Trial Outcomes & Findings for Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE) (NCT NCT02379052)
NCT ID: NCT02379052
Last Updated: 2020-02-28
Results Overview
The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Baseline, Week 10
Results posted on
2020-02-28
Participant Flow
A total of 80 participants were screened, of whom 47 were enrolled at 14 sites. Screen failures did not meet all inclusion criteria, met one or more exclusion criterion, or withdrew consent (33 participants). Of the 47 enrolled, 23 participants were randomized to receive dupilumab 300 mg QW and 24 participants were randomized to receive placebo.
After providing informed consent, participants were assessed at screening (to occur between day -35 \& day -1) for eligibility to participate in the study. Participants who met the eligibility criteria underwent day 1 baseline assessments \& randomized in a 1:1 ratio to receive dupilumab or placebo during the 12-week double-blind treatment phase.
Participant milestones
| Measure |
Placebo
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Did Not Meet Inc./ Exclusion Criteria
|
1
|
0
|
|
Overall Study
Subject was Incarcerated
|
0
|
1
|
Baseline Characteristics
Includes number of participants evaluable for this characteristic
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.1 Years
STANDARD_DEVIATION 12.75 • n=24 Participants
|
33.1 Years
STANDARD_DEVIATION 8.70 • n=23 Participants
|
34.7 Years
STANDARD_DEVIATION 10.94 • n=47 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=24 Participants
|
10 Participants
n=23 Participants
|
24 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=24 Participants
|
13 Participants
n=23 Participants
|
23 Participants
n=47 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
24 Participants
n=24 Participants
|
23 Participants
n=23 Participants
|
47 Participants
n=47 Participants
|
|
Weekly Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Score (0-9)
|
6.4 Score on a Scale
STANDARD_DEVIATION 1.01 • n=24 Participants
|
6.4 Score on a Scale
STANDARD_DEVIATION 1.04 • n=23 Participants
|
6.4 Score on a Scale
STANDARD_DEVIATION 1.01 • n=47 Participants
|
|
Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) PRO Score (0-100)
|
62.2 Score on a Scale
STANDARD_DEVIATION 16.45 • n=22 Participants • Includes number of participants evaluable for this characteristic
|
62.0 Score on a Scale
STANDARD_DEVIATION 18.36 • n=23 Participants • Includes number of participants evaluable for this characteristic
|
62.1 Score on a Scale
STANDARD_DEVIATION 17.25 • n=45 Participants • Includes number of participants evaluable for this characteristic
|
|
Adult Eosinophilic Esophagitis Quality of Life (EoE-QOL-A) Total Mean Score (1-5)
|
3.11 Score on a Scale
STANDARD_DEVIATION 0.995 • n=24 Participants
|
3.02 Score on a Scale
STANDARD_DEVIATION 0.899 • n=23 Participants
|
3.06 Score on a Scale
STANDARD_DEVIATION 0.940 • n=47 Participants
|
|
Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) Total Score (0-8)
|
4.3 Score on a Scale
STANDARD_DEVIATION 1.46 • n=24 Participants
|
3.9 Score on a Scale
STANDARD_DEVIATION 1.87 • n=23 Participants
|
4.1 Score on a Scale
STANDARD_DEVIATION 1.67 • n=47 Participants
|
|
Baseline Blood Peripheral Eosinophils (EOS)
|
0.43 Giga/Liter (L)
STANDARD_DEVIATION 0.285 • n=24 Participants
|
0.31 Giga/Liter (L)
STANDARD_DEVIATION 0.177 • n=23 Participants
|
0.37 Giga/Liter (L)
STANDARD_DEVIATION 0.242 • n=47 Participants
|
|
Number of Esophageal Dilations
|
3.9 Count of Esophageal Dilations
STANDARD_DEVIATION 3.31 • n=10 Participants • Analysis included only participants with any dilations
|
5.7 Count of Esophageal Dilations
STANDARD_DEVIATION 8.03 • n=11 Participants • Analysis included only participants with any dilations
|
4.9 Count of Esophageal Dilations
STANDARD_DEVIATION 6.17 • n=21 Participants • Analysis included only participants with any dilations
|
|
Age Group
≥18 to <40 years
|
15 Count of Participants
n=24 Participants
|
16 Count of Participants
n=23 Participants
|
31 Count of Participants
n=47 Participants
|
|
Age Group
≥40 to <65 years
|
9 Count of Participants
n=24 Participants
|
7 Count of Participants
n=23 Participants
|
16 Count of Participants
n=47 Participants
|
|
Age Group
≥65 years
|
0 Count of Participants
n=24 Participants
|
0 Count of Participants
n=23 Participants
|
0 Count of Participants
n=47 Participants
|
|
Baseline Blood Peripheral Eosinophils (EOS)
Number of participants with EOS < 0.25 Giga/L
|
8 Count of Participants
n=24 Participants
|
11 Count of Participants
n=23 Participants
|
19 Count of Participants
n=47 Participants
|
|
Baseline Blood Peripheral Eosinophils (EOS)
Number of participants with EOS ≥ 0.25 Giga/L
|
16 Count of Participants
n=24 Participants
|
12 Count of Participants
n=23 Participants
|
28 Count of Participants
n=47 Participants
|
|
Peak Eosinophils/ High Power Field (eos/hpf) Count
|
101.1 Count of Eosinophils
STANDARD_DEVIATION 57.12 • n=24 Participants
|
102.1 Count of Eosinophils
STANDARD_DEVIATION 53.46 • n=23 Participants
|
101.6 Count of Eosinophils
STANDARD_DEVIATION 54.76 • n=47 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 10Population: Full Analysis Set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated by the interactive voice and web response system (IVRS/IWRS) at randomization (as randomized).
The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10
|
-1.3 Score on a Scale
Standard Error 0.57
|
-3.0 Score on a Scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: Full analysis set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Percent Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10
|
-18.59 Percent Change
Standard Error 8.978
|
-45.05 Percent Change
Standard Error 8.435
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The SDI is a PRO used to determine frequency/intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 12
|
-2.2 Score on a Scale
Standard Error 0.69
|
-2.9 Score on a Scale
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Percent Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 12
|
-31.83 Percent Change
Standard Error 10.674
|
-42.83 Percent Change
Standard Error 8.573
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Percentage of Participants Achieving a Reduction of ≥ 3 Points in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score From Baseline at Week 10
|
12.5 Percentage of Participants
|
39.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Percentage of Participants Achieving a Reduction of ≥ 3 Points in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score From Baseline at Week 12
|
12.5 Percentage of Participants
|
39.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Percent Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 10
|
-11.33 Percent Change
Standard Error 9.915
|
-34.56 Percent Change
Standard Error 9.076
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Absolute Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 10
|
-9.0 Score on a Scale
Standard Error 5.58
|
-22.9 Score on a Scale
Standard Error 5.01
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Percent Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 12
|
-3.34 Percent Change
Standard Error 12.701
|
-36.99 Percent Change
Standard Error 11.168
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Absolute Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 12
|
-5.0 Score on a Scale
Standard Error 7.06
|
-26.1 Score on a Scale
Standard Error 5.87
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Percentage of Participants Achieving ≥ 40% Improvement in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score From Baseline at Week 10
|
8.3 Percentage of Participants
|
26.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Percentage of Participants Achieving ≥ 40% Improvement in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score From Baseline at Week 12
|
4.2 Percentage of Participants
|
39.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
Peak eosinophils/high power field (eos/hpf) was determined by counting eosinophils in the most inflamed areas of each esophageal region sampled at each time point and calculating the change in the peak count at each site.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophils of 3 Esophageal Regions at Week 12
|
14.23 Percent Change
Standard Error 12.495
|
-92.90 Percent Change
Standard Error 12.068
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The EoE-EREFS includes a total of 6 major items related to the presence/ severity of esophageal features. Specific features scored by the investigator include rings (absent\[0\], mild\[1\], moderate\[2\], severe\[3\], not applicable); stricture (yes\[1\], no\[0\], not applicable); diameter of the stricture (if applicable; measurement not scored); exudates (absent\[0\], mild \[1\], severe\[2\]); furrows (absent\[0\], present\[1\]); edema (absent\[0\], present\[1\]). The total score of the 5 scored items ranges from 0 to 8 (higher score indicates worsening symptoms).
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Absolute Change From Baseline in Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) by Feature at Week 12
|
-0.3 Score on a Scale
Standard Error 0.33
|
-1.9 Score on a Scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
The EoE-QOL-A questionnaire includes 30 items related to 5 established domains (eating/diet impact, social impact, emotional impact, disease anxiety, and swallowing anxiety) of daily life experiences. The EoE-QOL-A has a 1-week recall period. The items are graded on a 5-point scale: 1 (Not at All), 2 (Slightly), 3 (Moderately), 4 (Quite a bit), and 5 (Extremely). The EoE-QOL-A score is the average obtained by dividing the total score by the number of questions (for participants without disease, 120/30 = 4). Total scores range from 1 to 5 (higher scores indicate worsening symptoms).
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Change From Baseline in Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EoE-QOL-A) Score at Week 12
|
0.47 Score on a Scale
Standard Error 0.141
|
0.80 Score on a Scale
Standard Error 0.137
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Percentage of Participants With Use of Rescue Medication or Procedure (e.g., Esophageal Dilation) Through Week 12
|
0 Percent of Participants
|
0 Percent of Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 28Population: The safety analysis set (SAF) included all randomized participants who received any study drug, and were analyzed as treated.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that developed or worsened or became serious during the on-treatment period (time from the first dose of study drug up to the end of study (Week 28). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-participant hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 Participants
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Percent of Participants With Treatment-Emergent Adverse Events (TEAEs) During the Study
|
66.7 Percent of Participants
|
91.3 Percent of Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Dupilumab 300 mg QW
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=24 participants at risk
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 participants at risk
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Immune system disorders
Food allergy
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
4.3%
1/23 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
4.3%
1/23 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
4.3%
1/23 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
Other adverse events
| Measure |
Placebo
n=24 participants at risk
Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
|
Dupilumab 300 mg QW
n=23 participants at risk
Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
2/24 • Number of events 3 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
4.3%
1/23 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24 • Number of events 3 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
4.3%
1/23 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
8.3%
2/24 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
0.00%
0/23 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 3 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
General disorders
Injection site erythema
|
8.3%
2/24 • Number of events 3 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
34.8%
8/23 • Number of events 29 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
General disorders
Injection site inflammation
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
13.0%
3/23 • Number of events 9 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
General disorders
Injection site pain
|
8.3%
2/24 • Number of events 3 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 8 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
General disorders
Injection site rash
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
13.0%
3/23 • Number of events 10 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
General disorders
Injection site urticaria
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 10 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
General disorders
Pyrexia
|
4.2%
1/24 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 3 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Infections and infestations
Influenza
|
8.3%
2/24 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
0.00%
0/23 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
2/24 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
21.7%
5/23 • Number of events 5 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Infections and infestations
Sinusitis
|
8.3%
2/24 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
4.3%
1/23 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
3/24 • Number of events 3 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
13.0%
3/23 • Number of events 3 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
1/24 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 3 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 3 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
0.00%
0/23 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
4.3%
1/23 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
1/24 • Number of events 1 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 3 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/24 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
8.7%
2/23 • Number of events 2 • Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
An AE is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease which was temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety analysis set (SAF) included all randomized participants who received any study drug, and the analyses were based on as treated. The safety analyses were based on the SAF.
|
Additional Information
Clinical Trial Management
Regeneron Pharmaceuticals, Inc
Phone: 844-734-6643
Email: [email protected]
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