REGN1908-1909 for Allergic Eye

No longer recruiting at 4 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Antibiotics, Antivirals, Antifungals

Disqualifiers: Severe allergies, Uncontrolled asthma, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental drug mix called REGN1908-1909 to determine its effectiveness in reducing eye allergy symptoms caused by cat allergies. Researchers aim to assess the drug's safety and effectiveness compared to a placebo (a treatment with no active medicine). The study also examines possible side effects and how the body processes the drug. Individuals with moderate to severe cat allergies, noticeable eye symptoms for at least two years, and who do not live with cats might be suitable for this trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In earlier studies, researchers tested REGN1908-1909 for its effectiveness against cat allergies. Research has shown that a single dose of REGN1908-1909 reduced some allergy symptoms in individuals with mild asthma triggered by cat allergens. Participants generally tolerated the treatment well, with few adverse side effects reported.

Since this study is in a later phase, evidence already suggests that REGN1908-1909 is safe for humans. This indicates that the treatment has been administered to people before, and researchers have assessed its safety. However, as with any new treatment, researchers will closely monitor for any potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for allergic eye?

Unlike the standard treatments for allergic eye conditions that often focus on alleviating symptoms through antihistamines or corticosteroids, REGN1908-1909 targets the root cause of the allergy. This investigational treatment is a biologic therapy designed to specifically bind and neutralize the allergens themselves, potentially reducing the allergic response at its source. Researchers are excited about REGN1908-1909 because it could offer a more targeted and effective approach, possibly leading to longer-lasting relief with fewer side effects compared to traditional medications.

What evidence suggests that REGN1908-1909 might be an effective treatment for allergic eye?

Research shows that REGN1908-1909, which trial participants may receive, targets FelD1, a major substance causing cat allergies. FelD1 triggers allergic reactions in people allergic to cats. Studies have shown that blocking FelD1 can greatly reduce allergy symptoms, including those affecting the eyes. Although specific data on eye allergies is limited, the mechanism suggests high effectiveness. Overall, early findings are promising for reducing eye allergy symptoms in people allergic to cats. ^{1 6 7 8 9}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: REGN1908-1909 Experimental Treatment 2 Interventions

Group II: Placebo Placebo Group 1 Intervention

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

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

MK-3641, a sublingual ragweed tablet approved by the FDA, has been shown to be a safe and effective treatment for ragweed-induced allergic rhinitis, particularly when started at least 12 weeks before pollen season.

In clinical studies, the 12μg dose of MK-3641 demonstrated the highest efficacy, with common but generally mild local reactions and only one non-serious systemic reaction reported across multiple safety studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ragweed allergy immunotherapy tablet MK-3641 (Ragwitek®) for the treatment of allergic rhinitis. Nelson, HS.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in ocular allergy: basic mechanisms, clinical patterns and new therapies. Solomon, A., Pe'er, J., Levi-Schaffer, F.[2022]

A study involving seven families showed a strong correlation between HL-A haplotypes and the production of IgE antibodies specific to ragweed pollen, indicating a genetic component to hay fever susceptibility.

The findings suggest the presence of an immune response gene specific for ragweed antigen E, which is necessary for developing hay fever, marking the first documentation of such a gene in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ragweed hay fever: genetic control and linkage to HL-A haplotypes. Levine, BB., Stember, RH., Fotino, M.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demographic and clinical factors associated with development of brimonidine tartrate 0.2%-induced ocular allergy. Manni, G., Centofanti, M., Sacchetti, M., et al.[2022]

Topical treatments for ocular allergies range from safe but moderately effective options like antihistamines and mast cell stabilizers to very potent steroids that have serious side effects, highlighting the need for safer alternatives.

Research into new therapeutic targets, such as cytokine antagonism and eosinophil inhibition, may lead to the development of more effective and safer treatments for ocular allergies, provided suitable topical formulations can be created.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug therapy for ocular allergy. Hingorani, M.[2019]

In a study of 52 patients with ragweed pollen allergy, those with asthma had significantly higher levels of IgE antibodies against Amb a V compared to patients with only rhinitis, suggesting a strong association between asthma and specific IgE responses.

The presence of the MHC haplotype [HLA-B7, SC31, DR2] was linked to higher IgE anti-Amb a V levels and asthma, while the haplotype [HLA-B8, SC01, DR3] appeared to be protective against asthma and the production of this antibody, indicating a potential genetic influence on allergic responses.

