Clinical trial NCT04709575: Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Anti-Bet v 1 Monoclonal Antibodies to Reduce Symptoms of Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Conjunctivitis
Keywords: Birch Allergy
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-01-14
Enrollment: 353
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
timeFrame: Until the end of Birch Pollen Season, up to Week 16
Secondary outcomes:
measure: 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
timeFrame: Until the end of Birch Pollen Season, up to Week 16
measure: 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
timeFrame: Until the end of Birch Pollen Season, up to Week 16
measure: 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
timeFrame: Until the end of Birch Pollen Season, up to Week 16
measure: 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
timeFrame: Until the end of Birch Pollen Season, up to Week 16
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study
timeFrame: Up to Day 127
measure: Number of Participants With Serious TEAEs Throughout the Study
timeFrame: Up to Day 127
measure: 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
timeFrame: Baseline through Day 127
measure: 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
timeFrame: Baseline through Day 127
measure: Serum Concentration of REGN5713 Over the Study Duration
timeFrame: Day 0, Day 56, Day 112
measure: Serum Concentration of REGN5714 Over the Study Duration
timeFrame: Up to Day 127
measure: Serum Concentration of REGN5715 Over the Study Duration
timeFrame: Up to Day 127
measure: Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5713 Throughout the Study
timeFrame: Up to Day 127
measure: Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5714 Throughout the Study
timeFrame: Up to Day 127
measure: Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5715 Throughout the Study
timeFrame: Up to Day 127
measure: Number of "Well Days"
timeFrame: Until the end of Birch Pollen Season, up to Week 16
Other outcomes:
Locations:
city: Bangor
country: United States
facility: Regeneron Study Site
state: Maine
city: Baltimore
country: United States
facility: Regeneron Study Site
state: Maryland
city: Plymouth
country: United States
facility: Regeneron Study Site
state: Minnesota
city: Columbia
country: United States
facility: Regeneron Study Site
state: Missouri
city: Saint Louis
country: United States
facility: Regeneron Study Site
state: Missouri
city: Missoula
country: United States
facility: Regeneron Study Site
state: Montana
city: Verona
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Great Neck
country: United States
facility: Regeneron Study Site
state: New York
city: Cincinnati
country: United States
facility: Regeneron Study Site
state: Ohio
city: Toledo
country: United States
facility: Regeneron Study Site
state: Ohio
city: Portland
country: United States
facility: Regeneron Study Site
state: Oregon
city: Pittsburgh
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Lincoln
country: United States
facility: Regeneron Study Site
state: Rhode Island
city: Greenfield
country: United States
facility: Regeneron Study Site
state: Wisconsin
city: Gent
country: Belgium
facility: Regeneron Study Site
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Regeneron Study Site
state: Vlaams Brabant
city: Kingston
country: Canada
facility: Regeneron Study Site
state: Ontario
city: London
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Ottawa
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Toronto
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Toronto
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Toronto
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Regeneron Study Site
state: Quebec
city: Quebec
country: Canada
facility: Regeneron Study Site
city: Hvidovre
country: Denmark
facility: Regeneron Study Site
state: Capital
city: Hellerup
country: Denmark
facility: Regeneron Study Site
state: Copenhagen Surroundings
city: Vejle
country: Denmark
facility: Regeneron Study Site
state: South Jutland
city: Heidelberg
country: Germany
facility: Regeneron Study Site
state: Baden-Wurttemberg
city: Stuttgart
country: Germany
facility: Regeneron Study Site
state: Baden-Wurttemberg
city: Dreieich
country: Germany
facility: Regeneron Study Site
state: Hessen
city: Wiesbaden
country: Germany
facility: Regeneron Study Site
state: Hessen
city: Duisburg
country: Germany
facility: Regeneron Study Site
state: Nordrhein-Westfalen
city: Dusseldorf
country: Germany
facility: Regeneron Study Site
state: North Rhine-Westphalia
city: Dresden
country: Germany
facility: Regeneron Study Site
state: Sachsen
city: Berlin
country: Germany
facility: Regeneron Study Site
city: Berlin
country: Germany
facility: Regeneron Study Site
city: Hamburg
country: Germany
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: