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Allergic ConjunctivitisPhase 3NCT07675811

A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy

A Phase 3 study testing REGN-2Cat, Freneslerbart and Mevonlerbart in people with Allergic Conjunctivitis, run by Regeneron Pharmaceuticals at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is researching two experimental medicines, freneslerbart and mevonlerbart. Freneslerbart and mevonlerbart can be given alone or together. When given together, the medicine is called "REGN-2Cat". These medicines are also known as the "study drugs". Read more about this study

Who is it for?
Ages 8 years and older
Conditions the study is for
Allergic Conjunctivitis
What is being tested?
REGN-2Cat, Freneslerbart and Mevonlerbart
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
570 participants
Where
2 sitesUnited States
Study dates
31 Jul 2026to 20 Sep 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 8 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Part A: adult participants aged 18 years and older. For part B: pediatric participants ≥8 years and <18 years, and adult participants aged 18 years and older.
  • Positive SPT to cat allergen extract
  • Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1
  • Positive CAC criteria

Who cannot join

  • Significant and/or severe environmental allergies causing symptoms (eg, ocular itching, ocular redness, etc) outside of the challenge setting that are expected to coincide or may interfere with study assessments
  • Presence of any ophthalmic disease/ abnormality/ condition that may interfere with study assessments, affect the study outcomes or participant safety
  • A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment as defined in the protocol
  • Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

United States2 sites, 2 recruiting

  • Andover Eye Associates

    Andover, Massachusetts, 01810

    Recruiting

  • Ark Clinical Research, LLC

    Long Beach, California, 90815

    Recruiting

Other trials in United States

About this study

Official title: A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Cat Allergy

This study is researching two experimental medicines, freneslerbart and mevonlerbart. Freneslerbart and mevonlerbart can be given alone or together. When given together, the medicine is called "REGN-2Cat". These medicines are also known as the "study drugs".

The aim of the study is to see what side effects freneslerbart, mevonlerbart, and REGN-2Cat may have and if they help reduce eye allergy symptoms caused by cat hair/dander compared with a placebo.

Read more

The study is looking at several other research questions, including:

  • 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)
  • How long the study drug effect lasts
Being tested
REGN-2Cat, Freneslerbart, Mevonlerbart, Placebo
Keywords
Cat allergy, Eye allergy, Cat-induced eye allergy, Ocular allergy signs/symptoms, Allergic conjunctivitis signs/symptoms
Medical subject headings
Conjunctivitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REGN-2CatDrug

    Also called REGN1908-REGN1909

    Administered per the protocol

  • FreneslerbartDrug

    Also called REGN1908

    Administered per the protocol

  • MevonlerbartDrug

    Also called REGN1909

    Administered per the protocol

  • PlaceboDrug

    Administered per the protocol

Study groups in NCT07675811
Study groupRoleWhat they receive
REGN-2CatExperimentalPart A and B
Receives: Drug: REGN-2Cat
FreneslerbartExperimentalPart A and B
Receives: Drug: Freneslerbart
MevonlerbartExperimentalPart A
Receives: Drug: Mevonlerbart
Matching placeboPlacebo comparatorPart A and B
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ocular itch score in participants receiving REGN-2Cat as compared to placebo

    Measured: At day 8, post-Conjunctival Allergen Challenge (CAC)

Secondary outcomes (35)

  1. 1. Ocular itch score in participants receiving REGN-2Cat as compared to placebo

    Measured: Up to day 85, post-CAC

  2. 2. Conjunctival redness score in participants receiving REGN-2Cat as compared to placebo

    Measured: Up to day 85, post-CAC

  3. 3. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo

    Measured: Up to day 85, post-CAC

  4. 4. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving REGN-2Cat as compared to placebo

    Measured: Up to day 85, post-CAC

  5. 5. Percent change from baseline in cat titrated Skin Prick Test (tSPT) in participants receiving REGN-2Cat as compared to placebo

    Measured: Up to day 85

  6. 6. Ocular itch score in participants receiving freneslerbart as compared to placebo

    Measured: Up to day 85, post-CAC

  7. 7. Conjunctival redness score in participants receiving freneslerbart as compared to placebo

    Measured: Up to day 85, post-CAC

  8. 8. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving freneslerbart as compared to placebo

    Measured: Up to day 85, post-CAC

  9. 9. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving freneslerbart as compared to placebo

    Measured: Up to day 85, post-CAC

  10. 10. Percent change from baseline in cat tSPT in participants receiving freneslerbart as compared to placebo

    Measured: Up to day 85

  11. 11. Ocular itch score in participants receiving mevonlerbart as compared to placebo

    Part A

    Measured: At day 8, post-CAC

  12. 12. Conjunctival redness score in participants receiving mevonlerbart as compared to placebo

    Part A

    Measured: At day 8, post-CAC

  13. 13. Achievement of at least a 1-point reduction from baseline in ocular itch score for at least 2 out of 3 post-CAC time points in participants receiving mevonlerbart as compared to placebo

    Part A

    Measured: At day 8, post-CAC

  14. 14. Achievement of at least a 1-point reduction from baseline in conjunctival redness score for at least 2 out of 3 post-CAC time points in participants receiving mevonlerbart as compared to placebo

    Part A

    Measured: At day 8, post-CAC

  15. 15. Ocular itch score in participants receiving REGN-2Cat as compared to mevonlerbart

    Part A

    Measured: At day 8, post-CAC

  16. 16. Ocular itch score in participants receiving REGN-2Cat as compared to freneslerbart

    Measured: At day 8, post-CAC

  17. 17. Achievements of different degrees of clinical response, as measured by change from baseline in ocular itch score among participants receiving REGN-2Cat, freneslerbart, mevonlerbart or placebo

    Measured: At day 8, post-CAC

  18. 18. Percent change from baseline in cat tSPT in participants receiving REGN-2Cat as compared to freneslerbart

    Measured: At day 8

  19. 19. Percent change from baseline in cat tSPT in participants receiving REGN-2Cat as compared to mevonlerbart

    Part A

    Measured: At day 8

  20. 20. Ciliary redness score in participants receiving REGN-2Cat as compared to placebo

    Measured: Up to day 85, post-CAC

  21. 21. Episcleral redness score in participants receiving REGN-2Cat as compared to placebo

    Measured: Up to day 85, post-CAC

  22. 22. Total redness score in participants receiving REGN-2Cat as compared to placebo

    Measured: Up to day 85, post-CAC

  23. 23. Ciliary redness score in participants receiving freneslerbart as compared to placebo

    Measured: Up to day 85, post-CAC

  24. 24. Episcleral redness score in participants receiving freneslerbart as compared to placebo

    Measured: Up to day 85, post-CAC

  25. 25. Total redness score in participants receiving freneslerbart as compared to placebo

    Measured: Up to day 85, post-CAC

  26. 26. Percent change from baseline in cat tSPT in participants receiving mevonlerbart as compared to placebo

    Part A

    Measured: Up to day 85

  27. 27. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to day 113

  28. 28. Severity of TEAEs

    Measured: Up to day 113

  29. 29. Occurrence of Treatment Emergent-Serious Adverse Events (TE-SAEs)

    Measured: Up to day 113

  30. 30. Concentrations of total freneslerbart in serum

    Measured: Up to day 113

  31. 31. Concentrations of total mevonlerbart in serum

    Measured: Up to day 113

  32. 32. Occurrence of Anti-Drug Antibodies (ADA) to freneslerbart

    Measured: Up to day 113

  33. 33. Magnitude of ADA to freneslerbart

    Measured: Up to day 113

  34. 34. Occurrence of ADA to mevonlerbart

    Measured: Up to day 113

  35. 35. Magnitude of ADA to mevonlerbart

    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.

  1. First posted30 Jun 2026
  2. Study start31 Jul 2026
  3. Primary completion31 May 2029 (estimated)
  4. Study completion20 Sep 2029 (estimated)

Resources

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
570 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07675811
Sponsor's protocol ID
R1908-1909-ALG-2582
Status last verified
Nov 2026
First submitted
23 Jun 2026
Last updated
5 Nov 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing REGN-2Cat, Freneslerbart and Mevonlerbart 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 4 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: looking for participants now, as of the sponsor's last update on 5 Nov 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular itch score in participants receiving REGN-2Cat as 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?

On the ClinicalTrials.gov record for NCT07675811.

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 5 Nov 2026.

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