Phase 3
Completed N=367
Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT03345914 ↗
Enrolled (actual)
367
Serious AEs
1.4%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 at Week 16 — 11.4; 32.8; 29.5 Percentage of Participants — p== 0.0004
◆ Published Evidence
Established
37citations · ~12 / year
Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age with Severe Atopic Dermatitis.
Summary
The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to <12 years of age with severe atopic dermatitis (AD).
The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to <12 years of age with severe AD.
Linked Publications (5)
-
Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age with Severe Atopic Dermatitis.
-
Dupilumab Provides Clinically Meaningful Responses in Children Aged 6-11 Years with Severe Atopic Dermatitis: Post Hoc Analysis Results from a Phase III Trial.
-
Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis.
-
The Safety Data of Dupilumab for the Treatment of Moderate‑to‑Severe Atopic Dermatitis in Infants, Children, Adolescents, and Adults.
-
Development, Psychometric Validation and Responder Definition of Worst Itch Scale in Children with Severe Atopic Dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 at Week 16 |
11.4; 32.8; 29.5 | = 0.0004 sig |
| SECONDARY Percentage of Participants With Eczema Area and Severity Index -75 (EASI-75) (≥ 75 Percent (%) Improvement From Baseline) at Week 16 |
26.8; 69.7; 67.2 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 |
-48.6; -82.1; -78.4 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Weekly Average of Daily Worst Itch Score at Week 16 |
-25.9; -54.6; -57.0 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥3 Points at Week 16 |
21.1; 60.3; 67.5 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥4 Points at Week 16 |
12.3; 50.8; 58.3 | < 0.0001 sig |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index - 50 (EASI-50) (≥ 50% Improvement From Baseline) at Week 16 |
43.1; 91.0; 82.8 | < 0.0001 sig |
| SECONDARY Percentage of Participants Achieving Eczema Area and Severity Index - 90 (EASI - 90) (≥ 90% Improvement From Baseline) at Week 16 |
7.3; 41.8; 30.3 | < 0.0001 sig |
| SECONDARY Time to Achieve ≥ 4 Point Reduction of Weekly Average of Daily Worst Itch Score From Baseline During the 16-week Treatment Period |
NA; 10.0; 10.0 | < 0.0001 sig |
| SECONDARY Time to Achieve ≥ 3 Point Reduction of Weekly Average of Daily Worst Itch Score From Baseline During the 16-week Treatment Period |
NA; 6.0; 5.0 | < 0.0001 sig |
| SECONDARY Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 16 |
-21.65; -40.53; -39.37 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16 |
-29.8; -62.4; -60.2 | < 0.0001 sig |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 |
-6.4; -10.6; -10.7 | < 0.0001 sig |
| SECONDARY Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 |
-5.3; -13.6; -13.4 | < 0.0001 sig |
| SECONDARY Change From Baseline in Weekly Average of Daily Worst Itch Score at Week 16 |
-2.05; -4.22; -4.45 | < 0.0001 sig |
| SECONDARY Change From Baseline in Dermatitis Family Index (DFI) at Week 16 |
-6.77; -10.75; -10.89 | < 0.0001 sig |
| SECONDARY Change From Baseline in Patient Reported Outcomes Measurements Information Systems (PROMIS) Pediatric Anxiety Short Form Scale Total Score at Week 16 |
-10.17; -13.19; -13.54 | = 0.0061 sig |
| SECONDARY Change From Baseline in Patient Reported Outcomes Measurements Information Systems (PROMIS) Pediatric Depressive Symptoms Short Form Scale Score at Week 16 |
-7.42; -12.84; -11.92 | < 0.0001 sig |
| SECONDARY Percentage of Participants Having at Least One Skin Infection Treatment Emergent Adverse Event (TEAE) (Excluding Herpetic Infections) Through Week 16 |
13.0; 5.7; 8.2 | = 0.222 |
| SECONDARY Percentage of Participants Having at Least One Serious Treatment Emergent Adverse Event (TEAE) Through Week 16 |
1.6; 1.6; 0 | — |
| SECONDARY Proportion of Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 16 |
0.11; 0.20; 0.19 | — |
| SECONDARY Mean Weekly Dose of Topical Corticosteroid (TCS) in Grams for Low or Medium Potency TCS From Baseline to Week 16 |
20.1; 15.0; 14.4 | = 0.003 sig |
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of AD according to the American Academy of Dermatology consensus criteria (Eichenfield 2003) at screening visit
- Chronic AD diagnosed at least 1 year prior to the screening visit
- IGA = 4 at screening and baseline visits
- EASI ≥21 at the screening and baseline visits
- BSA ≥15% at screening and baseline visits
- Documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s)
- At least 11 (of a total of 14) applications of a stable dose of topical emollient (moisturizer) twice daily during the 7 consecutive days immediately before the baseline visit
Key Exclusion Criteria
- Participation in a prior dupilumab clinical study
- Treatment with a systemic investigational drug before the baseline visit
- Treatment with a topical investigational drug within 2 weeks prior to the baseline visit
- Treatment with crisabarole within 2 weeks prior to the baseline visit
- History of important side effects of medium potency topical corticosteroids (e.g, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient's treating physician
- Treatment with a topical calcineurin inhibitor (TCI) within 2 weeks prior to the baseline visit
- Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
- Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy for AD
- Treatment with biologics, as follows:
- Any cell-depleting agents including but not limited to rituximab:
within 6 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer
- Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer
- Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
- Body weight <15 kg at baseline
Note: Other Inclusion/ Exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03345914) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.