Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

NCT01859988 | Completed Phase 2 Results

• 1 other identifier: R668-AD-1021
• Study Type: interventional
• Target: 380
• Locations: 7 countries
• Sites: 84

Brief Summary

To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).

Conditions

Atopic Dermatitis

Keywords

Eczema

Outcome Measures

Primary Outcomes (1)

• Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16

  The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

  Baseline to Week 16

Secondary Outcomes (13)

• Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16

  Week 16

• Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16

  Week 16

• Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16

  Baseline to Week 16

• Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16

  Baseline to Week 16

• Absolute Change in EASI Score From Baseline to Week 16

  Baseline to Week 16

Study Arms (6)

Placebo qw

EXPERIMENTAL

Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15.

Drug: Placebo

Dupilumab 300 mg qw

EXPERIMENTAL

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.

Drug: Dupilumab

Dupilumab 300 mg q2w

EXPERIMENTAL

Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15.

Drug: Dupilumab; Drug: Placebo

Dupilumab 200 mg q2w

EXPERIMENTAL

Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.

Drug: Dupilumab; Drug: Placebo

Dupilumab 300 mg q4w

EXPERIMENTAL

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 every 4 weeks (q4w) and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.

Drug: Dupilumab; Drug: Placebo

Dupilumab 100 mg q4w

EXPERIMENTAL

Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.

Drug: Dupilumab; Drug: Placebo

Interventions

Dupilumab DRUG

Also known as: REGN668, SAR231893, Dupixent

Dupilumab 100 mg q4w; Dupilumab 200 mg q2w; Dupilumab 300 mg q2w; Dupilumab 300 mg q4w; Dupilumab 300 mg qw

Placebo DRUG

Dupilumab 100 mg q4w; Dupilumab 200 mg q2w; Dupilumab 300 mg q2w; Dupilumab 300 mg q4w; Placebo qw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Atopic Dermatitis that had been present for at least 3 years
• History of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable (e.g, because of important side effects or safety risks)
• Willing and able to comply with all clinic visits and study-related procedures

You may not qualify if:

• Prior treatment with dupilumab (REGN668/SAR231893)
• Presence of certain laboratory abnormalities at the screening visit
• Treatment with an investigational drug within 8 weeks of baseline visit
• Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
• Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
• Known history of human immunodeficiency virus (HIV) infection
• History of malignancy within 5 years before the baseline visit (with certain exceptions)
• Planned surgical procedure during the length of the study
• High risk of parasite infection
• Any other medical or psychological condition that in the opinion of the investigator or the sponsor's medical monitor, would place the participants at risk, interfere with participation in the study or interfere with interpretation of study results
• Pregnant or breast-feeding women

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (84)

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Tucson, Arizona, United States

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Bakersfield, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Jacksonville, Florida, United States

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Ormond Beach, Florida, United States

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Skokie, Illinois, United States

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New Orleans, Louisiana, United States

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Andover, Massachusetts, United States

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Boston, Massachusetts, United States

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Troy, Michigan, United States

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St Louis, Missouri, United States

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New York, New York, United States

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Rochester, New York, United States

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Winston-Salem, North Carolina, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Johnston, Rhode Island, United States

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Greer, South Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Seattle, Washington, United States

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Vancouver (2 Locations), British Columbia, Canada

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Winnipeg, Manitoba, 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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Oakville, Ontario, Canada

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Peterborough, Ontario, Canada

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Richmond Hill, Ontario, Canada

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Waterloo, Ontario, Canada

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Windsor, Ontario, Canada

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Saint-Hyacinthe, Quebec, Canada

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Québec, Canada

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Kutná Hora, 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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Augsburg, Germany

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Baden, Germany

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Berlin, Germany

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Bonn, Germany

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Dresden, Germany

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Dülmen, Germany

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Frankfurt am Main, Germany

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Frankfurt/Main, Hessen, Germany

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Gera, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Kiel, Germany

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Mahlow, Germany

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Munich, Germany

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Münster, Germany

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Osnabrück, Germany

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Tübingen, Germany

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Borsod-Abauj-Zemplen, Hungary

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Budapest, Hungary

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Kaposvár, Hungary

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Szeged, Hungary

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Szolnok, Hungary

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Tolna, Hungary

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Fukuoka, Japan

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Hokkaido, Japan

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Saitama, Japan

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Tokyo, Bunkyo-ku, Japan

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Tokyo, Chiyoda-ku, Japan

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Tokyo, Nakano-ku, Japan

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Tokyo, Nerima-ku, Japan

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Tokyo, Shibuya-ku, Japan

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Tokyo, Shinagawa-ku, Japan

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Tokyo, Shinjuku-ku (2 Locations), Japan

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Tokyo, Suginami-ku (2 Locations), Japan

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Yokohama, Japan

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Gdansk (2 Locations), Poland

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Katowice, Poland

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Lodz, Poland

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Lublin, Poland

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Poznan, Poland

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Warsaw (2 Locations), Poland

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Wroclaw, Poland

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Related Publications (6)

• Thaci D, Simpson EL, Beck LA, Bieber T, Blauvelt A, Papp K, Soong W, Worm M, Szepietowski JC, Sofen H, Kawashima M, Wu R, Weinstein SP, Graham NM, Pirozzi G, Teper A, Sutherland ER, Mastey V, Stahl N, Yancopoulos GD, Ardeleanu M. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2016 Jan 2;387(10013):40-52. doi: 10.1016/S0140-6736(15)00388-8. Epub 2015 Oct 8.

  PMID: 26454361 RESULT

• Simpson EL, Bieber T, Eckert L, Wu R, Ardeleanu M, Graham NM, Pirozzi G, Mastey V. Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults. J Am Acad Dermatol. 2016 Mar;74(3):491-8. doi: 10.1016/j.jaad.2015.10.043. Epub 2016 Jan 14.

  PMID: 26777100 RESULT

• Simpson EL, Gadkari A, Worm M, Soong W, Blauvelt A, Eckert L, Wu R, Ardeleanu M, Graham NMH, Pirozzi G, Sutherland ER, Mastey V. Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD). J Am Acad Dermatol. 2016 Sep;75(3):506-515. doi: 10.1016/j.jaad.2016.04.054. Epub 2016 Jun 4.

  PMID: 27268421 RESULT

• Paller 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: 36723913 DERIVED

• Kamal MA, Davis JD, Kovalenko P, Srinivasan K, Simpson EL, Nakahara T, Sugaya M, Igarashi A, Ardeleanu M, Xu C, Arima K. Pharmacokinetics, pharmacodynamics, and exposure-efficacy of dupilumab in adults with atopic dermatitis. Clin Transl Sci. 2022 Oct;15(10):2342-2354. doi: 10.1111/cts.13363. Epub 2022 Aug 20.

  PMID: 35986664 DERIVED

• 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.

  PMID: 33165005 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Regeneron Pharmaceuticals, Inc

clinicaltrials@regeneron.com

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 22, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 28, 2017
• Results First Posted: August 28, 2017

Record last verified: 2017-07

Locations

CA (12); HU (6); JP (12); PL (7); CZ (5); US (25); DE (17)