Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02260986




Registration number
NCT02260986
Ethics application status
Date submitted
6/10/2014
Date registered
9/10/2014
Date last updated
17/10/2017

Titles & IDs
Public title
Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Scientific title
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
Secondary ID [1] 0 0
R668-AD-1224
Universal Trial Number (UTN)
Trial acronym
CHRONOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab
Treatment: Drugs - Placebo (for Dupilumab)
Other interventions - Topical Corticosteroid (TCS)

Experimental: Placebo qw - Two 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.

Experimental: Dupilumab 300 mg q2w - Two 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.

Experimental: 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 of Dupilumab qw from Week 1 to Week 51.


Treatment: Drugs: Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs

Treatment: Drugs: Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs

Other interventions: Topical Corticosteroid (TCS)
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of =2 Points at Week 16
Timepoint [1] 0 0
Baseline to Week 16
Secondary outcome [1] 0 0
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (=75% Improvement From Baseline) at Week 16
Timepoint [1] 0 0
Baseline to Week 16
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline to Week 16
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline to Week 16
Secondary outcome [4] 0 0
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of =2 Points at Week 52
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (=75% Improvement From Baseline) at Week 52
Timepoint [5] 0 0
Baseline to Week 52
Secondary outcome [6] 0 0
Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16
Timepoint [6] 0 0
Baseline to Week 16
Secondary outcome [7] 0 0
Percentage of Participants With Improvement (Reduction =4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52
Timepoint [7] 0 0
Baseline to Week 52
Secondary outcome [8] 0 0
Percentage of Participants With Improvement (Reduction =3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52
Timepoint [8] 0 0
Baseline to Week 52
Secondary outcome [9] 0 0
Percentage of Participants With Improvement (Reduction =4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24
Timepoint [9] 0 0
Baseline to Week 24
Secondary outcome [10] 0 0
Percentage of Participants With Improvement (Reduction =4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4
Timepoint [10] 0 0
Baseline to Week 4
Secondary outcome [11] 0 0
Percentage of Participants With Improvement (Reduction =4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2
Timepoint [11] 0 0
Baseline to Week 2
Secondary outcome [12] 0 0
Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16
Timepoint [12] 0 0
Baseline to Week 16
Secondary outcome [13] 0 0
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16
Timepoint [13] 0 0
Baseline to Week 16
Secondary outcome [14] 0 0
Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16
Timepoint [14] 0 0
Baseline to Week 16
Secondary outcome [15] 0 0
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16
Timepoint [15] 0 0
Baseline to Week 16
Secondary outcome [16] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16
Timepoint [16] 0 0
Baseline to Week 16
Secondary outcome [17] 0 0
Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16
Timepoint [17] 0 0
Baseline to Week 16
Secondary outcome [18] 0 0
Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16
Timepoint [18] 0 0
Baseline to Week 16
Secondary outcome [19] 0 0
Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16
Timepoint [19] 0 0
Baseline to Week 16
Secondary outcome [20] 0 0
Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52
Timepoint [20] 0 0
Baseline to Week 52
Secondary outcome [21] 0 0
Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2
Timepoint [21] 0 0
Baseline to Week 2
Secondary outcome [22] 0 0
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52
Timepoint [22] 0 0
Baseline to Week 52
Secondary outcome [23] 0 0
Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52
Timepoint [23] 0 0
Baseline to Week 52
Secondary outcome [24] 0 0
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52
Timepoint [24] 0 0
Baseline to Week 52
Secondary outcome [25] 0 0
Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52
Timepoint [25] 0 0
Baseline to Week 52
Secondary outcome [26] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52
Timepoint [26] 0 0
Baseline to Week 52
Secondary outcome [27] 0 0
Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52
Timepoint [27] 0 0
Baseline to Week 52
Secondary outcome [28] 0 0
Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52
Timepoint [28] 0 0
Baseline to Week 52
Secondary outcome [29] 0 0
Number of Flares Through Week 52
Timepoint [29] 0 0
Baseline up to Week 52
Secondary outcome [30] 0 0
Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52
Timepoint [30] 0 0
Baseline up to Week 52
Secondary outcome [31] 0 0
Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52
Timepoint [31] 0 0
Baseline up to Week 52
Secondary outcome [32] 0 0
Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52
Timepoint [32] 0 0
Baseline up to Week 52
Secondary outcome [33] 0 0
Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52
Timepoint [33] 0 0
Baseline up to Week 52
Secondary outcome [34] 0 0
Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52
Timepoint [34] 0 0
Baseline up to Week 52

Eligibility
Key inclusion criteria
Key

1. Chronic AD that had been present for at least 3 years before the screening visit;
2. 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).

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participation in a prior Dupilumab clinical trial;
2. 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;
3. 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:

1. Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma [IFN-?], azathioprine, methotrexate, etc.);
2. Phototherapy for AD;
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
5. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
6. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit;
7. Active or acute infection requiring systemic treatment within 2 weeks before baseline visit;
8. Known or suspected history of immunosuppression;
9. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the participant's participation in this study.

Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
740
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Phillip
Recruitment hospital [2] 0 0
- Kogarah
Recruitment hospital [3] 0 0
- Benowa
Recruitment hospital [4] 0 0
- Dulwich
Recruitment hospital [5] 0 0
- Hectorville
Recruitment hospital [6] 0 0
- Carlton
Recruitment postcode(s) [1] 0 0
- Phillip
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Benowa
Recruitment postcode(s) [4] 0 0
- Dulwich
Recruitment postcode(s) [5] 0 0
- Hectorville
Recruitment postcode(s) [6] 0 0
- Carlton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Vermont
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Czechia
State/province [30] 0 0
Hradec Kralove
Country [31] 0 0
Czechia
State/province [31] 0 0
Nachod
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha 10
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 5
Country [34] 0 0
Czechia
State/province [34] 0 0
Svitavy
Country [35] 0 0
Czechia
State/province [35] 0 0
Usti nad Labem
Country [36] 0 0
Hungary
State/province [36] 0 0
Békés
Country [37] 0 0
Hungary
State/province [37] 0 0
Jász-Nagykun-Szolnok
Country [38] 0 0
Hungary
State/province [38] 0 0
Veszprém
Country [39] 0 0
Hungary
State/province [39] 0 0
Budapest
Country [40] 0 0
Italy
State/province [40] 0 0
Ancona
Country [41] 0 0
Italy
State/province [41] 0 0
Bologna
Country [42] 0 0
Italy
State/province [42] 0 0
Brescia
Country [43] 0 0
Italy
State/province [43] 0 0
Novara
Country [44] 0 0
Italy
State/province [44] 0 0
Pavia
Country [45] 0 0
Italy
State/province [45] 0 0
Perugia
Country [46] 0 0
Italy
State/province [46] 0 0
Roma
Country [47] 0 0
Japan
State/province [47] 0 0
Fukuoka
Country [48] 0 0
Japan
State/province [48] 0 0
Hyôgo
Country [49] 0 0
Japan
State/province [49] 0 0
Kanagawa
Country [50] 0 0
Japan
State/province [50] 0 0
Kumamoto
Country [51] 0 0
Japan
State/province [51] 0 0
Saitama
Country [52] 0 0
Japan
State/province [52] 0 0
Shizuoka
Country [53] 0 0
Japan
State/province [53] 0 0
Tokyo
Country [54] 0 0
Japan
State/province [54] 0 0
Tôkyô
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Gyeonggido
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul Teugbyeolsi
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Seodaemun-gu
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Uijeongbu-si
Country [59] 0 0
Netherlands
State/province [59] 0 0
Noord-Brabant
Country [60] 0 0
Netherlands
State/province [60] 0 0
Noord-Holland
Country [61] 0 0
Netherlands
State/province [61] 0 0
Zuid-Holland
Country [62] 0 0
Netherlands
State/province [62] 0 0
Groningen
Country [63] 0 0
Netherlands
State/province [63] 0 0
Utrecht
Country [64] 0 0
New Zealand
State/province [64] 0 0
South Island
Country [65] 0 0
New Zealand
State/province [65] 0 0
Auckland
Country [66] 0 0
Poland
State/province [66] 0 0
Dolnoslaskie
Country [67] 0 0
Poland
State/province [67] 0 0
Lubelskie
Country [68] 0 0
Poland
State/province [68] 0 0
Mazowieckie
Country [69] 0 0
Poland
State/province [69] 0 0
Malopolskie
Country [70] 0 0
Poland
State/province [70] 0 0
Opolskie
Country [71] 0 0
Poland
State/province [71] 0 0
Podkarpackie
Country [72] 0 0
Poland
State/province [72] 0 0
Podlaskie
Country [73] 0 0
Poland
State/province [73] 0 0
Pomorskie
Country [74] 0 0
Poland
State/province [74] 0 0
Wielkopolskie
Country [75] 0 0
Poland
State/province [75] 0 0
Zachodniopomorskie
Country [76] 0 0
Poland
State/province [76] 0 0
Gdynia
Country [77] 0 0
Poland
State/province [77] 0 0
Lódzkie
Country [78] 0 0
Poland
State/province [78] 0 0
Slaskie
Country [79] 0 0
Poland
State/province [79] 0 0
Swietokrzyskie
Country [80] 0 0
Romania
State/province [80] 0 0
Brasov
Country [81] 0 0
Romania
State/province [81] 0 0
Bucuresti
Country [82] 0 0
Romania
State/province [82] 0 0
Cluj
Country [83] 0 0
Romania
State/province [83] 0 0
Dolj
Country [84] 0 0
Romania
State/province [84] 0 0
Mures
Country [85] 0 0
Spain
State/province [85] 0 0
Cataluña
Country [86] 0 0
Spain
State/province [86] 0 0
Alicante
Country [87] 0 0
Spain
State/province [87] 0 0
Madrid
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Angus
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Birmingham
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Glasgow City
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Kent
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Middlesex
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Liverpool
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Manchester
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Reading
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02260986
Trial related presentations / publications
Wechsler 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.
Blauvelt 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.
Blauvelt 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.
Griffiths 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.
Hamilton 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.
Wu 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.
Boguniewicz 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.
Silverberg 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.
Weyne 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.
Katoh 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.
Alexis 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.
Wollenberg 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.
Blauvelt 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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02260986