Trial Outcomes & Findings for 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 (NCT NCT04981717)
NCT ID: NCT04981717
Last Updated: 2024-06-11
Results Overview
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).
TERMINATED
PHASE3
446 participants
Weeks 48 to 60
2024-06-11
Participant Flow
1,227 participants were screened, 446 participants were randomized
Participant milestones
| Measure |
Placebo
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
REGN1908-1909
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
Overall Study
STARTED
|
222
|
224
|
|
Overall Study
COMPLETED
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
214
|
220
|
Reasons for withdrawal
| Measure |
Placebo
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
REGN1908-1909
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Sponsor Request
|
157
|
172
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
50
|
37
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
REGN1908-1909
n=224 Participants
Randomized 1:1
|
Total
n=446 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 12.58 • n=7 Participants
|
37.2 years
STANDARD_DEVIATION 12.62 • n=5 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Customized
Adults (18-64 years)
|
211 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
426 Participants
n=5 Participants
|
|
Age, Customized
From 65-84 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
283 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
210 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
416 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity
NOT HISPANIC OR LATINO
|
216 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
433 Participants
n=5 Participants
|
|
Ethnicity
HISPANIC OR LATINO
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity
NOT REPORTED
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 48 to 60Population: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 48 to 60Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 48 to 60Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 48 to 60Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 48 to 60Population: 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.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 48 to 60Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 60Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 0 to 12Population: 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.
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).
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 0.9370 • Interval 0.937 to
|
15.290 Scores on a Scale
Standard Error 0.9173 • Interval 0.9173 to
|
SECONDARY outcome
Timeframe: Weeks 0 to 12Population: 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
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.
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 0.320 • Interval 0.32 to
|
5.88 Average Score
Standard Error 0.314 • Interval 0.314 to
|
SECONDARY outcome
Timeframe: Weeks 0 to 12Population: 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.
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).
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 4.363 to
|
-33.16 Percent Change
Standard Deviation 28.299 • Interval 28.299 to
|
SECONDARY outcome
Timeframe: Weeks 0 to 12Population: 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.
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.
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 29.471 to
|
-30.33 Percent Change
Standard Deviation 27.976 • Interval 27.976 to
|
SECONDARY outcome
Timeframe: Weeks 0 to 12Population: 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.
Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score \[TOSS\]) plus daily medication score (DMS).
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 30.185 to
|
-31.16 Percent
Standard Deviation 28.390 • Interval 28.39 to
|
SECONDARY outcome
Timeframe: Weeks 0 to 12Population: 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.
Total symptom score (TSS: calculated as the sum of TNSS and total ocular symptom score \[TOSS\]) plus daily medication score (DMS).
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 3.743 to
|
7.80 Average Score
Standard Deviation 3.507 • Interval 3.507 to
|
SECONDARY outcome
Timeframe: Weeks 0 to 12Population: 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.
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)
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 38.216 to
|
-32.92 Percent Change
Standard Deviation 35.708 • Interval 35.708 to
|
SECONDARY outcome
Timeframe: Weeks 48 to 60Population: 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.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 48 to 60Population: 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.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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.
In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L).
Outcome measures
| Measure |
REGN1908-1909
n=117 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=112 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 7.314 to
|
-0.05 Percent Change
Standard Deviation 5.334 • Interval 5.334 to
|
SECONDARY outcome
Timeframe: Baseline to week 60Population: 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.
In-clinic spirometry on all patients to determine FEV1 (forced expiratory volume in 1 second) in liters (L).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to week 72Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 0 to 12Population: 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.
Outcome measures
| Measure |
REGN1908-1909
n=117 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=112 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 0.846 to
|
0.72 Nighttime awakenings/Day
Standard Deviation 1.166 • Interval 1.166 to
|
SECONDARY outcome
Timeframe: Weeks 0 to 72Outcome measures
| Measure |
REGN1908-1909
n=222 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=224 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Weeks 0 to 60Outcome measures
| Measure |
REGN1908-1909
n=222 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=224 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Weeks 0 to 72Outcome measures
| Measure |
REGN1908-1909
n=222 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=224 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Weeks 0 to 60Population: 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.
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
Total REGN1908 Concentration in Serum Over the Study Duration
Baseline [12 years old < 18 years old]
|
0.0753 mg/L
Standard Deviation 0.123
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
Total REGN1908 Concentration in Serum Over the Study Duration
Baseline ( >= 18 years old)
|
0.0179 mg/L
Standard Deviation 0.116
|
—
|
|
Total REGN1908 Concentration in Serum Over the Study Duration
Week 12 ( >= 18 years old) 3
|
5.26 mg/L
Standard Deviation 2.60
|
—
|
|
Total REGN1908 Concentration in Serum Over the Study Duration
Week 24 ( >= 18 years old)
|
5.99 mg/L
Standard Deviation 3.58
|
—
|
|
Total REGN1908 Concentration in Serum Over the Study Duration
Week 36 ( >= 18 years old)
|
4.47 mg/L
Standard Deviation 3.63
|
—
|
|
Total REGN1908 Concentration in Serum Over the Study Duration
Week 48 ( >= 18 years old)
|
2.14 mg/L
Standard Deviation 2.76
|
—
|
|
Total REGN1908 Concentration in Serum Over the Study Duration
Week 60 ( >= 18 years old)
|
0.526 mg/L
Standard Deviation 0.377
|
—
|
SECONDARY outcome
Timeframe: Weeks 0 to 60Population: 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.
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
Total REGN1909 Concentration in Serum Over the Study Duration
Week 24 [>= 18 years old]
|
2.46 mg/L
Standard Deviation 1.79
|
—
|
|
Total REGN1909 Concentration in Serum Over the Study Duration
Week 36 [>= 18 years old]
|
1.91 mg/L
Standard Deviation 2.03
|
—
|
|
Total REGN1909 Concentration in Serum Over the Study Duration
Week 48 [>= 18 years old]
|
0.903 mg/L
Standard Deviation 1.47
|
—
|
|
Total REGN1909 Concentration in Serum Over the Study Duration
Baseline [12 years old < 18 years old]
|
0 mg/L
Standard Deviation 0
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
Total REGN1909 Concentration in Serum Over the Study Duration
Baseline [>= 18 years old]
|
0.0160 mg/L
Standard Deviation 0.118
|
—
|
|
Total REGN1909 Concentration in Serum Over the Study Duration
Week 12 [>= 18 years old]
|
2.32 mg/L
Standard Deviation 1.50
|
—
|
|
Total REGN1909 Concentration in Serum Over the Study Duration
Week 60 [>= 18 years old]
|
0.161 mg/L
Standard Deviation 0.175
|
—
|
SECONDARY outcome
Timeframe: Weeks 0 to 72Population: 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.
Outcome measures
| Measure |
REGN1908-1909
n=210 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=213 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Weeks 0 to 72Population: 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.
Outcome measures
| Measure |
REGN1908-1909
n=210 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=213 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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.
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 31.438 to
|
-26.76 Percent Change
Standard Deviation 33.787 • Interval 33.787 to
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 0.21546 to
|
-0.0086 Percent Change
Standard Deviation 0.17005 • Interval 0.17005 to
|
SECONDARY outcome
Timeframe: Baseline to week 60Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to week 60Population: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 0 to 12Population: 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.
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)
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 4.9101 to
|
6.467 Score on a scale
Standard Deviation 4.5117 • Interval 4.5117 to
|
SECONDARY outcome
Timeframe: Weeks 48 to 60Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 48 to 60Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 0 to 12Population: 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
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').
Outcome measures
| Measure |
REGN1908-1909
n=117 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=112 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 2.005 to
|
2.52 Score on a scale
Standard Deviation 2.141 • Interval 2.141 to
|
SECONDARY outcome
Timeframe: Weeks 48 to 60Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 0 to 12Population: 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.
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).
Outcome measures
| Measure |
REGN1908-1909
n=224 Participants
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
Placebo
n=222 Participants
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
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 • Interval 1.414 to
|
2.33 Score on a scale
Standard Deviation 1.346 • Interval 1.346 to
|
SECONDARY outcome
Timeframe: Baseline to week 60Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 48 to 60Population: 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.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
R1908-1909 600 mg
Serious adverse events
| Measure |
Placebo
n=222 participants at risk
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
R1908-1909 600 mg
n=218 participants at risk
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
Ear and labyrinth disorders
Meniere's disease
|
0.45%
1/222 • Number of events 1 • From first dose to study termination (~60 weeks)
|
0.00%
0/218 • From first dose to study termination (~60 weeks)
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.45%
1/222 • Number of events 2 • From first dose to study termination (~60 weeks)
|
0.00%
0/218 • From first dose to study termination (~60 weeks)
|
|
Infections and infestations
COVID-19
|
0.00%
0/222 • From first dose to study termination (~60 weeks)
|
0.46%
1/218 • Number of events 1 • From first dose to study termination (~60 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/222 • From first dose to study termination (~60 weeks)
|
0.46%
1/218 • Number of events 2 • From first dose to study termination (~60 weeks)
|
Other adverse events
| Measure |
Placebo
n=222 participants at risk
Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
R1908-1909 600 mg
n=218 participants at risk
Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
|
|---|---|---|
|
Infections and infestations
COVID-19
|
12.6%
28/222 • Number of events 29 • From first dose to study termination (~60 weeks)
|
10.1%
22/218 • Number of events 22 • From first dose to study termination (~60 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
11.3%
25/222 • Number of events 30 • From first dose to study termination (~60 weeks)
|
9.6%
21/218 • Number of events 28 • From first dose to study termination (~60 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
9/222 • Number of events 11 • From first dose to study termination (~60 weeks)
|
6.4%
14/218 • Number of events 16 • From first dose to study termination (~60 weeks)
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER