Allergic ConjunctivitisPhase 3NCT07309432
Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy
A Phase 3 study testing REGN5713 and REGN5715 in people with Allergic Conjunctivitis, run by Regeneron Pharmaceuticals at 2 sites in United States.
Trial summary
This study is researching 2 experimental drugs, REGN5713 and REGN5715. The study drugs will be either of these drugs given alone (either REGN5713 or REGN5715) or given together (REGN5713 and REGN5715) to reduce eye allergy signs and symptoms due to birch tree pollen allergy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- REGN5713 and REGN5715
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2026to 15 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive SPT to birch allergen extract
- Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1
- Positive CAC criteria
Who cannot join
- Significant and/or severe environmental allergies causing symptoms (outside of the challenge setting) that are expected to interfere with study assessments
- Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or negatively impact participant safety
- A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within prior 12 months or once within 3 months prior to screening visit 1 or has been hospitalized or has attended the Emergency Room/Urgent Care facility for asthma in the 12 months prior to screening
- Note: Other protocol defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Somnos Clinical Research
Lincoln, Nebraska, 68510
About this study
Official title: A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Bet v 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Birch Pollen Allergy
This study is researching 2 experimental drugs, REGN5713 and REGN5715. The study drugs will be either of these drugs given alone (either REGN5713 or REGN5715) or given together (REGN5713 and REGN5715) to reduce eye allergy signs and symptoms due to birch tree pollen allergy.
The aim of the study is to see how safe and effective the study drugs are at lowering eye allergy signs and symptoms compared with placebo.
Read more
The study will also evaluate whether the combination (REGN5713-5715) has different effectiveness than REGN5713 or REGN5715 alone.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drugs
- How much of the study drugs is in the blood at different times
- Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
- Conditions
- Allergic Conjunctivitis
- Being tested
- REGN5713, REGN5715, Placebo
- Keywords
- Birch Pollen Allergy, Ocular allergy symptoms, Ocular allergy signs
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN5713Drug
Also called Bremzalerbart
Administered per protocol
REGN5715Drug
Also called Atisnolerbart
Administered per protocol
PlaceboDrug
Administered per protocol
| Study group | Role | What they receive |
|---|---|---|
| REGN5713-5715 | Experimental | Not described Receives: Drug: REGN5713; Drug: REGN5715 |
| REGN5713 | Experimental | Not described Receives: Drug: REGN5713 |
| REGN5715 | Experimental | Not described Receives: Drug: REGN5715 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular itch score in participants receiving REGN5713-5715 compared to placebo
Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 scale where 0 = none and 4= incapacitating itch, 0.5 unit increments
Measured: At Day 8 post-Conjunctival Allergen Challenge (CAC)
Secondary outcomes (34)
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo
Measured: Baseline to Day 8 post-CAC
Ocular itch score in participants receiving REGN5713-5715 compared to placebo
Measured: At Day 57 post-CAC
Conjunctival redness score in participants receiving REGN5713-5715 compared to placebo
Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival [conjunctival redness scale] ciliary [ciliary redness scale], episcleral [episcleral redness scale] vessel beds), a 0 to 4 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments
Measured: At Day 8 and Day 57 post-CAC
Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo
Measured: Baseline to Day 8 post-CAC
Total Nasal Symptom Score (TNSS) in participants receiving REGN5713-5715 compared to placebo
The TNSS ranges from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a verbal rating scale ranging from 0 (none) to 3 (severe) for nasal congestion, nasal itching, rhinorrhea, and sneezing.
Measured: At Day 8 post-CAC
Ocular itch score in participants receiving REGN5715 compared to placebo
Measured: At Day 8 and Day 57 post-CAC
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5715 compared to placebo
Measured: Baseline to Day 8 post-CAC
Conjunctival redness score in participants receiving REGN5715 compared to placebo
Measured: At Day 8 post-CAC
Achievement of at least a 1-point reduction in conjunctival redness score in for at least 2 out of 3 post-CAC time points participants receiving REGN5715 compared to placebo
Measured: Baseline to Day 8 post-CAC
Ocular itch score in participants receiving REGN5713 compared to placebo
Measured: At Day 8 and Day 57 post-CAC
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713 compared to placebo
Measured: Baseline to Day 8 post-CAC
Conjunctival redness score in participants receiving REGN5713 compared to placebo
Measured: At Day 8 post-CAC
Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713 compared to placebo
Measured: Baseline to Day 8 post-CAC
Percent change in birch titrated Skin Prick Test (tSPT) in participants receiving REGN5713-5715 compared to placebo
Area Under the Curve (AUC) of the mean wheal diameters
Measured: Baseline and at Day 8 post-CAC
Ocular itch score in participants receiving REGN5713-5715 compared to REGN5713
Measured: Baseline to Day 8 post-CAC
Ocular itch score in participants receiving REGN5713-5715 compared to REGN5715
Measured: Baseline to Day 8 post-CAC
Achievements of different response thresholds for the ocular itch score among participants receiving REGN5713-5715, REGN5713, REGN5715 or placebo
Measured: Baseline to Day 8 post-CAC
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo
Measured: Baseline to Day 57 post-CAC
Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo
Measured: Baseline to Day 57 post-CAC
Ciliary redness score in participants receiving REGN5713-5715 compared to placebo
Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival [conjunctival redness scale] ciliary [ciliary redness scale], episcleral [episcleral redness scale] vessel beds), a 0 to 4 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments
Measured: At Day 8 and Day 57 post-CAC
Episcleral redness score in participants receiving REGN5713-5715 compared to placebo
Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival [conjunctival redness scale] ciliary [ciliary redness scale], episcleral [episcleral redness scale] vessel beds), a 0 to 4 scale, where 0 = none and 4 = extremely severe, 0.5 unit increments
Measured: At Day 8 and Day 57 post-CAC
Total redness score in participants receiving REGN5713-5715 compared to placebo
The total redness score is calculated for CAC: range 0 to 12, where higher scores indicate worse responses (calculated as a sum of the bilateral averages for conjunctival redness score, graded 0 = none to 4 = extremely severe + ciliary redness score, graded 0 = none and 4 = extremely severe + episcleral redness score, graded 0 = none and 4 = extremely severe)
Measured: At Day 8 and Day 57 post-CAC
Percent change in birch tSPT in participants receiving REGN5713-5715 compared to placebo
Measured: Baseline and at Day 57 post-CAC
Percent change in birch tSPT in participants receiving REGN5715 compared to placebo
Measured: Baseline, at Day 8 and at Day 57 post-CAC
Percent change in birch tSPT in participants receiving REGN5713 compared to placebo
Measured: Baseline, at Day 8 and at Day 57 post-CAC
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Day 113
Severity of TEAEs
Measured: Up to Day 113
Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs)
Measured: Up to Day 113
Concentrations of total REGN5713 is serum over time
Measured: Up to Day 113
Concentrations of total REGN5715 is serum over time
Measured: Up to Day 113
Occurrence of Anti-Drug Antibodies (ADA) responses to REGN5713
Measured: Up to Day 113
Magnitude of ADA to REGN5713
Measured: Up to Day 113
Occurrence of ADA responses to REGN5715
Measured: Up to Day 113
Magnitude of ADA to REGN5715
Measured: Up to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start10 Jan 2026
- Primary completion2 May 2026
- Study completion15 Jun 2026
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309432
- Sponsor's protocol ID
- R5713-5715-ALG-2556
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Bet v 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Birch Pollen Allergy
- ClinicalTrials.gov ID
- NCT07309432
- Acronym / sponsor ID
- R5713-5715-ALG-2556
- Conditions
- Allergic Conjunctivitis
- Keywords
- Birch Pollen Allergy, Ocular allergy symptoms, Ocular allergy signs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 2 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is researching 2 experimental drugs, REGN5713 and REGN5715. The study drugs will be either of these drugs given alone (either REGN5713 or REGN5715) or given together (REGN5713 and REGN5715) to reduce eye allergy signs and symptoms due to birch tree pollen allergy.
The aim of the study is to see how safe and effective the study drugs are at lowering eye allergy signs and symptoms compared with placebo.
The study will also evaluate whether the combination (REGN5713-5715) has different effectiveness than REGN5713 or REGN5715 alone.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drugs
- How much of the study drugs is in the blood at different times
- Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| REGN5713-5715 | Experimental | Drug: REGN5713, Drug: REGN5715 |
| REGN5713 | Experimental | Drug: REGN5713 |
| REGN5715 | Experimental | Drug: REGN5715 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Positive SPT to birch allergen extract
- Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1
- Positive CAC criteria
Key exclusion criteria (4 listed)
- Significant and/or severe environmental allergies causing symptoms (outside of the challenge setting) that are expected to interfere with study assessments
- Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or negatively impact participant safety
- A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within prior 12 months or once within 3 months prior to screening visit 1 or has been hospitalized or has attended the Emergency Room/Urgent Care facility for asthma in the 12 months prior to screening
- Note: Other protocol defined Inclusion/Exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN5713Also: BremzalerbartAdministered per protocol | Drug | REGN5713, REGN5713-5715 |
| REGN5715Also: AtisnolerbartAdministered per protocol | Drug | REGN5713-5715, REGN5715 |
| PlaceboAdministered per protocol | Drug | Placebo |
Primary outcome
Ocular itch score in participants receiving REGN5713-5715 compared to placebo
Time frame: At Day 8 post-Conjunctival Allergen Challenge (CAC)
Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 scale where 0 = none and 4= incapacitating itch, 0.5 unit increments
34 secondary outcomes
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo
Time frame: Baseline to Day 8 post-CAC
Ocular itch score in participants receiving REGN5713-5715 compared to placebo
Time frame: At Day 57 post-CAC
Conjunctival redness score in participants receiving REGN5713-5715 compared to placebo
Time frame: At Day 8 and Day 57 post-CAC
Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo
Time frame: Baseline to Day 8 post-CAC
Total Nasal Symptom Score (TNSS) in participants receiving REGN5713-5715 compared to placebo
Time frame: At Day 8 post-CAC
Ocular itch score in participants receiving REGN5715 compared to placebo
Time frame: At Day 8 and Day 57 post-CAC
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5715 compared to placebo
Time frame: Baseline to Day 8 post-CAC
Conjunctival redness score in participants receiving REGN5715 compared to placebo
Time frame: At Day 8 post-CAC
Achievement of at least a 1-point reduction in conjunctival redness score in for at least 2 out of 3 post-CAC time points participants receiving REGN5715 compared to placebo
Time frame: Baseline to Day 8 post-CAC
Ocular itch score in participants receiving REGN5713 compared to placebo
Time frame: At Day 8 and Day 57 post-CAC
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713 compared to placebo
Time frame: Baseline to Day 8 post-CAC
Conjunctival redness score in participants receiving REGN5713 compared to placebo
Time frame: At Day 8 post-CAC
Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713 compared to placebo
Time frame: Baseline to Day 8 post-CAC
Percent change in birch titrated Skin Prick Test (tSPT) in participants receiving REGN5713-5715 compared to placebo
Time frame: Baseline and at Day 8 post-CAC
Ocular itch score in participants receiving REGN5713-5715 compared to REGN5713
Time frame: Baseline to Day 8 post-CAC
Ocular itch score in participants receiving REGN5713-5715 compared to REGN5715
Time frame: Baseline to Day 8 post-CAC
Achievements of different response thresholds for the ocular itch score among participants receiving REGN5713-5715, REGN5713, REGN5715 or placebo
Time frame: Baseline to Day 8 post-CAC
Achievement of at least a 1-point reduction in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo
Time frame: Baseline to Day 57 post-CAC
Achievement of at least a 1-point reduction in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN5713-5715 compared to placebo
Time frame: Baseline to Day 57 post-CAC
Ciliary redness score in participants receiving REGN5713-5715 compared to placebo
Time frame: At Day 8 and Day 57 post-CAC
Episcleral redness score in participants receiving REGN5713-5715 compared to placebo
Time frame: At Day 8 and Day 57 post-CAC
Total redness score in participants receiving REGN5713-5715 compared to placebo
Time frame: At Day 8 and Day 57 post-CAC
Percent change in birch tSPT in participants receiving REGN5713-5715 compared to placebo
Time frame: Baseline and at Day 57 post-CAC
Percent change in birch tSPT in participants receiving REGN5715 compared to placebo
Time frame: Baseline, at Day 8 and at Day 57 post-CAC
Percent change in birch tSPT in participants receiving REGN5713 compared to placebo
Time frame: Baseline, at Day 8 and at Day 57 post-CAC
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 113
Severity of TEAEs
Time frame: Up to Day 113
Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs)
Time frame: Up to Day 113
Concentrations of total REGN5713 is serum over time
Time frame: Up to Day 113
Concentrations of total REGN5715 is serum over time
Time frame: Up to Day 113
Occurrence of Anti-Drug Antibodies (ADA) responses to REGN5713
Time frame: Up to Day 113
Magnitude of ADA to REGN5713
Time frame: Up to Day 113
Occurrence of ADA responses to REGN5715
Time frame: Up to Day 113
Magnitude of ADA to REGN5715
Time frame: Up to Day 113
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REGN5713 and REGN5715 in people with Allergic Conjunctivitis, run by Regeneron Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular itch score in participants receiving REGN5713-5715 compared to placebo (time frame: At Day 8 post-Conjunctival Allergen Challenge (CAC)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.