Trial Outcomes & Findings for Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis (NCT NCT04823130)
NCT ID: NCT04823130
Last Updated: 2025-09-16
Results Overview
Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker protein gene product 9.5 (PGP9.5); and the basement membrane was visualized by staining for collagen type 4. Quantification of intraepidermal nerve fiber density was calculated by assessing nerve fibers crossing the basement membrane per square millimeter (F/mm\^2). Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
COMPLETED
PHASE4
54 participants
Baseline, Week 17
2025-09-16
Participant Flow
The study was conducted at 3 active sites in the United States and Germany. A total of 54 participants were enrolled between 22 April 2021 to 30 March 2022.
Healthy participants were considered as a reference comparator group and received no treatment. Healthy participants underwent only an additional 7-days observational period following collection of the skin biopsy on Day 1 (i.e., up to Day 8). Only safety data was collected for the healthy participants and no other outcome measures were assessed.
Participant milestones
| Measure |
Healthy Participants: Control
Healthy participants with site, age, gender, race, location of targeted lesional and non-lesional skin area matched to selected atopic dermatitis (AD) participants, received no treatment, and were considered as a control group.
|
Participants With AD: Dupilumab
Participants with moderate to severe AD received dupilumab 600 milligrams (mg) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) from Week 3 to Week 15.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
35
|
|
Overall Study
Safety Population
|
13
|
31
|
|
Overall Study
COMPLETED
|
10
|
28
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
Healthy Participants: Control
Healthy participants with site, age, gender, race, location of targeted lesional and non-lesional skin area matched to selected atopic dermatitis (AD) participants, received no treatment, and were considered as a control group.
|
Participants With AD: Dupilumab
Participants with moderate to severe AD received dupilumab 600 milligrams (mg) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) from Week 3 to Week 15.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Failure to meet inclusion criteria
|
6
|
4
|
|
Overall Study
Other-unspecified
|
1
|
0
|
Baseline Characteristics
Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Healthy Participants: Control
n=19 Participants
Healthy participants with site, age, gender, race, location of targeted lesional and non-lesional skin area matched to selected AD participants, received no treatment, and were considered as a control group.
|
Participants With AD: Dupilumab
n=35 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 18.1 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 17Population: Analyzed on modified intent-to-treat (mITT) population which included all AD participants who received at least 1 dose of IMP who had at least 1 skin biopsy performed, irrespective of compliance with study protocol and procedures, and who did not use prohibited therapies for AD from screening to end of study. 'Overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker protein gene product 9.5 (PGP9.5); and the basement membrane was visualized by staining for collagen type 4. Quantification of intraepidermal nerve fiber density was calculated by assessing nerve fibers crossing the basement membrane per square millimeter (F/mm\^2). Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=27 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Week 17
Baseline
|
8.4567 F/mm^2
Standard Deviation 7.2502
|
|
Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Week 17
Change at Week 17
|
4.2618 F/mm^2
Standard Deviation 6.7538
|
PRIMARY outcome
Timeframe: Baseline, Week 17Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
Skin biopsies were used to analyze the epidermal nerve fiber branching. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker PGP9.5; and the basement membrane was visualized by staining for collagen type 4. Branching of epidermal nerve fibers was assessed semi-quantitatively by classifying participants into 4 groups depending on the predominant intraepidermal nerve fiber branching pattern as follows: only linear (100% linear), mainly linear (\>60% linear), mainly branched (\>60% branched), only branched (100% branched). Percentage of participants with change in nerve fiber branching status from baseline on lesional skin at Week 17 are reported in this outcome measure.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=15 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Percentage of Participants With Change From Baseline in Nerve Fiber Branching on Lesional Skin at Week 17
Only linear
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Nerve Fiber Branching on Lesional Skin at Week 17
Mainly linear
|
60.0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Nerve Fiber Branching on Lesional Skin at Week 17
Mainly branched
|
40.0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Nerve Fiber Branching on Lesional Skin at Week 17
Only branched
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3 and 21Population: Data was not collected and analyzed for this outcome measure as no optional skin biopsies were done at Weeks 3 and 21.
Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker PGP9.5; and the basement membrane was visualized by staining for collagen type 4. Quantification of intraepidermal nerve fiber density was calculated by assessing nerve fibers crossing the basement membrane per square millimeter (F/mm\^2).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 3 and 21Population: Data was not collected and analyzed for this outcome measure as no optional skin biopsies were done at Weeks 3 and 21.
