Phase 2
N=194
Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02210780 ↗Enrolled (actual)
194
Serious AEs
1.6%
Results posted
May 2020
Primary outcome: Primary: Percentage of Participants With a Positive Response (≥4-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16 — 83.7; 83.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dupilumab (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Positive Response (≥4-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16 |
83.7; 83.3 | — |
| SECONDARY Percentage of Participants With a Positive Response (≥2-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16 |
94.6; 95.6 | — |
| SECONDARY Percentage of Participants With a Positive Response (SBA Antibody Titer of ≥8 for Serogroup C) to Menomune Vaccine at Week 16 |
87.0; 86.7 | — |
| SECONDARY Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16 |
10.3; 44.3 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving an Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16 |
32.0; 72.2 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving an Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16 |
19.6; 53.6 | <0.0001 sig |
| SECONDARY Change From Baseline in Peak Weekly Averaged Pruritis Numerical Rating Scale (NRS) Scores at Week 16 |
-2.11; -4.24 | <0.0001 sig |
| SECONDARY Change From Baseline in Body Surface Area (BSA) Affected by AD at Week 16 |
-11.0; -28.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations and Lichenification) at Week 16 |
-0.4; -0.9; -0.4; -1.1; -0.5; -1.2 | — |
| SECONDARY Changes From Baseline in GISS Cumulative Score to Week 16 |
-1.7; -4.1 | <0.0001 sig |
| SECONDARY Change in Patient Oriented Eczema Measure (POEM) Score From Baseline to Week 16 |
-4.8; -13.1 | <0.0001 sig |
Summary
This was a 32-week, randomized, double-blind, placebo-controlled, parallel-group study assessing immunization responses to vaccination in adults with moderate to severe atopic dermatitis who are treated with subcutaneous dupilumab.
Eligibility Criteria
Key Inclusion Criteria
- Male or female adults ages 18 to 64 years with Chronic AD (according to the American Academy of Dermatology Consensus Criteria, [Eichenfeld 2004])that has been present for at least 3 years before the screening visit
- Participants with documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of outpatient treatment with topical AD medication(s), or for whom topical AD therapies are otherwise inadvisable (e.g., because of side effects or safety risks).
- Eczema Area and Severity Index (EASI) score ≥16 at the screening visit and the baseline visit
- Investigator's Global Assessment (IGA) score ≥3 (on the 0-4 IGA scale) at the screening and baseline visits
- ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits
Key Exclusion Criteria
- Prior treatment with dupilumab (REGN668/ SAR231893)
- Patients needing >10 mg of daily prednisone (including equivalent doses of other steroids) or high dose systemic corticosteroids (≥2 mg/kg) for 14 days or longer during the 16 week treatment period of the study
- History of Guillain-Barre syndrome
- History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol
- Patients with a severe reaction to natural rubber latex products (some packaging components of the vaccines contain rubber latex and may cause a reaction in susceptible individuals)
- Treatment with biologics within 4 months of baseline visit
- Chronic or acute infection requiring treatment with antibiotics, antivirals, antiparasitics, antifungals within 4 weeks before screening visit or superficial skin infections within 1 week of screening visit
The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
Data sourced from ClinicalTrials.gov (NCT02210780). 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.