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TerminatedNCT04981717Updated Jun 11, 2024Results posted

A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat

A Phase 3 interventional study of REGN1908-1909 and Matching Placebo in Allergic Rhinitis Due to Cat Allergy, sponsored by Regeneron Pharmaceuticals. Terminated at 92 sites in 6 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

Why this study was terminated
Lack of efficacy
Phase
Phase 3
Study type
Interventional
Enrollment
446
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

The primary objective of the study is to determine the efficacy of REGN1908-1909, as compared to placebo, to reduce allergic rhinitis/conjunctivitis symptoms and allergy rescue medication use during natural cat exposure.

The Secondary Objectives are:

  • To assess the reduction of allergic symptoms and use of allergy rescue medications after treatment with REGN1908-1909 versus placebo, as measured by the individual components of the CSMS
  • To assess health-related quality of life (HRQoL) as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S])
  • To determine the efficacy of REGN1908-1909, as compared to placebo, to inhibit a wheal-and-flare response to a skin prick test with cat allergen
  • To assess the durability of effect in allergic rhinitis and conjunctivitis symptom and medication scores after multiple doses of REGN1908-1909 compared to placebo given every 12 weeks (Q12W)
  • To determine the efficacy following multiple doses of REGN1908-1909 compared to placebo at inhibiting a wheal-and-flare response to a skin prick test with cat allergen
  • To estimate the effect of REGN1908-1909 on lung function, as compared to placebo, in patients with asthma
  • To determine the efficacy of REGN1908-1909 as compared to placebo to reduce asthma symptoms in patients with asthma
  • To assess whether there is a difference in asthma rescue medication use in patients with asthma who are treated with REGN1908-1909 compared to placebo
  • To assess whether there is a difference in nighttime awakenings in patients with asthma treated with REGN1908-1909 compared to placebo
  • To evaluate the short-term and long-term safety and tolerability of REGN1908-1909, including the incidence of hypersensitivity reactions, local injection site reactions, and asthma exacerbations
  • To determine systemic exposure of total (free and antigen-bound) antibodies as measured by concentration of REGN1908 and REGN1909
  • To assess the immunogenicity of REGN1908 and REGN1909
02

Conditions studied

  • Allergic Rhinitis Due to Cat Allergy

Keywords

  • Cat allergy induced allergic rhinitis
  • Allergic conjunctivitis
  • Asthma
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 446 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Generally healthy males and females who are 12 years and older at the time of screening.
  2. Weight must be ≥40 kg at the time of screening

  3. Documented or patient reported history (for at least 2 years) of symptomatic cat allergen-triggered allergic rhinitis with or without conjunctivitis and with or without asthma as defined by all of the following criteria:

    1. Positive skin prick test (SPT) with cat hair extract (mean wheal diameter at least 5 mm greater than a negative control) at screening
    2. Positive allergen-specific IgE (sIgE) tests for cat and Fel d 1 (both ≥0.7 kUa/L at screening)
    3. Documented or patient reported history of nasal and/or ocular symptoms upon cat exposure
    4. Symptomatic despite the use of medications to treat their nasal and/or ocular symptoms
  4. At least 1 generally healthy cat (that is unlikely to die during the study) living in the home resulting in regular exposure
  5. A daily total rhinitis/conjunctivitis symptom score (total symptom score [TSS]) of at least 8 of 18 during at least 8 days of the 15-day baseline assessment period and use of standard, therapeutic doses of pharmacotherapy for the treatment of allergic rhinoconjunctivitis on at least 8 days of the 15-day baseline assessment period.

Key Exclusion Criteria:

  1. History of significant multiple and/or severe allergies, as assessed by the investigator, that would potentially interfere with the assessments during the baseline and 12-week efficacy assessment periods or confound results, per investigator discretion, including significant rhinitis or sinusitis due to daily contact with other allergens causing symptoms that are expected to coincide with the baseline period or any of the efficacy assessment periods
  2. Received REGN1908-1909 in a prior REGN1908-1909 clinical trial (receipt of placebo in a previous trial is allowed)
  3. Active lung disease other than asthma
  4. FEV1 less than 70% of predicted at screening or randomization
  5. Treatment with an investigational drug within 2 months or within 5 half-lives (if known), whichever is longer, prior to screening
  6. Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening. Patients may be re-evaluated after resolution of symptoms and specified time duration

NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
446 participants (actual)

Study arms

  • Experimental
    REGN1908-1909

    Randomized 1:1

    Drug: REGN1908-1909

  • Placebo comparator
    Placebo

    Randomized 1:1

    Drug: Matching Placebo

Interventions

  • DrugREGN1908-1909

    Subcutaneous (SC) for a total of 5 administrations

  • DrugMatching Placebo

    SC for a total of 5 administrations

06

What researchers measure

Primary outcomes

  1. Daily Combined Symptom and Medication Score (CSMS) Averaged Over Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    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: Weeks 48 to 60

Secondary outcomes

  1. Daily Total Nasal Symptom Score (TNSS) Averaged Over the Last 12 Weeks of Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    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: Weeks 48 to 60

  2. Percent Change From Pre-treatment Baseline in Average CSMS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    Time frame: Weeks 48 to 60

  3. Percent Change From Pre-treatment Baseline in Average TNSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    Time frame: Weeks 48 to 60

  4. Daily Total Symptom Score (TSS) Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    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: Weeks 48 to 60

  5. Percent Change From Pre-treatment Baseline in Average TSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    Time frame: Weeks 48 to 60

  6. Percent Change From Baseline to the End of Treatment in Cat Skin Prick Test (SPT) Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo

    Time frame: Week 60

  7. Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score \[TNSS\] and total ocular symptom score \[TOSS\]) plus daily medication score (DMS). Scores ranging between 0 (none) and 38 (severe).

    Time frame: Weeks 0 to 12

  8. Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.

    Time frame: Weeks 0 to 12

  9. Percent Change From Pre-treatment Baseline in Average CSMS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score \[TNSS\] and total ocular symptom score \[TOSS\]) plus daily medication score (DMS).

    Time frame: Weeks 0 to 12

  10. Percent Change From Pre-treatment Baseline in Average TNSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.

    Time frame: Weeks 0 to 12

  11. Percent Change From Pre-treatment Baseline in Average TSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score \[TOSS\]) plus daily medication score (DMS).

    Time frame: Weeks 0 to 12

  12. Daily TSS Score Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score \[TOSS\]) plus daily medication score (DMS).

    Time frame: Weeks 0 to 12

  13. Percent Change From Pre-treatment Baseline in Average TOSS, Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    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: Weeks 0 to 12

  14. Daily TOSS Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    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: Weeks 48 to 60

  15. Percent Change From Pre-treatment Baseline in Average TOSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

    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: Weeks 48 to 60

  16. Percent Change in Forced Expiratory Volume (FEV)1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo

    In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L).

    Time frame: Baseline to week 12

  17. Percent Change in FEV1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo

    In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L).

    Time frame: Baseline to week 60

  18. Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo

    The full analysis set (FAS) includes all randomized participants; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.

    Time frame: Baseline to week 72

  19. Daily Number of Nighttime Awakenings Averaged Over the Initial 12 Weeks of the Treatment Period in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo

    Time frame: Weeks 0 to 12

  20. Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study

    Time frame: Weeks 0 to 72

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

    Time frame: Weeks 0 to 60

  22. Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study

    Time frame: Weeks 0 to 72

  23. Total REGN1908 Concentration in Serum Over the Study Duration

    Time frame: Weeks 0 to 60

  24. Total REGN1909 Concentration in Serum Over the Study Duration

    Time frame: Weeks 0 to 60

  25. Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study

    Time frame: Weeks 0 to 72

  26. Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study

    Time frame: Weeks 0 to 72

  27. Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo (up to Week 12)

    Time frame: Baseline to week 12

  28. Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 12)

    Time frame: Baseline to week 12

  29. Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 60)

    Time frame: Baseline to week 60

  30. Change From Baseline to Week 60 in Rhinoconjunctivitis Quality of Life Questionnaire for Ages 12+ (RQLQ(S)+12) in Participants Who Received REGN1908-1909 Versus Placebo

    The RQLQ had 25 questions in 6 domains (nose symptoms, eye symptoms, practical problems, activity limitation, non-hay fever symptoms and emotional function). Participants recalled how they have been during the previous week and responded to each question on a 7-point scale. The overall RQLQ score was the mean of all 25 responses and the individual domain scores were the means of the items in those domains. The RQLQ(S) responses are based on a 7-point Likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled).

    Time frame: Baseline to week 60

  31. Daily Medication Score (DMS) Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo

    The Daily Medication Score (DMS) was calculated by adding points for each pre-specified medication. Participants will be asked to record their daily rescue medication use using an e-diary, including which medications and the amount of these prespecified medications. The scale is 0 (minimum) to 20 (maximum)

    Time frame: Weeks 0 to 12

  32. DMS Averaged Over the Last 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo

    Time frame: Weeks 48 to 60

  33. Percent Change From Pre-treatment Baseline in Average DMS Averaged Over the Last 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo

    Time frame: Weeks 48 to 60

  34. Asthma Daily Symptom (ADS) Score, Averaged Over the Initial 12 Weeks of the Treatment Period Using Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo

    The total daily asthma symptom score is a participant-reported outcome concerning the occurrence of asthma symptoms and their effect on a patient's daily activities and sleep. It is composed of two parts: daytime (five items) and nighttime (four items), both scored ordinally. Higher scores indicate more severe symptoms. The ADSD score will be based on 6 patient-reported symptoms (difficulty breathing, wheezing, shortness of breath, chest tightness, chest pain, and cough at their worst using an 11-point numeric rating scale (NRS) ranging from 0 ('None') to 10 ('As bad as you can imagine').

    Time frame: Weeks 0 to 12

  35. ADS Score Averaged Over the Last 12 Weeks of the Treatment Period Using ADSD and the ANSD in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (Weeks 48 to 60)

    Time frame: Weeks 48 to 60

  36. Daily TOSS Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo

    The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).

    Time frame: Weeks 0 to 12

  37. Change From Baseline to Week 60 in Asthma Control Questionnaire 5 Question Version (ACQ-5) in Participant With Asthma Who Receive REGN1908-1909 Versus Placebo

    The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control.

    Time frame: Baseline to week 60

  38. Daily Number of Nighttime Awakenings Averaged Over the Last 12 Weeks of the Treatment Period in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo (Weeks 48 to 60)

    Time frame: Weeks 48 to 60

07

Results

Posted Jun 11, 2024
Limitations and caveats
The study met prespecified interim futility criteria for CSMS and TNSS, therefore, an efficacy analysis was not performed for the primary and secondary endpoints as specified in the protocol

Participant flow

Participant flow — Overall Study
MilestonePlaceboREGN1908-1909
Started222224
Completed84
Not completed214220
Withdrew: Protocol violation03
Withdrew: Adverse event13
Withdrew: Pregnancy10
Withdrew: Physician decision10
Withdrew: Sponsor request157172
Withdrew: Lost to follow-up45
Withdrew: Withdrawal by subject5037

Outcome measures

PrimaryDaily Combined Symptom and Medication Score (CSMS) Averaged Over Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

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:
Weeks 48 to 60

No measurements were reported for this outcome.

SecondaryDaily Total Nasal Symptom Score (TNSS) Averaged Over the Last 12 Weeks of Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

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:
Weeks 48 to 60

No measurements were reported for this outcome.

SecondaryPercent Change From Pre-treatment Baseline in Average CSMS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
Time frame:
Weeks 48 to 60

No measurements were reported for this outcome.

SecondaryPercent Change From Pre-treatment Baseline in Average TNSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
Time frame:
Weeks 48 to 60

No measurements were reported for this outcome.

SecondaryDaily Total Symptom Score (TSS) Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

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:
Weeks 48 to 60

No measurements were reported for this outcome.

SecondaryPercent Change From Pre-treatment Baseline in Average TSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
Time frame:
Weeks 48 to 60

No measurements were reported for this outcome.

SecondaryPercent Change From Baseline to the End of Treatment in Cat Skin Prick Test (SPT) Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo
Time frame:
Week 60

No measurements were reported for this outcome.

SecondaryDaily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score \[TNSS\] and total ocular symptom score \[TOSS\]) plus daily medication score (DMS). Scores ranging between 0 (none) and 38 (severe).

Time frame:
Weeks 0 to 12
Reported as:
Least squares mean · Scores on a Scale
Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
Scores on a ScaleREGN1908-1909Placebo
Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo16.184 ± 0.937015.290 ± 0.9173
SecondaryDaily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.

Time frame:
Weeks 0 to 12
Reported as:
Least squares mean · Average Score
Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
Average ScoreREGN1908-1909Placebo
Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo6.18 ± 0.3205.88 ± 0.314
SecondaryPercent Change From Pre-treatment Baseline in Average CSMS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score \[TNSS\] and total ocular symptom score \[TOSS\]) plus daily medication score (DMS).

Time frame:
Weeks 0 to 12
Reported as:
Mean · Percent Change
Percent Change From Pre-treatment Baseline in Average CSMS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
Percent ChangeREGN1908-1909Placebo
Percent Change From Pre-treatment Baseline in Average CSMS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo-29.25 ± 4.363-33.16 ± 28.299
SecondaryPercent Change From Pre-treatment Baseline in Average TNSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing.

Time frame:
Weeks 0 to 12
Reported as:
Mean · Percent Change
Percent Change From Pre-treatment Baseline in Average TNSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
Percent ChangeREGN1908-1909Placebo
Percent Change From Pre-treatment Baseline in Average TNSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo-26.77 ± 29.471-30.33 ± 27.976
SecondaryPercent Change From Pre-treatment Baseline in Average TSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score \[TOSS\]) plus daily medication score (DMS).

Time frame:
Weeks 0 to 12
Reported as:
Mean · Percent
Percent Change From Pre-treatment Baseline in Average TSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
PercentREGN1908-1909Placebo
Percent Change From Pre-treatment Baseline in Average TSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo-27.25 ± 30.185-31.16 ± 28.390
SecondaryDaily TSS Score Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score \[TOSS\]) plus daily medication score (DMS).

Time frame:
Weeks 0 to 12
Reported as:
Mean · Average Score
Daily TSS Score Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
Average ScoreREGN1908-1909Placebo
Daily TSS Score Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo8.11 ± 3.7437.80 ± 3.507
SecondaryPercent Change From Pre-treatment Baseline in Average TOSS, Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

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:
Weeks 0 to 12
Reported as:
Mean · Percent Change
Percent Change From Pre-treatment Baseline in Average TOSS, Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo
Percent ChangeREGN1908-1909Placebo
Percent Change From Pre-treatment Baseline in Average TOSS, Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo-27.90 ± 38.216-32.92 ± 35.708
SecondaryDaily TOSS Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

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:
Weeks 48 to 60

No measurements were reported for this outcome.

SecondaryPercent Change From Pre-treatment Baseline in Average TOSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo

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:
Weeks 48 to 60

No measurements were reported for this outcome.

SecondaryPercent Change in Forced Expiratory Volume (FEV)1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo

In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L).

Time frame:
Baseline to week 12
Reported as:
Mean · Percent Change
Percent Change in Forced Expiratory Volume (FEV)1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo
Percent ChangeREGN1908-1909Placebo
Percent Change in Forced Expiratory Volume (FEV)1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo1.35 ± 7.314-0.05 ± 5.334
SecondaryPercent Change in FEV1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo

In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L).

Time frame:
Baseline to week 60

No measurements were reported for this outcome.

SecondaryPercent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo

The full analysis set (FAS) includes all randomized participants; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.

Time frame:
Baseline to week 72

No measurements were reported for this outcome.

SecondaryDaily Number of Nighttime Awakenings Averaged Over the Initial 12 Weeks of the Treatment Period in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo
Time frame:
Weeks 0 to 12
Reported as:
Mean · Nighttime awakenings/Day
Daily Number of Nighttime Awakenings Averaged Over the Initial 12 Weeks of the Treatment Period in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo
Nighttime awakenings/DayREGN1908-1909Placebo
Daily Number of Nighttime Awakenings Averaged Over the Initial 12 Weeks of the Treatment Period in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo0.54 ± 0.8460.72 ± 1.166
SecondaryNumber of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study
Time frame:
Weeks 0 to 72
Reported as:
Number · Participants
Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study
ParticipantsPlaceboREGN1908-1909
Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study02
SecondaryNumber of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study
Time frame:
Weeks 0 to 60
Reported as:
Number · Participants
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study
ParticipantsPlaceboREGN1908-1909
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study22
SecondaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study
Time frame:
Weeks 0 to 72
Reported as:
Number · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study
ParticipantsPlaceboREGN1908-1909
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study22
SecondaryTotal REGN1908 Concentration in Serum Over the Study Duration
Time frame:
Weeks 0 to 60
Reported as:
Mean · mg/L
Total REGN1908 Concentration in Serum Over the Study Duration
mg/LREGN1908-1909
Baseline [12 years old < 18 years old]0.0753 ± 0.123
Week 12 [12 years old < 18 years old]7.19 ± 2.54
Week 24 [12 years old < 18 years old]10.5 ± 2.04
Week 36 [12 years old < 18 years old]9.56 ± 4.98
Baseline ( >= 18 years old)0.0179 ± 0.116
Week 12 ( >= 18 years old) 35.26 ± 2.60
Week 24 ( >= 18 years old)5.99 ± 3.58
Week 36 ( >= 18 years old)4.47 ± 3.63
Week 48 ( >= 18 years old)2.14 ± 2.76
Week 60 ( >= 18 years old)0.526 ± 0.377
SecondaryTotal REGN1909 Concentration in Serum Over the Study Duration
Time frame:
Weeks 0 to 60
Reported as:
Mean · mg/L
Total REGN1909 Concentration in Serum Over the Study Duration
mg/LREGN1908-1909
Baseline [12 years old < 18 years old]0 ± 0
Week 12 [12 years old < 18 years old]3.49 ± 1.99
Week 24 [12 years old < 18 years old]4.59 ± 0.957
Week 36 [12 years old < 18 years old]4.02 ± 2.39
Baseline [>= 18 years old]0.0160 ± 0.118
Week 12 [>= 18 years old]2.32 ± 1.50
Week 24 [>= 18 years old]2.46 ± 1.79
Week 36 [>= 18 years old]1.91 ± 2.03
Week 48 [>= 18 years old]0.903 ± 1.47
Week 60 [>= 18 years old]0.161 ± 0.175
SecondaryIncidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study
Time frame:
Weeks 0 to 72
Reported as:
Count of participants · Participants
Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study
ParticipantsREGN1908-1909Placebo
Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study64
SecondaryIncidence of Treatment-emergent ADAs to REGN1909 Throughout the Study
Time frame:
Weeks 0 to 72
Reported as:
Count of participants · Participants
Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study
ParticipantsREGN1908-1909Placebo
Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study55
SecondaryPercent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo (up to Week 12)
Time frame:
Baseline to week 12
Reported as:
Mean · Percent Change
Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo (up to Week 12)
Percent ChangeREGN1908-1909Placebo
Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo (up to Week 12)-35.27 ± 31.438-26.76 ± 33.787
SecondaryPercent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 12)
Time frame:
Baseline to week 12
Reported as:
Mean · Percent Change
Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 12)
Percent ChangeREGN1908-1909Placebo
Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 12)0.0321 ± 0.21546-0.0086 ± 0.17005
SecondaryPercent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 60)
Time frame:
Baseline to week 60

No measurements were reported for this outcome.

SecondaryChange From Baseline to Week 60 in Rhinoconjunctivitis Quality of Life Questionnaire for Ages 12+ (RQLQ(S)+12) in Participants Who Received REGN1908-1909 Versus Placebo

The RQLQ had 25 questions in 6 domains (nose symptoms, eye symptoms, practical problems, activity limitation, non-hay fever symptoms and emotional function). Participants recalled how they have been during the previous week and responded to each question on a 7-point scale. The overall RQLQ score was the mean of all 25 responses and the individual domain scores were the means of the items in those domains. The RQLQ(S) responses are based on a 7-point Likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled).

Time frame:
Baseline to week 60

No measurements were reported for this outcome.

SecondaryDaily Medication Score (DMS) Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo

The Daily Medication Score (DMS) was calculated by adding points for each pre-specified medication. Participants will be asked to record their daily rescue medication use using an e-diary, including which medications and the amount of these prespecified medications. The scale is 0 (minimum) to 20 (maximum)

Time frame:
Weeks 0 to 12
Reported as:
Mean · Score on a scale
Daily Medication Score (DMS) Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo
Score on a scaleREGN1908-1909Placebo
Daily Medication Score (DMS) Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo6.582 ± 4.91016.467 ± 4.5117
SecondaryDMS Averaged Over the Last 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo
Time frame:
Weeks 48 to 60

No measurements were reported for this outcome.

SecondaryPercent Change From Pre-treatment Baseline in Average DMS Averaged Over the Last 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo
Time frame:
Weeks 48 to 60

No measurements were reported for this outcome.

SecondaryAsthma Daily Symptom (ADS) Score, Averaged Over the Initial 12 Weeks of the Treatment Period Using Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo

The total daily asthma symptom score is a participant-reported outcome concerning the occurrence of asthma symptoms and their effect on a patient's daily activities and sleep. It is composed of two parts: daytime (five items) and nighttime (four items), both scored ordinally. Higher scores indicate more severe symptoms. The ADSD score will be based on 6 patient-reported symptoms (difficulty breathing, wheezing, shortness of breath, chest tightness, chest pain, and cough at their worst using an 11-point numeric rating scale (NRS) ranging from 0 ('None') to 10 ('As bad as you can imagine').

Time frame:
Weeks 0 to 12
Reported as:
Mean · Score on a scale
Asthma Daily Symptom (ADS) Score, Averaged Over the Initial 12 Weeks of the Treatment Period Using Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo
Score on a scaleREGN1908-1909Placebo
Asthma Daily Symptom (ADS) Score, Averaged Over the Initial 12 Weeks of the Treatment Period Using Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo2.17 ± 2.0052.52 ± 2.141
SecondaryADS Score Averaged Over the Last 12 Weeks of the Treatment Period Using ADSD and the ANSD in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (Weeks 48 to 60)
Time frame:
Weeks 48 to 60

No measurements were reported for this outcome.

SecondaryDaily TOSS Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo

The TOSS ranges from 0 to 6 and is based on 2 eye symptoms: itching/redness/gritty feeling and tearing/watering. Each of the 2 symptoms is graded on a Likert scale ranging from 0 (none) to 3 (severe).

Time frame:
Weeks 0 to 12
Reported as:
Mean · Score on a scale
Daily TOSS Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo
Score on a scaleREGN1908-1909Placebo
Daily TOSS Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo2.42 ± 1.4142.33 ± 1.346
SecondaryChange From Baseline to Week 60 in Asthma Control Questionnaire 5 Question Version (ACQ-5) in Participant With Asthma Who Receive REGN1908-1909 Versus Placebo

The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control.

Time frame:
Baseline to week 60

No measurements were reported for this outcome.

SecondaryDaily Number of Nighttime Awakenings Averaged Over the Last 12 Weeks of the Treatment Period in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo (Weeks 48 to 60)
Time frame:
Weeks 48 to 60

No measurements were reported for this outcome.

Adverse events

Collected over From first dose to study termination (~60 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/222 (0%)2/222 (0.9%)58/222 (26.1%)
R1908-1909 600 mg0/218 (0%)2/218 (0.9%)54/218 (24.8%)
Most frequent serious events
Most frequent serious events
EventPlaceboR1908-1909 600 mg
COVID-19Infections and infestations0/2221/218
AsthmaRespiratory, thoracic and mediastinal disorders0/2221/218
Meniere's diseaseEar and labyrinth disorders1/2220/218
Gastrointestinal procedural complicationInjury, poisoning and procedural complications1/2220/218
Most frequent other events
Most frequent other events
EventPlaceboR1908-1909 600 mg
COVID-19Infections and infestations28/22222/218
NasopharyngitisInfections and infestations25/22221/218
Upper respiratory tract infectionInfections and infestations9/22214/218

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboREGN1908-1909Total
Mean37.0 ± 12.6837.4 ± 12.5837.2 ± 12.62
Age, Customized
Age, Customized(Participants)PlaceboREGN1908-1909Total
In utero000
Preterm newborn infants (gestational age < 37 wks)000
Newborns (0-27 days)000
Infants and toddlers (28 days-23 months)000
Children (2-11 years)000
Adolescents (12-17 years)8614
Adults (18-64 years)211215426
From 65-84 years336
85 years and over000
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboREGN1908-1909Total
Female136147283
Male8677163
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboREGN1908-1909Total
American Indian or Alaska Native101
Asian71118
Native Hawaiian or Other Pacific Islander000
Black or African American134
White210206416
More than one race134
Unknown or Not Reported213
Ethnicity
Ethnicity(Participants)PlaceboREGN1908-1909Total
NOT HISPANIC OR LATINO216217433
HISPANIC OR LATINO5510
NOT REPORTED123
08

Study locations

92 sites
  • Allergy and Asthma Associates of Southern California - CRN - PPDS
    Mission Viejo, California 92691, United States
  • Integrated Research of Inland, Inc
    Riverside, California 92506, United States
  • Peninsula Research Associates - CRN - PPDS
    Rolling Hills Estates, California 90274, United States
  • Allergy and Asthma Medical Group and Research Center - CRN - PPDS
    San Diego, California 92123, United States
  • Asthma and Allergy Associates PC - CRN - PPDS
    Colorado Springs, Colorado 80907, United States
  • Colorado Allergy and Asthma Centers PC - CRN - PPDS
    Denver, Colorado 80230, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • Velocity Clinical Research, Inc. (Meridan)
    Meridian, Idaho 83642, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Asthma and Allergy Center of Chicago Sc-Oak Park
    Oak Park, Illinois 60301, United States
  • Sneeze Wheeze and Itch Associates LLC
    Springfield, Illinois 62702, United States
  • South Bend Clinic
    South Bend, Indiana 46617, United States
  • Bluegrass Allergy Research
    Lexington, Kentucky 40509, United States
  • Allergy and Asthma Specialists PSC
    Owensboro, Kentucky 42301, United States
  • Charleston Allergy and Asthma
    Baltimore, Maryland 21224, United States
  • Institute For Asthma and Allergy
    Chevy Chase, Maryland 20815, United States
  • Respiratory Medicine Research Institute of Michigan PLC
    Ypsilanti, Michigan 48187, United States
  • Clinical Research Institute, Inc - CRN - PPDS
    Plymouth, Minnesota 55441, United States
  • University of Missouri - Hospital
    Columbia, Missouri 65212, United States
  • Montana Medical Research
    Missoula, Montana 59808, United States
  • Somnos Clinical Research
    Lincoln, Nebraska 68505, United States
  • Nebraska Medical Research Institute, Inc. - CRN - PPDS
    Papillion, Nebraska 68046, United States
  • Riverside Medical Group - Circuit - PPDS
    Belleville, New Jersey 07109, United States
  • Atlantic Research Center LLC
    Ocean City, New Jersey 07712, United States
  • Princeton Center For Clinical Research - CRN - PPDS
    Skillman, New Jersey 08558, United States
  • Allergy Partners of NJ, P.C.
    Teaneck, New Jersey 07666, United States
  • Allergy Consultants PA
    Verona, New Jersey 07044, United States
  • Montefiore Medical Center
    Bronx, New York 10461, United States
  • SUNY Downstate Health Science University
    Brooklyn, New York 11203, United States
  • NYU Langone Medical Center
    New York, New York 10029, United States
  • Allergy Partners of Western North Carolina
    Asheville, North Carolina 28801, United States
  • Bernstein Clinical Research Center Inc
    Cincinnati, Ohio 45231, United States
  • Optimed Research Ltd - Clinedge - PPDS
    Columbus, Ohio 43235, United States
  • Aventiv Research Inc - Columbus - HyperCore - PPDS
    Dublin, Ohio 43016, United States
  • Allergy Asthma and Clinical Research Center
    Oklahoma City, Oklahoma 73120, United States
  • PDX Allergy, LLC dba Portland Research
    Happy Valley, Oregon 97068, United States
  • Northwest Research Center - CRN - PPDS
    Portland, Oregon 97202, United States
  • Allergy and Clinical Immunology Associates
    Pittsburgh, Pennsylvania 15241, United States
  • Asthma, Nasal Disease and Allergy Research Center of New England
    East Providence, Rhode Island 02914, United States
  • Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
    Warwick, Rhode Island 02886, United States
  • Seattle Allergy & Asthma Research Institute
    Seattle, Washington 98115, United States
  • The Medical College of Wisconsin, Inc.
    Greenfield, Wisconsin 53228, United States
  • UZ Gent
    Gent, Oost-Vlaanderen 9000, Belgium
  • UZ Leuven
    Leuven, Vlaams Brabant 3000, Belgium
  • Private Practice Dr Jean Benoit Martinot
    Erpent, 5101, Belgium
  • CHR de la Citadelle
    Liege, 4000, Belgium
