REGN5713
DrugAdministered subcutaneously
NCT Number: NCT04709575
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Regeneron Study Site, Ghent, Oost-Vlaanderen, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Administered subcutaneously
Administered subcutaneously
Administered subcutaneously
Placebo that replaces REGN5713-5714-5715
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).
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)
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.
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)
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)
Time frame: Up to Day 127
Number of participants with any Treatment Emergent Adverse Events (TEAEs) from participating in study
Time frame: Up to Day 127
Number of participants with any Serious Treatment Emergent Adverse Events (TEAEs) from participating in study
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
Time frame: Baseline through Day 127
Time frame: Day 0, Day 56, Day 112
Time frame: Up to Day 127
Time frame: Up to Day 127
Time frame: Up to Day 127
Percentage of participants who developed antibodies to intervention provided during study
Time frame: Up to Day 127
Percentage of participants who developed antibodies to intervention provided during study
Time frame: Up to Day 127
Percentage of participants who developed antibodies to intervention provided during study
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
Regeneron Pharmaceuticals
Industry
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
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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.
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