Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)
A Randomized, Double-Blind, Placebo-Controlled, Study Investigating Vaccine Responses in Adults With Moderate to Severe Atopic Dermatitis Treated With Dupilumab
1 other identifier
interventional
194
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2014
Shorter than P25 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2014
CompletedStudy Start
First participant enrolled
August 5, 2014
CompletedFirst Posted
Study publicly available on registry
August 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2015
CompletedResults Posted
Study results publicly available
May 7, 2020
CompletedMay 7, 2020
April 1, 2020
1.1 years
August 5, 2014
March 20, 2020
April 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Positive Response (≥4-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16
A positive response was defined as a ≥ 4-fold increase from pre-vaccination at baseline in anti-tetanus immunoglobulin G (IgG) titer for participants with a pre-vaccination tetanus antibody titers ≥ 0.1 IU/ml or a titer of ≥ 0.2 IU/ml for participants with pre-vaccination titers of \<0.1 IU/ml. There was no planned statistical hypothesis testing regarding the difference in immune response between the 2 treatment groups for this study, therefore no formal statistical hypothesis between groups was performed.
Week 16
Secondary Outcomes (10)
Percentage of Participants With a Positive Response (≥2-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16
Week 16
Percentage of Participants With a Positive Response (SBA Antibody Titer of ≥8 for Serogroup C) to Menomune Vaccine at Week 16
Week 16
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16
Week 16
Percentage of Participants Achieving an Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16
Week 16
Percentage of Participants Achieving an Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16
Week 16
- +5 more secondary outcomes
Study Arms (2)
Placebo qw
EXPERIMENTALTwo subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Dupilumab 300 mg qw
EXPERIMENTALTwo subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (42)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Fort Smith, Arkansas, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Mission Viejo, California, United States
Unknown Facility
Rolling Hills Estates, California, United States
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San Diego, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Jacksonville, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Macon, Georgia, United States
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Chicago, Illinois, United States
Unknown Facility
Maywood, Illinois, United States
Unknown Facility
West Dundee, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Plainfield, Indiana, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
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Troy, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Hackensack, New Jersey, United States
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Albuquerque, New Mexico, United States
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Buffalo, New York, United States
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Forest Hills, New York, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Norman, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Medford, Oregon, United States
Unknown Facility
Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greer, South Carolina, United States
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Arlington, Texas, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Webster, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Related Publications (1)
Mickevicius T, Pink AE, Bhogal M, O'Brart D, Robbie SJ. Dupilumab-Induced, Tralokinumab-Induced, and Belantamab Mafodotin-Induced Adverse Ocular Events-Incidence, Etiology, and Management. Cornea. 2023 Apr 1;42(4):507-519. doi: 10.1097/ICO.0000000000003162. Epub 2022 Dec 15.
PMID: 36525340DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Management
- Organization
- Regeneron Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2014
First Posted
August 7, 2014
Study Start
August 5, 2014
Primary Completion
September 15, 2015
Study Completion
September 15, 2015
Last Updated
May 7, 2020
Results First Posted
May 7, 2020
Record last verified: 2020-04