Skin biopsies were used to analyze the epidermal nerve fiber branching. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker PGP9.5; and the basement membrane was visualized by staining for collagen type 4. Branching of epidermal nerve fibers was assessed semi-quantitatively by classifying participants into 4 groups depending on the predominant intraepidermal nerve fiber branching pattern as follows: only linear (100% linear), mainly linear (\>60% linear), mainly branched (\>60% branched), only branched (100% branched).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
Peak Pruritus NRS was an assessment tool used to report the intensity of participant's pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 ("No itch") to 10 ("Worst itch imaginable") NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated greater severity.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=7 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Peak Pruritus Assessed by Numeric Rating Scale (NRS) Scores at Weeks 17 and 21
Week 17
|
-6.6 score on a scale
Standard Deviation 3.6
|
|
Change From Baseline in Peak Pruritus Assessed by Numeric Rating Scale (NRS) Scores at Weeks 17 and 21
Week 21
|
-7.4 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
EASI was a validated measure used to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness \[induration, papulation, and edema\], scratching \[excoriation\], and lichenification) were each assessed for severity by the Investigator on a scale of "0" (absent) through "3" (severe). EASI area score was based upon percent (%) body surface area (BSA) with AD in each body region: 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), and 6 (90% to 100%). Total EASI score was derived as the sum of the 4 region scores and ranged from 0 (minimum) to 72 (maximum). Higher scores indicated greater severity of AD.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=12 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Eczema and Severity Index (EASI) Total Score at Weeks 17 and 21
Week 17
|
-18.9 score on a scale
Standard Deviation 6.4
|
|
Change From Baseline in Eczema and Severity Index (EASI) Total Score at Weeks 17 and 21
Week 21
|
-19.5 score on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
SCORAD was used to standardize the extent and severity of AD. It consisted of 3 components i.e., A =extent or affected BSA assessed as a % of each defined body area and reported as sum of all areas, with a maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points) and C=subjective symptoms scored by participants on VAS, where "0"=no itch (or no sleeplessness) and "10"=worst imaginable itch (or sleeplessness) with a maximum score of 20. SCORAD total score was calculated using these 3 aspects: extent (A: 0-100), severity (B: 0-18), and subjective symptoms (C: 0-20) using the formula: A/5 + 7\*B/2+ C. SCORAD total score ranged from 0 to 103, where 0 = no disease to 103 = severe disease. Higher values of SCORAD represent worse outcome.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=19 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 17 and 21
Week 17
|
-77.2 score on a scale
Standard Deviation 32.3
|
|
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 17 and 21
Week 21
|
-81.3 score on a scale
Standard Deviation 35.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
PROMIS-itch represents a novel suite of participant-reported outcome (PRO) measures for the itch. The PROMIS-Itch severity score consists of 7 questions: 4 questions scored on a scale of 1 to 5: 1) How intense was your itch at its worst; 2) How intense was your itch in general; 3) What is your level of itch right now; 4) How often did you feel the itch; and rest 3 questions (same questions as 1 to 3 mentioned before but scaled on a scale of 0 to 10) were scored on a scale of 0 to 10. Higher scores for each question indicated worse outcome. The total PROMIS-itch score was calculated as the sum of the 7 questions and ranged from 4 (better outcome) to 50 (worse outcome), where a higher score indicated worse condition.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=13 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Patient-Reported Outcomes Measurement Information (PROMIS-itch) Itch-Severity Total Score at Weeks 17 and 21
Week 17
|
-30.8 score on a scale
Standard Deviation 9.0
|
|
Change From Baseline in Patient-Reported Outcomes Measurement Information (PROMIS-itch) Itch-Severity Total Score at Weeks 17 and 21
Week 21
|
-28.8 score on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
The POEM was a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults with AD. The format is participant response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (i.e., 0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=14 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Weeks 17 and 21
Week 17
|
-17.2 score on a scale
Standard Deviation 5.3
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Weeks 17 and 21
Week 21
|
-16.1 score on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
DLQI was a 10-item PRO questionnaire that measured the impact of AD disease symptoms and treatment on quality of life. Each question was evaluated on a 4-point scale ranged from 0 to 3 where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score that ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=17 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 17 and 21
Week 17
|
-16.1 score on a scale
Standard Deviation 7.4
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 17 and 21
Week 21
|
-14.8 score on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
ADCT was a PRO questionnaire designed to assess participant-self-perceived control of their eczema. ADCT contained 6 items allowing a comprehensive coverage of the dimensions defining AD control, i.e., overall severity of AD symptoms, frequency of intense episodes of itching, extent of AD related bother, impact on sleep, impact on daily activities, impact on mood or emotions. Each item of the ADCT is rated from 0 (no problem) to 4 (worst) Likert scale and is equally weighted. The sum of the 6 items gives the total score that ranged from 0 (best disease control) to 24 (worst disease control). Higher scores indicate lower AD control.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=14 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Total Score at Weeks 17 and 21
Week 17
|
-17.9 score on a scale
Standard Deviation 4.1
|
|
Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Total Score at Weeks 17 and 21
Week 21
|
-15.9 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
Sleep quality NRS was used to assess the quality of the participant's previous night's sleep using a 0 ("Worst possible sleep") to 10 ("Best possible sleep") NRS. Participants were asked to complete the following question upon awakening: "Select the number (0 to 10) that best describes the quality of your sleep last night". Higher score indicated better outcome.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=5 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Sleep Quality Numerical Rating Scale Score at Weeks 17 and 21
Week 17
|
0.7 score on a scale
Standard Deviation 5.0
|
|
Change From Baseline in Sleep Quality Numerical Rating Scale Score at Weeks 17 and 21
Week 21
|
3.0 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
Skin pain NRS was used to assess participant's skin pain at its worst in the past 24 hours using a 0 ("Not at all") to 10 ("Very much") NRS. Participants were asked the following question: "Think about all the areas of your skin with eczema. How much did your skin burn at its worst in the past 24 hours?" Lower score indicated better outcome.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=4 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Skin Pain Numerical Rating Scale Score at Weeks 17 and 21
Week 17
|
-5.3 score on a scale
Standard Deviation 2.9
|
|
Change From Baseline in Skin Pain Numerical Rating Scale Score at Weeks 17 and 21
Week 21
|
-5.3 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
Skin sensitivity NRS was a 1 item PRO measure asking the participants to rate their skin sensitivity to touch using a 0 ("Normal") to 10 ("Extremely sensitive") NRS. Participants were asked the following question: "Think about all the areas of your skin with eczema. How sensitive was your skin at its worst in the past 24 hours?" Lower score indicated better outcome.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=4 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Skin Sensitivity Numerical Rating Scale Score at Weeks 17 and 21
Week 17
|
-7.7 score on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Skin Sensitivity Numerical Rating Scale Score at Weeks 17 and 21
Week 21
|
-7.3 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
Skin burning NRS was a 1-item PRO measure asking participants to rate the burning sensation of their skin in the past 24 hours using a 0 ("Not at all") to 10 ("Very much") NRS. Participants were asked the following question: "Think about all the areas of your skin with eczema. How much did your skin burn at its worst in the past 24 hours?" Lower score indicated better outcome.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=4 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Change From Baseline in Skin Burning Numerical Rating Scale Score at Weeks 17 and 21
Week 17
|
-4.3 score on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Skin Burning Numerical Rating Scale Score at Weeks 17 and 21
Week 21
|
-5.5 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 17 and 21Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
Pruritus NRS was an assessment tool used to report the intensity of participant's pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 ("No itch") to 10 ("Worst itch imaginable") NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated greater severity. Percentage of participants with change of \>=4 point in pruritus NRS scale from baseline at Weeks 17 and 21 are reported in this outcome measure.
Outcome measures
| Measure |
Participants With AD: Dupilumab
n=7 Participants
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|
|
Percentage of Participants With Change of Greater Than or Equal to (>=4) Point in Pruritus Numerical Rating Scale From Baseline at Weeks 17 and 21
Week 17
|
0 percentage of participants
|
|
Percentage of Participants With Change of Greater Than or Equal to (>=4) Point in Pruritus Numerical Rating Scale From Baseline at Weeks 17 and 21
Week 21
|
0 percentage of participants
|
Adverse Events
Healthy Participants: Control
Participants With AD: Dupilumab
Serious adverse events
| Measure |
Healthy Participants: Control
n=13 participants at risk
Healthy participants with site, age, gender, race, location of targeted lesional and non-lesional skin area matched to selected AD participants, received no treatment, and were considered as a control group.
|
Participants With AD: Dupilumab
n=31 participants at risk
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
Other adverse events
| Measure |
Healthy Participants: Control
n=13 participants at risk
Healthy participants with site, age, gender, race, location of targeted lesional and non-lesional skin area matched to selected AD participants, received no treatment, and were considered as a control group.
|
Participants With AD: Dupilumab
n=31 participants at risk
Participants with moderate to severe AD received dupilumab 600 mg SC injection on Day 1, followed by dupilumab 300 mg SC injection Q2W from Week 3 to Week 15.
|
|---|---|---|
|
Infections and infestations
Asymptomatic Covid-19
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
6.5%
2/31 • Number of events 2 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Infections and infestations
Cystitis
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Infections and infestations
Impetigo
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Infections and infestations
Suspected Covid-19
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Infections and infestations
Tinea Infection
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
22.6%
7/31 • Number of events 9 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 2 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
6.5%
2/31 • Number of events 2 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
6.5%
2/31 • Number of events 3 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
9.7%
3/31 • Number of events 3 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
General disorders
Injection Site Mass
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
General disorders
Injection Site Swelling
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/13 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
3.2%
1/31 • Number of events 1 • For Dupilumab group participants: from first dose (i.e., Day 1) of IMP administration up to end of study visit (i.e., up to Week 21). For healthy participants: from Baseline up to end of study for healthy participants group (i.e., at Day 8)
Analysis was performed on safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER