Phase 2
N=54
Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)
Atopic Dermatitis (AD)
Bottom Line
View on ClinicalTrials.gov: NCT01979016 ↗Enrolled (actual)
54
Serious AEs
5.6%
Results posted
Mar 2020
Primary outcome: Primary: Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16 — -5.8; -75.2 percent change — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dupilumab (Drug); Placebo (Drug); Background treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16 |
-5.8; -75.2 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16 |
0; 37.0 | = 0.0006 sig |
| SECONDARY Percentage of Participants Who Achieved IGA Score Reduction From Baseline of ≥2 Points at Week 16 |
3.7; 51.9 | < 0.0001 sig |
| SECONDARY Absolute Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16 |
-0.98; -3.64 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16 |
-8.36; -56.44 | = 0.0001 sig |
| SECONDARY Absolute Change From Baseline in EASI Score to Week 16 |
-3.7; -25.2 | <0.0001 sig |
| SECONDARY Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16 |
-5.1; -36.4 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16 |
-8.2; -54.8 | < 0.0001 sig |
| 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 |
22.2; 77.8; 14.8; 66.7; 0; 33.3 | < 0.0001 sig |
| 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 |
7.4; 55.6; 0; 11.1; 0; 7.4 | = 0.0002 sig |
| SECONDARY Absolute Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16 |
-2.6; -13.1 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16 |
-12.1; -58.3 | < 0.0001 sig |
| SECONDARY Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) to Week 16 |
0.0; -0.7; -0.1; -1.0; -0.3; -1.3 | — |
| SECONDARY Changes From Baseline in GISS Cumulative Score to Week 16 |
-0.5; -4.2 | < 0.0001 sig |
Summary
The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 years or older;
- Chronic AD that had been present for at least 3 years before the screening visit;
- Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable;
- Willing and able to comply with all clinic visits and study-related procedures.
Exclusion Criteria
- Prior participation in a Dupilumab clinical trial;
- Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;
- The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment:
- Systemic corticosteroids;
- Immunosuppressive/immunomodulating drugs;
- Phototherapy for AD;
- Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
- Treatment with certain biologics;
- Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;
- Planned major surgical procedure during the participant's participation in this study;
- Participant was a member of the investigational team or his/her immediate family;
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
- Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;
Note: The information 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 (NCT01979016). 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.