Clinical trial NCT02210780: Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study Investigating Vaccine Responses in Adults With Moderate to Severe Atopic Dermatitis Treated With Dupilumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2014-08-07
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

1. 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
2. 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).
3. Eczema Area and Severity Index (EASI) score ≥16 at the screening visit and the baseline visit
4. Investigator's Global Assessment (IGA) score ≥3 (on the 0-4 IGA scale) at the screening and baseline visits
5. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits

Key Exclusion Criteria:

1. Prior treatment with dupilumab (REGN668/ SAR231893)
2. 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
3. History of Guillain-Barre syndrome
4. History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol
5. 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)
6. Treatment with biologics within 4 months of baseline visit
7. 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.

Primary outcomes:
measure: Percentage of Participants With a Positive Response (≥4-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants With a Positive Response (≥2-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a Positive Response (SBA Antibody Titer of ≥8 for Serogroup C) to Menomune Vaccine at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving an Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving an Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16
timeFrame: Week 16
measure: Change From Baseline in Peak Weekly Averaged Pruritis Numerical Rating Scale (NRS) Scores at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in Body Surface Area (BSA) Affected by AD at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations and Lichenification) at Week 16
timeFrame: Baseline to Week 16
measure: Changes From Baseline in GISS Cumulative Score to Week 16
timeFrame: Baseline to Week 16
measure: Change in Patient Oriented Eczema Measure (POEM) Score From Baseline to Week 16
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Fort Smith
country: United States
state: Arkansas
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Rolling Hills Estates
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Macon
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: West Dundee
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Plainfield
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Hackensack
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Buffalo
country: United States
state: New York
city: Forest Hills
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: