Clinical trial NCT06602726: A Study to Demonstrate How Well REGN1908-1909 Works in Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Cat Allergy
Official title: A Randomized, Double-masked, Placebo-controlled Study to Assess the Efficacy and Safety of REGN1908-1909 to Reduce Signs and Symptoms of Allergic Conjunctivitis in Participants With Cat Allergy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Keywords: Cat allergy
Eye allergy
Ocular allergy
Ocular allergy symptoms
Ocular allergy signs
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


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 Forced expiratory volume in 1 second (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

Primary outcomes:
measure: Ocular itch score
timeFrame: At day 8 post-Conjunctival Allergen Challenge (CAC)
Secondary outcomes:
measure: Conjunctival redness score
timeFrame: At day 8 post-CAC
measure: Percent change in cat titrated Skin prick test (tSPT)
timeFrame: Baseline and day 8
measure: Tearing score
timeFrame: At day 8 post-CAC
measure: Total Ocular Symptom Score (TOSS)
timeFrame: At day 8 post-CAC
measure: Total redness score
timeFrame: At day 8 post-CAC
measure: Ciliary redness score
timeFrame: At day 8 post-CAC
measure: Episcleral redness score
timeFrame: At day 8 post-CAC
measure: Change in cat tSPT
timeFrame: Baseline and day 8
measure: Change in cat tSPT
timeFrame: Baseline and day 113
measure: Percent change in cat tSPT
timeFrame: Baseline and day 113
measure: Incidence of Treatment-emergent adverse events (TEAEs)
timeFrame: Up to Day 113
measure: Severity of TEAEs
timeFrame: Up to Day 113
measure: Incidence of serious TEAEs
timeFrame: Up to Day 113
measure: Incidence of Adverse event of special interest (AESIs)
timeFrame: Up to Day 113
measure: Total REGN1908 concentrations in serum over time
timeFrame: Up to Day 113
measure: Total REGN1909 concentrations in serum over time
timeFrame: Up to Day 113
measure: Incidence of Anti-drug antibodies (ADAs) to REGN1908
timeFrame: Up to Day 113
measure: Titers of ADAs to REGN1908
timeFrame: Up to Day 113
measure: Incidence of ADAs to REGN1909
timeFrame: Up to Day 113
measure: Titers of ADAs to REGN1909
timeFrame: Up to Day 113
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Red Maple Trials Inc.
state: Ontario
city: Quebec
country: Canada
facility: Clinique de Specialisee en Allergie de la Capitale
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: