Trial Outcomes & Findings for Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis (NCT NCT04709575)
NCT ID: NCT04709575
Last Updated: 2022-10-27
Results Overview
The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). 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).
COMPLETED
PHASE3
353 participants
Until the end of Birch Pollen Season, up to Week 16
2022-10-27
Participant Flow
589 participants screened, 353 randomized and from these 349 treated. 4 participants were randomized but not treated. Reasons not randomized: 235 did not meet I/E criteria, 1 withdrew consent.
Participant milestones
| Measure |
REGN5713-5714-5715
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
177
|
|
Overall Study
COMPLETED
|
166
|
172
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
REGN5713-5714-5715
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
REGN5713-5714-5715
n=176 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=177 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
Total
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 14.15 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 14.36 • n=7 Participants
|
40.9 years
STANDARD_DEVIATION 14.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
172 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
346 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until the end of Birch Pollen Season, up to Week 16Population: All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season.
The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). 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
| Measure |
REGN5713-5714-5715
n=171 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=172 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
|
7.503 Scores on a Scale
Standard Error 0.6545
|
8.498 Scores on a Scale
Standard Error 0.6534
|
SECONDARY outcome
Timeframe: Until the end of Birch Pollen Season, up to Week 16Population: All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season
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
| Measure |
REGN5713-5714-5715
n=171 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=172 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Total Symptom Score (TSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
|
5.19 Scores on a Scale
Standard Error 0.397
|
5.62 Scores on a Scale
Standard Error 0.396
|
SECONDARY outcome
Timeframe: Until the end of Birch Pollen Season, up to Week 16Population: All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season
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
| Measure |
REGN5713-5714-5715
n=171 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=172 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Total Nasal Symptom Score (TNSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
|
3.76 Score on a scale
Standard Error 0.278
|
4.00 Score on a scale
Standard Error 0.277
|
SECONDARY outcome
Timeframe: Until the end of Birch Pollen Season, up to Week 16Population: All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season
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 |
REGN5713-5714-5715
n=171 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=172 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Total Ocular Symptom Score (TOSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
|
1.43 Score on a scale
Standard Error 0.150
|
1.62 Score on a scale
Standard Error 0.150
|
SECONDARY outcome
Timeframe: Until the end of Birch Pollen Season, up to Week 16Population: All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season
The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication taken as follows: desloratadine 5 mg 6 points/dose; maximum daily score 6 points, olopatadine 1 mg/mL each drop 1.5 points/drop; maximum daily score 6 points, mometasone furoate 50 ug/dose 2.0 points/spray; maximum daily score 8 points). The scale is 0 (minimum) to 20 (maximum)
Outcome measures
| Measure |
REGN5713-5714-5715
n=171 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=172 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Daily Medication Score (DMS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
|
2.316 Score on a Scale
Standard Error 0.3993
|
2.882 Score on a Scale
Standard Error 0.3986
|
SECONDARY outcome
Timeframe: Up to Day 127Population: All participants in Safety Analysis Set (SAF) who received study drug and were recorded, if symptoms were displayed or not
Number of participants with any Treatment Emergent Adverse Events (TEAEs) from participating in study
Outcome measures
| Measure |
REGN5713-5714-5715
n=173 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=176 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study
|
92 Count of Participants
|
85 Count of Participants
|
SECONDARY outcome
Timeframe: Up to Day 127Population: All participants in Safety Analysis Set (SAF) who received study drug and were recorded, if symptoms were displayed or not
Number of participants with any Serious Treatment Emergent Adverse Events (TEAEs) from participating in study
Outcome measures
| Measure |
REGN5713-5714-5715
n=173 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=176 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Number of Participants With Serious TEAEs Throughout the Study
|
3 Count of Participants
|
0 Count of Participants
|
SECONDARY outcome
Timeframe: Baseline through Day 127Population: All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season
Number of participants who showed change from baseline to the end of the study in Birch Skin Prick Test (SPT) Mean Wheal Diameter, in participants who received REGN5713-5714-5715 compared to placebo
Outcome measures
| Measure |
REGN5713-5714-5715
n=171 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=172 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
|
-3.139 millimeters
Standard Error 0.5086
|
0.553 millimeters
Standard Error 0.5067
|
SECONDARY outcome
Timeframe: Baseline through Day 127Population: All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season
Outcome measures
| Measure |
REGN5713-5714-5715
n=171 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=172 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Percent Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo
|
-26.38 Percentage
Standard Error 5.179
|
8.17 Percentage
Standard Error 5.160
|
SECONDARY outcome
Timeframe: Day 0, Day 56, Day 112Population: All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days)
Outcome measures
| Measure |
REGN5713-5714-5715
n=172 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Serum Concentration of REGN5713 Over the Study Duration
Day 0
|
0 mg/L
Standard Deviation 0
|
—
|
|
Serum Concentration of REGN5713 Over the Study Duration
Day 56
|
10.0 mg/L
Standard Deviation 3.97
|
—
|
|
Serum Concentration of REGN5713 Over the Study Duration
Day 112
|
2.53 mg/L
Standard Deviation 1.57
|
—
|
SECONDARY outcome
Timeframe: Up to Day 127Population: All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days)
Outcome measures
| Measure |
REGN5713-5714-5715
n=172 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Serum Concentration of REGN5714 Over the Study Duration
Day 0
|
0 mg/L
Standard Deviation 0
|
—
|
|
Serum Concentration of REGN5714 Over the Study Duration
Day 56
|
14.7 mg/L
Standard Deviation 4.68
|
—
|
|
Serum Concentration of REGN5714 Over the Study Duration
Day 112
|
4.82 mg/L
Standard Deviation 2.16
|
—
|
SECONDARY outcome
Timeframe: Up to Day 127Population: All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days)
Outcome measures
| Measure |
REGN5713-5714-5715
n=172 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Serum Concentration of REGN5715 Over the Study Duration
Day 0
|
0 mg/L
Standard Deviation 0
|
—
|
|
Serum Concentration of REGN5715 Over the Study Duration
Day 56
|
16.6 mg/L
Standard Deviation 5.34
|
—
|
|
Serum Concentration of REGN5715 Over the Study Duration
Day 112
|
5.34 mg/L
Standard Deviation 2.35
|
—
|
SECONDARY outcome
Timeframe: Up to Day 127Population: All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days)
Percentage of participants who developed antibodies to intervention provided during study
Outcome measures
| Measure |
REGN5713-5714-5715
n=168 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=171 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5713 Throughout the Study
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Day 127Population: All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days)
Percentage of participants who developed antibodies to intervention provided during study
Outcome measures
| Measure |
REGN5713-5714-5715
n=168 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=171 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5714 Throughout the Study
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Day 127Population: All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days)
Percentage of participants who developed antibodies to intervention provided during study
Outcome measures
| Measure |
REGN5713-5714-5715
n=168 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=171 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5715 Throughout the Study
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Until the end of Birch Pollen Season, up to Week 16Population: All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season
"Well Days" are defined as days when rescue medication is not utilized and the Total symptom score (TSS) is ≤2/18
Outcome measures
| Measure |
REGN5713-5714-5715
n=171 Participants
REGN5713-5714-5715 administered subcutaneously
|
Placebo Only
n=172 Participants
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Number of "Well Days"
|
8.3 Days
Standard Error 1.42
|
8.6 Days
Standard Error 1.42
|
Adverse Events
Placebo
R5713-5714-5715 900 mg
Serious adverse events
| Measure |
Placebo
n=176 participants at risk
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
R5713-5714-5715 900 mg
n=173 participants at risk
REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/176 • 28 weeks
|
0.58%
1/173 • Number of events 1 • 28 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/176 • 28 weeks
|
0.58%
1/173 • Number of events 1 • 28 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/176 • 28 weeks
|
0.58%
1/173 • Number of events 1 • 28 weeks
|
Other adverse events
| Measure |
Placebo
n=176 participants at risk
Placebo matching REGN5713-5714-5715 administered subcutaneously
|
R5713-5714-5715 900 mg
n=173 participants at risk
REGN5713-5714-5715 administered subcutaneously
|
|---|---|---|
|
Injury, poisoning and procedural complications
Vaccination complication
|
12.5%
22/176 • Number of events 29 • 28 weeks
|
9.8%
17/173 • Number of events 26 • 28 weeks
|
|
Nervous system disorders
Headache
|
10.8%
19/176 • Number of events 22 • 28 weeks
|
8.7%
15/173 • Number of events 19 • 28 weeks
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
9/176 • Number of events 9 • 28 weeks
|
2.9%
5/173 • Number of events 5 • 28 weeks
|
Additional Information
Clinical Trial Management
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