Primary objective: To assess the efficacy of a single dose of the anti- Bet v 1 monoclonal antibodies (mAb(s ) in the reduction of allergic nasal symptoms during an out-of-season birch allergen environmental exposure unit (EEU) challenge in participants receiving REGN5713-5714-5715 versus placebo (Part A)
The study consists of Part A and Part B. All participants will be asked to complete both Part A and Part B of the study. The study lasts for a total duration of up to approximately 46 weeks (including up to a 10-week screening period). Part A of the study lasts up to approximately 28 weeks (including the screening period). Part B of the study starts after completion of Part A and lasts up to approximately 18 weeks (including an approximately 4-week follow-up period after end of birch pollen season (BPS)), dependent on the start and end times of the natural BPS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
217
Administered subcutaneously (SC)
Administered SC
Administered SC
Administered SC
Kingston General Health Research Institute
Kingston, Ontario, Canada
Inflamax Research Limited DBA Cliantha Research
Mississauga, Ontario, Canada
Clinique Specialisee en Allergie de la Capitale
Québec, Quebec, Canada
Mean Total Nasal Symptom Score (TNSS) (2 to 6 Hours) During Out-of-season Birch Allergen Environmental Exposure Unit (EEU) Challenge (REGN5713-5714-5715 vs. Placebo) at Day 29
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
Time frame: Day 29 from randomization (Out-of-season)
Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
Time frame: Day 29 from randomization (Out-of-season)
Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
Time frame: Day 57 and Day 85, from randomization (Out-of-season)
Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29
TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome.
Time frame: Day 29 from randomization (Out-of-season)
Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85
TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome.
Time frame: Day 57 and Day 85, from randomization (Out-of-season)
Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29
TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome
Time frame: Day 29 from randomization (Out-of-season)
Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85
TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome
Time frame: Day 57 and Day 85, from randomization (Out-of-season)
Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85
TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome.
Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85
TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome
Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Percent Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Percent Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85
TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome.
Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Percent Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and Day 85
TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome
Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29
Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Time frame: Day 29 from randomization (Out-of-season)
Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85
Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Time frame: Day 57 and Day 85, from randomization (Out-of-season)
Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127
Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Time frame: Day 127 from randomization
Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253
Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Time frame: Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study)
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29
Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Time frame: Day 29 from randomization (Out-of-season)
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85
Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Time frame: Day 57 and Day 85, from randomization (Out-of-season)
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127
Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Time frame: Day 127 from randomization
Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253
Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Time frame: Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study)
Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome.
Time frame: Day 36 from randomization (Out-of-season)
Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome.
Time frame: Day 36 from randomization (Out-of-season)
Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome.
Time frame: Day 36 from randomization (Out-of-season)
Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds
TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome.
Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds
TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome.
Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds
Titrated skin prick test (SPT) AUC= The skin prick test mean wheal diameters \[mm\] using serial dilutions of the allergen were used to calculate an AUC. AUC of titrated SPT mean wheal diameters were derived using the trapezoidal rule. For each participant, the AUC was calculated for the mean wheal diameter calculated over titrated concentrations of the allergen on a log scale and then normalized.
Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)
Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190
Peak season EEU is an in-season challenge corresponding to approximate timing of the anticipated peak BPS; TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome.
Time frame: Day 190 from randomization (In-season); Timing may vary based on local season
Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)
TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS \& TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for each pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS \& TSS higher score indicates worse outcome). Daily TNSS, TOSS, TSS, DMS \& CSMS each averaged over duration of birch pollen season presented.
Time frame: Up to 253 days from randomization (during BPS)
Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS
TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS \& TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for each pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS \& TSS higher score indicates worse outcome). Daily TNSS, TOSS, TSS, DMS \& CSMS each averaged over duration of peak birch pollen season presented.
Time frame: Up to 253 days from randomization (during peak BPS)
Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS
TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS \& TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS \& TSS; Higher score indicates worse outcome. Change from pre-treatment baseline in TNSS, TOSS, TSS, DMS \& CSMS each averaged over duration of birch pollen season presented.
Time frame: Up to 253 days from randomization (during BPS)
Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS
TNSS ranges from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS ranges from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. TSS ranges from 0 (none) to 18 (severe): Sum of TNSS \& TOSS; Higher score indicates worse outcome. DMS ranges from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS ranges from 0 to 38 (max): Sum of DMS \& TSS; Higher score indicates worse outcome. Change from pre-treatment baseline in TNSS, TOSS, TSS, DMS \& CSMS each averaged over duration of peak birch pollen season presented.
Time frame: Up to 253 days from randomization (during peak BPS)
Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS
TNSS range from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on Likert scale from 0 (none) to 3 (severe); Higher score indicates worse outcome. TOSS range from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. TSS range from 0 (none) to 18 (severe): Sum of TNSS \& TOSS; Higher score indicates worse outcome. DMS range from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS range from 0 to 38 (max): Sum of DMS \& TSS; Higher score indicates worse outcome. Percent change from pre-treatment baseline in TNSS, TOSS, TSS, DMS \& CSMS each averaged over duration of birch pollen season presented.
Time frame: Up to 253 days from randomization (during BPS)
Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS
TNSS range from 0 (none) to 12 (severe): Sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on Likert scale from 0 (none) to 3 (severe);Higher score indicates worse outcome. TOSS range from 0 (none) to 6 (severe): Sum of 2 eye symptoms graded on Likert scale each from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering;Higher score indicates worse outcome. TSS range from 0 (none) to 18 (severe): Sum of TNSS \& TOSS;Higher score indicates worse outcome. DMS range from 0 to 20 (max points): Sum for pre-specified medication taken as oral antihistamine 6 points/dose (max daily score 6), ocular antihistamine 1.5 points/drop (max daily score 6), intranasal corticosteroid 2.0 points/spray (max daily score 8). CSMS range from 0 to 38 (max): Sum of DMS \& TSS;Higher score indicates worse outcome. Percent change from pre-treatment baseline in TNSS, TOSS, TSS, DMS \& CSMS each averaged over duration of peak birch pollen season presented.
Time frame: Up to 253 days from randomization (during peak BPS)
Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS
The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Overall RQLQ(S) score averaged over duration of birch pollen season presented.
Time frame: Up to 253 days from randomization (during BPS)
Standardized RQLQ(S) Score Averaged During Peak BPS
The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Overall RQLQ(S) score averaged over duration of peak birch pollen season presented.
Time frame: Up to 253 days from randomization (during peak BPS)
Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS
The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Change from pre-treatment baseline averaged over duration of birch pollen season presented.
Time frame: Up to 253 days from randomization (during BPS)
Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS
The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Change from pre-treatment baseline averaged over duration of peak birch pollen season presented.
Time frame: Up to 253 days from randomization (during peak BPS)
Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS
The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Percent change from pre-treatment baseline averaged over duration of birch pollen season presented.
Time frame: Up to 253 days from randomization (during BPS)
Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS
The RQLQ(S) is a self-administered questionnaire to measure health-related quality of life in those 12 years of age and above, as a result of perennial or seasonal allergic rhinitis. There are 28 items in 7 domains: activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems, and emotional function with responses based on a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). Overall RQLQ(S) score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores indicate more health-related quality of life impairment (lower scores are better). Percent change from pre-treatment baseline averaged over duration of peak birch pollen season presented.
Time frame: Up to 253 days from randomization (during peak BPS)
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration
Time frame: Up to 253 Days
Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration
Time frame: Up to 253 Days
Serum Concentration of REGN5713 Over the Study Duration
Time frame: Up to Week 36
Serum Concentration of REGN5714 Over the Study Duration
Time frame: Up to Week 36
Serum Concentration of REGN5715 Over the Study Duration
Time frame: Up to Week 36
Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time
Time frame: Up to Week 36
Number of Participants With ADA to REGN5714 Over Time
Time frame: Up to Week 36
Number of Participants With ADA to REGN5715 Over Time
Time frame: Up to Week 36
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