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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 de octubre de 2017 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

740

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Placebo qw
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection weekly (qw) from Week 1 to Week 51.
Droga: Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Otro: 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.
Experimental: Dupilumab 300 mg q2w
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
Droga: Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Otro: 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.
Droga: Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Otros nombres:
  • Dupixent
  • REGN668
  • SAR231893
Experimental: Dupilumab 300 mg qw
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
Otro: 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.
Droga: Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Otros nombres:
  • Dupixent
  • REGN668
  • SAR231893

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambio porcentual desde el inicio en la puntuación del índice de gravedad y área de eccema (EASI) hasta la semana 16
Periodo de tiempo: Línea de base a la semana 16
El puntaje EASI se utilizó para medir la gravedad y extensión de la EA y midió el eritema, la infiltración, la excoriación y la liquenificación en 4 regiones anatómicas del cuerpo: cabeza, tronco, extremidades superiores e inferiores. La puntuación total de EASI varía de 0 (mínimo) a 72 (máximo) puntos, y las puntuaciones más altas reflejan la peor gravedad de la EA.
Línea de base a la semana 16
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Regeneron Pharmaceuticals

Colaboradores

Sanofi

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2014

Finalización primaria (Actual)

1 de agosto de 2015

Finalización del estudio (Actual)

1 de octubre de 2016

Fechas de registro del estudio

Enviado por primera vez

6 de octubre de 2014

Primero enviado que cumplió con los criterios de control de calidad

6 de octubre de 2014

Publicado por primera vez (Estimar)

9 de octubre de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de octubre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

12 de octubre de 2017

Última verificación

1 de octubre de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • R668-AD-1224

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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