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NCT Number: NCT05430919

Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants

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)

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Key information

Conditions

Allergic Rhinitis Conjunctival Diseases Conjunctivitis Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kingston General Health Research Institute, Kingston, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Documented or participant-reported history of birch tree pollen-triggered allergic-rhinitis (AR) symptoms with or without conjunctivitis (for at least 2 seasons)
  • Positive Skin prick test (SPT) with birch tree pollen extract (mean wheal diameter at least 5 mm greater than a negative control) in screening period
  • Positive allergen-specific immunoglobulin E (sIgE) tests for birch tree pollen and Bet v 1 (≥0.7 kUa/L) in screening period
  • Demonstrated TNSS ≥ 6 out of 12 on at least 2 time points during the birch EEU exposure challenge in screening period

Key Exclusion Criteria:

  • Participation in a prior REGN5713-5714-5715 clinical trial and received REGN5713-5714-5715 antibodies (receipt of placebo in a previous trial is allowed)
  • Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season, or due to daily contact with other non-birch related allergens causing symptoms that are expected to coincide or potentially interfere with the study EEU assessments or with the birch pollen season, as assessed by the investigator
  • Participants who anticipate major changes in allergen exposure during the birch pollen season that are expected to coincide with study assessments or planned travel that is expected to interfere with the study assessments, as assessed by the investigator (eg. anticipated travel during planned EEU sessions or birch pollen season)
  • Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening visit 1. Patients may be re-evaluated for eligibility after resolution of symptoms and specified duration.
  • History of significant, recurrent sinusitis, defined as at least 3 episodes requiring antibiotic treatment per year for the last 2 years
  • Abnormal lung function as judged by the investigator with Forced Expiratory Volume (FEV1) <75% of predicted at screening or randomization
  • A clinical history of moderate to severe asthma, uncontrolled asthma, global initiative for asthma [GINA] steps 3 to 5, history of life-threatening asthma, asthma exacerbations due to tree pollen allergy within 2 prior seasons, >2 asthma exacerbations requiring systemic steroids in past 12 months, asthma related emergency care or hospitalization within 12 months prior to screening, as defined in the protocol.
  • History of birch or other tree allergen immunotherapy in the 3 years prior to screening.
  • Use of anti-IgE or other biological therapy (including but not limited to anti IL-5, anti IL-4) that interferes with type 2 disease within 6 months prior to screening visit 1.
  • Allergen-specific immunotherapy with any allergen other than birch or other trees at screening.
  • History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease,
  • Any malignancy within the past 5 years, except for basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus that have been resected, with no evidence of local recurrence or metastatic disease for 3 years.

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Treatment and study plan

REGN5713

Drug

Administered subcutaneously (SC)

REGN5714

Drug

Administered SC

REGN5715

Drug

Administered SC

Placebo

Other

Administered SC

Primary outcomes

  1. 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

    Time frame: Day 29 from randomization (Out-of-season)

    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.

Secondary outcomes

  1. Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29

    Time frame: Day 29 from randomization (Out-of-season)

    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.

  2. Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85

    Time frame: Day 57 and Day 85, from randomization (Out-of-season)

    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.

  3. Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29

    Time frame: Day 29 from randomization (Out-of-season)

    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.

  4. Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85

    Time frame: Day 57 and Day 85, from randomization (Out-of-season)

    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.

  5. Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29

    Time frame: Day 29 from randomization (Out-of-season)

    TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome

  6. Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85

    Time frame: Day 57 and Day 85, from randomization (Out-of-season)

    TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome

  7. 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

    Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

    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.

  8. 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

    Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

    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.

  9. 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

    Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

    TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome

  10. 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

    Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

    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.

  11. 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

    Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

    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.

  12. 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

    Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

    TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome

  13. Change From Pre-treatment Baseline in the Birch Titrated Skin Prick Test (SPT) Mean Wheal Diameter Area Under the Curve (AUC) at Day 29

    Time frame: Day 29 from randomization (Out-of-season)

    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.

  14. Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85

    Time frame: Day 57 and Day 85, from randomization (Out-of-season)

    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.

  15. Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127

    Time frame: Day 127 from randomization

    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.

  16. Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253

    Time frame: Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study)

    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.

  17. Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 29

    Time frame: Day 29 from randomization (Out-of-season)

    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.

