Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Tutkimus rotatinlimabin (AMG 451) arvioimiseksi nuorilla, joilla on keskivaikea tai vaikea atooppinen ihottuma (AD) (ROCKET-ASTRO)

torstai 6. elokuuta 2026 päivittänyt: Amgen

Kolmannen vaiheen, satunnaistettu, 52-viikkoinen, lumekontrolloitu, kaksoissokkotutkimus, jossa satunnaistettiin uudelleen, arvioimaan rokatinlimabin (AMG 451) tehoa, turvallisuutta ja siedettävyyttä nuorilla, joilla on kohtalainen tai vaikea atooppinen ihottuma (AD) ( ROCKET-ASTRO)

Tämän tutkimuksen tarkoituksena on arvioida rokatinlimabin tehoa ja turvallisuutta yksin- ja yhdistelmähoidossa nuorilla koehenkilöillä.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

532

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Belgia
      • Brussels, Belgia, 1070
        • Hopital Erasme
      • Brussels, Belgia, 1200
        • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
      • Ghent, Belgia, 9000
        • Universitair Ziekenhuis Gent
      • Liège, Belgia, 4000
        • Centre Hospitalier Universitaire de Liege - Sart Tilman
      • Maldegem, Belgia, 9990
        • Dermatologie Maldegem
  • Brasilia
      • Rio de Janeiro, Brasilia, 20241-180
        • IBPClin Instituto Brasil de Pesquisa Clinica
    • Espírito Santo
      • Vitória, Espírito Santo, Brasilia, 29055-450
        • Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasilia, 41820-020
        • Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasilia, 30575-180
        • Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilia, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasilia, 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
    • São Paulo
      • Jaú, São Paulo, Brasilia, 17201-130
        • Cecip Centro Est Clin Int Paulista
      • Ribeirão Preto, São Paulo, Brasilia, 14026-020
        • Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli
      • São José do Rio Preto, São Paulo, Brasilia, 15090-000
        • Hospital de Base de Sao Jose do Rio Preto
      • São Paulo, São Paulo, Brasilia, 01228-200
        • Instituto Pesquisa e Ensino em Saúde Infantil
      • São Paulo, São Paulo, Brasilia, 05403-002
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Chile
      • Osorno, Chile, 5310644
        • Centro Dermatologico Dermisur
      • Santiago, Chile, 7640881
        • Clinica Dermacross SA
      • Santiago, Chile, 7580206
        • Centro Medico Skinmed Spa
      • Santiago, Chile, 8380465
        • Fundacion Innovacion Cardiovascular
      • Santiago, Chile, 8420383
        • Centro Internacional de Estudios Clínicos
  • Espanja
      • Madrid, Espanja, 28046
        • Hospital Universitario La Paz
      • Madrid, Espanja, 28007
        • Hospital General Universitario Gregorio Marañón
    • Catalonia
      • Barcelona, Catalonia, Espanja, 08041
        • Hospital de La Santa Creu i Sant Pau
      • Esplugues de Llobregat, Catalonia, Espanja, 08950
        • Hospital Sant Joan de Déu
    • Navarre
      • Pamplona, Navarre, Espanja, 31008
        • Clinica Universidad de Navarra
  • Etelä -Korea
      • Ansansi, Gyeonggido, Etelä -Korea, 15355
        • Korea University Ansan Hospital
      • Seoul, Etelä -Korea, 03080
        • Seoul National University Hospital
      • Seoul, Etelä -Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Etelä -Korea, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Etelä -Korea, 05278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Etelä -Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Etelä -Korea, 08308
        • Korea University Guro Hospital
      • Seoul, Etelä -Korea, 06973
        • Chung-Ang University Hospital
      • Seoul, Etelä -Korea, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Etelä -Korea, 04564
        • National Medical Center
      • Seoul, Etelä -Korea, 07804
        • Ewha Womans University Seoul Hospital
  • Israel
      • Bear Sheva, Israel, 8410101
        • Soroka Medical Center
      • Ramat Gan, Israel, 5262000
        • Sheba medical center
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center
  • Italia
      • Milan, Italia, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Naples, Italia, 80131
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli
      • Perugia, Italia, 06129
        • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
      • Torino, Italia, 10126
        • Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino
  • Japani
    • Aichi-ken
      • Nagoya, Aichi-ken, Japani, 464-0821
        • Central Clinic
    • Chiba
      • Matsudo-shi, Chiba, Japani, 271-0092
        • Miyata Dermatology Clinic
    • Fukuoka
      • Fukuoka, Fukuoka, Japani, 819-0373
        • Matsuo Clinic
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japani, 070-8610
        • Asahikawa City Hospital
      • Obihiro-shi, Hokkaido, Japani, 080-0013
        • Takagi Dermatological Clinic
    • Hyōgo
      • Akashi-shi, Hyōgo, Japani, 674-0068
        • Yoshimura Child Clinic
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japani, 890-0063
        • Katahira Dermatology Urology Clinic
    • Kanagawa
      • Yokohama, Kanagawa, Japani, 231-8682
        • Yokohama City Minato Red Cross Hospital
      • Yokohama, Kanagawa, Japani, 221-0825
        • Nomura Dermatology Clinic
    • Kumamoto
      • Kumamoto, Kumamoto, Japani, 860-0066
        • Jouzan Hihuka Hinyoukika Clinic
      • Kumamoto, Kumamoto, Japani, 862-0950
        • Suizenji Dermatology Clinic
    • Osaka
      • Neyagawa, Osaka, Japani, 572-0838
        • Yoshioka Dermatology Clinic
      • Sakai-shi, Osaka, Japani, 593-8324
        • Dermatology and Ophthalmology Kume Clinic
    • Shizuoka
      • Hamamatsu, Shizuoka, Japani, 431-3192
        • Hamamatsu University Hospital
    • Tokyo
      • Setagaya-ku, Tokyo, Japani, 158-0097
        • Naoko Dermatology Clinic
      • Shinagawa-ku, Tokyo, Japani, 141-8625
        • NTT Medical Center Tokyo
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T3K 6B8
        • Rejuvenation Dermatology Laser Calgary North
    • Ontario
      • Markham, Ontario, Kanada, L3P 1X3
        • Lynderm Research Inc
      • Newmarket, Ontario, Kanada, L3Y 5G8
        • Dr SK Siddha Medicine Professional Corporation
      • Niagara Falls, Ontario, Kanada, L2H 1H5
        • Allergy Research Canada Incorporated
      • Windsor, Ontario, Kanada, N8T 1E6
        • XLR8 Medical Research, Incorporated
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7K 2C1
        • Skinsense Medical Research
  • Kiina
      • Changsha, Kiina, 410007
        • Hunan Childrens Hospital
      • Shenzhen, Kiina, 518038
        • Shenzhen Childrens Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kiina, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, Kiina, 100020
        • Childrens Hospital Capital Institute of Pediatrics
      • Beijing, Beijing Municipality, Kiina, 100044
        • Peking University Peoples Hospital
      • Beijing, Beijing Municipality, Kiina, 100045
        • Beijing Childrens Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kiina, 400014
        • Childrens Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, Kiina, 510091
        • Dermatology Hospital of Southern Medical University
      • Guangzhou, Guangdong, Kiina, 510120
        • Sun Yat-sen Memorial Hospital Sun Yat-sen university
      • Guangzhou, Guangdong, Kiina, 510080
        • The First Affiliated Hospital Sun-Yat Sen University
    • Henan
      • Nanyang, Henan, Kiina, 473002
        • Nanyang First Peoples Hospital
    • Hubei
      • Wuhan, Hubei, Kiina, 430022
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
      • Wuhan, Hubei, Kiina, 430014
        • The Central Hospital of Wuhan
    • Jiangsu
      • Jiangyin, Jiangsu, Kiina, 214400
        • Jiangyin Hospital of Traditional Chinese Medicine
    • Jilin
      • Changchun, Jilin, Kiina, 130021
        • The First Bethune Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, Kiina, 116011
        • Dalian Women and Childrens Medical Group
    • Ningxia
      • Yinchuan, Ningxia, Kiina, 750003
        • General Hospital of Ningxia Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kiina, 200443
        • Shanghai Skin Disease Hospital
    • Sichuan
      • Chengdu, Sichuan, Kiina, 610021
        • Chengdu Second Peoples Hospital
      • Suining, Sichuan, Kiina, 629099
        • Suining Central Hospital
    • Yunnan
      • Kunming, Yunnan, Kiina, 650103
        • Kunming Childrens Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Kiina, 310020
        • Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
      • Ningbo, Zhejiang, Kiina, 315010
        • Ningbo NO 2 Hospital
      • Taizhou, Zhejiang, Kiina, 318000
        • Taizhou Central Hospital
  • Kreikka
      • Athens, Kreikka, 11521
        • Athens Naval Hospital
      • Athens, Kreikka, 11527
        • Thoracic General Hospital Of Athens Sotiria
      • Athens, Kreikka, 11527
        • Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
      • Thessaloniki, Kreikka, 54643
        • Ippokratio General Hospital of Thessaloniki
  • Kroatia
      • Ivanić-Grad, Kroatia, 10310
        • Special Hospital for Medical Rehabilitation Naftalan
      • Osijek, Kroatia, 31000
        • University Hospital Centre Osijek
      • Zagreb, Kroatia, 10000
        • University Hospital Centre Zagreb
      • Zagreb, Kroatia, 10000
        • Sestre milosrdnice University Hospital Center
      • Zagreb, Kroatia, 10000
        • Children s Hospital Zagreb
  • Meksiko
      • Toluca, Meksiko, 50090
        • Phylasis Clinicas Research Toluca
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group, PSC
      • San Juan, Puerto Rico, 00909
        • Clinical Research of Puerto Rico
  • Puola
      • Gdansk, Puola, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gdansk, Puola, 80-280
        • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
      • Katowice, Puola, 40-611
        • Centrum Medyczne Angelius Provita
      • Katowice, Puola, 40-600
        • GynCentrum Sp zoo NZOZ Holsamed
      • Krakow, Puola, 30-002
        • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
      • Krakow, Puola, 31-559
        • Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
      • Lodz, Puola, 90-349
        • AppleTreeClinics Network Spzoo
      • Lodz, Puola, 91-495
        • Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
      • Lublin, Puola, 20-011
        • Clinical Best Solutions Sp zoo Spolka komandytowa
      • Sosnowiec, Puola, 41-200
        • Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
      • Tarnów, Puola, 33-100
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
      • Warsaw, Puola, 02-962
        • Royalderm Agnieszka Nawrocka
      • Warsaw, Puola, 02-953
        • Klinika Ambroziak Dermatologia
      • Warsaw, Puola, 00-716
        • Klinika Osipowicz and Turkowski Sp zoo
      • Warsaw, Puola, 01-817
        • High Med Przychodnia Specjalistyczna
      • Wroclaw, Puola, 50-450
        • Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
  • Ranska
      • Antony, Ranska, 92160
        • Hopital Prive d Antony
      • Brest, Ranska, 29200
        • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
      • Marseille, Ranska, 13285
        • Hôpital Saint-Joseph
