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Badanie fazy 3, kontrolowane placebo, z podwójnie ślepą próbą oceniające monoterapię rokatynlimabem (AMG 451) w umiarkowanym do ciężkiego atopowym zapaleniu skóry (AZS) (ROCKET-Horizon) (ROCKET-Horizon)

2 czerwca 2026 zaktualizowane przez: Amgen

Randomizowane, 24-tygodniowe, kontrolowane placebo badanie fazy III z podwójnie ślepą próbą oceniające skuteczność, bezpieczeństwo i tolerancję rocatinlimabu (AMG 451) w monoterapii u dorosłych pacjentów z atopowym zapaleniem skóry (AZS) o nasileniu umiarkowanym do ciężkiego (ROCKET- Horyzont)

Nadrzędnymi celami badania są:

  • Ocena skuteczności rokatynlimabu w porównaniu z placebo w 24. tygodniu, oceniana za pomocą globalnej oceny atopowego zapalenia skóry zatwierdzonego badacza (vIGA-AD).
  • Ocena skuteczności rokatynlimabu w porównaniu z placebo w 24. tygodniu, oceniana za pomocą wskaźnika obszaru i nasilenia wyprysku (EASI).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

726

Faza

  • Faza 3

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Afryka Południowa
      • Durban, Afryka Południowa, 3630
        • Hiway Medical Centre
    • Gauteng
      • Centurion, Gauteng, Afryka Południowa, 0157
        • Ryexo Clinical Research
      • Johannesburg, Gauteng, Afryka Południowa, 2057
        • About Allergy
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St George Dermatology and Skin Cancer Centre
      • Kogarah, New South Wales, Australia, 2217
        • Premier Specialists
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Carlton, Victoria, Australia, 3053
        • Skin Health Institute
      • East Melbourne, Victoria, Australia, 3002
        • Sinclair Dermatology
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
  • Belgia
      • Brussels, Belgia, 1070
        • Hopital Erasme
      • Herstal, Belgia, 4040
        • Clinique Andre Renard
      • Maldegem, Belgia, 9990
        • Dermatologie Maldegem
  • Brazylia
    • Paraná
      • Curitiba, Paraná, Brazylia, 80030-110
        • CETI - Centro de Estudo em Terapias Inovadoras
    • São Paulo
      • São Bernardo do Campo, São Paulo, Brazylia, 09715-090
        • Centro Multidisciplinar de Estudos Clínicos - CEMEC
      • São José dos Campos, São Paulo, Brazylia, 12243-280
        • ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
  • Czechy
      • Kutná Hora, Czechy, 284 01
        • Kozni ambulance Kutna Hora sro
      • Nový Jičín, Czechy, 741 01
        • Nemocnice Novy Jicin as
      • Pardubice, Czechy, 530 02
        • CCR Czech as
      • Pilsen, Czechy, 305 99
        • Fakultni Nemocnice Plzen
      • Prague, Czechy, 130 00
        • CCR Prague sro
      • Prague, Czechy, 120 00
        • Dermamedest sro
      • Prague, Czechy, 106 00
        • Kozni ambulance Fialova sro
      • Prague, Czechy, 150 00
        • Praglandia sro
      • Svitavy, Czechy, 568 02
        • Dermatologicka ambulance MUDr Petr Trestik
  • Dania
      • Hellerup, Dania, 2900
        • Gentofte Hospital
      • Odense, Dania, 5000
        • Odense University Hospital
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre
      • Tartu, Estonia, 50106
        • Clinical Research Centre
  • Finlandia
      • Helsinki, Finlandia, 00180
        • CRST Helsinki
      • Helsinki, Finlandia, 00180
        • CRST Turku
      • Oulu, Finlandia, 90029
        • Oulun Yliopistollinen sairaala (OYS)
      • Tampere, Finlandia, 33100
        • Terveystalo Tampere
  • Hiszpania
      • Madrid, Hiszpania, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Hiszpania, 28046
        • Hospital Universitario La Paz
      • Majadahonda, Hiszpania, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Andalusia
      • Seville, Andalusia, Hiszpania, 41009
        • Hospital Universitario Virgen Macarena
    • Navarre
      • Pamplona, Navarre, Hiszpania, 31008
        • Clinica Universidad de Navarra
    • Valencia
      • Alicante, Valencia, Hiszpania, 03010
        • Hospital General Universitario de Alicante
      • Manises, Valencia, Hiszpania, 46940
        • Hospital de Manises
      • Valencia, Valencia, Hiszpania, 46015
        • Hospital Arnau de Vilanova de Valencia
  • Japonia
    • Chiba
      • Matsudo-shi, Chiba, Japonia, 271-0092
        • Miyata Dermatology Clinic
      • Narita-shi, Chiba, Japonia, 286-8520
        • International University of Health and Welfare Narita Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japonia, 650-0017
        • Kobe University Hospital
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japonia, 216-8511
        • St Marianna University Hospital
      • Sagamihara-shi, Kanagawa, Japonia, 252-0392
        • National Hospital Organization Sagamihara National Hospital
      • Yokohama, Kanagawa, Japonia, 224-8503
        • Showa University Northern Yokohama Hospital
    • Nagasaki
      • Nagasaki, Nagasaki, Japonia, 852-8501
        • Nagasaki University Hospital
    • Osaka
      • Habikino-shi, Osaka, Japonia, 583-8588
        • Osaka Habikino Medical Center
      • Sakai-shi, Osaka, Japonia, 593-8324
        • Dermatology and Ophthalmology Kume Clinic
    • Shizuoka
      • Hamamatsu, Shizuoka, Japonia, 431-3192
        • Hamamatsu University Hospital
    • Tokyo
      • Minato-ku, Tokyo, Japonia, 108-0014
        • Mita Dermatology Clinic
      • Shinagawa-ku, Tokyo, Japonia, 142-8666
        • Showa University Hospital
      • Shinjuku-ku, Tokyo, Japonia, 161-8521
        • Seibo International Catholic Hospital
      • Toshima-ku, Tokyo, Japonia, 170-0002
        • Sugamo Kobayashi Derma Clinic
    • Toyama
      • Takaoka-shi, Toyama, Japonia, 933-0871
        • Shirasaki dermatology clinic
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T3E 0B2
        • Beacon Dermatology
    • British Columbia
      • Surrey, British Columbia, Kanada, V3R 6A7
        • Doctor Chih-Ho Hong Medical Incorporated
    • Ontario
      • Etobicoke, Ontario, Kanada, M8X 1Y9
        • Kingsway Clinical Research
      • Markham, Ontario, Kanada, L3P 1X3
        • Lynderm Research Inc
      • Oakville, Ontario, Kanada, L6J 7W5
        • The Centre for Clinical Trials Inc
      • Peterborough, Ontario, Kanada, K9J 5K2
        • SKiN Centre for Dermatology
      • Richmond Hill, Ontario, Kanada, L4B 1A5
        • The Centre for Dermatology
      • Toronto, Ontario, Kanada, M4W 2N4
        • Research Toronto
      • Windsor, Ontario, Kanada, N8T 1E6
        • XLR8 Medical Research, Incorporated
    • Quebec
      • Québec, Quebec, Kanada, G1V 4X7
        • Centre de Recherche Dermatologique du Quebec metropolitain
      • Sherbrooke, Quebec, Kanada, J1G 1X9
        • Clinique Dermatologique de Sherbrooke
  • Korea Południowa
      • Ansansi, Gyeonggido, Korea Południowa, 15355
        • Korea University Ansan Hospital
      • Bucheon-si, Gyeonggi-do, Korea Południowa, 14584
        • Soon Chun Hyang University Bucheon Hospital
      • Busan, Korea Południowa, 49241
        • Pusan National University Hospital
      • Daegu, Korea Południowa, 41944
        • Kyungpook National University Hospital
      • Gwangju, Korea Południowa, 61453
        • Chosun University Hospital
      • Incheon, Korea Południowa, 22332
        • Inha University Hospital
      • Incheon, Korea Południowa, 21431
        • The Catholic University of Korea Incheon St Marys Hospital
      • Seongnam-si, Gyeonggi-do, Korea Południowa, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea Południowa, 03080
        • Seoul National University Hospital
      • Seoul, Korea Południowa, 05505
        • Asan Medical Center
      • Seoul, Korea Południowa, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea Południowa, 05278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Korea Południowa, 02841
        • Korea University Anam Hospital
      • Seoul, Korea Południowa, 05030
        • Konkuk University Medical Center
      • Seoul, Korea Południowa, 06973
        • Chung-Ang University Hospital
      • Seoul, Korea Południowa, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Korea Południowa, 04564
        • National Medical Center
      • Seoul, Korea Południowa, 07804
        • Ewha Womans University Seoul Hospital
      • Seoul, Korea Południowa, 06591
        • The Catholic Univ of Korea Seoul St Marys Hospital
      • Suwon-si, Gyeonggi-do, Korea Południowa, 16499
        • Ajou University Hospital
  • Meksyk
      • Chihuahua City, Meksyk, 31203
        • SCIENTIA Investigacion Clinica SC
      • Cuautitlán Izcalli, Meksyk, 54750
        • Phylasis Clínicas Research S. De R. L. De C. V.
    • Michoacán
      • Morelia, Michoacán, Meksyk, 58249
        • Clinica de Enfermedades Cronicas y de Procedimientos Especiales
  • Niemcy
      • Bad Bentheim, Niemcy, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Niemcy, 10247
        • Hautzentrum Friedrichshain - Dermatologie
      • Berlin, Niemcy, 13672
        • Clinical Research Services Berlin GmbH
      • Halle, Niemcy, 06120
        • Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
      • Hamburg, Niemcy, 20354
        • Dermatologikum Hamburg
      • Kiel, Niemcy, 24105
        • Universitaetsklinikum Schleswig-Holstein
      • Leipzig, Niemcy, 04103
        • Velocity Clinical Research
      • Münster, Niemcy, 48149
        • Universitaetsklinikum Muenster
      • Osnabrück, Niemcy, 49074
        • KliFOs Klinische Forschung Osnabrueck
      • Remscheid, Niemcy, 42897
        • Hautarztpraxis Mortazawi
      • Wuppertal, Niemcy, 42283
        • Helios Klinikum Wuppertal
  • Polska
      • Bialystok, Polska, 15-879
        • ClinicMed Daniluk Nowak Spolka Komandytowa
      • Chorzów, Polska, 41-500
        • Dermapolis Medical Dermatology Center dr n med Edyta Gebska
      • Gdansk, Polska, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Polska, 31-530
        • Centermed krakow sp zoo
      • Lodz, Polska, 90-349
        • AppleTreeClinics Network Spzoo
      • Lodz, Polska, 90-338
        • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
      • Lodz, Polska, 91-495
        • Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
      • Lublin, Polska, 20-078
        • Clinical Best Solutions Sp zoo Spolka komandytowa
      • Poznan, Polska, 61-731
        • Clinical Research Center Spzoo Medic-R Spolka Komandytowa
      • Warsaw, Polska, 02-625
        • Evimed sp zoo centrum medyczne evimed
  • Portugalia
      • Almada, Portugalia, 2801-951
        • Hospital Garcia de Orta, EPE
      • Coimbra, Portugalia, 3000-075
        • Centro Hospitalar e Universitário de Coimbra, EPE
      • Lisbon, Portugalia, 1998-018
        • Hospital CUF Descobertas
      • Porto, Portugalia, 4099-001
        • Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
      • Porto, Portugalia, 4200-319
        • Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
  • Rumunia
      • Bucharest, Rumunia, 020125
        • Spitalul Clinic Colentina
  • Stany Zjednoczone
    • Arizona
      • Litchfield Park, Arizona, Stany Zjednoczone, 85340
        • Research Solutions of Arizona, PC
      • Scottsdale, Arizona, Stany Zjednoczone, 85260
        • Center for Dermatology and Plastic Surgery
    • Arkansas
      • Fayetteville, Arkansas, Stany Zjednoczone, 72703
        • Clinical Trials Institute of Northwest Arkansas
      • Hot Springs, Arkansas, Stany Zjednoczone, 71913
        • Burke Pharmaceutical Research
    • California
      • Chula Vista, California, Stany Zjednoczone, 91911
        • Velocity Clinical Research Chula Vista
      • Dublin, California, Stany Zjednoczone, 94568
        • West Coast Research LLC
      • Encinitas, California, Stany Zjednoczone, 92024
        • California Dermatology and Clinical Research Institute
      • Fremont, California, Stany Zjednoczone, 94538
        • Center for Dermatology Clinical Research Inc
      • La Mesa, California, Stany Zjednoczone, 91942
        • Velocity Clinical Research - San Diego
      • North Hollywood, California, Stany Zjednoczone, 91606
        • Velocity Clinical Research - North Hollywood
      • Palmdale, California, Stany Zjednoczone, 93551
        • Cura Clinical Research
      • San Francisco, California, Stany Zjednoczone, 94115
        • University of California at San Francisco, Dermatology Clinic at Mount Zion
      • Santa Monica, California, Stany Zjednoczone, 90404
        • Clinical Science Institute
    • Colorado
      • Castle Rock, Colorado, Stany Zjednoczone, 80109
        • Clarity Dermatology
      • Denver, Colorado, Stany Zjednoczone, 80209
        • Velocity Clinical Research - Denver
    • District of Columbia
      • Washington D.C., District of Columbia, Stany Zjednoczone, 20016
        • Foxhall Research Center
    • Florida
      • Cape Coral, Florida, Stany Zjednoczone, 33991
        • Renaissance Research and Medical Group
      • Coral Gables, Florida, Stany Zjednoczone, 33134
        • Driven Research LLC
      • Doral, Florida, Stany Zjednoczone, 33172
        • Saint Jude Clinical Research
      • Hialeah, Florida, Stany Zjednoczone, 33012
        • Direct Helpers Research Center
      • Margate, Florida, Stany Zjednoczone, 33063
        • Glick Skin Institute
      • Miami, Florida, Stany Zjednoczone, 33176
        • Miami Dade Medical Research Institute, LLC
      • Palmetto Bay, Florida, Stany Zjednoczone, 33157
        • Innovation Medical Research Center Inc
      • Tampa, Florida, Stany Zjednoczone, 33612
        • University of South Florida Health Morsani Center for Advanced Healthcare
    • Georgia
      • Sandy Springs, Georgia, Stany Zjednoczone, 30328
        • Advanced Medical Research Pc
    • Illinois
      • Normal, Illinois, Stany Zjednoczone, 61761
        • Sneeze, Wheeze, and Itch Associates, LLC
    • Indiana
      • South Bend, Indiana, Stany Zjednoczone, 46617
        • The South Bend Clinic LLP
      • West Lafayette, Indiana, Stany Zjednoczone, 47906
        • Options Research Group LLC
    • Kansas
      • Overland Park, Kansas, Stany Zjednoczone, 66223
        • Dermatology and Skin Cancer Center of Overland Park
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40241
        • DS Research
      • Murray, Kentucky, Stany Zjednoczone, 42071
        • Kentucky Advanced Medical Research LLC
    • Massachusetts
      • Brighton, Massachusetts, Stany Zjednoczone, 02135
        • MetroBoston Clinical Partners
    • Michigan
      • Farmington Hills, Michigan, Stany Zjednoczone, 48334
        • Wendy Sadoff MD Dermatology PC
      • Troy, Michigan, Stany Zjednoczone, 48084
        • Somerset Skin Centre
      • Troy, Michigan, Stany Zjednoczone, 48084
        • Revival Research Institute LLC
    • Nebraska
      • Omaha, Nebraska, Stany Zjednoczone, 68144
        • Advanced Dermatology of the Midlands
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89117
        • James Del Rosso Dermatology Research
      • Reno, Nevada, Stany Zjednoczone, 89509
        • Skin Cancer and Dermatology Institute
    • New Hampshire
      • Lebanon, New Hampshire, Stany Zjednoczone, 03766
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Riverdale, New Jersey, Stany Zjednoczone, 07457
        • Weiss Medical
    • New York
      • Horseheads, New York, Stany Zjednoczone, 14845
        • Corning Center for Clinical Research
      • Kew Gardens, New York, Stany Zjednoczone, 11415
        • Forest Hills Dermatology Group
      • Monroe, New York, Stany Zjednoczone, 10950
        • Crystal Run Healthcare
      • New York, New York, Stany Zjednoczone, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Stany Zjednoczone, 10022
        • Ace Clinical Trials
      • New York, New York, Stany Zjednoczone, 10128
        • OptiSkin Medical
      • The Bronx, New York, Stany Zjednoczone, 10467
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, Stany Zjednoczone, 27713
        • Duke South Durham
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone, 45219
        • University of Cincinnati
      • Cincinnati, Ohio, Stany Zjednoczone, 45236
        • Bernstein Clinical Research Center LLC
      • Gahanna, Ohio, Stany Zjednoczone, 43230
        • The Ohio State University Dermatology East
    • Oregon
      • Grants Pass, Oregon, Stany Zjednoczone, 97527
        • Velocity Clinical Research - Grants Pass
      • Portland, Oregon, Stany Zjednoczone, 97223
        • Oregon Medical Research Center
    • Rhode Island
      • Warwick, Rhode Island, Stany Zjednoczone, 02886
        • Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
    • Texas
      • Bellaire, Texas, Stany Zjednoczone, 77401
        • Bellaire Dermatology Associates
      • Cedar Park, Texas, Stany Zjednoczone, 78613
        • US Dermatology Partners Cedar Park
      • Dallas, Texas, Stany Zjednoczone, 75225
        • Alina Clinical Trials, LLC
      • Dallas, Texas, Stany Zjednoczone, 75230
        • Zenos Clinical Research, LLC
      • Houston, Texas, Stany Zjednoczone, 77030
        • The University of Texas Health Science Center at Houston
      • Houston, Texas, Stany Zjednoczone, 77037
        • MedCare Pharma - Houston
      • Lampasas, Texas, Stany Zjednoczone, 76550
        • FMCScience LLC
      • Lewisville, Texas, Stany Zjednoczone, 75057
        • Epic Clinical Research Incorporated
      • Missouri City, Texas, Stany Zjednoczone, 77459
        • Sienna Dermatology Research
      • San Antonio, Texas, Stany Zjednoczone, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Dermatology Clinical Research Center of San Antonio
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Andante Research
    • Utah
      • Murray, Utah, Stany Zjednoczone, 84107
        • University of Utah Midvalley Dermatology
    • Virginia
      • Norfolk, Virginia, Stany Zjednoczone, 23507
        • Eastern Virginia Medical School
    • Washington
      • Spokane, Washington, Stany Zjednoczone, 99202
        • MultiCare Institute for Research and Innovation
  • Szwecja
      • Stockholm, Szwecja, 171 76
        • Karolinska Universitetssjukhuset Solna
  • Turcja (Türkiye)
      • Ankara, Turcja (Türkiye), 06230
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Gaziantep, Turcja (Türkiye), 27310
        • Gaziantep Universitesi Tip Fakultesi Hastanesi
      • Istanbul, Turcja (Türkiye), 34093
        • Bezmialem Vakif Universitesi Hastanesi
      • Izmir, Turcja (Türkiye), 35620
        • Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
      • Kayseri, Turcja (Türkiye), 38030
        • Erciyes Universitesi Tip Fakultesi Hastanesi
      • Kocaeli, Turcja (Türkiye), 41380
        • Kocaeli Universitesi Tip Fakultesi Hastanesi
      • Sakarya, Turcja (Türkiye), 54050
        • Sakarya Egitim ve Arastirma Hastanesi
  • Zjednoczone Królestwo
      • Corby, Zjednoczone Królestwo, NN17 2UR
        • Lakeside Healthcare
      • London, Zjednoczone Królestwo, SE1 9RT
        • Guys Hospital
      • Southampton, Zjednoczone Królestwo, SO16 6YD
        • Southampton General Hospital

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 do 100 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Wiek ≥ 18 lat z rozpoznaniem AZS według AAD Consensus Criteria (2014) obecne od co najmniej 6 miesięcy
  • Historia niewystarczającej odpowiedzi na TCS (miejscowe kortykosteroidy) o średniej lub większej sile działania w ciągu 6 miesięcy (z miejscowymi inhibitorami kalcyneuryny [TCI] lub bez)
  • Wynik EASI ≥16
  • Wynik VIGA-AD ≥3
  • ≥10% powierzchni ciała (BSA) zajęcia AD
  • Numeryczna skala oceny najgorszego świądu ≥ 4

Kryteria wyłączenia:

  • Leczenie produktem biologicznym w ciągu 12 tygodni lub 5 okresów półtrwania, w zależności od tego, który okres jest dłuższy, przed 1. dniem

  • Leczenie dowolnym z poniższych leków lub terapii w ciągu 4 tygodni lub 5 okresów półtrwania, w zależności od tego, który z tych okresów jest dłuższy, przed 1. dniem:

    • Ogólnoustrojowe kortykosteroidy
    • Ogólnoustrojowe leki immunosupresyjne
    • Światłolecznictwo
    • Inhibitory kinazy janusowej

  • Leczenie dowolnym z poniższych leków lub terapii w ciągu 1 tygodnia przed dniem 1:

    • TCS o dowolnej mocy
    • TCI
    • Miejscowe inhibitory fosfodiesterazy typu 4
    • Inne miejscowe środki immunosupresyjne

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: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Rocatinlimab
Rocatinlimab Dawka 1 co 4 tygodnie (Q4W) przez 24 tygodnie z dawką nasycającą w 2. tygodniu.
Lek: Rocatinlimab
Rocatinlimab będzie podawany we wstrzyknięciu podskórnym (SC).
Inne nazwy:
  • AMG 451
  • KHK 4083
Komparator placebo: Placebo
Placebo Q4W przez 24 tygodnie z dawką nasycającą w 2. tygodniu.
Inny: Placebo
Dopasowane placebo zostanie podane przez wstrzyknięcie SC.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (vIGA-AD) 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
Ramy czasowe: Baseline and Week 24
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," the participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, the participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Ramy czasowe: Baseline and Week 24
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants Who Achieved EASI 75 at Week 16
Ramy czasowe: Baseline and Week 16
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (vIGA-AD 0/1) at Week 16
Ramy czasowe: Baseline and Week 16
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Ramy czasowe: Baseline and Week 16
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Ramy czasowe: Baseline and Week 24
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Ramy czasowe: Baseline and Week 24
The EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Ramy czasowe: Baseline and Week 24
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) With a ≥ 2-Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
Ramy czasowe: Baseline and Week 24
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
Ramy czasowe: Baseline and Week 24
The severity of facial AD was assessed using the Facial AD Severity Scale (FASS). The FASS was an instrument used to rate the overall severity of facial AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline
Ramy czasowe: Baseline and Week 24
The severity of hand AD was assessed using the Hand Atopic Dermatitis Severity Scale (HASS). The HASS was an instrument used to rate the overall severity of hand AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Ramy czasowe: Baseline and Week 16
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward [WOCF]) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Baseline and Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Ramy czasowe: Baseline and Week 24
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Baseline and Week 24
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Ramy czasowe: Baseline and Week 16
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Baseline and Week 16
Change From Baseline in SCORAD Itch VAS Score at Week 24
Ramy czasowe: Baseline and Week 24
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Baseline and Week 24
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
Ramy czasowe: Baseline and Week 24
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adult patients suffering from skin disease. The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in DLQI Score at Week 24
Ramy czasowe: Baseline and Week 24
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adult patients suffering from skin disease. The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
Baseline and Week 24
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
Ramy czasowe: Baseline and Week 24
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in POEM Score at Week 24
Ramy czasowe: Baseline and Week 24
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Baseline and Week 24
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Ramy czasowe: Baseline and Week 16
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Ramy czasowe: Baseline and Week 24
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Ramy czasowe: Baseline and Week 16
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Baseline and Week 16
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Ramy czasowe: Baseline and Week 24
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Ramy czasowe: Baseline and Week 16
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Ramy czasowe: Baseline and Week 24
Weekly average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours. Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance. Participants were asked to rate the intensity of their sleep disturbance using this scale each day. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in level of sleep disturbance.
Baseline and Week 24
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
Ramy czasowe: Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
Ramy czasowe: Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Ramy czasowe: Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Baseline and Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24
Ramy czasowe: Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Baseline and Week 24
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
Ramy czasowe: Baseline and Week 24
The SCORAD total score used to assess the severity of AD using both physician and patient-reported data. SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Amgen

