A Phase 3 interventional study of Dupilumab in Atopic Dermatitis, sponsored by Regeneron Pharmaceuticals. Completed at 432 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-17.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD).
The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.
Optional Sub-Study:
The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product.
The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.
1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.
This study's enrollment of 2,733 is above the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Regeneron Pharmaceuticals is the lead sponsor of 409 studies on the registry; 92 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 79 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Participation in a prior clinical trial of dupilumab for AD and met one of the following:
Optional Sub-Study:
Key Exclusion Criteria:
Conditions in the previous dupilumab study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to dupilumab* or led to investigator - or sponsor-initiated withdrawal of patient from the study (eg, non-compliance, inability to complete study assessments, etc.).
*Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions deemed related to the study treatment will be considered related to dupilumab.
Optional Sub-Study:
1. Patients who have already completed the end of treatment visit (ie, visit 44) for the main study R668-AD-1225
Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply.
Participants will receive repeat doses of dupilumab
Drug: Dupilumab
Also known as: DUPIXENT®, REGN668, SAR231893
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 272 weeks
OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product
Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
Time frame: Up to 24 Weeks
Number of Serious Adverse Events (SAEs) of Special Interest
Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
Time frame: Up to 272 weeks
Rate of AESIs
Rate (events per patient-year) of AESIs Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
Time frame: Up to 272 weeks
Number of AESIs
Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
Time frame: Up to 272 weeks
Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit
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.
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)
Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, 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.
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"
Percentage of Participants With Low Disease Activity State (eg, IGA ≤2) at Each Visit
Low disease activity state is defined as an IGA score of ≤2 \[mild = 2, almost clear = 1, or clear = 0\]
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"
Change From Baseline in EASI Score at Each Visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, 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.
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"
Percent Change From Baseline in EASI Score at Each Visit
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 range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"
Percentage of Participants With EASI-50 (≥50% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit
EASI-50 was defined as \>=50% reduction in EASI scores from baseline of the parent study
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"
Percentage of Participants With EASI-90 (≥90% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit
EASI-90 was defined as \>=90% reduction in EASI scores from baseline of the parent study
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"
Change From Baseline in Pruritus Numerical Rating Scale (NRS) in Parent Study
The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"
Percent Change From Baseline in Pruritus NRS
The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"
Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥3 From Baseline
The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"
Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥4 From Baseline
The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"
Percentage of Participants Requiring Rescue Treatment: Overall
Time frame: Up to 272 weeks
Percentage of Participants Requiring Rescue Treatment: Systemic Treatment
Time frame: Up to 272 weeks
Percentage of Participants Requiring Rescue Treatment: Phototherapy
Time frame: Up to 272 weeks
Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Dermatology Life Quality Index (DLQI)
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Patient Oriented Eczema Measure (POEM)
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults. The format is a response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) with a scoring system of 0 to 28; a high score is indicative of a poor QOL.
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
Changes From Parent Study Baseline to Prespecified Time Points Through the End of the Study: EuroQol-5D (EQ-5D)
The EuroQOL 5-Dimension Health Questionnaire (EQ-5D) is a standardized measure of health status developed by the EuroQOL Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The minimum value for the single index utility score is -0.594 (Best imaginable health state) and the maximum value for the single index utility score is 1 (Worst imaginable health state).
Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
OPTIONAL SUB-STUDY: Ctrough of Functional Dupilumab in Serum Before and After Switching to the New Dupilumab Drug Product
Time frame: Up to week 12
OPTIONAL SUB-STUDY: Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response in Patients Receiving the New Dupilumab Drug Product
For participants receiving dupilumab from a new manufacturing process, ADA baseline was defined as the baseline visit in the sub-study, or at the end of the main study, dependent on available data.
Time frame: Up to 24 Weeks
| Milestone | Dupilumab |
|---|---|
| Started | 2677 |
| Completed | 1297 |
| Not completed | 1380 |
| Withdrew: Lost to follow-up | 73 |
| Withdrew: Terminated by sponsor | 708 |
| Withdrew: Withdrawal by subject | 375 |
| Withdrew: Lack of efficacy | 50 |
| Withdrew: Protocol deviation | 34 |
| Withdrew: Pregnancy | 20 |
| Withdrew: Physician decision | 9 |
| Withdrew: Other | 4 |
| Withdrew: Adverse event | 107 |
| Number of Events | Dupilumab |
|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) | 14717 |
Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
| Events | Dupilumab |
|---|---|
| OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product | 0 |
Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
| Events | Dupilumab |
|---|---|
| Number of Serious Adverse Events (SAEs) of Special Interest | 9 |
Rate (events per patient-year) of AESIs Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
| Events per Patient-Year | Dupilumab |
|---|---|
| Rate of AESIs | 2.762 |
Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
| Events | Dupilumab |
|---|---|
| Number of AESIs | 161 |
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.
