Clinical trial NCT06602739: A Study to Demonstrate the Effect of REGN5713-5715 on Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Birch Pollen Allergy
Official title: A Randomized, Double-Masked, Placebo-Controlled Study to Assess the Efficacy and Safety of REGN5713-5715 to Reduce Signs and Symptoms of Allergic Conjunctivitis in Participants With Birch Pollen Allergy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Keywords: Birch Pollen Allergy
Ocular allergy symptoms
Ocular allergy signs
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 54
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, REGN5713 and REGN5715, which are called REGN5713-5715 when mixed together (called "study drug") 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 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 birch pollen allergy for at least 2 years with bothersome ocular symptoms during the birch season
2. Positive SPT to birch allergen extract, as described in the protocol
3. Positive allergen specific immunoglobulin E (sIgE) tests for birch and Bet v 1 (≥0.7 kUa/L) at screening visit 1
4. Must be able to complete birch screening CACs and meet the criteria, as described in the protocol

Key Exclusion Criteria:

1. Participation in a prior clinical study and received either REGN5713-5714-5715, REGN5713-5715, or REGN5715 antibodies, as described in the protocol
2. Inability to complete or termination of the screening or confirmatory CACs due to a safety concern (eg, anaphylaxis) per Principal Investigator (PI) judgement
3. Significant and/or severe allergies causing symptoms that are expected to coincide or potentially interfere with the study CAC assessments, as assessed by the investigator, 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. The presence of an active ocular infection (bacterial, viral, or fungal) or diagnosis by a physician within 30 days prior to screening visit 1, as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Ocular itch score in response to birch allergen challenge
timeFrame: At Day 8 post-Conjunctival Allergen Challenge (CAC)
Secondary outcomes:
measure: Conjunctival redness score in response to birch allergen challenge
timeFrame: At Day 8 post-CAC
measure: Percent change in birch titrated Skin Prick Test (tSPT) in response to birch allergen challenge
timeFrame: Baseline and at Day 8
measure: Tearing score in response to birch allergen challenge
timeFrame: At Day 8 post-CAC
measure: Total ocular symptom score (TOSS) in response to birch allergen challenge
timeFrame: At Day 8 post-CAC
measure: Total redness score in response to birch allergen challenge
timeFrame: At Day 8 post-CAC
measure: Ciliary redness score in response to birch allergen challenge
timeFrame: At Day 8 post-CAC
measure: Episcleral redness score
timeFrame: At Day 8 post-CAC
measure: Change in birch tSPT
timeFrame: Baseline and Day 8
measure: Change in birch tSPT
timeFrame: Baseline and Day 113
measure: Percent change in birch tSPT
timeFrame: Baseline and Day 113
measure: Change in oak tSPT
timeFrame: Baseline and Day 8
measure: Percent change in oak tSPT
timeFrame: Baseline and Day 8
measure: Incidence of Treatment-emergent adverse event (TEAEs)
timeFrame: Up to Day 113
measure: Incidence of serious TEAEs
timeFrame: Up to Day 113
measure: Incidence of Adverse Events of Special Interest (AESIs)
timeFrame: Up to Day 113
measure: Total REGN5713 concentrations in serum over time
timeFrame: Up to Day 113
measure: Total REGN5715 concentrations in serum over time
timeFrame: Up to Day 113
measure: Incidence of Anti-drug antibody (ADAs) to REGN5713
timeFrame: Up to Day 113
measure: Titers of ADAs to REGN5713
timeFrame: Up to Day 113
measure: Incidence of ADAs to REGN5715
timeFrame: Up to Day 113
measure: Titers of ADAs to REGN5715
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: 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: