Skip to main content
OpenTrials
Completed

NCT Number: NCT04709575

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Regeneron Study Site, Ghent, Oost-Vlaanderen, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria

  • Documented or participant-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years
  • Positive Skin prick test (SPT) with birch pollen extract in the screening period, as defined in the protocol
  • Positive Allergen-specific IgE (sIgE) tests for birch pollen and Bet v 1 in the screening period, as defined in the protocol
  • Willing and able to comply with clinic visits and study-related procedures

Key Exclusion Criteria:

  • Participation in a prior REGN5713-5714-5715 clinical trial
  • 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
  • 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
  • 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
  • Documentation of active SARS-CoV-2 infection, as defined in the protocol
  • A clinical history of asthma with 2 or more asthma exacerbations requiring hospitalizations or systemic corticosteroids in the previous year
  • History of birch allergy immunotherapy as defined in the protocol
  • 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

Treatment and study plan

REGN5713

Drug

Administered subcutaneously

REGN5714

Drug

Administered subcutaneously

REGN5715

Drug

Administered subcutaneously

Placebo

Drug

Placebo that replaces REGN5713-5714-5715

Primary outcomes

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

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

    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).

Secondary outcomes

  1. 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

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

    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)

  2. 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

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

    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.

  3. 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

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

    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)

  4. 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

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

    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)

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

    Time frame: Up to Day 127

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

  6. Number of Participants With Serious TEAEs Throughout the Study

    Time frame: Up to Day 127

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

  7. 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

    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

  8. 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

  9. Serum Concentration of REGN5713 Over the Study Duration

    Time frame: Day 0, Day 56, Day 112

  10. Serum Concentration of REGN5714 Over the Study Duration

    Time frame: Up to Day 127

  11. Serum Concentration of REGN5715 Over the Study Duration

    Time frame: Up to Day 127

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

    Time frame: Up to Day 127

    Percentage of participants who developed antibodies to intervention provided during study

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

    Time frame: Up to Day 127

    Percentage of participants who developed antibodies to intervention provided during study

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

    Time frame: Up to Day 127

    Percentage of participants who developed antibodies to intervention provided during study

  15. Number of "Well Days"

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

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

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2021
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.