Phase 3
Completed N=740
Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Source: ClinicalTrials.gov NCT02260986 ↗Enrolled (actual)
740
Serious AEs
4.9%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 — 12.4; 38.7; 39.2 percentage of participants — p=<0.0001
◆ Published Evidence
Emerging
1citation · ~1 / year
Identifying the Most Relevant Eczema Area and Severity Index Thresholds from the Patient Perspective in Atopic Dermatitis Treatment.
Summary
The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.
Linked Publications (5)
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Identifying the Most Relevant Eczema Area and Severity Index Thresholds from the Patient Perspective in Atopic Dermatitis Treatment.
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Cost-Per-Responder Analysis for Tralokinumab and Dupilumab in Combination with Topical Corticosteroids in Patients with Moderate-To-Severe Atopic Dermatitis.
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Long-Term Dupilumab Treatment Is Not Associated with an Increased Overall Risk of Infections in Adults with Moderate-to-Severe Atopic Dermatitis: Results from an Open-Label 5-Year Extension Study.
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Dupilumab Treatment Up to 5 Years Shows No Clinically Meaningful Changes in Laboratory Parameters in Adults with Moderate-to-Severe Atopic Dermatitis.
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Dupilumab Reduces Pruritus in Clinically Distinct Dermatologic Diseases: Data from Clinical Trials on Atopic Dermatitis, Prurigo Nodularis, and Chronic Spontaneous Urticaria.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 |
12.4; 38.7; 39.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16 |
23.2; 68.9; 63.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 |
19.7; 58.8; 50.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 |
27.8; 65.7; 62.5 | <0.0001 sig |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 52 |
12.5; 36.0; 40.0 | <0.0001 sig |
| SECONDARY Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52 |
21.6; 65.2; 64.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16 |
-30.3; -56.6; -57.1 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52 |
12.9; 51.2; 39.0 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52 |
15.6; 55.7; 42.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24 |
16.1; 53.9; 43.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4 |
16.4; 37.3; 27.1 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2 |
8.0; 17.6; 13.6 | 0.0062 sig |
| SECONDARY Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16 |
-2.36; -4.17; -4.27 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16 |
-48.4; -80.5; -81.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16 |
-22.01; -40.39; -39.58 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16 |
-36.2; -63.9; -65.9 | <0.0001 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16 |
-5.8; -10.0; -10.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16 |
-5.3; -12.7; -12.9 | <0.0001 sig |
| SECONDARY Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16 |
-4.0; -4.9; -5.4 | 0.1596 |
| SECONDARY Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16 |
-33.3; -55.4; -59.3 | — |
| SECONDARY Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52 |
10.5; 16.6; 22.5 | — |
| SECONDARY Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2 |
-19.7; -27.3; -25.7 | — |
| SECONDARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52 |
-60.9; -84.9; -87.8 | — |
| SECONDARY Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52 |
-29.41; -43.75; -43.67 | — |
| SECONDARY Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52 |
-47.3; -69.7; -70.4 | — |
| SECONDARY Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52 |
-40.8; -62.8; -64.4 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52 |
-7.2; -11.4; -11.1 | — |
| SECONDARY Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52 |
-7.0; -14.2; -13.2 | — |
| SECONDARY Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52 |
-3.8; -5.5; -5.9 | — |
| SECONDARY Number of Flares Through Week 52 |
216; 20; 51 | — |
| SECONDARY Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52 |
28; 2; 10 | — |
| SECONDARY Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52 |
17.8; 10.9; 8.3 | — |
| SECONDARY Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52 |
80; 15; 29 | — |
| SECONDARY Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52 |
9.5; 5.5; 3.8 | — |
| SECONDARY Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52 |
44; 7; 13 | — |
Eligibility Criteria
Key Inclusion Criteria
- Chronic AD that had been present for at least 3 years before the screening visit;
- Documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of out-patient treatment with topical AD medication(s).
Key Exclusion Criteria
- Participation in a prior Dupilumab clinical trial;
- Important side effects of topical medication (e.g. intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician;
- Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require such treatment(s) during the first 2 weeks of study treatment:
- Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma [IFN-γ], azathioprine, methotrexate, etc.);
- Phototherapy for AD;
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
- Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit;
- Active or acute infection requiring systemic treatment within 2 weeks before baseline visit;
- Known or suspected history of immunosuppression;
- Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the participant's participation in this study.
Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.
Data sourced from ClinicalTrials.gov (NCT02260986) 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.