Phase 2
N=380
Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT01859988 ↗Enrolled (actual)
380
Serious AEs
4.2%
Results posted
Aug 2017
Primary outcome: Primary: Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 — -75.5; -70.5; -67.4; -64.9 Percent change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dupilumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 |
-75.5; -70.5; -67.4; -64.9; -46.7; -20.2 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16 |
33.3; 29.7; 27.9; 21.5; 12.3; 1.6 | — |
| SECONDARY Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16 |
50.8; 46.9; 42.6; 35.4; 20.0; 9.8 | — |
| SECONDARY Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16 |
-52.85; -46.22; -40.6; -38.69; -21.47; -0.43 | — |
| SECONDARY Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16 |
6.54; 6.74; 6.98; 6.84; 6.71; 6.34 | — |
| SECONDARY Absolute Change in EASI Score From Baseline to Week 16 |
30.1; 33.8; 32.9; 29.4; 32.2; 32.9 | — |
| SECONDARY Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16 |
-56.9; -51.2; -46.0; -48.8; -26.6; -13.8 | — |
| SECONDARY Absolute Change in SCORAD Scores From Baseline to Week 16 |
-38.2; -34.4; -30.9; -33.1; -18.0; -10.5 | — |
| SECONDARY Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16 |
82.5; 78.1; 62.3; 70.8; 44.6; 29.5 | — |
| SECONDARY Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16 |
68.3; 59.4; 52.5; 55.4; 26.2; 19.7 | — |
| SECONDARY Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16 |
-57.3; -44.0; -49.2; -46.6; -14.2; 0.2 | — |
| SECONDARY Absolute Change in POEM Scores From Baseline to Week 16 |
-12.1; -9.8; -10.4; -9.9; -3.3; -1.1 | — |
| SECONDARY Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16 |
-0.9; -0.9; -0.8; -0.8; -0.4; -0.2 | — |
| SECONDARY Changes in GISS Cumulative Score From Baseline to Week 16 |
-4.6; -4.5; -3.9; -4.3; -2.3; -1.2 | — |
Summary
To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).
Eligibility Criteria
The inclusion criteria included, but were not limited to, the following:
- Chronic Atopic Dermatitis that had been present for at least 3 years
- History of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable (e.g, because of important side effects or safety risks)
- Willing and able to comply with all clinic visits and study-related procedures
The exclusion criteria included, but were not limited to, the following:
- Prior treatment with dupilumab (REGN668/SAR231893)
- Presence of certain laboratory abnormalities at the screening visit
- Treatment with an investigational drug within 8 weeks of baseline visit
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
- Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
- 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 study
- High risk of parasite infection
- Any other medical or psychological condition that in the opinion of the investigator or the sponsor's medical monitor, would place the participants at risk, interfere with participation in the study or interfere with interpretation of study results
- Pregnant or breast-feeding women
Data sourced from ClinicalTrials.gov (NCT01859988). 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.