Śledczy

  • Dyrektor Studium: MD, Amgen

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

Przydatne linki

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 (Rzeczywisty)

14 grudnia 2022

Zakończenie podstawowe (Rzeczywisty)

5 czerwca 2024

Ukończenie studiów (Rzeczywisty)

27 sierpnia 2024

Daty rejestracji na studia

Pierwszy przesłany

7 grudnia 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 grudnia 2022

Pierwszy wysłany (Rzeczywisty)

15 grudnia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20210143
  • 2022-501538-44 (Inny identyfikator: EU CT Number)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Pozbawione elementów umożliwiających identyfikację dane poszczególnych pacjentów dla zmiennych niezbędnych do rozwiązania konkretnego pytania badawczego w zatwierdzonym wniosku o udostępnienie danych.

Ramy czasowe udostępniania IPD

Prośby o udostępnienie danych dotyczące tego badania będą rozpatrywane począwszy od 18 miesięcy po zakończeniu badania i albo 1) produkt i wskazanie uzyskały pozwolenie na dopuszczenie do obrotu zarówno w USA, jak i Europie, albo 2) badania kliniczne produktu i/lub wskazania zostały przerwane a dane nie będą przekazywane organom regulacyjnym. Nie ma ostatecznej daty kwalifikowalności do przesłania prośby o udostępnienie danych dla tego badania.

Kryteria dostępu do udostępniania IPD

Wykwalifikowani badacze mogą złożyć wniosek zawierający cele badawcze, produkt(y) firmy Amgen i badanie/badania firmy Amgen w zakresie, punkty końcowe/wyniki będące przedmiotem zainteresowania, plan analizy statystycznej, wymagania dotyczące danych, plan publikacji oraz kwalifikacje badacza(ów). Ogólnie rzecz biorąc, firma Amgen nie przyjmuje zewnętrznych próśb o dane poszczególnych pacjentów w celu ponownej oceny kwestii bezpieczeństwa i skuteczności, które zostały już uwzględnione na etykiecie produktu. Wnioski są rozpatrywane przez komitet doradców wewnętrznych. Jeśli nie zostanie to zatwierdzone, niezależny panel kontrolny ds. udostępniania danych przeprowadzi arbitraż i podejmie ostateczną decyzję. Po zatwierdzeniu informacje niezbędne do odpowiedzi na pytanie badawcze zostaną dostarczone zgodnie z warunkami umowy o udostępnianiu danych. Może to obejmować zanonimizowane dane poszczególnych pacjentów i/lub dostępne dokumenty potwierdzające, zawierające fragmenty kodu analizy, jeśli podano w specyfikacjach analizy. Dalsze szczegóły są dostępne pod poniższym adresem URL.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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