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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 października 2017 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

740

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Inny: 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.
Eksperymentalny: 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.
Lek: Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Inny: 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.
Lek: Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Inne nazwy:
  • Dupixent
  • REGN668
  • SAR231893
Eksperymentalny: 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.
Inny: 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.
Lek: Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Inne nazwy:
  • Dupixent
  • REGN668
  • SAR231893

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Procentowa zmiana wyniku wskaźnika obszaru i nasilenia wyprysku (EASI) od wartości początkowej do tygodnia 16
Ramy czasowe: Linia bazowa do tygodnia 16
Skalę EASI wykorzystano do pomiaru ciężkości i rozległości AZS oraz zmierzono rumień, nacieki, otarcia i lichenizację w 4 anatomicznych obszarach ciała: głowie, tułowiu, kończynach górnych i dolnych. Całkowity wynik EASI mieści się w zakresie od 0 (minimum) do 72 (maksimum) punktów, przy czym wyższe wyniki odzwierciedlają gorsze nasilenie AZS.
Linia bazowa do tygodnia 16
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Regeneron Pharmaceuticals

Współpracownicy

Sanofi

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 września 2014

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2015

Ukończenie studiów (Rzeczywisty)

1 października 2016

Daty rejestracji na studia

Pierwszy przesłany

6 października 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 października 2014

Pierwszy wysłany (Oszacować)

9 października 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 października 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 października 2017

Ostatnia weryfikacja

1 października 2017

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • R668-AD-1224

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