Phase 2
N=109
Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT01548404 ↗Enrolled (actual)
109
Serious AEs
7.3%
Results posted
Aug 2018
Primary outcome: Primary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF) — -23.3; -74.0 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Dupilumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF) |
-23.3; -74.0 | — |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 12- LOCF |
7.4; 40.0 | — |
| SECONDARY Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI-50) at Week 12- LOCF |
35.2; 85.5 | — |
| SECONDARY Change From Baseline in EASI Score at Week 12- LOCF |
-6.4; -19.9 | — |
| SECONDARY Percent Change From Baseline in IGA Score at Week 12- LOCF |
-14.7; -49.5 | — |
| SECONDARY Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 12 - LOCF |
-9.0; -27.4 | — |
| SECONDARY Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 12- LOCF |
-9.8; -35.0 | — |
| SECONDARY Change From Baseline in Pruritus Numerical Rating Scale (NRS) to Week 12- LOCF |
-0.9; -3.5 | — |
| SECONDARY Change From Baseline in 5-D Pruritus Scale at Week 12 |
-1.9; -7.4 | — |
Summary
The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).
Eligibility Criteria
Inclusion Criteria
The inclusion criteria included, but were not limited to the following:
- Male or female, 18 years or older;
- Chronic Atopic Dermatitis (AD) for at least 3 years;
- History of inadequate response to a stable (>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.
Exclusion Criteria
- Prior treatment with REGN668;
- Presence of certain laboratory abnormalities at the screening visit;
- Treatment with an investigational drug within 8 weeks ;
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
- Certain treatments and medical procedures, undertaken within a particular time-frame prior to the baseline visit, preclude eligibility for participation in the study;
- Known history of human immunodeficiency virus (HIV) infection;
- History of malignancy within 5 years before the baseline visit, with certain exceptions;
- Planned surgical procedure during the length of the patient's participation in this study;
- History of clinical parasite infection;
- Any medical or psychiatric condition which in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results;
- Pregnant or breast-feeding women.
Data sourced from ClinicalTrials.gov (NCT01548404). 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.