| Percentage of Participants | Dupilumab |
|---|---|
| Baseline of study | 12.0 |
| Week 4 | 31.1 |
| Week 16 | 46.7 |
| Week 36 | 46.2 |
| Week 52 | 53.8 |
| Week 100 | 58.2 |
| Week 124 | 59.6 |
| Week 156 | 67.2 |
| Week 172 | 71.1 |
| Week 188 | 56.5 |
| Week 204 | 64.4 |
| Week 220 | 81.2 |
| Week 236 | 50.0 |
| End of Study (Extension) | 67.5 |
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, 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.
| Percentage of Participants | Dupilumab |
|---|---|
| Baseline of study | 33.4 |
| Week 4 | 65.3 |
| Week 16 | 82.0 |
| Week 36 | 85.3 |
| Week 52 | 88.8 |
| Week 100 | 91.4 |
| Week 124 | 92.0 |
| Week 156 | 89.5 |
| Week 172 | 94.1 |
| Week 188 | 96.8 |
| Week 204 | 90.9 |
| Week 220 | 93.5 |
| Week 236 | 100 |
| End of Study (Extension) | 88.9 |
Low disease activity state is defined as an IGA score of ≤2 \[mild = 2, almost clear = 1, or clear = 0\]
| Percentage of Participants | Dupilumab |
|---|---|
| Baseline of study | 34.7 |
| Week 4 | 70.0 |
| Week 16 | 83.0 |
| Week 36 | 84.6 |
| Week 52 | 89.6 |
| Week 100 | 90.9 |
| Week 124 | 93.1 |
| Week 156 | 94.8 |
| Week 172 | 96.3 |
| Week 188 | 96.8 |
| Week 204 | 96.0 |
| Week 220 | 97.1 |
| Week 236 | 90.0 |
| End of Study (Extension) | 92.6 |
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, 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.
| Score on a scale | Dupilumab |
|---|---|
| Week 4 | -8.59 ± 10.196 |
| Week 16 | -11.89 ± 12.583 |
| Week 36 | -17.32 ± 13.989 |
| Week 52 | -16.46 ± 13.719 |
| Week 100 | -17.99 ± 14.049 |
| Week 124 | -17.68 ± 13.794 |
| Week 156 | -14.23 ± 14.358 |
| Week 172 | -13.23 ± 13.651 |
| Week 188 | -19.24 ± 11.253 |
| Week 204 | -14.50 ± 15.615 |
| Week 220 | -12.75 ± 14.444 |
| Week 236 | -16.69 ± 9.743 |
| End of Study (Extension) | -13.14 ± 14.614 |
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 range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
| Percent of Change | Dupilumab |
|---|---|
| Week 4 | -42.02 ± 88.963 |
| Week 16 | -54.82 ± 316.630 |
| Week 36 | -60.40 ± 603.886 |
| Week 52 | -75.76 ± 73.014 |
| Week 100 | -82.61 ± 29.534 |
| Week 124 | -84.15 ± 27.737 |
| Week 156 | -83.45 ± 32.410 |
| Week 172 | -74.98 ± 78.138 |
| Week 188 | -88.72 ± 15.122 |
| Week 204 | -70.91 ± 74.941 |
| Week 220 | -30.79 ± 370.994 |
| Week 236 | -87.56 ± 10.851 |
| End of Study (Extension) | -55.44 ± 213.819 |
EASI-50 was defined as \>=50% reduction in EASI scores from baseline of the parent study
| Percentage of Participants | Dupilumab |
|---|---|
| Week 4 | 86.0 |
| Week 16 | 95.0 |
| Week 36 | 96.7 |
| Week 52 | 97.4 |
| Week 100 | 98.5 |
| Week 124 | 98.3 |
| Week 156 | 97.4 |
| Week 172 | 98.4 |
| Week 188 | 100 |
| Week 204 | 94.9 |
| Week 220 | 97.8 |
| Week 236 | 100 |
| End of Study (Extension) | 96.9 |
EASI-90 was defined as \>=90% reduction in EASI scores from baseline of the parent study
| Percentage of Participants | Dupilumab |
|---|---|
| Week 4 | 38.6 |
| Week 16 | 57.7 |
| Week 36 | 59.7 |
| Week 52 | 68.4 |
| Week 100 | 73.0 |
| Week 124 | 74.4 |
| Week 156 | 76.3 |
| Week 172 | 81.8 |
| Week 188 | 72.6 |
| Week 204 | 75.8 |
| Week 220 | 84.1 |
| Week 236 | 70.0 |
| End of Study (Extension) | 76.2 |
The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
| Score on a Scale | Dupilumab |
|---|---|
| Week 1 | -2.86 ± 2.492 |
| Week 4 | -3.81 ± 2.403 |
| Week 16 | -4.44 ± 2.377 |
| Week 36 | -4.67 ± 2.365 |
| Week 52 | -4.76 ± 2.371 |
| Week 100 | -4.69 ± 2.315 |
| Week 124 | -4.56 ± 2.359 |
| Week 156 | -4.37 ± 2.352 |
| Week 172 | -4.64 ± 2.256 |
| Week 188 | -4.73 ± 2.194 |
| Week 204 | -4.83 ± 2.341 |
| Week 220 | -4.90 ± 2.231 |
| Week 236 | -4.81 ± 2.308 |
| Week 252 | -4.89 ± 2.201 |
| Week 272 | -4.69 ± 2.238 |
The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
| Percent Change | Dupilumab |
|---|---|
| Week 1 | -9.55 ± 40.989 |
| Week 4 | -28.88 ± 41.792 |
| Week 16 | -38.96 ± 47.891 |
| Week 36 | -41.38 ± 52.300 |
| Week 52 | -46.41 ± 41.912 |
| Week 100 | -50.62 ± 42.112 |
| Week 124 | -51.47 ± 39.063 |
| Week 156 | -48.16 ± 55.076 |
| Week 172 | -50.30 ± 42.907 |
| Week 188 | -50.56 ± 43.444 |
| Week 204 | -52.53 ± 43.465 |
| Week 220 | -51.18 ± 39.244 |
| Week 236 | -51.67 ± 37.690 |
| Week 252 | -51.01 ± 47.328 |
| Week 272 | -46.23 ± 46.404 |
The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
| Percentage of Participants | Dupilumab |
|---|---|
| Week 1 | 11.9 |
| Week 4 | 28.3 |
| Week 16 | 39.3 |
| Week 36 | 43.8 |
| Week 52 | 45.9 |
| Week 100 | 51.1 |
| Week 124 | 48.8 |
| Week 156 | 46.5 |
| Week 172 | 54.1 |
| Week 188 | 52.5 |
| Week 204 | 56.9 |
| Week 220 | 51.5 |
| Week 236 | 51.3 |
| Week 252 | 56.2 |
| Week 272 | 50.0 |
The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
| Percentage of Participants | Dupilumab |
|---|---|
| Week 1 | 7.0 |
| Week 4 | 18.6 |
| Week 16 | 29.3 |
| Week 36 | 33.3 |
| Week 52 | 35.4 |
| Week 100 | 41.4 |
| Week 124 | 39.4 |
| Week 156 | 35.6 |
| Week 172 | 42.9 |
| Week 188 | 40.9 |
| Week 204 | 44.1 |
| Week 220 | 40.2 |
| Week 236 | 37.2 |
| Week 252 | 42.7 |
| Week 272 | 36.0 |
| Percentage of Participants | Dupilumab |
|---|---|
| Percentage of Participants Requiring Rescue Treatment: Overall | 1.7 |
| Percentage of Participants | Dupilumab |
|---|---|
| Percentage of Participants Requiring Rescue Treatment: Systemic Treatment | 1.6 |
| Percentage of Participants | Dupilumab |
|---|---|
| Percentage of Participants Requiring Rescue Treatment: Phototherapy | 0.0747 |
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL
| Score on a scale | Dupilumab |
|---|---|
| Baseline of Current Study | 8.5 ± 7.11 |
| Week 12 | -4.9 ± 5.93 |
| Week 24 | -6.0 ± 6.41 |
| Week 36 | -6.5 ± 6.51 |
| Week 48 | -5.6 ± 6.20 |
| Week 76 | -7.2 ± 6.41 |
| Week 100 | -7.3 ± 6.66 |
| Week 124 | -7.9 ± 6.40 |
| Week 148 | -8.3 ± 5.14 |
| End of Study | -3.6 ± 7.37 |
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults. The format is a response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) with a scoring system of 0 to 28; a high score is indicative of a poor QOL.
| Score on a scale | Dupilumab |
|---|---|
| Week 12 | -7.7 ± 7.32 |
| Week 24 | -9.3 ± 7.44 |
| Week 36 | -10.0 ± 7.46 |
| Week 48 | -8.8 ± 7.46 |
| Week 76 | -11.6 ± 7.79 |
| Week 100 | -11.4 ± 7.30 |
| Week 124 | -12.7 ± 7.11 |
| Week 148 | -10.5 ± 6.06 |
| End of Study | -4.5 ± 10.91 |
The EuroQOL 5-Dimension Health Questionnaire (EQ-5D) is a standardized measure of health status developed by the EuroQOL Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The minimum value for the single index utility score is -0.594 (Best imaginable health state) and the maximum value for the single index utility score is 1 (Worst imaginable health state).
| Score on a scale | Dupilumab |
|---|---|
| Week 12 | 0.2769 ± 0.31571 |
| Week 24 | 0.3001 ± 0.32062 |
| Week 36 | 0.3056 ± 0.33204 |
| Week 48 | 0.2854 ± 0.31017 |
| Week 76 | 0.2965 ± 0.30658 |
| Week 100 | 0.3217 ± 0.33832 |
| Week 124 | 0.3242 ± 0.28937 |
| Week 148 | 0.3046 ± 0.26337 |
| End of Study | 0.1864 ± 0.32838 |
| mg/L | Dupilumab |
|---|---|
| Week 0 | 65.9 ± 40.8 |
| Week 12 | 65.4 ± 34.7 |
For participants receiving dupilumab from a new manufacturing process, ADA baseline was defined as the baseline visit in the sub-study, or at the end of the main study, dependent on available data.
No measurements were reported for this outcome.
Collected over From first dose to end of study (plus extension), approximately 272 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dupilumab | 3/2,677 (0.1%) | 283/2,677 (10.6%) | 1,613/2,677 (60.3%) |
| Event | Dupilumab |
|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 11/2677 |
| Squamous cell carcinoma of skinNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 8/2677 |
| AppendicitisInfections and infestations | 6/2677 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 6/2677 |
| Ligament ruptureInjury, poisoning and procedural complications | 5/2677 |
| SyncopeNervous system disorders | 5/2677 |
| Inguinal herniaGastrointestinal disorders | 5/2677 |
| Ankle fractureInjury, poisoning and procedural complications | 4/2677 |
| Nasal septum deviationRespiratory, thoracic and mediastinal disorders | 4/2677 |
| DepressionPsychiatric disorders | 4/2677 |
| Event | Dupilumab |
|---|---|
| NasopharyngitisInfections and infestations | 774/2677 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 446/2677 |
| Upper respiratory tract infectionInfections and infestations | 365/2677 |
| ConjunctivitisInfections and infestations | 277/2677 |
| Conjunctivitis allergicEye disorders | 242/2677 |
| HeadacheNervous system disorders | 218/2677 |
| Oral herpesInfections and infestations | 200/2677 |
| Injection site reactionGeneral disorders | 138/2677 |
| Age, Continuous(Years) | Dupilumab |
|---|---|
| Mean | 39.2 ± 13.42 |
| Sex: Female, Male(Participants) | Dupilumab |
|---|---|
| Female | 1066 |
| Male | 1611 |
| Ethnicity (NIH/OMB)(Participants) | Dupilumab |
|---|---|
| Hispanic or Latino | 94 |
| Not Hispanic or Latino | 2532 |
| Unknown or Not Reported | 51 |
| Race (NIH/OMB)(Participants) | Dupilumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 541 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 147 |
| White | 1936 |
| More than one race | 33 |
| Unknown or Not Reported | 20 |
Showing the first 100 of 432 sites across 28 countries.
Documents are hosted by the registry — open the source record to download them.
Ran from Oct 2013 to primary completion in Jun 2022, 104 months.
Results were first posted in Oct 2023, 1 year 3 months after primary completion.
Of 132 industry-sponsored phase 3 interventional studies under Dermatitis, Atopic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 26. This study's 104 months is above that.
Counting every sponsor, half of 139 studies reached it within 18 months; a quarter within 13 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dupilumab