  18. Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 57 and Day 85

    Time frame: Day 57 and Day 85, from randomization (Out-of-season)

    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.

  19. Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 127

    Time frame: Day 127 from randomization

    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.

  20. Percent Change From Pre-treatment Baseline in the Birch Titrated SPT Mean Wheal Diameter AUC at Day 225 and Day 253

    Time frame: Day 225 from randomization (end-of-season) and Day 253 from randomization (end of study)

    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.

  21. Mean TNSS, TOSS and TSS (2 to 6 Hours) During Out-of-season Oak Allergen EEU Challenge at Day 36

    Time frame: Day 36 from randomization (Out-of-season)

    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.

  22. Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36

    Time frame: Day 36 from randomization (Out-of-season)

    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.

  23. Percent Change From Pre-treatment Baseline in TNSS, TOSS and TSS (2 to 6 Hours) During Oak Allergen EEU Challenge at Day 36

    Time frame: Day 36 from randomization (Out-of-season)

    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.

  24. Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TNSS (2 to 6 Hours) Response Thresholds

    Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

    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.

  25. Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TOSS (2 to 6 Hours) Response Thresholds

    Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

    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.

  26. Number of Participants Achieving Different Degrees of Clinical Responses Compared Across TSS (2 to 6 Hours) Response Thresholds

    Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

    TSS ranges from 0 (none) to 18 (severe): sum of TNSS & TOSS combined; Higher score indicates worse outcome.

  27. Number of Participants Achieving Different Degrees of Responses in the Birch Titrated SPT Mean Wheal Diameter AUC Compared Across Different Response Thresholds

    Time frame: Day 29, Day 57 and Day 85, from randomization (Out-of-season)

    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.

  28. Mean TNSS, TOSS and TSS (2 to 6 Hours) During Peak-season Birch Allergen EEU Challenge at Day 190

    Time frame: Day 190 from randomization (In-season); Timing may vary based on local season

    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.

  29. Daily Averaged TNSS, TOSS, TSS, Daily Medication Score (DMS) and Combined Symptom and Medication Score (CSMS) During Birch Pollen Season (BPS)

    Time frame: Up to 253 days from randomization (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 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.

  30. Daily Averaged TNSS, TOSS, TSS, DMS and CSMS During Peak BPS

    Time frame: Up to 253 days from randomization (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.

  31. Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS

    Time frame: Up to 253 days from randomization (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.

  32. Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS

    Time frame: Up to 253 days from randomization (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.

  33. Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During BPS

    Time frame: Up to 253 days from randomization (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.

  34. Percent Change From Pre-treatment Baseline in TNSS, TOSS, TSS, DMS and CSMS Averaged During Peak BPS

    Time frame: Up to 253 days from randomization (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.

  35. Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) Score Averaged During BPS

    Time frame: Up to 253 days from randomization (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.

  36. Standardized RQLQ(S) Score Averaged During Peak BPS

    Time frame: Up to 253 days from randomization (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.

  37. Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS

    Time frame: Up to 253 days from randomization (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.

  38. Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS

    Time frame: Up to 253 days from randomization (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.

  39. Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During BPS

    Time frame: Up to 253 days from randomization (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.

  40. Percent Change From Pre-treatment Baseline in the Average RQLQ(S) Score During Peak BPS

    Time frame: Up to 253 days from randomization (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.

  41. Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) Over the Study Duration

    Time frame: Up to 253 Days

  42. Number of Participants With Any Treatment-Emergent Serious AE (TESAE) Over the Study Duration

    Time frame: Up to 253 Days

  43. Serum Concentration of REGN5713 Over the Study Duration

    Time frame: Up to Week 36

  44. Serum Concentration of REGN5714 Over the Study Duration

    Time frame: Up to Week 36

  45. Serum Concentration of REGN5715 Over the Study Duration

    Time frame: Up to Week 36

  46. Number of Participants With Anti-drug Antibodies (ADA) to REGN5713 Over Time

    Time frame: Up to Week 36

  47. Number of Participants With ADA to REGN5714 Over Time

    Time frame: Up to Week 36

  48. Number of Participants With ADA to REGN5715 Over Time

    Time frame: Up to Week 36

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Two-Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of the Anti-Bet v 1 Monoclonal Antibodies to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2022
Registry last updated
Nov 19, 2024

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.

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