      • Nantes, Ranska, 44093
        • Centre Hospitalier Universitaire de Nantes Hôtel Dieu
      • Rennes, Ranska, 35033
        • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
      • Rouen, Ranska, 76031
        • Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
      • Toulouse, Ranska, 31059
        • Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
  • Romania
      • Bucharest, Romania, 011216
        • Dr Leventer Centre Clinica Dermatologie Bucuresti
      • Cluj-Napoca, Romania, 400431
        • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
      • Cluj-Napoca, Romania, 400105
        • Derma Cluj
  • Saksa
      • Bad Bentheim, Saksa, 48455
        • Fachklinik Bad Bentheim
      • Bonn, Saksa, 53127
        • Universitaetsklinikum Bonn
      • Darmstadt, Saksa, 64283
        • Rosenpark Research GmbH
      • Dresden, Saksa, 01307
        • Universitaetsklinikum Dresden
      • Erlangen, Saksa, 91054
        • Universitaetsklinikum Erlangen
      • Frankfurt am Main, Saksa, 60590
        • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
      • Leipzig, Saksa, 04103
        • Velocity Clinical Research
      • Mainz, Saksa, 55101
        • Johannes Gutenberg Universitaet Mainz
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital
  • Thaimaa
      • Bangkok, Thaimaa, 10330
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thaimaa, 10700
        • Siriraj Hospital
      • Chiang Mai, Thaimaa, 50200
        • Maharaj Nakorn Chiang Mai Hospital
      • Pathum Thani, Thaimaa, 12120
        • Thammasat University Hospital
  • Unkari
      • Budapest, Unkari, 1033
        • Clinexpert Kft
      • Debrecen, Unkari, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Unkari, 4031
        • Derma-B Egeszsegugyi es Szolgaltato Kft
      • Kaposvár, Unkari, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
  • Yhdysvallat
    • Alabama
      • Birmingham, Alabama, Yhdysvallat, 35244
        • Cahaba Dermatology and Skin Health Center
      • Cullman, Alabama, Yhdysvallat, 35058
        • AllerVie Clinical Research- Cullman
    • Arizona
      • Tucson, Arizona, Yhdysvallat, 85745
        • Eclipse Clinical Research
    • Arkansas
      • North Little Rock, Arkansas, Yhdysvallat, 72117
        • Arkansas Research Trials, LLC
    • California
      • Fremont, California, Yhdysvallat, 94538
        • Center for Dermatology Clinical Research Inc
      • Fullerton, California, Yhdysvallat, 92831
        • Doc1 Healthcare Systems Incorporated
      • Inglewood, California, Yhdysvallat, 90301
        • Axon Clinical Research
      • Laguna Niguel, California, Yhdysvallat, 92677
        • Avance Clinical Trials
      • Palmdale, California, Yhdysvallat, 93551
        • Cura Clinical Research
      • Sacramento, California, Yhdysvallat, 95815
        • Integrative Skin Science and Research
      • Sacramento, California, Yhdysvallat, 95816
        • University of California at Davis Medical Center
      • San Diego, California, Yhdysvallat, 92123
        • Allergy and Asthma Medical Group and Research Center
      • San Diego, California, Yhdysvallat, 92123
        • University of California at San Diego Rady Childrens Hospital San Diego
      • Santa Monica, California, Yhdysvallat, 90404
        • Clinical Science Institute
      • Sherman Oaks, California, Yhdysvallat, 91403
        • Cura Clinical Research Sherman Oaks
    • Colorado
      • Denver, Colorado, Yhdysvallat, 80209
        • Velocity Clinical Research - Denver
    • District of Columbia
      • Washington D.C., District of Columbia, Yhdysvallat, 20010
        • Childrens National Medical Center
    • Florida
      • Brandon, Florida, Yhdysvallat, 33511
        • Clinical Research of Brandon
      • Clearwater, Florida, Yhdysvallat, 33761
        • Academic Alliance in Dermatology - Saint Petersburg Office
      • Coral Springs, Florida, Yhdysvallat, 33071
        • Corazon United States of America, LLC doing business as Life Clinical Trials
      • Delray Beach, Florida, Yhdysvallat, 33484
        • Palm Beach Dermatology Group
      • Hialeah, Florida, Yhdysvallat, 33012
        • Direct Helpers Research Center
      • Margate, Florida, Yhdysvallat, 33063
        • Glick Skin Institute
      • Miami, Florida, Yhdysvallat, 33155
        • Miami Clinical Research
      • Miami, Florida, Yhdysvallat, 33176
        • ara Professionals Limited Liability Corporation
      • Miami Lakes, Florida, Yhdysvallat, 33014
        • Savin Medical Group LLC
      • Miami Lakes, Florida, Yhdysvallat, 33016
        • Angels Clinical Research Institute
      • Miami Lakes, Florida, Yhdysvallat, 33014
        • Deluxe Health Care LLC
      • Orange City, Florida, Yhdysvallat, 32763
        • Optimal Research Sites, LLC
      • Orlando, Florida, Yhdysvallat, 32819
        • Clinical Research Investments
      • Orlando, Florida, Yhdysvallat, 32819
        • Clinical Associates of Orlando Limited Liability Company
      • Tampa, Florida, Yhdysvallat, 33612
        • University of South Florida
    • Georgia
      • Columbus, Georgia, Yhdysvallat, 31904
        • Centricity Research Columbus
      • Sandy Springs, Georgia, Yhdysvallat, 30328
        • Advanced Medical Research Pc
      • Savannah, Georgia, Yhdysvallat, 31419
        • Divine Dermatology and Aesthetics
      • Thomasville, Georgia, Yhdysvallat, 31792
        • McIntosh Clinic PC
    • Idaho
      • Boise, Idaho, Yhdysvallat, 83706-1345
        • Treasure Valley Medical Research
      • Meridian, Idaho, Yhdysvallat, 83642
        • Velocity Clinical Research - Boise
    • Illinois
      • Skokie, Illinois, Yhdysvallat, 60077
        • NorthShore University HealthSystem Clinical Trials Center
    • Indiana
      • Indianapolis, Indiana, Yhdysvallat, 46250
        • Dawes Fretzin Clinical Research Group, LLC
      • New Albany, Indiana, Yhdysvallat, 47150
        • Southern Indiana Clinical Trials
      • Plainfield, Indiana, Yhdysvallat, 46168
        • The Indiana Clinical Trials Center PC
    • Kentucky
      • Bowling Green, Kentucky, Yhdysvallat, 42104
        • Equity Medical
      • Murray, Kentucky, Yhdysvallat, 42071
        • Kentucky Advanced Medical Research LLC
    • Louisiana
      • Monroe, Louisiana, Yhdysvallat, 71201
        • Industrial Medicine Associates Clinical Research Advanced Dermatology Care
    • Maryland
      • Rockville, Maryland, Yhdysvallat, 20850
        • Aesthetic and Dermatology Center
      • Rockville, Maryland, Yhdysvallat, 20850
        • Derm Associates, PC
    • Michigan
      • Auburn Hills, Michigan, Yhdysvallat, 48326
        • Oakland Hills Dermatology
      • Detroit, Michigan, Yhdysvallat, 48202
        • Henry Ford Health System
      • Flint, Michigan, Yhdysvallat, 48532
        • Onyx Clinical Research
    • Missouri
      • Saint Joseph, Missouri, Yhdysvallat, 64506
        • MediSearch Clinical Trials
      • St Louis, Missouri, Yhdysvallat, 63110
        • Saint Louis University
    • Nebraska
      • Lincoln, Nebraska, Yhdysvallat, 68505
        • Somnos Clinical Research
    • Nevada
      • Reno, Nevada, Yhdysvallat, 89509
        • Skin Cancer and Dermatology Institute
    • New Hampshire
      • Portsmouth, New Hampshire, Yhdysvallat, 03801
        • Allcutis Research
    • New Jersey
      • Bridgewater, New Jersey, Yhdysvallat, 08807
        • The Dermatology Center of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, Yhdysvallat, 87102
        • University of New Mexico
    • New York
      • Brooklyn, New York, Yhdysvallat, 11211
        • Ace Clinical Trials
      • East Syracuse, New York, Yhdysvallat, 13057
        • Empire Dermatology
      • Jackson Heights, New York, Yhdysvallat, 11372
        • Smart Medical Research Inc
      • Kew Gardens, New York, Yhdysvallat, 11415
        • Forest Hills Dermatology Group
      • New York, New York, Yhdysvallat, 10016
        • Pioneer Clinical Research New York
      • New York, New York, Yhdysvallat, 10075
        • Cornell University - Weill Cornell Medicine
      • Rochester, New York, Yhdysvallat, 14609
        • Rochester Clinical Research
      • The Bronx, New York, Yhdysvallat, 10467
        • Yeshiva University - Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, Yhdysvallat, 27713
        • Duke South Durham
    • Ohio
      • Boardman, Ohio, Yhdysvallat, 44512
        • Optima Research
      • Mayfield Heights, Ohio, Yhdysvallat, 44124
        • Apex Clinical Research Center LLC
    • Oklahoma
      • Chickasha, Oklahoma, Yhdysvallat, 73018
        • Epic Medical Research - Oklahoma
      • Oklahoma City, Oklahoma, Yhdysvallat, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, Yhdysvallat, 73120
        • Dermatology and Aesthetics of Oklahoma
      • Tulsa, Oklahoma, Yhdysvallat, 74132
        • Dermatology Research Center of Oklahoma, PLLC
      • Tulsa, Oklahoma, Yhdysvallat, 74137
        • Essential Medical Research LLC
    • Oregon
      • Grants Pass, Oregon, Yhdysvallat, 97527
        • Velocity Clinical Research - Grants Pass
      • Portland, Oregon, Yhdysvallat, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Yhdysvallat, 19103
        • Paddington Testing Company Inc
    • Rhode Island
      • Providence, Rhode Island, Yhdysvallat, 02903
        • Rhode Island Hospital, Lifespan
    • South Carolina
      • Charleston, South Carolina, Yhdysvallat, 29425
        • Medical University of South Carolina
      • North Charleston, South Carolina, Yhdysvallat, 29420
        • National Allergy and Asthma Research, LLC
      • Summerville, South Carolina, Yhdysvallat, 29486
        • Coastal Pediatric Research
    • Tennessee
      • Morristown, Tennessee, Yhdysvallat, 37813
        • HealthStar Physicians Dermatology
    • Texas
      • Bellaire, Texas, Yhdysvallat, 77401
        • The University of Texas Health Science Center at Houston
      • Cedar Park, Texas, Yhdysvallat, 78613
        • US Dermatology Partners Cedar Park
      • Cypress, Texas, Yhdysvallat, 77429
        • Studies in Dermatology LLC
      • Houston, Texas, Yhdysvallat, 77037
        • MedCare Pharma - Houston
      • Houston, Texas, Yhdysvallat, 77098
        • Tranquil Clinical Research
      • Kerrville, Texas, Yhdysvallat, 78028
        • Sante Clinical Research
      • Lubbock, Texas, Yhdysvallat, 79424
        • Long and Harris Dermatology
      • Mesquite, Texas, Yhdysvallat, 75149
        • Sms Clinical Research Limited Liability Company
      • Missouri City, Texas, Yhdysvallat, 77459
        • Sienna Dermatology Research
      • San Antonio, Texas, Yhdysvallat, 78218
        • Texas Dermatology and Laser Specialists
      • Southlake, Texas, Yhdysvallat, 76092
        • Epiphany Dermatology
      • Sugar Land, Texas, Yhdysvallat, 77479
        • Pioneer Research Solutions
    • Utah
      • Murray, Utah, Yhdysvallat, 84107
        • Tanner Clinic
      • Providence, Utah, Yhdysvallat, 84332
        • Dermatology Research of Utah, dba Providence Dermatology
      • South Jordan, Utah, Yhdysvallat, 84095
        • Jordan Valley Dermatology Center
    • Virginia
      • Franklin, Virginia, Yhdysvallat, 23851
        • Maria M Ona MD PC
    • Washington
      • Bellevue, Washington, Yhdysvallat, 98007
        • Northwest Clinical Research Center

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

12 vuotta - 17 vuotta (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

  • Ikä ≥ 12 - < 18 vuotta päivänä 1.
  • Ruumiinpaino ≥ 40 kg seulonnassa.
  • Aikaisempi riittämätön vaste keskitehoiseen tai tehokkaampaan TCS:ään 6 kuukauden sisällä (TCI:n kanssa tai ilman).
  • EASI-pisteet ≥ 16.
  • vIGA-AD pisteet ≥ 3.
  • ≥10 % kehon pinta-alasta (BSA) AD:n vaikutuksesta.
  • Pahin kutina NRS ≥ 4.

Poissulkemiskriteerit:

  • Hoito biologisella tuotteella 12 viikon tai 5 puoliintumisajan kuluessa, riippuen siitä kumpi on pidempi, ennen päivää 1.

  • Hoito jollakin seuraavista lääkkeistä tai hoidoista 4 viikon tai 5 puoliintumisajan kuluessa, sen mukaan, kumpi on pidempi, ennen päivää 1:

    1. Systeemiset kortikosteroidit
    2. Systeemiset immunosuppressantit
    3. Valohoito
    4. Oraaliset tai paikalliset Janus-kinaasin estäjät

  • Hoito jollakin seuraavista lääkkeistä tai hoidoista 1 viikon sisällä ennen päivää 1:

    1. TCS
    2. TCI
    3. Paikalliset fosfodiesteraasin tyypin 4 estäjät
    4. Muut paikalliset immunosuppressiiviset aineet

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Peräkkäinen tehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Käsivarsi A: Annos 1

Osa 1 (Alkujakso); Viikko 0 - viikko 24: Rokatinlimabi Annos 1 joka 4. viikko (Q4W) 24 viikon ajan kyllästysannoksella viikolla 2 (+ paikalliset kortikosteroidit (TCS)/paikallinen kalsineuriinin estäjä (TCI), jos yhdistelmähoitokohortissa).

Osa 2 (huoltojakso); Viikosta 24 viikolle 52: Osaan 1 vastaajat satunnaistetaan viikolla 24 Rocatinlimab-annokseen 1 Q4W tai 8 viikon välein (Q8W) 28 viikon ajan (+ TCS/TCI, jos yhdistelmähoitokohortti kuuluu).
Lääke: Rokatinlimabi
Ihonalainen (SC) injektio
Muut nimet:
  • AMG 451
Kokeellinen: Käsivarsi B: annos 2

Osa 1 (Alkujakso); Viikko 0 - viikko 24: Rokatinlimabiannos 2 Q4W 24 viikon ajan, kyllästysannos viikolla 2 (+TCS/TCI, jos yhdistelmähoitokohortissa).

Osa 2 (huoltojakso); Viikosta 24 viikolle 52: Osaan 1 vastaajat satunnaistetaan viikolla 24 Rocatinlimab-annokseen 2 Q4W tai Q8W 28 viikon ajaksi (TCS/TCI:llä, jos se kuuluu yhdistelmähoitokohorttiin).
Lääke: Rokatinlimabi
Ihonalainen (SC) injektio
Muut nimet:
  • AMG 451
Kokeellinen: Käsivarsi C: Placebo

Osa 1 (Alkujakso); Viikko 0 - viikko 24: lumelääke Q4W 24 viikon ajan, kyllästysannos viikolla 2 (+TCS/TCI, jos yhdistelmähoitokohortissa).

Osa 2 (huoltojakso); Viikosta 24 viikoksi 52: Osan 1 vastaajat jaetaan uudelleen viikolla 24 lumelääkkeellä Q4W 28 viikoksi (TCS/TCI, jos yhdistelmähoitokohortti).
Lääke: Plasebo
SC-injektio
Kokeellinen: Käsivarsi D: avoin annos 1
Osa 2; Viikosta 24 viikoksi 52: Osa 1 Reagoimattomat henkilöt jaetaan uudelleen viikolla 24 Rocatinlimab-avoin annoksella 1 Q4W 28 viikoksi (TCS/TCI, jos yhdistelmähoitokohortti). A-, B- tai C-hoitojakson osallistujille määrätään uudelleen Rocatinlimab Open-label Dose 1 Q4W (TCS/TCI, jos se kuuluu yhdistelmähoitokohorttiin), kun uusiutuminen tapahtuu viikon 24 jälkeen.
Lääke: Rokatinlimabi
Ihonalainen (SC) injektio
Muut nimet:
  • AMG 451

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants Who Achieved 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
Aikaikkuna: 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," participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, 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 EASI 75 at Week 24
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants Who Achieved EASI 75 at Week 16
Aikaikkuna: 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 ≥ 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
Aikaikkuna: 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 ≥ 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
Aikaikkuna: 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 ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
Aikaikkuna: 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
Aikaikkuna: 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
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
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
Aikaikkuna: 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
Number of Participants Who Achieved vIGA-AD 0/1 at Week 16
Aikaikkuna: 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
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Aikaikkuna: 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 symptoms of 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
Aikaikkuna: 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 symptoms of 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
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Aikaikkuna: Baseline and Week 24
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 ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Aikaikkuna: 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
Number of Participants Who Achieved vIGA-AD 0/1 at Week 24
Aikaikkuna: 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 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
Aikaikkuna: 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. Only 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
Aikaikkuna: Baseline and Week 24
The EASI was designed by modifying the Psoriasis Area and Severity Index, 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
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16
Aikaikkuna: Up to Week 16
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
Up to Week 16
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24
Aikaikkuna: Up to Week 24
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
Up to Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Aikaikkuna: Baseline and Week 16
The Worst Pruritus was assessed 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
Aikaikkuna: Baseline and Week 24
The Worst Pruritus was assessed 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
Number of Participants ≥ 16 Years Old at Enrollment Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
Aikaikkuna: 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 adolescent 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 For Participants ≥ 16 Years Old at Enrollment
Aikaikkuna: 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 adolescent 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
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment
Aikaikkuna: Baseline and Week 24
The CDLQI was a 10-item 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 child patients suffering from skin disease. The CDLQI 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 Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
Aikaikkuna: 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 worse anxiety. 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
Aikaikkuna: 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 worse depression. 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
Aikaikkuna: 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 worse anxiety. 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 anxiety.
Baseline and Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24
Aikaikkuna: 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 worse depression. 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 depression.
Baseline and Week 24

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Amgen

Tutkijat

  • Opintojohtaja: MD, Amgen

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Torstai 20. huhtikuuta 2023

Ensisijainen valmistuminen (Todellinen)

Torstai 27. helmikuuta 2025

Opintojen valmistuminen (Todellinen)

Tiistai 25. marraskuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 20. tammikuuta 2023

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 20. tammikuuta 2023

Ensimmäinen Lähetetty (Todellinen)

Maanantai 30. tammikuuta 2023

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 28. elokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 6. elokuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. heinäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 20210145
  • 2022-501586-50 (Muu tunniste: EUCTR)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

Yksittäisten potilastietojen tunnistamattomat muuttujat, jotka ovat tarpeen tietyn tutkimuskysymyksen käsittelemiseksi hyväksytyssä tiedonjakopyynnössä.

IPD-jaon aikakehys

Tähän tutkimukseen liittyvät tiedonjakopyynnöt otetaan huomioon 18 kuukauden kuluttua tutkimuksen päättymisestä ja joko 1) tuotteelle ja käyttöaiheelle on myönnetty myyntilupa sekä Yhdysvalloissa että Euroopassa tai 2) tuotteen ja/tai käyttöaiheen kliininen kehitys lopetetaan. eikä tietoja luovuteta valvontaviranomaisille. Tätä tutkimusta koskevien tietojen jakamispyynnön kelpoisuuden jättämiselle ei ole päättymispäivää.

IPD-jaon käyttöoikeuskriteerit

Pätevät tutkijat voivat lähettää pyynnön, joka sisältää tutkimuksen tavoitteet, Amgen-tuotteen (tuotteet) ja Amgen-tutkimuksen/tutkimukset laajuuden, päätepisteet/kiinnostavat tulokset, tilastollisen analyysisuunnitelman, tietovaatimukset, julkaisusuunnitelman ja tutkijan tai tutkijoiden pätevyyden. Yleisesti ottaen Amgen ei hyväksy yksittäisiä potilastietoja koskevia ulkoisia pyyntöjä, joiden tarkoituksena on arvioida uudelleen tuotemerkinnöissä jo käsiteltyjä turvallisuus- ja tehokysymyksiä. Pyynnöt käsittelee sisäisten neuvonantajien komitea. Jos sitä ei hyväksytä, tietojen jakamisesta riippumaton arviointipaneeli ratkaisee ja tekee lopullisen päätöksen. Hyväksymisen jälkeen tutkimuskysymyksen ratkaisemiseen tarvittavat tiedot toimitetaan tiedonjakosopimuksen ehtojen mukaisesti. Tämä voi sisältää anonymisoituja yksittäisiä potilastietoja ja/tai saatavilla olevia tukiasiakirjoja, jotka sisältävät analyysikoodin fragmentteja, jos niitä on analyysispesifikaatioissa. Lisätietoja on alla olevasta URL-osoitteesta.

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • ICF
  • CSR

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa