Allergic Rhinitis Due to Cat Allergy
Conditions
Keywords
Cat allergy induced allergic rhinitis, Allergic conjunctivitis, Asthma
Brief 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
Interventions
DRUGREGN1908-1909
Subcutaneous (SC) for a total of 5 administrations
DRUGMatching Placebo
SC for a total of 5 administrations
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Combined Symptom and Medication Score (CSMS) Averaged Over Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Weeks 48 to 60 | — |
| 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 | Weeks 48 to 60 | — |
| Daily Total Symptom Score (TSS) Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | 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) |
| 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 | Weeks 48 to 60 | — |
| 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 | Week 60 | — |
| Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 0 to 12 | 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). |
| Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 0 to 12 | 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. |
| 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 | Weeks 0 to 12 | 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). |
| 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 | Weeks 0 to 12 | 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. |
| 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 | Weeks 0 to 12 | Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score \[TOSS\]) plus daily medication score (DMS). |
| Daily TSS Score Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 0 to 12 | Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score \[TOSS\]) plus daily medication score (DMS). |
| 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 | Weeks 0 to 12 | 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) |
| Daily Medication Score (DMS) Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo | Weeks 0 to 12 | 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) |
| Daily TOSS Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | 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) |
| 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 | Weeks 48 to 60 | 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) |
| Percent Change in Forced Expiratory Volume (FEV)1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo | Baseline to week 12 | In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L). |
| Percent Change in FEV1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo | Baseline to week 60 | In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L). |
| Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo | Baseline to week 72 | 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. |
| Daily Total Nasal Symptom Score (TNSS) Averaged Over the Last 12 Weeks of Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | 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. |
| Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study | Weeks 0 to 72 | — |
| Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study | Weeks 0 to 60 | — |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | Weeks 0 to 72 | — |
| Total REGN1908 Concentration in Serum Over the Study Duration | Weeks 0 to 60 | — |
| Total REGN1909 Concentration in Serum Over the Study Duration | Weeks 0 to 60 | — |
| Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study | Weeks 0 to 72 | — |
| Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study | Weeks 0 to 72 | — |
| Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo (up to Week 12) | Baseline to week 12 | — |
| Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 12) | Baseline to week 12 | — |
| Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 60) | Baseline to week 60 | — |
| 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 | Baseline to week 60 | 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). |
| DMS Averaged Over the Last 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | — |
| 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 | Weeks 48 to 60 | — |
| 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 | Weeks 0 to 12 | 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'). |
| 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) | Weeks 48 to 60 | — |
| Daily TOSS Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo | Weeks 0 to 12 | 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). |
| 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 | Baseline to week 60 | 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. |
| 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) | Weeks 48 to 60 | — |
| 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 | Weeks 0 to 12 | — |
Countries
Belgium, Canada, France, Germany, Poland, United States
Participant flow
Pre-assignment details
1,227 participants were screened, 446 participants were randomized
Participants by arm
| Arm | Count |
|---|---|
| Placebo Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations | 222 |
| REGN1908-1909 Randomized 1:1 | 224 |
| Total | 446 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Lost to Follow-up | 4 | 5 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 3 |
| Overall Study | Sponsor Request | 157 | 172 |
| Overall Study | Withdrawal by Subject | 50 | 37 |
Baseline characteristics
| Characteristic | Placebo | REGN1908-1909 | Total |
|---|---|---|---|
| Age, Continuous | 37.0 years STANDARD_DEVIATION 12.68 | 37.4 years STANDARD_DEVIATION 12.58 | 37.2 years STANDARD_DEVIATION 12.62 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 8 Participants | 6 Participants | 14 Participants |
| Age, Customized Adults (18-64 years) | 211 Participants | 215 Participants | 426 Participants |
| Age, Customized Children (2-11 years) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized From 65-84 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Customized Infants and toddlers (28 days-23 months) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized In utero | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Newborns (0-27 days) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Preterm newborn infants (gestational age < 37 wks) | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity HISPANIC OR LATINO | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity NOT HISPANIC OR LATINO | 216 Participants | 217 Participants | 433 Participants |
| Ethnicity NOT REPORTED | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 11 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 210 Participants | 206 Participants | 416 Participants |
| Sex: Female, Male Female | 136 Participants | 147 Participants | 283 Participants |
| Sex: Female, Male Male | 86 Participants | 77 Participants | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 222 | 0 / 218 |
| other Total, other adverse events | 58 / 222 | 54 / 218 |
| serious Total, serious adverse events | 2 / 222 | 2 / 218 |
Outcome results
Primary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | 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 | 2.17 Score on a scale | Standard Deviation 2.005 |
| Placebo | 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 | 2.52 Score on a scale | Standard Deviation 2.141 |
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | 16.184 Scores on a Scale | Standard Error 0.937 |
| Placebo | Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | 15.290 Scores on a Scale | Standard Error 0.9173 |
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | Daily Medication Score (DMS) Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo | 6.582 Score on a scale | Standard Deviation 4.9101 |
| Placebo | Daily Medication Score (DMS) Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo | 6.467 Score on a scale | Standard Deviation 4.5117 |
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | 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 | 0.54 Nighttime awakenings/Day | Standard Deviation 0.846 |
| Placebo | 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 | 0.72 Nighttime awakenings/Day | Standard Deviation 1.166 |
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | 6.18 Average Score | Standard Error 0.32 |
| Placebo | Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | 5.88 Average Score | Standard Error 0.314 |
Secondary
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
Population: The full analysis set (FAS) includes all randomized patrticipants; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | Daily TOSS Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo | 2.42 Score on a scale | Standard Deviation 1.414 |
| Placebo | Daily TOSS Averaged Over the Initial 12 Weeks of the Treatment Period in Participants Who Receive REGN1908-1909 Versus Placebo | 2.33 Score on a scale | Standard Deviation 1.346 |
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | Daily TSS Score Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | 8.11 Average Score | Standard Deviation 3.743 |
| Placebo | Daily TSS Score Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | 7.80 Average Score | Standard Deviation 3.507 |
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study
Time frame: Weeks 0 to 72
Population: The AAS is defined for each study drug separately and includes all treated participants who received any amount of study drug (active or placebo, \[SAF\]) and had at least 1 non-missing ADA result following the first dose of study drug or placebo. The AAS is based on the actual treatment received (as treated) rather than as randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| REGN1908-1909 | Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study | 5 Participants |
| Placebo | Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study | 5 Participants |
Secondary
Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study
Time frame: Weeks 0 to 72
Population: The AAS is defined for each study drug separately and includes all treated participants who received any amount of study drug (active or placebo, \[SAF\]) and had at least 1 non-missing ADA result following the first dose of study drug or placebo. The AAS is based on the actual treatment received (as treated) rather than as randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| REGN1908-1909 | Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study | 6 Participants |
| Placebo | Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study | 4 Participants |
Secondary
Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study
Time frame: Weeks 0 to 72
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| REGN1908-1909 | Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study | 0 Participants |
| Placebo | Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study | 2 Participants |
Secondary
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study
Time frame: Weeks 0 to 60
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| REGN1908-1909 | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study | 2 Participants |
| Placebo | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study | 2 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study
Time frame: Weeks 0 to 72
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| REGN1908-1909 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 2 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | 2 Participants |
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | 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 Percent Change | Standard Deviation 4.363 |
| Placebo | 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 | -33.16 Percent Change | Standard Deviation 28.299 |
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | 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 Percent Change | Standard Deviation 29.471 |
| Placebo | 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 | -30.33 Percent Change | Standard Deviation 27.976 |
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | 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 Percent Change | Standard Deviation 38.216 |
| Placebo | 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 | -32.92 Percent Change | Standard Deviation 35.708 |
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | 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 Percent | Standard Deviation 30.185 |
| Placebo | 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 | -31.16 Percent | Standard Deviation 28.39 |
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo (up to Week 12) | -35.27 Percent Change | Standard Deviation 31.438 |
| Placebo | Percent Change in Cat SPT Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo (up to Week 12) | -26.76 Percent Change | Standard Deviation 33.787 |
Secondary
Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 12)
Time frame: Baseline to week 12
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 12) | 0.0321 Percent Change | Standard Deviation 0.21546 |
| Placebo | Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 12) | -0.0086 Percent Change | Standard Deviation 0.17005 |
Secondary
Percent Change in FEV1 in Participants With Asthma Who Receive REGN1908-1909 Versus Placebo (up to Week 60)
Time frame: Baseline to week 60
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected.
Secondary
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
Population: The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1908-1909 | Percent Change in Forced Expiratory Volume (FEV)1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo | 1.35 Percent Change | Standard Deviation 7.314 |
| Placebo | Percent Change in Forced Expiratory Volume (FEV)1 in Patients With Asthma Who Receive REGN1908-1909 Versus Placebo | -0.05 Percent Change | Standard Deviation 5.334 |
Secondary
Total REGN1908 Concentration in Serum Over the Study Duration
Time frame: Weeks 0 to 60
Population: Each PK analysis includes all treated participants who received any amount of study drug (active, \[SAF\]) and had at least 1 non-missing result of each respective analyte following the first dose of study drug. The PKAS is based on the actual treatment received (as treated) rather than as randomized. Placebo participants were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1908-1909 | Total REGN1908 Concentration in Serum Over the Study Duration | Baseline [12 years old < 18 years old] | 0.0753 mg/L | Standard Deviation 0.123 |
| REGN1908-1909 | Total REGN1908 Concentration in Serum Over the Study Duration | Week 12 [12 years old < 18 years old] | 7.19 mg/L | Standard Deviation 2.54 |
| REGN1908-1909 | Total REGN1908 Concentration in Serum Over the Study Duration | Week 24 [12 years old < 18 years old] | 10.5 mg/L | Standard Deviation 2.04 |
| REGN1908-1909 | Total REGN1908 Concentration in Serum Over the Study Duration | Week 36 [12 years old < 18 years old] | 9.56 mg/L | Standard Deviation 4.98 |
| REGN1908-1909 | Total REGN1908 Concentration in Serum Over the Study Duration | Baseline ( >= 18 years old) | 0.0179 mg/L | Standard Deviation 0.116 |
| REGN1908-1909 | Total REGN1908 Concentration in Serum Over the Study Duration | Week 12 ( >= 18 years old) 3 | 5.26 mg/L | Standard Deviation 2.6 |
| REGN1908-1909 | Total REGN1908 Concentration in Serum Over the Study Duration | Week 24 ( >= 18 years old) | 5.99 mg/L | Standard Deviation 3.58 |
| REGN1908-1909 | Total REGN1908 Concentration in Serum Over the Study Duration | Week 36 ( >= 18 years old) | 4.47 mg/L | Standard Deviation 3.63 |
| REGN1908-1909 | Total REGN1908 Concentration in Serum Over the Study Duration | Week 48 ( >= 18 years old) | 2.14 mg/L | Standard Deviation 2.76 |
| REGN1908-1909 | Total REGN1908 Concentration in Serum Over the Study Duration | Week 60 ( >= 18 years old) | 0.526 mg/L | Standard Deviation 0.377 |
Secondary
Total REGN1909 Concentration in Serum Over the Study Duration
Time frame: Weeks 0 to 60
Population: Each PK analysis includes all treated participants who received any amount of study drug (active, \[SAF\]) and had at least 1 non-missing result of each respective analyte following the first dose of study drug. The PKAS is based on the actual treatment received (as treated) rather than as randomized. Placebo participants were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1908-1909 | Total REGN1909 Concentration in Serum Over the Study Duration | Baseline [12 years old < 18 years old] | 0 mg/L | Standard Deviation 0 |
| REGN1908-1909 | Total REGN1909 Concentration in Serum Over the Study Duration | Week 12 [12 years old < 18 years old] | 3.49 mg/L | Standard Deviation 1.99 |
| REGN1908-1909 | Total REGN1909 Concentration in Serum Over the Study Duration | Week 24 [12 years old < 18 years old] | 4.59 mg/L | Standard Deviation 0.957 |
| REGN1908-1909 | Total REGN1909 Concentration in Serum Over the Study Duration | Week 36 [12 years old < 18 years old] | 4.02 mg/L | Standard Deviation 2.39 |
| REGN1908-1909 | Total REGN1909 Concentration in Serum Over the Study Duration | Baseline [>= 18 years old] | 0.0160 mg/L | Standard Deviation 0.118 |
| REGN1908-1909 | Total REGN1909 Concentration in Serum Over the Study Duration | Week 12 [>= 18 years old] | 2.32 mg/L | Standard Deviation 1.5 |
| REGN1908-1909 | Total REGN1909 Concentration in Serum Over the Study Duration | Week 24 [>= 18 years old] | 2.46 mg/L | Standard Deviation 1.79 |
| REGN1908-1909 | Total REGN1909 Concentration in Serum Over the Study Duration | Week 36 [>= 18 years old] | 1.91 mg/L | Standard Deviation 2.03 |
| REGN1908-1909 | Total REGN1909 Concentration in Serum Over the Study Duration | Week 48 [>= 18 years old] | 0.903 mg/L | Standard Deviation 1.47 |
| REGN1908-1909 | Total REGN1909 Concentration in Serum Over the Study Duration | Week 60 [>= 18 years old] | 0.161 mg/L | Standard Deviation 0.175 |