A Phase 3 interventional study of REGN5713 and REGN5715 in Allergic Conjunctivitis, sponsored by Regeneron Pharmaceuticals. Terminated at 2 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
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:
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's enrollment of 24 is below the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: REGN5713 · Drug: REGN5715
Drug: REGN5713
Drug: REGN5715
Drug: Placebo
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
Time frame: At Day 8 post-Conjunctival Allergen Challenge (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 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
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
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
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.
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
Area Under the Curve (AUC) of the mean wheal diameters
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
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
Time frame: 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
Time frame: 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)
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
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Ran from Jan 2026 to primary completion in May 2026, 3 months.
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This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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