Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
CHRONOS
A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
1 other identifier
interventional
740
14 countries
148
Brief Summary
The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2014
148 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
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 6, 2014
CompletedFirst Posted
Study publicly available on registry
October 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
October 17, 2017
CompletedOctober 17, 2017
October 1, 2017
11 months
October 6, 2014
April 30, 2017
October 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16
IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported.
Baseline to Week 16
Secondary Outcomes (34)
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16
Baseline to Week 16
Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Baseline to Week 16
Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Baseline to Week 16
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 52
Baseline to Week 52
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52
Baseline to Week 52
- +29 more secondary outcomes
Other Outcomes (2)
Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16
Baseline to Week 16
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score to Week 16
Baseline to Week 16
Study Arms (3)
Placebo qw
EXPERIMENTALTwo subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection weekly (qw) from Week 1 to Week 51.
Dupilumab 300 mg q2w
EXPERIMENTALTwo subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
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 of Dupilumab qw from Week 1 to Week 51.
Interventions
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.
Eligibility Criteria
You may qualify if:
- Chronic AD that had been present for at least 3 years before the screening visit;
- Documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of out-patient treatment with topical AD medication(s).
You may not qualify if:
- Participation in a prior Dupilumab clinical trial;
- Important side effects of topical medication (e.g. intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician;
- Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require such treatment(s) during the first 2 weeks of study treatment:
- Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma \[IFN-γ\], azathioprine, methotrexate, etc.);
- Phototherapy for AD;
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
- Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit;
- Active or acute infection requiring systemic treatment within 2 weeks before baseline visit;
- Known or suspected history of immunosuppression;
- Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the participant's participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (148)
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Phoenix, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Encinitas, California, United States
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Oceanside, California, United States
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Palmdale, California, United States
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San Diego, California, United States
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New Haven, Connecticut, United States
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Trumbull, Connecticut, United States
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Edgewater, Florida, United States
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Lake Worth, Florida, United States
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Miami Lakes, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Alpharetta, Georgia, United States
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Columbus, Georgia, United States
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Savannah, Georgia, United States
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West Dundee, Illinois, United States
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Carmel, Indiana, United States
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New Albany, Indiana, United States
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Rockville, Maryland, United States
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Ann Arbor, Michigan, United States
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Bay City, Michigan, United States
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Edina, Minnesota, United States
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Fridley, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Verona, New Jersey, United States
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Albuquerque, New Mexico, United States
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Corning, New York, United States
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New York, New York, United States
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Smithtown, New York, United States
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Stony Brook, New York, United States
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Cincinnati, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Lake Oswego, Oregon, United States
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Portland, Oregon, United States
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Exton, Pennsylvania, United States
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Hazleton, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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West Jordan, Utah, United States
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South Burlington, Vermont, United States
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Henrico, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Spokane, Washington, United States
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Phillip, Australian Capital Territory, Australia
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Kogarah, New South Wales, Australia
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Benowa, Queensland, Australia
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Dulwich, Queensland, Australia
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Hectorville, South Australia, Australia
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Carlton, Victoria, Australia
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Ajax, Ontario, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Markham, Ontario, Canada
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North Bay, Ontario, Canada
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Oakville, Ontario, Canada
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Ottawa, Ontario, Canada
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Peterborough, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Drummondville, Quebec, Canada
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Québec, Canada
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Hradec Králové, Czechia
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Náchod, Czechia
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Prague, Czechia
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Svitavy, Czechia
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Ústí nad Labem, Czechia
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Orosháza, Bekes County, Hungary
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Szolnok, Jász-Nagykun-Szolnok, Hungary
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Veszprém, Veszprém megye, Hungary
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Budapest, Hungary
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Ancona, Italy
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Bologna, Italy
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Brescia, Italy
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Novara, Italy
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Pavia, Italy
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Perugia, Italy
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Roma, Italy
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Kitakyushu, Fukuoka, Japan
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Amagasaki, Hyôgo, Japan
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Yokohama, Kanagawa, Japan
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Kamimashiki-gun, Kumamoto, Japan
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Saitama-shi, Saitama, Japan
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Yaizu, Shizuoka, Japan
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Koto-ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
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Adachi-ku, Tôkyô, Japan
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Chiyoda-ku, Tôkyô, Japan
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Nakano, Tôkyô, Japan
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Nerima-ku, Tôkyô, Japan
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Shibuya-ku, Tôkyô, Japan
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Shinagawa-ku, Tôkyô, Japan
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Shinjuku-ku, Tôkyô, Japan
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Suginami-ku, Tôkyô, Japan
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Fukuoka, Japan
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Breda, North Brabant, Netherlands
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Amsterdam, North Holland, Netherlands
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Rotterdam, South Holland, Netherlands
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Groningen, Netherlands
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Utrecht, Netherlands
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Dunedin, South Island, New Zealand
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Auckland, New Zealand
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Poznan, Greater Poland Voivodeship, Poland
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Krakow, Lesser Poland Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Lublin, Lublin Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Strzelce Opolskie, Opole Voivodeship, Poland
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Iwonicz-Zdrój, Podkarpackie Voivodeship, Poland
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Bialystok, Podlaskie Voivodeship, Poland
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Gdansk, Pomeranian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Szczecin, West Pomeranian Voivodeship, Poland
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Gdynia, Poland
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Lodz, Łódź Voivodeship, Poland
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Skarżysko-Kamienna, Świętokrzyskie Voivodeship, Poland
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Brasov, Brașov County, Romania
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Bucharest, București, Romania
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Cluj-Napoca, Cluj, Romania
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Craiova, Dolj, Romania
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Târgu Mureş, Mureș County, Romania
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Bucheon-si, Gyeonggido, South Korea
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Suwon, Gyeonggido, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Seodaemun-gu, South Korea
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Uijeongbu-si, South Korea
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Barcelona, Catalonia, Spain
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Alicante, Spain
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Madrid, Spain
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Dundee, Angus, United Kingdom
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Edgbaston, Birmingham, United Kingdom
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Glasgow, Glasgow City, United Kingdom
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Sidcup, Kent, United Kingdom
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Northwood, Middlesex, United Kingdom
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Liverpool, United Kingdom
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Manchester, United Kingdom
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Reading, United Kingdom
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Salford, United Kingdom
Related Publications (23)
Simpson EL, Bissonnette R, Deleuran M, Nakahara T, Galus R, de Bruin-Weller M, Coleman A, van Spall M, Chen Z, Avetisova E, Bastian M, Khokhar FA. Dupilumab Treatment Up to 5 Years Shows No Clinically Meaningful Changes in Laboratory Parameters in Adults with Moderate-to-Severe Atopic Dermatitis. Adv Ther. 2026 Jan 21. doi: 10.1007/s12325-025-03458-3. Online ahead of print.
PMID: 41563707DERIVEDYosipovitch G, Kim BS, Koo JY, Chen Z, Wiggins S, Zahn J, Sugerman P, Haddad EB, Cyr SL. Dupilumab Reduces Pruritus in Clinically Distinct Dermatologic Diseases: Data from Clinical Trials on Atopic Dermatitis, Prurigo Nodularis, and Chronic Spontaneous Urticaria. Dermatol Ther (Heidelb). 2025 Nov 22. doi: 10.1007/s13555-025-01596-8. Online ahead of print.
PMID: 41272364DERIVEDWiseman M, Benvenuto M, Stromkjaer L, Paludan-Muller A, Ryttig L, Petersen AS, Wollenberg A. Cost-Per-Responder Analysis for Tralokinumab and Dupilumab in Combination with Topical Corticosteroids in Patients with Moderate-To-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Oct 16. doi: 10.1007/s13555-025-01565-1. Online ahead of print.
PMID: 41102518DERIVEDLangley RG, Gherardi G, Coleman A, Ardeleanu M, Rodriguez-Marco A, Levy S, Bansal A, Chen Z, Rossi AB, Shumel B, Khokhar FA. The Safety Data of Dupilumab for the Treatment of Moderate-to-Severe Atopic Dermatitis in Infants, Children, Adolescents, and Adults. Am J Clin Dermatol. 2025 Nov;26(6):981-1002. doi: 10.1007/s40257-025-00952-w. Epub 2025 Sep 24.
PMID: 40993471DERIVEDStander S, Yosipovitch G, Kim BS, Steinhoff M, Armstrong A, Legat FJ, Kabashima K, Nakahara T, Igarashi A, Praestgaard AH, Nguyen TV, Bastian M. Optimal Itch Response in Adults Treated with Dupilumab for Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Nov;15(11):3437-3446. doi: 10.1007/s13555-025-01519-7. Epub 2025 Sep 19.
PMID: 40971025DERIVEDStander S, Yosipovitch G, Simpson EL, Kim BS, Kabashima K, Thaci D, Metz M, Chen Z, Hagen S, Bastian M. Onset and Long-Term Maintenance of Optimal Itch Response in Adult Patients with Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab: Post Hoc Analysis from Two Phase 3 Trials. Adv Ther. 2025 Apr;42(4):1800-1810. doi: 10.1007/s12325-025-03124-8. Epub 2025 Feb 19.
PMID: 39969783DERIVEDKamal MA, Kosloski MP, Lai CH, Partridge MA, Rajadhyaksha M, Kanamaluru V, Bansal A, Shabbir A, Shumel B, Ardeleanu M, Richards SM, Yan H, Xu CR, Rodriguez-Marco A, Xiao J, Khokhar FA, Gherardi G, Babilonia E, Maloney J, Mortensen E, Akinlade B, Braunstein N, Stahl N, Torri A, Davis JD, DiCioccio AT. Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis. Front Immunol. 2024 Nov 11;15:1466372. doi: 10.3389/fimmu.2024.1466372. eCollection 2024.
PMID: 39588375DERIVEDSilverberg JI, Lynde CW, Abuabara K, Patruno C, de Benedetto A, Zhang H, Thomas RB, Bego-Le-Bagousse G, Khokhar FA, Vakil J, Marco AR, Levit NA. Efficacy and Safety of Dupilumab Maintained in Adults >/= 60 Years of Age with Moderate-to-Severe Atopic Dermatitis: Analysis of Pooled Data from Four Randomized Clinical Trials. Am J Clin Dermatol. 2023 May;24(3):469-483. doi: 10.1007/s40257-022-00754-4. Epub 2023 Feb 20.
PMID: 36808602DERIVEDPaller AS, Silverberg JI, Cork MJ, Guttman-Yassky E, Lockshin B, Irvine AD, Kim MB, Kabashima K, Chen Z, Lu Y, Bansal A, Rossi AB, Shabbir A. Efficacy and Safety of Dupilumab in Patients With Erythrodermic Atopic Dermatitis: A Post Hoc Analysis of 6 Randomized Clinical Trials. JAMA Dermatol. 2023 Mar 1;159(3):255-266. doi: 10.1001/jamadermatol.2022.6192.
PMID: 36723913DERIVEDWechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.
PMID: 35636689DERIVEDBlauvelt A, de Bruin-Weller M, Simpson EL, Chen Z, Ardeleanu M, Rossi AB. Consistency of Response to Dupilumab in Adults with Moderate-to-Severe Atopic Dermatitis Over 1 Year. Dermatol Ther (Heidelb). 2022 Jan;12(1):9-13. doi: 10.1007/s13555-021-00657-y. Epub 2022 Jan 7.
PMID: 34994968DERIVEDBlauvelt A, de Bruin-Weller M, Simpson EL, Chen Z, Zhang A, Shumel B. Dupilumab with Topical Corticosteroids Provides Rapid and Sustained Improvement in Adults with Moderate-to-Severe Atopic Dermatitis Across Anatomic Regions Over 52 Weeks. Dermatol Ther (Heidelb). 2022 Jan;12(1):223-231. doi: 10.1007/s13555-021-00638-1. Epub 2021 Nov 22.
PMID: 34806137DERIVEDGriffiths C, de Bruin-Weller M, Deleuran M, Fargnoli MC, Staumont-Salle D, Hong CH, Sanchez-Carazo J, Foley P, Seo SJ, Msihid J, Chen Z, Cyr SL, Rossi AB. Dupilumab in Adults with Moderate-to-Severe Atopic Dermatitis and Prior Use of Systemic Non-Steroidal Immunosuppressants: Analysis of Four Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Aug;11(4):1357-1372. doi: 10.1007/s13555-021-00558-0. Epub 2021 Jun 18.
PMID: 34142350DERIVEDHamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26.
PMID: 34037993DERIVEDWu JJ, Spelman L, Tan JL, Etoh T, Zhang H, Shumel B, Rossi AB. Dupilumab Maintains Long-Term Disease Control in Adults with Moderate-to-Severe Atopic Dermatitis as Measured by Well-Controlled Weeks: Results From the LIBERTY AD CHRONOS Clinical Trial. Dermatol Ther (Heidelb). 2021 Apr;11(2):327-330. doi: 10.1007/s13555-021-00487-y. Epub 2021 Jan 28. No abstract available.
PMID: 33511576DERIVEDBoguniewicz M, Beck LA, Sher L, Guttman-Yassky E, Thaci D, Blauvelt A, Worm M, Corren J, Soong W, Lio P, Rossi AB, Lu Y, Chao J, Eckert L, Gadkari A, Hultsch T, Ruddy M, Mannent LP, Graham NMH, Pirozzi G, Chen Z, Ardeleanu M. Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1212-1223.e6. doi: 10.1016/j.jaip.2020.12.059. Epub 2021 Jan 13.
PMID: 33453450DERIVEDSilverberg JI, Simpson EL, Guttman-Yassky E, Cork MJ, de Bruin-Weller M, Yosipovitch G, Eckert L, Chen Z, Ardeleanu M, Shumel B, Hultsch T, Rossi AB, Hamilton JD, Orengo JM, Ruddy M, Graham NMH, Pirozzi G, Gadkari A. Dupilumab Significantly Modulates Pain and Discomfort in Patients With Atopic Dermatitis: A Post Hoc Analysis of 5 Randomized Clinical Trials. Dermatitis. 2021 Oct 1;32(1S):S81-S91. doi: 10.1097/DER.0000000000000698.
PMID: 33165005DERIVEDWeyne J, Blauvelt A, de Bruin-Weller M, Prens E, Asbell P, Sierka D, Chen Z, Shumel B. Patient-Reported Ocular Disorders and Symptoms in Adults with Moderate-to-Severe Atopic Dermatitis: Screening and Baseline Survey Data from a Clinical Trial. Dermatol Ther (Heidelb). 2020 Dec;10(6):1415-1421. doi: 10.1007/s13555-020-00456-x. Epub 2020 Oct 12.
PMID: 33047298DERIVEDKatoh N, Kataoka Y, Saeki H, Hide M, Kabashima K, Etoh T, Igarashi A, Imafuku S, Kawashima M, Ohtsuki M, Fujita H, Arima K, Takagi H, Chen Z, Shumel B, Ardeleanu M. Efficacy and safety of dupilumab in Japanese adults with moderate-to-severe atopic dermatitis: a subanalysis of three clinical trials. Br J Dermatol. 2020 Jul;183(1):39-51. doi: 10.1111/bjd.18565. Epub 2019 Nov 28.
PMID: 31564057DERIVEDAlexis AF, Rendon M, Silverberg JI, Pariser DM, Lockshin B, Griffiths CE, Weisman J, Wollenberg A, Chen Z, Davis JD, Li M, Eckert L, Gadkari A, Shumel B, Rossi AB, Graham NM, Ardeleanu M. Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials. J Drugs Dermatol. 2019 Aug 1;18(8):804-813.
PMID: 31424712DERIVEDWollenberg A, Beck LA, Blauvelt A, Simpson EL, Chen Z, Chen Q, Shumel B, Khokhar FA, Hultsch T, Rizova E, Rossi AB, Graham NMH, Pirozzi G, Lu Y, Ardeleanu M. Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS). Br J Dermatol. 2020 May;182(5):1120-1135. doi: 10.1111/bjd.18434. Epub 2019 Dec 1.
PMID: 31407311DERIVEDEichenfield LF, Bieber T, Beck LA, Simpson EL, Thaci D, de Bruin-Weller M, Deleuran M, Silverberg JI, Ferrandiz C, Folster-Holst R, Chen Z, Graham NMH, Pirozzi G, Akinlade B, Yancopoulos GD, Ardeleanu M. Infections in Dupilumab Clinical Trials in Atopic Dermatitis: A Comprehensive Pooled Analysis. Am J Clin Dermatol. 2019 Jun;20(3):443-456. doi: 10.1007/s40257-019-00445-7.
PMID: 31066001DERIVEDBlauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemeny L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4.
PMID: 28478972DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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 3
- 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
October 6, 2014
First Posted
October 9, 2014
Study Start
September 1, 2014
Primary Completion
August 1, 2015
Study Completion
October 1, 2016
Last Updated
October 17, 2017
Results First Posted
October 17, 2017
Record last verified: 2017-10