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

Phase 3RecruitingNCT07675811

Regeneron Pharmaceuticals570 enrolled

Overview

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. 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

570

Conditions

Allergic Conjunctivitis

Interventions

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. 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. 2. Positive SPT to cat allergen extract 3. Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1 4. Positive CAC criteria Key Exclusion Criteria: 1. 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 2. Presence of any ophthalmic disease/ abnormality/ condition that may interfere with study assessments, affect the study outcomes or participant safety 3. 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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85

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

Part A

Time frame: At day 8, post-CAC

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

Part A

Time frame: At day 8, post-CAC

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

Time frame: At day 8, post-CAC

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

Time frame: At day 8, post-CAC

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

Part A

Time frame: At day 8, post-CAC

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

Time frame: At day 8, post-CAC

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

Time frame: At day 8, post-CAC

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

Time frame: At day 8

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

Part A

Time frame: At day 8

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85, post-CAC

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

Time frame: Up to day 85, post-CAC

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

Part A

Time frame: Up to day 85

27. Occurrence of Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to day 113

28. Severity of TEAEs

Time frame: Up to day 113

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

Time frame: Up to day 113

30. Concentrations of total freneslerbart in serum

Time frame: Up to day 113

31. Concentrations of total mevonlerbart in serum

Time frame: Up to day 113

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

Time frame: Up to day 113

33. Magnitude of ADA to freneslerbart

Time frame: Up to day 113

34. Occurrence of ADA to mevonlerbart

Time frame: Up to day 113

35. Magnitude of ADA to mevonlerbart

Time frame: Up to day 113

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts