Trial Outcomes & Findings for Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis (NCT NCT05247866)
NCT ID: NCT05247866
Last Updated: 2025-11-10
Results Overview
Eosinophils per high power field on esophageal biopsy
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
week 24
Results posted on
2025-11-10
Participant Flow
21 patients recruited
Open label study, all assigned dupilumab
Participant milestones
| Measure |
Study Group
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Study Group
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis
Baseline characteristics by cohort
| Measure |
Study Group
n=21 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Atopy
|
19 Count of Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 24Population: 5 patients dropped out to subject withrdraw and anxiety due to injections before completing this endpoint
Eosinophils per high power field on esophageal biopsy
Outcome measures
| Measure |
Study Group
n=16 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)
|
5.3 eosinophils/high power field
Standard Deviation 8.9
|
PRIMARY outcome
Timeframe: week 48Population: 2 patients dropped before this time point
Eosinophils per high power field on esophageal biopsy
Outcome measures
| Measure |
Study Group
n=14 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)
|
2.6 eosinophils per high power field
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: week 36Eosinophils per high power field on esophageal biopsy
Outcome measures
| Measure |
Study Group
n=14 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)
|
1.3 eosinophils/high power field
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: week 24Min 0-Max-100, lower is better
Outcome measures
| Measure |
Study Group
n=16 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score)
|
7.7 units on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: week 36Min 0-Max-100, lower is better
Outcome measures
| Measure |
Study Group
n=14 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score)
|
5.1 units on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: week 48Min 0-Max-100, lower is better
Outcome measures
| Measure |
Study Group
n=16 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score)
|
8 units on a scale
Standard Deviation 11.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 24Less than 6 eosinophils per high power field in peak count in esophageal biopsy
Outcome measures
| Measure |
Study Group
n=16 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Rate of Maintenance of Remission (Less Than <6 Eos/Hpf) in Esophageal Biopsy
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 36Less than 6 eosinophils per high power field in peak count in esophageal biopsy
Outcome measures
| Measure |
Study Group
n=14 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Rate of Maintenance of Remission (Less Than <6 Eos/Hpf) in Esophageal Biopsy
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 48Less than 6 eosinophils per high power field in peak count in esophageal biopsy
Outcome measures
| Measure |
Study Group
n=14 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Rate of Maintenance of Remission (Less Than <6 Eos/Hpf) in Esophageal Biopsy
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24Less than 15 eosinophils per high power field in peak count in esophageal biopsy
Outcome measures
| Measure |
Study Group
n=16 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Rate of Maintenance of Remission (Less Than <15 Eos/Hpf) in Esophageal Biopsy
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 36Less than 15 eosinophils per high power field in peak count in esophageal biopsy
Outcome measures
| Measure |
Study Group
n=14 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Rate of Maintenance of Remission (Less Than <15 Eos/Hpf) in Esophageal Biopsy
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 48Less than15 eosinophils per high power field in peak count in esophageal biopsy
Outcome measures
| Measure |
Study Group
n=14 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Rate of Maintenance of Remission (Less Than <15 Eos/Hpf) in Esophageal Biopsy
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 24Changes from baseline from upper endoscopy validated score (0-10), lower is better
Outcome measures
| Measure |
Study Group
n=16 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Change in Endoscopic Scoring System (EREFS)
|
0.6 units on a scale
Standard Deviation 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 36Changes from baseline from upper endoscopy validated score (0-10), lower is better
Outcome measures
| Measure |
Study Group
n=14 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Change in Endoscopic Scoring System (EREFS)
|
0.4 units on a scale
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 48Changes from baseline from upper endoscopy validated score (0-10), lower is better
Outcome measures
| Measure |
Study Group
n=14 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Change in Endoscopic Scoring System (EREFS)
|
0.2 units on a scale
Standard Deviation 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 24Changes from baseline in EoE specific Health related Quality of Life (range 0-96), higher is worse
Outcome measures
| Measure |
Study Group
n=19 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Changes in EoE Quality of Life From Baseline
|
7.06 units on a scale
Standard Deviation 6.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 36Changes from baseline in EoE Health related Quality of Life (range 0-96), higher is worse
Outcome measures
| Measure |
Study Group
n=14 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Changes in EoE Quality of Life From Baseline
|
5.14 units on a scale
Standard Deviation 6.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 48Changes from baseline in EoE Health related Quality of Life (range 0-96), higher is worse
Outcome measures
| Measure |
Study Group
n=14 Participants
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Changes in EoE Quality of Life From Baseline
|
8 units on a scale
Standard Deviation 11.31
|
Adverse Events
Study Group
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Group
n=21 participants at risk
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • Number of events 1 • Enrollment until end of follow-up (up to 52 weeks)
|
Other adverse events
| Measure |
Study Group
n=21 participants at risk
30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
\>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W
|
|---|---|
|
Nervous system disorders
headache
|
19.0%
4/21 • Enrollment until end of follow-up (up to 52 weeks)
|
|
Infections and infestations
Upper respiratory infection
|
38.1%
8/21 • Enrollment until end of follow-up (up to 52 weeks)
|
|
Gastrointestinal disorders
abdominal Pain
|
19.0%
4/21 • Enrollment until end of follow-up (up to 52 weeks)
|
|
Skin and subcutaneous tissue disorders
Injection Reaction
|
23.8%
5/21 • Enrollment until end of follow-up (up to 52 weeks)
|
|
Gastrointestinal disorders
nausea
|
9.5%
2/21 • Enrollment until end of follow-up (up to 52 weeks)
|
|
Gastrointestinal disorders
diarrhea
|
9.5%
2/21 • Enrollment until end of follow-up (up to 52 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
9.5%
2/21 • Enrollment until end of follow-up (up to 52 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60