ClinicalTrials.gg
CompletedNCT06602726Updated May 8, 2026

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

A Phase 3 interventional study of REGN1908 and REGN1909 in Allergic Conjunctivitis, sponsored by Regeneron Pharmaceuticals. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2025, 1 year 6 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in May 2026.
Phase
Phase 3
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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)
02

Conditions studied

  • Allergic Conjunctivitis

Keywords

  • Cat allergy
  • Eye allergy
  • Ocular allergy
  • Ocular allergy symptoms
  • Ocular allergy signs
03

In context

Conjunctivitis, Allergic

210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.

This study's enrollment of 64 is below the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.

Browse Conjunctivitis, Allergic studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Documented or participant-reported history of moderate to severe cat allergy for at least 2 years with bothersome ocular symptoms being near cat(s)
  2. Positive SPT with cat allergen extract (mean wheal diameter at least 5 mm greater than the negative control) at screening visit 1
  3. Positive Allergen-specific Immunoglobulin E (sIgE) tests for cat allergen and Fel d 1 (both ≥0.7 kUa/L) at screening visit 1
  4. Must be able to complete the screening CACs to confirm moderate to severe cat allergen-induced allergic conjunctivitis as described in the protocol
  5. Must not have lived with a cat(s) in the home for the past 3 years and must be willing to have no exposure to cat(s) at home throughout the study duration as described in the protocol

Key Exclusion Criteria:

  1. Participation in a prior clinical study and received either REGN1908-1909, REGN1908, or REGN1909 antibodies as described in the protocol
  2. Inability to complete or termination of the screening or confirmatory CAC (where applicable) due to a safety concern (eg, anaphylaxis), per PI judgement
  3. Significant and/or severe allergies, ocular, nasal, or systemic disease causing symptoms (eg, ocular itching, ocular redness, etc) that are expected to coincide or potentially interfere with the study CAC assessments, as described in the protocol
  4. Persistent chronic or recurring acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening visit 1 as described in the protocol
  5. Presence of ocular conditions associated with acute or chronic vision loss, or any other ophthalmic disease or abnormality that may affect the study outcomes or participant safety, per Principal Investigator (PI) judgement as described in the protocol
  6. Uncontrolled asthma or on Global Initiative for Asthma (GINA) steps 4 to 5 as described in the protocol
  7. Abnormal lung function as judged by the investigator with (FEV1) \<70% of predicted at screening
  8. History of cat immunotherapy (eg, subcutaneous immunotherapy or any other route) in the 3 years prior to screening visit 1
  9. Ongoing Allergen immunotherapy (AIT) with any allergen other than cat at screening visit 1 as described in the protocol

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Terms in these criteria, in plain language(1)

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.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    REGN1908-1909

    Drug: REGN1908 · Drug: REGN1909

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugREGN1908

    Administered per the protocol

  • DrugREGN1909

    Administered per the protocol

  • DrugPlacebo

    Administered per the protocol

06

What researchers measure

Primary outcomes

  1. Ocular itch score

    Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 point scale where 0= none and 4= incapacitating itch, 0.5 unit increments

    Time frame: At day 8 post-Conjunctival Allergen Challenge (CAC)

Secondary outcomes

  1. Conjunctival redness score

    Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\], ciliary \[ciliary redness scale\] and episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

    Time frame: At day 8 post-CAC

  2. Percent change in cat titrated Skin prick test (tSPT)

    Area under the curve (AUC) of the mean wheal diameters

    Time frame: Baseline and day 8

  3. Tearing score

    Assessed using the Ora Calibra® Conjunctival Allergen Challenge Tearing Scale, a 0-4 scale where 0 = none and 4 = very severe, 1 unit increments

    Time frame: At day 8 post-CAC

  4. Total Ocular Symptom Score (TOSS)

    TOSS is a summed score of ocular itch score (graded 0 = none to 4 = incapacitating itch), conjunctival redness score (graded 0 = none to 4 = extremely severe), and tearing score (graded 0 = none to 4 = very severe) for a total range from 0 to 12, where higher scores indicate worse responses

    Time frame: At day 8 post-CAC

  5. Total redness score

    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 post-CAC

  6. Ciliary redness score

    Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\], ciliary \[ciliary redness scale\] and episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

    Time frame: At day 8 post-CAC

  7. Episcleral redness score

    Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\], ciliary \[ciliary redness scale\] and episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments

    Time frame: At day 8 post-CAC

  8. Change in cat tSPT

    AUC of the mean wheal diameters

    Time frame: Baseline and day 8

  9. Change in cat tSPT

    AUC of the mean wheal diameters

    Time frame: Baseline and day 113

  10. Percent change in cat tSPT

    AUC of the mean wheal diameters

    Time frame: Baseline and day 113

  11. Incidence of Treatment-emergent adverse events (TEAEs)

    Time frame: Up to Day 113

  12. Severity of TEAEs

    Time frame: Up to Day 113

  13. Incidence of serious TEAEs

    Time frame: Up to Day 113

  14. Incidence of Adverse event of special interest (AESIs)

    Time frame: Up to Day 113

  15. Total REGN1908 concentrations in serum over time

    Time frame: Up to Day 113

  16. Total REGN1909 concentrations in serum over time

    Time frame: Up to Day 113

  17. Incidence of Anti-drug antibodies (ADAs) to REGN1908

    Time frame: Up to Day 113

  18. Titers of ADAs to REGN1908

    Time frame: Up to Day 113

  19. Incidence of ADAs to REGN1909

    Time frame: Up to Day 113

  20. Titers of ADAs to REGN1909

    Time frame: Up to Day 113

07

Study locations

4 sites
  • Andover Eye Associates
    Andover, Massachusetts 01810, United States
  • Kingston Health Sciences Centre
    Kingston, Ontario K7L 2V7, Canada
  • Red Maple Trials Inc.
    Ottawa, Ontario K1H 1E4, Canada
  • Clinique de Specialisee en Allergie de la Capitale
    Québec, G1V 4W2, Canada
08

References and documents

Individual participant data

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06602726
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Nov 6, 2024
Primary completion
May 10, 2025
Completion
Aug 2, 2025
Last update
May 8, 2026

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion