Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT) (NCT NCT04417894)
NCT ID: NCT04417894
Last Updated: 2023-12-22
Results Overview
IGA is an assessment scale used to determine severity of hand and foot 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. Higher score is indicative of more severe disease.
COMPLETED
PHASE3
133 participants
At week 16
2023-12-22
Participant Flow
A total of 170 participants were screened, 37 participants failed screening, and 133 participants were randomized. Of the 37 screen failures: 2 withdrew consent, 33 did not meet inclusion/exclusion criteria, 1 was lost to follow-up and 1 was for an unknown reason.
Participant milestones
| Measure |
Matching Placebo
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
Administered SC Q2W, following a loading dose on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
67
|
|
Overall Study
COMPLETED
|
53
|
60
|
|
Overall Study
NOT COMPLETED
|
13
|
7
|
Reasons for withdrawal
| Measure |
Matching Placebo
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
Administered SC Q2W, following a loading dose on Day 1
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT)
Baseline characteristics by cohort
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Continuous
|
33.4 Years
STANDARD_DEVIATION 14.66 • n=93 Participants
|
35.8 Years
STANDARD_DEVIATION 17.07 • n=4 Participants
|
34.6 Years
STANDARD_DEVIATION 15.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
127 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
53 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At week 16IGA is an assessment scale used to determine severity of hand and foot 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. Higher score is indicative of more severe disease.
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16
|
16.7 Percentage of participants
|
40.3 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus Numerical Rating Scale (NRS) of ≥4 Points From Baseline to Week 16
|
13.6 Percentage of participants
|
52.2 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16
|
16.7 Percentage of participants
|
61.2 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
|
-26.2 Percentage of change
Interval -38.0 to -14.4
|
-62.9 Percentage of change
Interval -74.6 to -51.3
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized).
mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease).
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16
|
-31.0 Percentage of change
Interval -42.6 to -19.4
|
-69.4 Percentage of change
Interval -80.9 to -58.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
Pain NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS
|
-1.93 Score on a scale
Standard Error 0.432
|
-4.66 Score on a scale
Standard Error 0.426
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS
|
-0.00 Score on a scale
Standard Error 0.335
|
0.88 Score on a scale
Standard Error 0.334
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD)
|
-10.01 Percentage of hand and foot BSA
Standard Error 2.388
|
-16.70 Percentage of hand and foot BSA
Standard Error 2.375
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 4Population: The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
|
-25.6 Percentage of change
Interval -36.3 to -15.0
|
-47.2 Percentage of change
Interval -57.7 to -36.6
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 4Population: The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4
|
9.1 Percentage of participants
|
34.3 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16For participants with hand dermatitis HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The range for the combined HECSI score is from 0 to 360 (5x6x3x4).
Outcome measures
| Measure |
Matching Placebo
n=65 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=64 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis
|
-33.8 Percentage of change
Standard Deviation 42.21
|
-68.2 Percentage of change
Standard Deviation 25.56
|
—
|
SECONDARY outcome
Timeframe: At week 16Population: Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
HECSI-75 is defined as HECSI score has ≥75% improvement from baseline for participants with hand dermatitis.
Outcome measures
| Measure |
Matching Placebo
n=65 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=64 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percentage of Participants With HECSI-75 at Week 16
|
21.5 Percentage of participants
|
46.9 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: At week 16Population: Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
HECSI-50 is defined as HECSI score has ≥50% improvement from baseline, for participants with hand dermatitis.
Outcome measures
| Measure |
Matching Placebo
n=65 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=64 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percentage of Participants With HECSI-50 at Week 16
|
30.8 Percentage of participants
|
75.0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: At week 16Population: Efficacy analyses was based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
HECSI-90 is defined as HECSI score has ≥90% improvement from baseline for participants with hand dermatitis.
Outcome measures
| Measure |
Matching Placebo
n=65 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=64 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percentage of Participants With HECSI-90 at Week 16
|
9.2 Percentage of participants
|
18.8 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16Population: Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time.
For participants with hand dermatitis, QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in those suffering from hand eczema. QOLHEQ overall scoring ranges as follows: 0 (best score) to 117 (worst score).
Outcome measures
| Measure |
Matching Placebo
n=65 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=64 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
|
-13.36 Score on a scale
Standard Deviation 21.222
|
-38.70 Score on a scale
Standard Deviation 23.920
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16WPAI + CIQ is a self-administered instrument used to capture the impairment to work productivity/classroom impairment and activity due to atopic hand and foot dermatitis. The WPAI+CIQ yields 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. All scores range from 0 to 100% with 100% indicating total work/classroom productivity impairment and 0 no impairment at all.
