Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)
NCT ID: NCT02210780
Last Updated: 2020-05-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
194 participants
INTERVENTIONAL
2014-08-05
2015-09-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)
NCT01979016
Open-label Study of Dupilumab in Patients With Atopic Dermatitis
NCT01949311
Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
NCT02277769
Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
NCT01859988
Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
NCT03054428
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo qw
Two 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.
Placebo
An inactive substance containing no medicine administered via subcutaneous injection.
Dupilumab 300 mg qw
Two 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.
Dupilumab
Administered via subcutaneous injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dupilumab
Administered via subcutaneous injection.
Placebo
An inactive substance containing no medicine administered via subcutaneous injection.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
18 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Fort Smith, Arkansas, United States
Long Beach, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Rolling Hills Estates, California, United States
San Diego, California, United States
Santa Monica, California, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Macon, Georgia, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
West Dundee, Illinois, United States
Indianapolis, Indiana, United States
Plainfield, Indiana, United States
Overland Park, Kansas, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Troy, Michigan, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
Forest Hills, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Norman, Oklahoma, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Greer, South Carolina, United States
Arlington, Texas, United States
Austin, Texas, United States
Houston, Texas, United States
Webster, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R668-AD-1314
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.