Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis

Regeneron Pharmaceuticals353 enrolled

Overview

The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

353

Conditions

Allergic Rhinitis Conjunctivitis

Interventions

REGN5713DRUG

Administered subcutaneously

REGN5714DRUG

Administered subcutaneously

REGN5715DRUG

Administered subcutaneously

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria 1. Documented or participant-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years 2. Positive Skin prick test (SPT) with birch pollen extract in the screening period, as defined in the protocol 3. Positive Allergen-specific IgE (sIgE) tests for birch pollen and Bet v 1 in the screening period, as defined in the protocol 4. Willing and able to comply with clinic visits and study-related procedures Key Exclusion Criteria: 1. Participation in a prior REGN5713-5714-5715 clinical trial 2. Recurrent or chronic rhinitis or sinusitis not associated with birch pollen season, or due to daily contact with other allergens causing symptoms that are expected to coincide with birch pollen season, as assessed by the investigator 3. Participants who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the study assessments as assessed by the investigator 4. Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections (at the discretion of the investigator) within 4 weeks prior to screening visit. Participants may be re-evaluated for eligibility after symptoms resolve 5. Documentation of active SARS-CoV-2 infection, as defined in the protocol 6. A clinical history of asthma with 2 or more asthma exacerbations requiring hospitalizations or systemic corticosteroids in the previous year 7. History of birch allergy immunotherapy as defined in the protocol 8. Use of anti-IgE or other biological therapy in treatment of asthma or allergy within 6 months prior to screening NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Locations (37)

Outcomes

Primary Outcomes

Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).

Time frame: Until the end of Birch Pollen Season, up to Week 16

Secondary Outcomes

Total Symptom Score (TSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

TSS is a combined score of TOSS and TNSS. TNSS and TOSS are scored as in part 1 each for a combined TSS of 0 (none) to 18 (severe)

Time frame: Until the end of Birch Pollen Season, up to Week 16

Total Nasal Symptom Score (TNSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

Total nasal symptom score (TNSS) is from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for congestion, itching, and rhinorrhea, and from 0 (none) to 3 (5 or more sneezes) for sneezing.

Time frame: Until the end of Birch Pollen Season, up to Week 16

Total Ocular Symptom Score (TOSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

Total ocular symptom score is 0 to 6 and is based on itching/redness/gritty feeling and tearing/watering; each of the 2 symptoms is graded 0 (absent), 1 (mild), 2 (moderate), and 3 (severe)

Time frame: Until the end of Birch Pollen Season, up to Week 16

Daily Medication Score (DMS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Placebo that replaces REGN5713-5714-5715

Regeneron Study Site

Bangor, Maine, United States

Regeneron Study Site

Baltimore, Maryland, United States

Regeneron Study Site

Plymouth, Minnesota, United States

Regeneron Study Site

Columbia, Missouri, United States

Regeneron Study Site

St Louis, Missouri, United States

Regeneron Study Site

Missoula, Montana, United States

Regeneron Study Site

Verona, New Jersey, United States

Regeneron Study Site

Great Neck, New York, United States

Regeneron Study Site

Cincinnati, Ohio, United States

Regeneron Study Site

Toledo, Ohio, United States

...and 27 more locations

The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication taken as follows: desloratadine 5 mg 6 points/dose; maximum daily score 6 points, olopatadine 1 mg/mL each drop 1.5 points/drop; maximum daily score 6 points, mometasone furoate 50 ug/dose 2.0 points/spray; maximum daily score 8 points). The scale is 0 (minimum) to 20 (maximum)

Time frame: Until the end of Birch Pollen Season, up to Week 16

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study

Number of participants with any Treatment Emergent Adverse Events (TEAEs) from participating in study

Time frame: Up to Day 127

Number of Participants With Serious TEAEs Throughout the Study

Number of participants with any Serious Treatment Emergent Adverse Events (TEAEs) from participating in study

Time frame: Up to Day 127

Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

Number of participants who showed change from baseline to the end of the study in Birch Skin Prick Test (SPT) Mean Wheal Diameter, in participants who received REGN5713-5714-5715 compared to placebo

Time frame: Baseline through Day 127

Percent Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

Time frame: Baseline through Day 127

Serum Concentration of REGN5713 Over the Study Duration

Time frame: Day 0, Day 56, Day 112

Serum Concentration of REGN5714 Over the Study Duration

Time frame: Up to Day 127

Serum Concentration of REGN5715 Over the Study Duration

Time frame: Up to Day 127

Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5713 Throughout the Study

Percentage of participants who developed antibodies to intervention provided during study

Time frame: Up to Day 127

Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5714 Throughout the Study

Percentage of participants who developed antibodies to intervention provided during study

Time frame: Up to Day 127

Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5715 Throughout the Study

Percentage of participants who developed antibodies to intervention provided during study

Time frame: Up to Day 127

Number of "Well Days"

"Well Days" are defined as days when rescue medication is not utilized and the Total symptom score (TSS) is ≤2/18

Time frame: Until the end of Birch Pollen Season, up to Week 16