immunotherapy, but do not mention REGN1908-1909.36789

Is the drug REGN1908-1909 a promising treatment for allergic eye conditions?

Yes, REGN1908-1909 is a promising drug for treating allergic eye conditions because it targets specific immune responses linked to allergies, potentially offering a more effective and focused treatment option.3461011

Research Team

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

Adults with a history of moderate to severe cat allergy for at least 2 years, confirmed by skin and blood tests. Participants must have significant eye allergy symptoms when near cats, not live with cats for the past 3 years, and avoid contact with cats during the trial.

Inclusion Criteria

I have had a moderate to severe cat allergy with eye symptoms for at least 2 years.
I am allergic to cats, confirmed by blood tests.
I haven't lived with a cat for the past 3 years and can avoid them during the study.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study drug REGN1908-1909 or placebo to assess efficacy and safety in reducing ocular allergy signs and symptoms

8 days
Multiple visits for assessments and administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of ocular symptoms and immune response

16 weeks

Treatment Details

Interventions

  • REGN1908-1909
Trial Overview The study is testing REGN1908-1909, a combination of two experimental drugs aimed at reducing allergic eye reactions in adults with cat allergies. It's being compared to a placebo to evaluate safety and effectiveness.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: REGN1908-1909Experimental Treatment2 Interventions
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Findings from Research

Omalizumab, an anti-IgE antibody, effectively reduces serum IgE levels in a dose-dependent manner, leading to significant improvements in symptoms of seasonal allergic rhinitis (SAR) in patients, particularly at a dose of 300 mg administered subcutaneously.
The treatment is safe, well-tolerated, and can be readministered in subsequent pollen seasons without issues, making it a reliable option for managing SAR symptoms.
Anti-immunoglobulin E (omalizumab) therapy in seasonal allergic rhinitis.Casale, TB.[2007]
Recent research highlights the role of T helper type 2 cytokines and other inflammatory mediators in ocular allergies, suggesting new targets for pharmacological treatments.
Newly available topical mast cell stabilizers and H1 receptor antagonists are effective for managing common allergic conjunctivitis, while innovative treatments like immunostimulatory DNA sequences show promise but require further clinical validation.
Advances in ocular allergy: basic mechanisms, clinical patterns and new therapies.Solomon, A., Pe'er, J., Levi-Schaffer, F.[2022]
In a study of 133 glaucoma patients treated with brimonidine tartrate 0.2%, 13.5% developed an ocular allergy, typically within two weeks of starting treatment.
Patients with a history of eye-drop allergies and reduced tear film production were more likely to experience brimonidine-induced ocular allergy, suggesting these factors may help identify at-risk individuals.
Demographic and clinical factors associated with development of brimonidine tartrate 0.2%-induced ocular allergy.Manni, G., Centofanti, M., Sacchetti, M., et al.[2022]

References

Anti-immunoglobulin E (omalizumab) therapy in seasonal allergic rhinitis. [2007]
Advances in ocular allergy: basic mechanisms, clinical patterns and new therapies. [2022]
Demographic and clinical factors associated with development of brimonidine tartrate 0.2%-induced ocular allergy. [2022]
Drug therapy for ocular allergy. [2019]
Using the AllerSearch Smartphone App to Assess the Association Between Dry Eye and Hay Fever: mHealth-Based Cross-Sectional Study. [2023]
Cryptomeria japonica-induced allergic conjunctivitis in mice. [2019]
Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects. [2022]
Prolonged efficacy of the 300IR 5-grass pollen tablet up to 2 years after treatment cessation, as measured by a recommended daily combined score. [2022]
Ragweed allergy immunotherapy tablet MK-3641 (Ragwitek®) for the treatment of allergic rhinitis. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Ragweed hay fever: genetic control and linkage to HL-A haplotypes. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
HLA-DR2, [HLA-B7, SC31, DR2], and [HLA-B8, SC01, DR3] haplotypes distinguish subjects with asthma from those with rhinitis only in ragweed pollen allergy. [2007]
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