Phase 3
N=740
Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02260986 ↗Enrolled (actual)
740
Serious AEs
4.9%
Results posted
Oct 2017
Primary outcome: 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 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dupilumab (Drug); Placebo (for Dupilumab) (Drug); Topical Corticosteroid (TCS) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Aug 2015
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 | — |
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.
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). 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.