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)
|
-21.26 Score on a scale
Standard Error 3.761
|
-36.39 Score on a scale
Standard Error 3.649
|
—
|
SECONDARY outcome
Timeframe: Through week 16Population: The safety analysis set (SAF) includes all randomized patients who receive at least one dose of study drug and will be analyzed as treated.
Outcome measures
| Measure |
Matching Placebo
n=66 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16
|
74.2 Percentage of participants
|
65.7 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to week 28Population: The pharmacokinetic analysis set (PKAS) includes all treated participants who received any amount of study drug (active or placebo \[SAF\]) and had at least 1 non-missing dupilumab measurement following the first dose of study drug or placebo. The PKAS is based on the actual treatment received (as treated) rather than as randomized. Here 'n' = number of evaluable participants at a specified point in time
Outcome measures
| Measure |
Matching Placebo
n=49 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=6 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
n=6 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Trough Concentration of Functional Dupilumab in Serum at Various Time Points
Week 0
|
0 Milligrams per Liter (mg/L)
Standard Deviation 0
|
0 Milligrams per Liter (mg/L)
Standard Deviation 0
|
0 Milligrams per Liter (mg/L)
Standard Deviation 0
|
|
Trough Concentration of Functional Dupilumab in Serum at Various Time Points
Week 16
|
51.2 Milligrams per Liter (mg/L)
Standard Deviation 22.0
|
34.0 Milligrams per Liter (mg/L)
Standard Deviation 10.7
|
37.1 Milligrams per Liter (mg/L)
Standard Deviation 15.9
|
|
Trough Concentration of Functional Dupilumab in Serum at Various Time Points
Week 28
|
7.37 Milligrams per Liter (mg/L)
Standard Deviation 25.0
|
60.0 Milligrams per Liter (mg/L)
Standard Deviation 84.9
|
7.54 Milligrams per Liter (mg/L)
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: Up to week 28Population: The ADA analysis set (AAS) includes all treated participants who received any amount of study drug (active or placebo \[safety analysis set\]) and had at least one non-missing ADA result following the first dose of study drug or placebo. The ADA analysis set is based on the actual treatment received (active drug or placebo) rather than as randomized. Here 'n'= number of evaluable participants at a specified point in time.
Outcome measures
| Measure |
Matching Placebo
n=55 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=61 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA)
Treatment-Boosted Response
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA)
Treatment-Emergent Response
|
1 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 28Population: The ADA analysis set (AAS) includes all treated participants who received any amount of study drug (active or placebo \[safety analysis set\]) and had at least one non-missing ADA result following the first dose of study drug or placebo. The ADA analysis set is based on the actual treatment received (active drug or placebo) rather than as randomized. Here 'n'= number of evaluable participants at a specified point in time.
Outcome measures
| Measure |
Matching Placebo
n=55 Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=61 Participants
Administered SC Q2W, following a loading dose on Day 1
|
Dupilumab 300 mg - Adolescent Participants
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent ADA by Maximum Titer Category
Low (<1,000)
|
1 Participants
|
8 Participants
|
—
|
|
Number of Participants With Treatment-Emergent ADA by Maximum Titer Category
Moderate (1,000 to 10,000)
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-Emergent ADA by Maximum Titer Category
High (>10,000)
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Matching Placebo
Dupilumab Q2W
Serious adverse events
| Measure |
Matching Placebo
n=66 participants at risk
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 participants at risk
Administered SC Q2W, following a loading dose on Day 1
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
1.5%
1/66 • Number of events 1 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
0.00%
0/67 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/66 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
1.5%
1/67 • Number of events 1 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/66 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
1.5%
1/67 • Number of events 1 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/66 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
1.5%
1/67 • Number of events 1 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/66 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
1.5%
1/67 • Number of events 1 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
|
Nervous system disorders
Syncope
|
0.00%
0/66 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
1.5%
1/67 • Number of events 1 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
Other adverse events
| Measure |
Matching Placebo
n=66 participants at risk
Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1
|
Dupilumab Q2W
n=67 participants at risk
Administered SC Q2W, following a loading dose on Day 1
|
|---|---|---|
|
Infections and infestations
COVID-19
|
21.2%
14/66 • Number of events 14 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
16.4%
11/67 • Number of events 11 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
|
Infections and infestations
Nasopharyngitis
|
12.1%
8/66 • Number of events 13 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
23.9%
16/67 • Number of events 18 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
3/66 • Number of events 3 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
10.4%
7/67 • Number of events 9 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
24.2%
16/66 • Number of events 18 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
9.0%
6/67 • Number of events 6 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.5%
1/66 • Number of events 1 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
6.0%
4/67 • Number of events 4 • From first dose to Week 28
Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.
|
Additional Information
Clinical Trials Administrator
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