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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

740

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia
    • New South Wales
      • Kogarah, New South Wales, Australia
    • Queensland
      • Benowa, Queensland, Australia
      • Dulwich, Queensland, Australia
    • South Australia
      • Hectorville, South Australia, Australia
    • Victoria
      • Carlton, Victoria, Australia
  • 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
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater
    • Arkansas
      • Hot Springs, Arkansas, Forente stater
      • Little Rock, Arkansas, Forente stater
    • California
      • Encinitas, California, Forente stater
      • Oceanside, California, Forente stater
      • Palmdale, California, Forente stater
      • San Diego, California, Forente stater
    • Connecticut
      • New Haven, Connecticut, Forente stater
      • Trumbull, Connecticut, Forente stater
    • Florida
      • Edgewater, Florida, Forente stater
      • Lake Worth, Florida, Forente stater
      • Miami Lakes, Florida, Forente stater
      • Orlando, Florida, Forente stater
      • Tampa, Florida, Forente stater
    • Georgia
      • Alpharetta, Georgia, Forente stater
      • Columbus, Georgia, Forente stater
      • Savannah, Georgia, Forente stater
    • Illinois
      • West Dundee, Illinois, Forente stater
    • Indiana
      • Carmel, Indiana, Forente stater
      • New Albany, Indiana, Forente stater
    • Maryland
      • Rockville, Maryland, Forente stater
    • Michigan
      • Ann Arbor, Michigan, Forente stater
      • Bay City, Michigan, Forente stater
    • Minnesota
      • Edina, Minnesota, Forente stater
      • Fridley, Minnesota, Forente stater
    • Missouri
      • Saint Louis, Missouri, Forente stater
    • Nebraska
      • Omaha, Nebraska, Forente stater
    • Nevada
      • Henderson, Nevada, Forente stater
    • New Jersey
      • Verona, New Jersey, Forente stater
    • New Mexico
      • Albuquerque, New Mexico, Forente stater
    • New York
      • Corning, New York, Forente stater
      • New York, New York, Forente stater
      • Smithtown, New York, Forente stater
      • Stony Brook, New York, Forente stater
    • Ohio
      • Cincinnati, Ohio, Forente stater
    • Oklahoma
      • Norman, Oklahoma, Forente stater
      • Oklahoma City, Oklahoma, Forente stater
    • Oregon
      • Lake Oswego, Oregon, Forente stater
      • Portland, Oregon, Forente stater
    • Pennsylvania
      • Exton, Pennsylvania, Forente stater
      • Hazleton, Pennsylvania, Forente stater
      • Philadelphia, Pennsylvania, Forente stater
    • Texas
      • Austin, Texas, Forente stater
      • Dallas, Texas, Forente stater
    • Utah
      • West Jordan, Utah, Forente stater
    • Vermont
      • South Burlington, Vermont, Forente stater
    • Virginia
      • Henrico, Virginia, Forente stater
      • Norfolk, Virginia, Forente stater
      • Richmond, Virginia, Forente stater
    • Washington
      • Spokane, Washington, Forente stater
  • Italia
      • Ancona, Italia
      • Bologna, Italia
      • Brescia, Italia
      • Novara, Italia
      • Pavia, Italia
      • Perugia, Italia
      • Roma, Italia
  • 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, Republikken
      • Seodaemun-gu, Korea, Republikken
      • Uijeongbu-si, Korea, Republikken
    • Gyeonggido
      • Bucheon-si, Gyeonggido, Korea, Republikken
      • Suwon, Gyeonggido, Korea, Republikken
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republikken
  • Nederland
      • Groningen, Nederland
      • Utrecht, Nederland
    • Noord-Brabant
      • Breda, Noord-Brabant, Nederland
    • Noord-Holland
      • Amsterdam, Noord-Holland, Nederland
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Nederland
  • New Zealand
      • Auckland, New Zealand
    • South Island
      • Dunedin, South Island, New Zealand
  • 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
  • Romania
    • Braşov
      • Brasov, Braşov, Romania
    • Bucureşti
      • Bucuresti, Bucureşti, Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania
    • Dolj
      • Craiova, Dolj, Romania
    • Mureş
      • Targu Mures, Mureş, Romania
  • Spania
      • Alicante, Spania
      • Madrid, Spania
    • Cataluña
      • Barcelona, Cataluña, Spania
  • Storbritannia
      • Liverpool, Storbritannia
      • Manchester, Storbritannia
      • Reading, Storbritannia
      • Salford, Storbritannia
    • Angus
      • Dundee, Angus, Storbritannia
    • Birmingham
      • Edgbaston, Birmingham, Storbritannia
    • Glasgow City
      • Glasgow, Glasgow City, Storbritannia
    • Kent
      • Sidcup, Kent, Storbritannia
    • Middlesex
      • Northwood, Middlesex, Storbritannia
  • Tsjekkia
      • Hradec Kralove, Tsjekkia
      • Nachod, Tsjekkia
      • Praha 10, Tsjekkia
      • Praha 5, Tsjekkia
      • Svitavy, Tsjekkia
      • Usti nad Labem, Tsjekkia
  • Ungarn
      • Budapest, Ungarn
    • Békés
      • Oroshaza, Békés, Ungarn
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Ungarn
    • Veszprém
      • Veszprem, Veszprém, Ungarn

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Annen: 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.
Eksperimentell: 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.
Legemiddel: Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Annen: 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.
Legemiddel: Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Andre navn:
  • Dupixent
  • REGN668
  • SAR231893
Eksperimentell: 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.
Annen: 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.
Legemiddel: Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Andre navn:
  • Dupixent
  • REGN668
  • SAR231893

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentvis endring fra baseline i eksemområde og alvorlighetsindeks (EASI)-score til uke 16
Tidsramme: Baseline til uke 16
EASI-skåren ble brukt til å måle alvorlighetsgraden og omfanget av AD og målte erytem, ​​infiltrasjon, ekskoriasjon og lichenifisering på 4 anatomiske områder av kroppen: hode, trunk, øvre og nedre ekstremiteter. Den totale EASI-poengsummen varierer fra 0 (minimum) til 72 (maksimum) poeng, med de høyere poengsummene som gjenspeiler den verste alvorlighetsgraden av AD.
Baseline til uke 16
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Regeneron Pharmaceuticals

Samarbeidspartnere

Sanofi

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2014

Primær fullføring (Faktiske)

1. august 2015

Studiet fullført (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først innsendt

6. oktober 2014

Først innsendt som oppfylte QC-kriteriene

6. oktober 2014

Først lagt ut (Anslag)

9. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. oktober 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. oktober 2017

Sist bekreftet

1. oktober 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R668-AD-1224

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Legemiddelintervensjoner

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Forhold

Sjeldne sykdommer

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