REGN5713-5715 for Allergic Conjunctivitis

No longer recruiting at 3 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, Chronic infections, 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: 8

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment option for people with allergic conjunctivitis, an eye allergy caused by birch tree pollen. The research focuses on two experimental drugs, REGN5713 and REGN5715, combined to assess their effectiveness in reducing symptoms like itchy, watery eyes compared to a placebo (a treatment with no active medicine). Researchers aim to understand any side effects, how the drug moves in the body, and whether the body reacts against it, which could affect its effectiveness. This trial may suit those who have experienced moderate to severe birch pollen allergies affecting their eyes for at least two years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a persistent infection requiring treatment with systemic antibiotics, antivirals, or antifungals, you may be excluded from the trial.

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

Research has shown that the study drug, a combination of REGN5713 and REGN5715, is generally safe for people. Previous studies with similar treatments have found them to be safe, with most individuals experiencing only mild side effects. These may include skin reactions at the injection site or mild allergy-like symptoms. Serious side effects are rare.

Keep in mind, this treatment remains under investigation. While early results are promising, consider all potential risks. Always consult a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

REGN5713-5715 is unique because it targets specific proteins involved in the allergic response, potentially offering more precise relief for allergic conjunctivitis. Unlike standard treatments like antihistamines or corticosteroids, which broadly suppress symptoms, REGN5713-5715 is designed to tackle the root cause of the allergic reaction at a molecular level. Researchers are excited about this treatment because it could lead to faster and more effective symptom control with fewer side effects, providing a significant improvement over existing options.

What evidence suggests that REGN5713-5715 might be an effective treatment for allergic conjunctivitis?

Research shows that REGN5713-5715, which participants in this trial may receive, targets Bet v 1, a protein in birch pollen responsible for allergic reactions. Studies have found that monoclonal antibodies, which are special proteins made in a lab to attach to substances in the body, against Bet v 1 can help reduce allergy symptoms. Other research has shown that these antibodies have successfully lessened symptoms in people with birch pollen allergies. This suggests that REGN5713-5715 might effectively reduce eye allergies caused by birch pollen. The treatment stops the allergic reaction and eases symptoms like itchy and watery eyes. ^{1 3 6 7 8}

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 birch pollen allergy for at least 2 years, bothersome eye symptoms during birch season, and positive tests for specific allergic responses (skin prick test and immunoglobulin E) can join. Those who don't meet the screening criteria or have conditions that might interfere with the study are excluded.

Inclusion Criteria

I have had severe birch pollen allergies with eye symptoms for over 2 years.

I am allergic to birch pollen.

I tested positive for birch and Bet v 1 allergies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REGN5713-5715 or placebo to assess efficacy and safety in reducing allergic conjunctivitis symptoms

16 weeks

Multiple visits including baseline and Day 8 assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• REGN5713-5715

Trial Overview The trial is testing REGN5713-5715, a combination of two experimental drugs aimed at reducing eye allergy symptoms from birch pollen compared to a placebo—a treatment lookalike without active medicine. It will also measure drug levels in blood and check if the body develops antibodies against it.

How Is the Trial Designed?

Group I: REGN5713-5715 Experimental Treatment 2 Interventions

Participants will be randomized 1:1

Group II: Placebo Placebo Group 1 Intervention

Participants will be randomized 1:1

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

IgE antibodies from birch pollen allergic patients primarily recognize conformational epitopes of Bet v 1, while IgG antibodies from both allergic and non-allergic individuals mainly target unfolded and sequential epitopes, indicating a difference in how these antibodies interact with the allergen.

Natural Bet v 1-specific IgG antibodies do not effectively inhibit IgE binding to Bet v 1 and may even enhance basophil activation, suggesting that these IgG antibodies do not provide protection against allergic reactions and have a different origin compared to IgE antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural human Bet v 1-specific IgG antibodies recognize non-conformational epitopes whereas IgE reacts with conformational epitopes. Brazhnikov, G., Smolnikov, E., Litovkina, A., et al.[2023]

Different production methods for the low IgE binding isoform of the birch pollen allergen Bet v 1 can significantly affect its immunological properties, which is crucial for developing effective allergy treatments.

The study highlights that optimizing the production of recombinant allergens is essential for improving allergen-specific immunotherapy (SIT) outcomes, as variations in protein characteristics can influence their clinical efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of recombinant production on the immunologic behavior of birch pollen isoallergens. Wallner, M., Himly, M., Neubauer, A., et al.[2021]

A specific monoclonal antibody (mAb), Bip 1, was characterized and found to enhance IgE binding to the allergen Bet v 1, indicating that it may stabilize certain conformations of the allergen that are more recognizable to the immune system.

This study suggests that allergic patients have a diverse range of IgE antibodies targeting different forms of Bet v 1, highlighting a potential new mechanism for how immune responses to allergens are regulated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular characterization of Bip 1, a monoclonal antibody that modulates IgE binding to birch pollen allergen, Bet v 1. Laffer, S., Vangelista, L., Steinberger, P., et al.[2014]

Five human monoclonal antibodies specific to the birch pollen allergen Bet v 1 were characterized, showing a high degree of somatic mutations that suggest they underwent an affinity maturation process after immunotherapy.

While one antibody (BAB1) effectively inhibited IgE binding to Bet v 1, another (BAB2) actually increased IgE recognition and enhanced allergic reactions, highlighting the complexity and unpredictability of immunotherapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular characterization of human IgG monoclonal antibodies specific for the major birch pollen allergen Bet v 1. Anti-allergen IgG can enhance the anaphylactic reaction. Denépoux, S., Eibensteiner, PB., Steinberger, P., et al.[2019]

A study of 14 patients allergic to European chestnut pollen revealed that 92% had IgE antibodies binding to a 22 kD protein, indicating its potential role as a major allergen in Type I allergies.

The research demonstrated that both the 22 kD and 14 kD proteins from European chestnut pollen share common allergenic structures with birch pollen allergens, suggesting cross-reactivity and aiding in the understanding of pollen allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergens from birch pollen and pollen of the European chestnut share common epitopes. Hirschwehr, R., Jäger, S., Horak, F., et al.[2019]

Recombinant Bet v 1 vaccines have been developed as a targeted treatment for birch pollen allergies, showing significant improvement in allergic symptoms and immune response in clinical trials.

In a phase II trial, patients receiving rBet v 1 experienced reduced symptoms of rhinoconjunctivitis and needed less rescue medication compared to those receiving a placebo, indicating its efficacy as a therapeutic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant Bet v 1 vaccine for treatment of allergy to birch pollen. Grönlund, H., Gafvelin, G.[2019]

Vaccination with hypoallergenic Bet v 1 derivatives, particularly the Bet v 1 trimer, significantly increases the levels of Bet v 1-specific IgG antibodies, which can inhibit the binding of allergen-IgE complexes to B cells, potentially reducing allergic responses.

The study involved 46 patients and demonstrated that the trimer group showed a statistically significant reduction in IgE binding to CD23 compared to placebo, indicating that this vaccination strategy may effectively modulate allergic reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of CD23-dependent facilitated allergen binding to B cells following vaccination with genetically modified hypoallergenic Bet v 1 molecules. Pree, I., Shamji, MH., Kimber, I., et al.[2021]

All examined birch species contain multiple PR-10 genes, with a total of 134 unique sequences identified, indicating a diverse genetic background that may contribute to allergenic potential.

The study found that birch species, particularly Betula pendula, express a mixture of Bet v 1 isoforms, including both highly allergenic and hypoallergenic types, suggesting that most birch species could pose a risk for Bet v 1-related allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of PR-10 genes from eight Betula species and detection of Bet v 1 isoforms in birch pollen. Schenk, MF., Cordewener, JH., America, AH., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05430919

Study Details | NCT05430919 | Efficacy of the Anti-Bet v 1 ... A two-part randomized, double-blind, placebo-controlled study to assess the efficacy of the anti-Bet v 1 monoclonal antibodies to reduce allergic rhinitis and ...

2. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0Mdy0000001CLiEAM/nct05430919

Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given ... Primary objective: To assess the efficacy of a single dose of the anti- Bet v 1 monoclonal antibodies (mAb(s ) in the reduction of allergic nasal symptoms ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04709575

NCT04709575 | Study to Assess the Efficacy of Anti-Bet v 1 ... Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis. ClinicalTrials.gov ID ...

4. ctv.veeva.com ctv.veeva.com/study/study-to-assess-the-efficacy-of-anti-bet-v-1-monoclonal-antibodies-in-adults-to-reduce-symptoms-of-s

Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal ... The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0091674921009039

Targeting immunodominant Bet v 1 epitopes with ... A combination of mAbs targeting Bet v 1, the immunodominant and most abundant allergenic protein in birch pollen, can prevent the birch allergic response.

6. synapse.patsnap.com synapse.patsnap.com/drug/ff16f94c633941dda744e0ebdc7fdd39

REGN-5713 - Drug Targets, Indications, Patents A Two-Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of the Anti-Bet v 1 Monoclonal Antibodies to Reduce Allergic Rhinitis ...

7. ctv.veeva.com ctv.veeva.com/study/efficacy-of-the-anti-bet-v-1-monoclonal-antibodies-given-subcutaneously-to-reduce-allergic-rhiniti

Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given ... Primary objective: To assess the efficacy of a single dose of the anti- Bet v 1 monoclonal antibodies (mAb(s ) in the reduction of allergic ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10144224/

Adverse Events for Monoclonal Antibodies in Patients with ... Monoclonal antibodies are considered well tolerated and relatively safe in patients with AR. The regions of patients and hypersensitive adverse reactions such ...