Trial Outcomes & Findings for Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD) (NCT NCT02210780)
NCT ID: NCT02210780
Last Updated: 2020-05-07
Results Overview
A positive response was defined as a ≥ 4-fold increase from pre-vaccination at baseline in anti-tetanus immunoglobulin G (IgG) titer for participants with a pre-vaccination tetanus antibody titers ≥ 0.1 IU/ml or a titer of ≥ 0.2 IU/ml for participants with pre-vaccination titers of \<0.1 IU/ml. There was no planned statistical hypothesis testing regarding the difference in immune response between the 2 treatment groups for this study, therefore no formal statistical hypothesis between groups was performed.
COMPLETED
PHASE2
194 participants
Week 16
2020-05-07
Participant Flow
The study was conducted at approximately 50 study sites in United States (US) between 05 August 2014 and 15 September 2015. A total of 243 participants were screened in the study.
Out of 243 participants, 194 were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive 600 mg subcutaneous (SC) dupilumab loading dose on day 1 and then dupilumab 300 mg once weekly (qw) or placebo qw.
Participant milestones
| Measure |
Placebo qw
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
97
|
|
Overall Study
COMPLETED
|
92
|
89
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Placebo qw
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Other than specified above
|
0
|
1
|
Baseline Characteristics
Pruritus NRS was a tool used to report intensity of participant's pruritus (itch)--max \& average intensity. Participants were asked: how would you rate the itch at worst moment during previous 24 hrs (max itch intensity, scale of 0-10 \[0=no itch;10=worst itch imaginable\]). Participants were excluded if baseline values were missed.
Baseline characteristics by cohort
| Measure |
Placebo qw
n=97 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=97 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 14.04 • n=97 Participants
|
39.2 years
STANDARD_DEVIATION 13.55 • n=97 Participants
|
39.6 years
STANDARD_DEVIATION 13.77 • n=194 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=97 Participants
|
48 Participants
n=97 Participants
|
99 Participants
n=194 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=97 Participants
|
49 Participants
n=97 Participants
|
95 Participants
n=194 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=97 Participants
|
15 Participants
n=97 Participants
|
28 Participants
n=194 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=97 Participants
|
81 Participants
n=97 Participants
|
165 Participants
n=194 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=97 Participants
|
1 Participants
n=97 Participants
|
1 Participants
n=194 Participants
|
|
Race/Ethnicity, Customized
White
|
67 Participants
n=97 Participants
|
60 Participants
n=97 Participants
|
127 Participants
n=194 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=97 Participants
|
23 Participants
n=97 Participants
|
40 Participants
n=194 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=97 Participants
|
12 Participants
n=97 Participants
|
23 Participants
n=194 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=97 Participants
|
1 Participants
n=97 Participants
|
1 Participants
n=194 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=97 Participants
|
1 Participants
n=97 Participants
|
3 Participants
n=194 Participants
|
|
Anti-tetanus Immunoglobulin G (IgG) Titer
|
1.74 IU/mL
STANDARD_DEVIATION 1.908 • n=97 Participants
|
1.51 IU/mL
STANDARD_DEVIATION 1.328 • n=97 Participants
|
1.62 IU/mL
STANDARD_DEVIATION 1.644 • n=194 Participants
|
|
Eczema Area and Severity Index (EASI) Score
|
31.23 units on a scale
STANDARD_DEVIATION 13.771 • n=97 Participants
|
29.04 units on a scale
STANDARD_DEVIATION 13.085 • n=97 Participants
|
30.14 units on a scale
STANDARD_DEVIATION 13.442 • n=194 Participants
|
|
Investigator Global Assessment (IGA) Score
|
3.4 units on a scale
STANDARD_DEVIATION 0.49 • n=97 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 0.49 • n=97 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 0.49 • n=194 Participants
|
|
Weekly Peak Pruritus Numeric Rating Scale (NRS)
|
7.3 Units on a Scale
STANDARD_DEVIATION 2.19 • n=90 Participants • Pruritus NRS was a tool used to report intensity of participant's pruritus (itch)--max \& average intensity. Participants were asked: how would you rate the itch at worst moment during previous 24 hrs (max itch intensity, scale of 0-10 \[0=no itch;10=worst itch imaginable\]). Participants were excluded if baseline values were missed.
|
7.4 Units on a Scale
STANDARD_DEVIATION 2.20 • n=94 Participants • Pruritus NRS was a tool used to report intensity of participant's pruritus (itch)--max \& average intensity. Participants were asked: how would you rate the itch at worst moment during previous 24 hrs (max itch intensity, scale of 0-10 \[0=no itch;10=worst itch imaginable\]). Participants were excluded if baseline values were missed.
|
7.3 Units on a Scale
STANDARD_DEVIATION 2.19 • n=184 Participants • Pruritus NRS was a tool used to report intensity of participant's pruritus (itch)--max \& average intensity. Participants were asked: how would you rate the itch at worst moment during previous 24 hrs (max itch intensity, scale of 0-10 \[0=no itch;10=worst itch imaginable\]). Participants were excluded if baseline values were missed.
|
|
Global Individual Signs Score (GISS) Total Score
|
8.8 units on a scale
STANDARD_DEVIATION 1.80 • n=97 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 1.76 • n=97 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 1.78 • n=194 Participants
|
|
Patient Oriented Eczema Measure (POEM) Score
|
20.6 units on a scale
STANDARD_DEVIATION 5.59 • n=97 Participants
|
21.5 units on a scale
STANDARD_DEVIATION 6.04 • n=97 Participants
|
21.1 units on a scale
STANDARD_DEVIATION 5.82 • n=194 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The immune response analysis set (IRS) included all randomized participants who received any study drug, vaccine injection at Week 12, and had 1 measurement for responses to tetanus toxoid vaccine at Week 16.
A positive response was defined as a ≥ 4-fold increase from pre-vaccination at baseline in anti-tetanus immunoglobulin G (IgG) titer for participants with a pre-vaccination tetanus antibody titers ≥ 0.1 IU/ml or a titer of ≥ 0.2 IU/ml for participants with pre-vaccination titers of \<0.1 IU/ml. There was no planned statistical hypothesis testing regarding the difference in immune response between the 2 treatment groups for this study, therefore no formal statistical hypothesis between groups was performed.
Outcome measures
| Measure |
Placebo qw
n=92 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=90 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Percentage of Participants With a Positive Response (≥4-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16
|
83.7 Percentage of participants
|
83.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The immune response analysis set (IRS) included all randomized participants who received any study drug, vaccine injection at Week 12, and had 1 measurement for responses to tetanus toxoid vaccine at Week 16.
Participants with positive response defined as a ≥2-fold increase from pre-vaccination baseline in anti-tetanus IgG titer for participants with pre-vaccination tetanus antibody titers ≥0.1 IU/ml or a titer of ≥0.2 IU/ml for participants with pre-vaccination titers of \<0.1 IU/ml.
Outcome measures
| Measure |
Placebo qw
n=92 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=90 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Percentage of Participants With a Positive Response (≥2-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16
|
94.6 Percentage of participants
|
95.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The immune response analysis set (IRS) included all randomized participants who received any study drug, vaccine injection at Week 12, and had 1 measurement for responses to tetanus toxoid vaccine at Week 16.
A positive response to the Menomune vaccine was a serum bactericidal antibody (SBA) titer of ≥8 for serogroup C.
Outcome measures
| Measure |
Placebo qw
n=92 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=90 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Percentage of Participants With a Positive Response (SBA Antibody Titer of ≥8 for Serogroup C) to Menomune Vaccine at Week 16
|
87.0 Percentage of participants
|
86.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set (FAS) that included all randomized participants.
IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were counted as non-responders.
Outcome measures
| Measure |
Placebo qw
n=97 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=97 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16
|
10.3 Percentage of participants
|
44.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set (FAS) that included all randomized participants.
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.
Outcome measures
| Measure |
Placebo qw
n=97 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=97 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Percentage of Participants Achieving an Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16
|
32.0 Percentage of participants
|
72.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set (FAS) that included all randomized participants.
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.
Outcome measures
| Measure |
Placebo qw
n=97 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=97 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Percentage of Participants Achieving an Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16
|
19.6 Percentage of participants
|
53.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set (FAS) that included all randomized participants. Here, number of participants analyzed=participants with available data for this endpoint.
Pruritus NRS was an assessment tool that was used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Weekly average obtained in the 7-day period prior to the baseline visit. Values after first rescue medication use were set to missing and missing values were imputed by Last observation carried forward (LOCF).
Outcome measures
| Measure |
Placebo qw
n=90 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=94 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Change From Baseline in Peak Weekly Averaged Pruritis Numerical Rating Scale (NRS) Scores at Week 16
|
-2.11 Units on a scale
Standard Error 0.259
|
-4.24 Units on a scale
Standard Error 0.250
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set (FAS) that included all randomized participants. Here, number of participants analyzed=participants with available data for this endpoint.
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]). It was reported as a percentage of all major body sections combined. Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Outcome measures
| Measure |
Placebo qw
n=97 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=97 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) Affected by AD at Week 16
|
-11.0 Percentage of BSA
Standard Error 2.11
|
-28.7 Percentage of BSA
Standard Error 2.00
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set (FAS) that included all randomized participants. Here, number of participants analyzed=participants with available data for this endpoint.
Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease). Values after first rescue treatment were set to missing. Analysis was completed using MMRM model which includes treatment, randomization strata, visit, baseline value, treatment-by-visit interaction, and baseline-by-visit interaction as covariates. These results are observed results without imputation.
Outcome measures
| Measure |
Placebo qw
n=97 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=97 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations and Lichenification) at Week 16
Erythema
|
-0.4 Units on a scale
Standard Error 0.08
|
-0.9 Units on a scale
Standard Error 0.08
|
|
Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations and Lichenification) at Week 16
Infiltration/Papulation
|
-0.4 Units on a scale
Standard Error 0.08
|
-1.1 Units on a scale
Standard Error 0.08
|
|
Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations and Lichenification) at Week 16
Excoriations
|
-0.5 Units on a scale
Standard Error 0.09
|
-1.2 Units on a scale
Standard Error 0.08
|
|
Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations and Lichenification) at Week 16
Lichenification
|
-0.4 Units on a scale
Standard Error 0.09
|
-1.0 Units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set (FAS) that included all randomized participants. Here, number of participants analyzed=participants with available data for this endpoint.
Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Outcome measures
| Measure |
Placebo qw
n=97 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=97 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Changes From Baseline in GISS Cumulative Score to Week 16
|
-1.7 Units on a scale
Standard Error 0.28
|
-4.1 Units on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set (FAS) that included all randomized participants. Here, number of participants analyzed=participants with available data for this endpoint.
The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life \[QOL\]). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Outcome measures
| Measure |
Placebo qw
n=97 Participants
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=97 Participants
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Change in Patient Oriented Eczema Measure (POEM) Score From Baseline to Week 16
|
-4.8 Units on a Scale
Standard Error 0.72
|
-13.1 Units on a Scale
Standard Error 0.70
|
Adverse Events
Placebo qw
Dupilumab 300 mg qw
Serious adverse events
| Measure |
Placebo qw
n=97 participants at risk
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=97 participants at risk
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
Immune system disorders
Serum sickness-like reaction
|
0.00%
0/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
1.0%
1/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides stage iv
|
0.00%
0/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
1.0%
1/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
1.0%
1/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
Other adverse events
| Measure |
Placebo qw
n=97 participants at risk
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
|
Dupilumab 300 mg qw
n=97 participants at risk
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
|
|---|---|---|
|
General disorders
Injection site reaction
|
0.00%
0/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
5.2%
5/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
8.2%
8/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
5/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
4.1%
4/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
|
Infections and infestations
Upper respiratory tract infection
|
14.4%
14/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
11.3%
11/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
|
Nervous system disorders
Headache
|
3.1%
3/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
5.2%
5/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
11.3%
11/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
1.0%
1/97 • Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product
Reported AEs are treatment-emergent adverse events which are AEs that developed/worsened during the 'on treatment period' (from the administration of first dose of study drug up to the final visit \[Week 32\]).
|
Additional Information
Clinical Trial Management
Regeneron Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER