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Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis (CHRONOS)

12 oktober 2017 bijgewerkt door: Regeneron Pharmaceuticals

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

740

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australië
    • New South Wales
      • Kogarah, New South Wales, Australië
    • Queensland
      • Benowa, Queensland, Australië
      • Dulwich, Queensland, Australië
    • South Australia
      • Hectorville, South Australia, Australië
    • Victoria
      • Carlton, Victoria, Australië
  • Canada
      • Quebec, Canada
    • British Columbia
      • Surrey, British Columbia, Canada
      • Vancouver, British Columbia, Canada
    • Ontario
      • Ajax, Ontario, Canada
      • Barrie, Ontario, Canada
      • Hamilton, Ontario, Canada
      • Markham, Ontario, Canada
      • North Bay, Ontario, Canada
      • Oakville, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Peterborough, Ontario, Canada
      • Richmond Hill, Ontario, Canada
      • Toronto, Ontario, Canada
      • Waterloo, Ontario, Canada
      • Windsor, Ontario, Canada
    • Quebec
      • Drummondville, Quebec, Canada
  • Hongarije
      • Budapest, Hongarije
    • Békés
      • Oroshaza, Békés, Hongarije
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hongarije
    • Veszprém
      • Veszprem, Veszprém, Hongarije
  • Italië
      • Ancona, Italië
      • Bologna, Italië
      • Brescia, Italië
      • Novara, Italië
      • Pavia, Italië
      • Perugia, Italië
      • Roma, Italië
  • Japan
      • Fukuoka, Japan
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan
    • Hyôgo
      • Amagasaki, Hyôgo, Japan
    • Kanagawa
      • Yokohama, Kanagawa, Japan
    • Kumamoto
      • Kamimashiki-gun, Kumamoto, Japan
    • Saitama
      • Saitama-shi, Saitama, Japan
    • Shizuoka
      • Yaizu, Shizuoka, Japan
    • Tokyo
      • Koto-ku, Tokyo, Japan
      • Setagaya-ku, Tokyo, Japan
    • Tôkyô
      • Adachi-ku, Tôkyô, Japan
      • Chiyoda-ku, Tôkyô, Japan
      • Nakano-ku, Tôkyô, Japan
      • Nerima-ku, Tôkyô, Japan
      • Shibuya-ku, Tôkyô, Japan
      • Shinagawa-ku, Tôkyô, Japan
      • Shinjuku-ku, Tôkyô, Japan
      • Suginami-ku, Tôkyô, Japan
  • Korea, republiek van
      • Seodaemun-gu, Korea, republiek van
      • Uijeongbu-si, Korea, republiek van
    • Gyeonggido
      • Bucheon-si, Gyeonggido, Korea, republiek van
      • Suwon, Gyeonggido, Korea, republiek van
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, republiek van
  • Nederland
      • Groningen, Nederland
      • Utrecht, Nederland
    • Noord-Brabant
      • Breda, Noord-Brabant, Nederland
    • Noord-Holland
      • Amsterdam, Noord-Holland, Nederland
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Nederland
  • Nieuw-Zeeland
      • Auckland, Nieuw-Zeeland
    • South Island
      • Dunedin, South Island, Nieuw-Zeeland
  • Polen
      • Gdynia, Polen
    • Dolnośląskie
      • Wroclaw, Dolnośląskie, Polen
    • Lubelskie
      • Lublin, Lubelskie, Polen
    • Mazowieckie
      • Warszawa, Mazowieckie, Polen
    • Małopolskie
      • Krakow, Małopolskie, Polen
    • Opolskie
      • Strzelce Opolskie, Opolskie, Polen
    • Podkarpackie
      • Iwonicz Zdroj, Podkarpackie, Polen
    • Podlaskie
      • Bialystok, Podlaskie, Polen
    • Pomorskie
      • Gdansk, Pomorskie, Polen
    • Wielkopolskie
      • Poznan, Wielkopolskie, Polen
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Polen
    • Łódzkie
      • Łódź, Łódzkie, Polen
    • Śląskie
      • Katowice, Śląskie, Polen
    • Świętokrzyskie
      • Skarzysko-Kamienna, Świętokrzyskie, Polen
  • Roemenië
    • Braşov
      • Brasov, Braşov, Roemenië
    • Bucureşti
      • Bucuresti, Bucureşti, Roemenië
    • Cluj
      • Cluj-Napoca, Cluj, Roemenië
    • Dolj
      • Craiova, Dolj, Roemenië
    • Mureş
      • Targu Mures, Mureş, Roemenië
  • Spanje
      • Alicante, Spanje
      • Madrid, Spanje
    • Cataluña
      • Barcelona, Cataluña, Spanje
  • Tsjechië
      • Hradec Kralove, Tsjechië
      • Nachod, Tsjechië
      • Praha 10, Tsjechië
      • Praha 5, Tsjechië
      • Svitavy, Tsjechië
      • Usti nad Labem, Tsjechië
  • Verenigd Koninkrijk
      • Liverpool, Verenigd Koninkrijk
      • Manchester, Verenigd Koninkrijk
      • Reading, Verenigd Koninkrijk
      • Salford, Verenigd Koninkrijk
    • Angus
      • Dundee, Angus, Verenigd Koninkrijk
    • Birmingham
      • Edgbaston, Birmingham, Verenigd Koninkrijk
    • Glasgow City
      • Glasgow, Glasgow City, Verenigd Koninkrijk
    • Kent
      • Sidcup, Kent, Verenigd Koninkrijk
    • Middlesex
      • Northwood, Middlesex, Verenigd Koninkrijk
  • Verenigde Staten
    • Arizona
      • Phoenix, Arizona, Verenigde Staten
    • Arkansas
      • Hot Springs, Arkansas, Verenigde Staten
      • Little Rock, Arkansas, Verenigde Staten
    • California
      • Encinitas, California, Verenigde Staten
      • Oceanside, California, Verenigde Staten
      • Palmdale, California, Verenigde Staten
      • San Diego, California, Verenigde Staten
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten
      • Trumbull, Connecticut, Verenigde Staten
    • Florida
      • Edgewater, Florida, Verenigde Staten
      • Lake Worth, Florida, Verenigde Staten
      • Miami Lakes, Florida, Verenigde Staten
      • Orlando, Florida, Verenigde Staten
      • Tampa, Florida, Verenigde Staten
    • Georgia
      • Alpharetta, Georgia, Verenigde Staten
      • Columbus, Georgia, Verenigde Staten
      • Savannah, Georgia, Verenigde Staten
    • Illinois
      • West Dundee, Illinois, Verenigde Staten
    • Indiana
      • Carmel, Indiana, Verenigde Staten
      • New Albany, Indiana, Verenigde Staten
    • Maryland
      • Rockville, Maryland, Verenigde Staten
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten
      • Bay City, Michigan, Verenigde Staten
    • Minnesota
      • Edina, Minnesota, Verenigde Staten
      • Fridley, Minnesota, Verenigde Staten
    • Missouri
      • Saint Louis, Missouri, Verenigde Staten
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten
    • Nevada
      • Henderson, Nevada, Verenigde Staten
    • New Jersey
      • Verona, New Jersey, Verenigde Staten
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten
    • New York
      • Corning, New York, Verenigde Staten
      • New York, New York, Verenigde Staten
      • Smithtown, New York, Verenigde Staten
      • Stony Brook, New York, Verenigde Staten
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten
    • Oklahoma
      • Norman, Oklahoma, Verenigde Staten
      • Oklahoma City, Oklahoma, Verenigde Staten
    • Oregon
      • Lake Oswego, Oregon, Verenigde Staten
      • Portland, Oregon, Verenigde Staten
    • Pennsylvania
      • Exton, Pennsylvania, Verenigde Staten
      • Hazleton, Pennsylvania, Verenigde Staten
      • Philadelphia, Pennsylvania, Verenigde Staten
    • Texas
      • Austin, Texas, Verenigde Staten
      • Dallas, Texas, Verenigde Staten
    • Utah
      • West Jordan, Utah, Verenigde Staten
    • Vermont
      • South Burlington, Vermont, Verenigde Staten
    • Virginia
      • Henrico, Virginia, Verenigde Staten
      • Norfolk, Virginia, Verenigde Staten
      • Richmond, Virginia, Verenigde Staten
    • Washington
      • Spokane, Washington, Verenigde Staten

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Key Inclusion Criteria:

  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 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-γ], 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Ander: 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.
Experimenteel: 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.
Geneesmiddel: Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Ander: 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.
Geneesmiddel: Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Andere namen:
  • Dubbelzinnig
  • REGN668
  • SAR231893
Experimenteel: 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.
Ander: 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.
Geneesmiddel: Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Andere namen:
  • Dubbelzinnig
  • REGN668
  • SAR231893

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16
Tijdsspanne: Baseline to 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage verandering vanaf baseline in eczeemgebied en Severity Index (EASI)-score tot week 16
Tijdsspanne: Basislijn tot week 16
De EASI-score werd gebruikt om de ernst en omvang van AD te meten en erytheem, infiltratie, ontvelling en lichenificatie te meten op 4 anatomische gebieden van het lichaam: hoofd, romp, bovenste en onderste ledematen. De totale EASI-score varieert van 0 (minimum) tot 72 (maximum) punten, waarbij de hogere scores de ernstigste AD weerspiegelen.
Basislijn tot week 16
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16
Tijdsspanne: 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 ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to 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
Tijdsspanne: Baseline to Week 16
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.
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
Tijdsspanne: Baseline to Week 16
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.
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
Tijdsspanne: Baseline to Week 52
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 of "0" or "1" and a reduction from baseline of ≥2 points at Week 52 were reported.
Baseline to Week 52
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52
Tijdsspanne: Baseline to Week 52
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 52.
Baseline to Week 52
Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16
Tijdsspanne: Baseline to Week 16
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
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 52
Tijdsspanne: Baseline to Week 52
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.
Baseline to Week 52
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
Tijdsspanne: Baseline to Week 52
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.
Baseline to Week 52
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
Tijdsspanne: Baseline to Week 24
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 24 were reported.
Baseline to Week 24
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
Tijdsspanne: Baseline to Week 4
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported.
Baseline to Week 4
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
Tijdsspanne: Baseline to Week 2
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported.
Baseline to Week 2
Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16
Tijdsspanne: Baseline to Week 16
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
Baseline to Week 16
Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16
Tijdsspanne: Baseline to Week 16
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.
Baseline to Week 16
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16
Tijdsspanne: Baseline to Week 16
SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Baseline to Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16
Tijdsspanne: Baseline to Week 16
The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.
Baseline to Week 16
Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16
Tijdsspanne: Baseline to Week 16
The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).
Baseline to Week 16
Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16
Tijdsspanne: Baseline to Week 16
HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
Baseline to Week 16
Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16
Tijdsspanne: Baseline to Week 16
Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
Baseline to Week 16
Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52
Tijdsspanne: Baseline to Week 52
Proportion of topical AD medication-free days through Week 52 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days of each period.
Baseline to Week 52
Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2
Tijdsspanne: Baseline to Week 2
Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
Baseline to Week 2
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52
Tijdsspanne: Baseline to Week 52
The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Baseline to Week 52
Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52
Tijdsspanne: Baseline to Week 52
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.
Baseline to Week 52
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52
Tijdsspanne: Baseline to Week 52
SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Baseline to Week 52
Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52
Tijdsspanne: Baseline to Week 52
Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).
Baseline to Week 52
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52
Tijdsspanne: Baseline to Week 52
The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.
Baseline to Week 52
Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52
Tijdsspanne: Baseline to Week 52
The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).
Baseline to Week 52
Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52
Tijdsspanne: Baseline to Week 52
HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
Baseline to Week 52
Number of Flares Through Week 52
Tijdsspanne: Baseline up to Week 52
Atopic dermatitis (AD) flares were defined as worsening of the disease that required escalation/intensification of AD treatment. Number of flares occurred in the participants starting from first dose through Week 52 were reported.
Baseline up to Week 52
Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52
Tijdsspanne: Baseline up to Week 52
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Baseline up to Week 52
Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52
Tijdsspanne: Baseline up to Week 52
Any untoward medical occurrence in a participants who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
Baseline up to Week 52
Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52
Tijdsspanne: Baseline up to Week 52
Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
Baseline up to Week 52
Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52
Tijdsspanne: Baseline up to Week 52
Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
Baseline up to Week 52
Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52
Tijdsspanne: Baseline up to Week 52
Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.
Baseline up to Week 52

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16
Tijdsspanne: Baseline to Week 16
The SNOT 22 was a validated measure of health related quality of life in sinonasal disease. It was a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease) (lower scores represent better health related quality of life). The SNOT-22 was administered only to participants with chronic inflammatory conditions of the nasal mucosa and/or paranasal sinuses.
Baseline to Week 16
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score to Week 16
Tijdsspanne: Baseline to Week 16
ACQ-5 questionnaire was a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score was the mean of the 5 questions and range between 0 (totally controlled) and 6 (severely uncontrolled) (a higher score indicated lower asthma control). The ACQ-5 questionnaire was administered only to the participants with a medical history of asthma.
Baseline to Week 16

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Regeneron Pharmaceuticals

Medewerkers

Sanofi

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2014

Primaire voltooiing (Werkelijk)

1 augustus 2015

Studie voltooiing (Werkelijk)

1 oktober 2016

Studieregistratiedata

Eerst ingediend

6 oktober 2014

Eerst ingediend dat voldeed aan de QC-criteria

6 oktober 2014

Eerst geplaatst (Schatting)

9 oktober 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 oktober 2017

Laatste update ingediend die voldeed aan QC-criteria

12 oktober 2017

Laatst geverifieerd

1 oktober 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R668-AD-1224

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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