NCBI (Pubmed)

pubmed.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. Blumenthal, M., Marcus-Bagley, D., Awdeh, Z., et al.[2007]

The study established a new model for allergic conjunctivitis in mice using Japanese cedar pollen (Cry j), which is the main allergen causing pollinosis in Japan, allowing for better research into this common allergy.

Pre-treatment with eye drops that block histamine H1 receptors significantly reduced the early phase allergic reaction, suggesting that targeting histamine pathways could be an effective strategy for managing Cry j-induced allergic conjunctivitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryptomeria japonica-induced allergic conjunctivitis in mice. Fukushima, A., Shii, D., Sumi, T., et al.[2019]

Cetirizine ophthalmic solution 0.24% was found to have a low incidence of mild adverse events and no severe or serious drug-related adverse events, indicating a strong safety profile for this new treatment for allergic conjunctivitis.

The medication was well-tolerated in both adult and pediatric populations (ages 2-18) over a treatment period of up to 6 weeks, with tolerability scores similar to those of the vehicle control, suggesting high comfort during administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects. Malhotra, RP., Meier, E., Torkildsen, G., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-immunoglobulin E (omalizumab) therapy in seasonal allergic rhinitis. Casale, TB.[2007]

In a study of 11,284 participants, nearly 50% of individuals with hay fever (HF) also experienced symptomatic dry eye (DE), indicating a strong association between the severity of DE and HF symptoms.

Severe DE symptoms were significantly linked to more severe HF symptoms, suggesting that managing DE could improve overall quality of life for those suffering from HF, highlighting the importance of concurrent treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the AllerSearch Smartphone App to Assess the Association Between Dry Eye and Hay Fever: mHealth-Based Cross-Sectional Study. Inomata, T., Sung, J., Nakamura, M., et al.[2023]

The 300IR 5-grass pollen tablet showed significant efficacy in reducing symptoms of allergic rhinoconjunctivitis (ARC) during active treatment and maintained this effect for up to 2 years after treatment ended, based on a study involving 633 patients.

The safety profile of the 5-grass pollen tablet remained comparable to placebo during the 2 years post-treatment, indicating that the treatment is not only effective but also safe over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged efficacy of the 300IR 5-grass pollen tablet up to 2 years after treatment cessation, as measured by a recommended daily combined score. Didier, A., Malling, HJ., Worm, M., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06602726

A Study to Demonstrate How Well REGN1908-1909 Works ... 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 ...

2. newsroom.regeneron.com newsroom.regeneron.com/news-releases/news-release-details/regeneron-advances-allergy-pipeline-two-positive-phase-3-trials

Regeneron Advances Allergy Pipeline with Two Positive ... REGN1908 and REGN1909 are two fully human monoclonal antibodies (mAbs) targeting and blocking FelD1 – the most dominant cat allergen – which “ ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-to-demonstrate-how-well-regn1908-1909-works-in-reducing-ocular-allergy-signs-and-symptoms-in

A Study to Demonstrate How Well REGN1908-1909 Works in ... 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.

4. withpower.com withpower.com/trial/regn1908-1909-for-allergic-eye-f9955

REGN1908-1909 for Allergic Eye · Info for Participants The available research does not provide specific data on the effectiveness of REGN1908-1909 for Allergic Eye. Instead, it discusses other treatments for ocular ...

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06602726/

Trial | NCT06602726 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 ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06602726/a-study-to-demonstrate-how-well-regn1908-1909-works-in-reducing-ocular-allergy-signs-and-symptoms-in-adult-participants-with-cat-allergy

A Study to Demonstrate How Well REGN1908-1909 Works ... 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 ...

7. jacionline.org jacionline.org/article/S0091-6749(22)00984-8/fulltext

REGN1908/1909 prevented cat allergen–induced early ... Conclusion. Single-dose REGN1908/1909 significantly prevented reductions in FEV1 in cat-allergic patients with mild asthma on cat allergen ...

8. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0MPr000000PFdOMAW/nct06602726

A Study to Demonstrate How Well REGN1908-1909 Works in ... A Study to Demonstrate How Well REGN1908-1909 Works in Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Cat Allergy.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0091674922009848

REGN1908/1909 prevented cat allergen–induced early ... Single-dose REGN1908/1909 significantly prevented reductions in FEV 1 in cat-allergic patients with mild asthma on cat allergen environmental exposure unit ...