  • Aggarwal and Associates Ltd
    Brampton, Ontario L6T 0G1, Canada
  • Hamilton Allergy
    Hamilton, Ontario L8S 1G5, Canada
  • Kingston Health Science Centre
    Kingston, Ontario K7L 2V7, Canada
  • Red Maple Trials
    Ottawa, Ontario K1Y 4G2, Canada
  • Stouffville Medical Clinic
    Stouffville, Ontario L4A 1H2, Canada
  • Gordon Sussman Clinical Research Inc
    Toronto, Ontario M4V 1R2, Canada
  • Toronto Allergy Clinic
    Toronto, Ontario M5G 1E2, Canada
  • Joel Liem Medicine Professional Corporation
    Windsor, Ontario N8X 2G1, Canada
  • LMC Manna Research - Quebec - HyperCore - PPDS
    Levis, Quebec G6W 5M6, Canada
  • Centre d'investigation Clinique Mauricie
    Trois-Rivieres, Quebec G8T 7A1, Canada
  • Clinique Spécialisée en Allergie de la Capitale
    Quebec, G1V 4M6, Canada
  • Nouvel Hopital Civil
    Strasbourg, Bas-Rhin 67000, France
  • HNO Praxis am Neckar
    Heidelberg, Baden-Wurttemberg 69120, Germany
  • Klinikum Stuttgart
    Stuttgart, Baden-Wurttemberg 70374, Germany
  • Beldio Research GmbH
    Memmingen, Bayern 87700, Germany
  • Praxis Dr. med. Elke Decot
    Dreieich, Hessen 63303, Germany
  • Praxis Dr. med. Claus Keller
    Frankfurt am Main, Hessen 60389, Germany
  • Praxis Dr. med. Gerhard Schindlbeck
    Viernheim, Hessen 68519, Germany
  • Universitatsklinikum Munster
    Munster, Nordrhein-Westfalen 48149, Germany
  • Klinische Forschung Dresden GmbH (KFGN)
    Dresden, Sachsen 01069, Germany
  • Praxis für HNO und Allergologie
    Dresden, Sachsen 01139, Germany
  • Universitätsklinikum Carl Gustav Carus an der TU Dresden
    Dresden, Sachsen 01307, Germany
  • Salvus-Klinische Studien GmbH
    Leipzig, Sachsen 04207, Germany
  • BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
    Leipzig, Sachsen 04275, Germany
  • Charité - Universitätsmedizin Berlin
    Berlin, 10117, Germany
  • Emovis GmbH
    Berlin, 10629, Germany
  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
    Wroclaw, Dolnoslaskie 50-088, Poland
  • ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy
    Wroclaw, Dolnoslaskie 53-201, Poland
  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
    Lodz, Lodzkie 90-153, Poland
  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
    Lodz, Lodzkie 90-153, Poland
  • ETG Lodz - PPDS
    Lodz, Lodzkie 90-302, Poland
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
    Lodz, Lodzkie 90-329, Poland
  • IP Clinic Sp. z o. o.
    Lodz, Lodzkie 90-752, Poland
  • ETG Lublin - PPDS
    Lublin, Lubelskie 20-089, Poland
  • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
    Lublin, Lubelskie 20-552, Poland
  • ETG Zamosc - PPDS
    Zamosc, Lubelskie 22-400, Poland
  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
    Krakow, Malopolskie 31-011, Poland
  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
    Tarnow, Malopolskie 33-100, Poland
  • Malopolskie Centrum Alergologii
    Krakow, Malopolski 31-624, Poland
  • ETG Warszawa - PPDS
    Piaseczno, Mazowieckie 05-500, Poland
  • EMed Centrum Uslug Medycznych
    Rzeszow, Podkarpackie 35-205, Poland
  • Homeo Medicus Szczesiul sp. j.
    Bialystok, Podlaskie 15-687, Poland
  • Clinica Vitae Sp z o o
    Gdansk, Pomorskie 80-382, Poland
  • ETG Kielce
    Kielce, Swietokrzyskie 25-355, Poland
  • Centrum Alergologii Teresa Hofman
    Pila, Wielkopolskie 64-920, Poland
  • Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z.o.o
    Poznan, 61-578, Poland
09

References and documents

Study documents

  • Study protocol · Dec 20, 2021
  • Statistical analysis plan · Aug 19, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04981717
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 29, 2021
Start date
Jul 30, 2021
Primary completion
Jan 4, 2023
Completion
Apr 24, 2023
Results posted
Jun 11, 2024
Last update
Jun 11, 2024

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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