Vaihe 3, lumekontrolloitu kaksoissokkotutkimus, jossa arvioidaan rokatinlimabia (AMG 451) monoterapiaa keskivaikeassa tai vaikeassa atooppisessa ihottumassa (AD) (ROCKET-Horizon) (ROCKET-Horizon)
tiistai 2. kesäkuuta 2026 päivittänyt: Amgen
Kolmannen vaiheen, satunnaistettu, 24-viikkoinen, lumekontrolloitu kaksoissokkotutkimus rotatinlimabin (AMG 451) monoterapian tehon, turvallisuuden ja siedettävyyden arvioimiseksi aikuisilla potilailla, joilla on keskivaikea tai vaikea atooppinen ihottuma (AD) (ROCKET- Horisontti)
Tutkimuksen ensisijaiset tavoitteet ovat:
- Arvioi rokatinlimabin tehokkuus lumelääkkeeseen verrattuna viikolla 24 käyttäen validoitua tutkijan maailmanlaajuista atooppisen ihottuman arviointia (vIGA-AD).
- Arvioi rokatinlimabin tehokkuus lumelääkkeeseen verrattuna viikolla 24, arvioituna ekseema-alue- ja vakavuusindeksillä (EASI).
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
726
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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New South Wales
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Darlinghurst, New South Wales, Australia, 2010
- St George Dermatology and Skin Cancer Centre
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Kogarah, New South Wales, Australia, 2217
- Premier Specialists
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Victoria
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Box Hill, Victoria, Australia, 3128
- Box Hill Hospital
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Carlton, Victoria, Australia, 3053
- Skin Health Institute
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East Melbourne, Victoria, Australia, 3002
- Sinclair Dermatology
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Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
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Parkville, Victoria, Australia, 3050
- The Royal Melbourne Hospital
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Brussels, Belgia, 1070
- Hopital Erasme
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Herstal, Belgia, 4040
- Clinique Andre Renard
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Maldegem, Belgia, 9990
- Dermatologie Maldegem
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Paraná
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Curitiba, Paraná, Brasilia, 80030-110
- CETI - Centro de Estudo em Terapias Inovadoras
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São Paulo
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São Bernardo do Campo, São Paulo, Brasilia, 09715-090
- Centro Multidisciplinar de Estudos Clínicos - CEMEC
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São José dos Campos, São Paulo, Brasilia, 12243-280
- ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
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Madrid, Espanja, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Espanja, 28046
- Hospital Universitario La Paz
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Majadahonda, Espanja, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Andalusia
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Seville, Andalusia, Espanja, 41009
- Hospital Universitario Virgen Macarena
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Navarre
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Pamplona, Navarre, Espanja, 31008
- Clinica Universidad de Navarra
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Valencia
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Alicante, Valencia, Espanja, 03010
- Hospital General Universitario de Alicante
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Manises, Valencia, Espanja, 46940
- Hospital de Manises
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Valencia, Valencia, Espanja, 46015
- Hospital Arnau de Vilanova de Valencia
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Ansansi, Gyeonggido, Etelä -Korea, 15355
- Korea University Ansan Hospital
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Bucheon-si, Gyeonggi-do, Etelä -Korea, 14584
- Soon Chun Hyang University Bucheon Hospital
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Busan, Etelä -Korea, 49241
- Pusan National University Hospital
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Daegu, Etelä -Korea, 41944
- Kyungpook National University Hospital
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Gwangju, Etelä -Korea, 61453
- Chosun University Hospital
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Incheon, Etelä -Korea, 22332
- Inha University Hospital
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Incheon, Etelä -Korea, 21431
- The Catholic University of Korea Incheon St Marys Hospital
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Seongnam-si, Gyeonggi-do, Etelä -Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, Etelä -Korea, 03080
- Seoul National University Hospital
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Seoul, Etelä -Korea, 05505
- Asan Medical Center
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Seoul, Etelä -Korea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Etelä -Korea, 05278
- Kyung Hee University Hospital at Gangdong
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Seoul, Etelä -Korea, 02841
- Korea University Anam Hospital
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Seoul, Etelä -Korea, 05030
- Konkuk University Medical Center
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Seoul, Etelä -Korea, 06973
- Chung-Ang University Hospital
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Seoul, Etelä -Korea, 07441
- Hallym University Kangnam Sacred Heart Hospital
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Seoul, Etelä -Korea, 04564
- National Medical Center
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Seoul, Etelä -Korea, 07804
- Ewha Womans University Seoul Hospital
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Seoul, Etelä -Korea, 06591
- The Catholic Univ of Korea Seoul St Marys Hospital
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Suwon-si, Gyeonggi-do, Etelä -Korea, 16499
- Ajou University Hospital
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Durban, Etelä-Afrikka, 3630
- Hiway Medical Centre
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Gauteng
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Centurion, Gauteng, Etelä-Afrikka, 0157
- Ryexo Clinical Research
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Johannesburg, Gauteng, Etelä-Afrikka, 2057
- About Allergy
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Chiba
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Matsudo-shi, Chiba, Japani, 271-0092
- Miyata Dermatology Clinic
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Narita-shi, Chiba, Japani, 286-8520
- International University of Health and Welfare Narita Hospital
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Hyōgo
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Kobe, Hyōgo, Japani, 650-0017
- Kobe University Hospital
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Kanagawa
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Kawasaki-shi, Kanagawa, Japani, 216-8511
- St Marianna University Hospital
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Sagamihara-shi, Kanagawa, Japani, 252-0392
- National Hospital Organization Sagamihara National Hospital
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Yokohama, Kanagawa, Japani, 224-8503
- Showa University Northern Yokohama Hospital
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Nagasaki
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Nagasaki, Nagasaki, Japani, 852-8501
- Nagasaki University Hospital
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Osaka
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Habikino-shi, Osaka, Japani, 583-8588
- Osaka Habikino Medical Center
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Sakai-shi, Osaka, Japani, 593-8324
- Dermatology and Ophthalmology Kume Clinic
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Shizuoka
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Hamamatsu, Shizuoka, Japani, 431-3192
- Hamamatsu University Hospital
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Tokyo
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Minato-ku, Tokyo, Japani, 108-0014
- Mita Dermatology Clinic
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Shinagawa-ku, Tokyo, Japani, 142-8666
- Showa University Hospital
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Shinjuku-ku, Tokyo, Japani, 161-8521
- Seibo International Catholic Hospital
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Toshima-ku, Tokyo, Japani, 170-0002
- Sugamo Kobayashi Derma Clinic
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Toyama
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Takaoka-shi, Toyama, Japani, 933-0871
- Shirasaki dermatology clinic
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Alberta
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Calgary, Alberta, Kanada, T3E 0B2
- Beacon Dermatology
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British Columbia
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Surrey, British Columbia, Kanada, V3R 6A7
- Doctor Chih-Ho Hong Medical Incorporated
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Ontario
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Etobicoke, Ontario, Kanada, M8X 1Y9
- Kingsway Clinical Research
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Markham, Ontario, Kanada, L3P 1X3
- Lynderm Research Inc
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Oakville, Ontario, Kanada, L6J 7W5
- The Centre for Clinical Trials Inc
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Peterborough, Ontario, Kanada, K9J 5K2
- SKiN Centre for Dermatology
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Richmond Hill, Ontario, Kanada, L4B 1A5
- The Centre for Dermatology
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Toronto, Ontario, Kanada, M4W 2N4
- Research Toronto
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Windsor, Ontario, Kanada, N8T 1E6
- XLR8 Medical Research, Incorporated
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Quebec
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Québec, Quebec, Kanada, G1V 4X7
- Centre de Recherche Dermatologique du Quebec metropolitain
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Sherbrooke, Quebec, Kanada, J1G 1X9
- Clinique Dermatologique de Sherbrooke
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Chihuahua City, Meksiko, 31203
- SCIENTIA Investigacion Clinica SC
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Cuautitlán Izcalli, Meksiko, 54750
- Phylasis Clínicas Research S. De R. L. De C. V.
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Michoacán
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Morelia, Michoacán, Meksiko, 58249
- Clinica de Enfermedades Cronicas y de Procedimientos Especiales
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Almada, Portugali, 2801-951
- Hospital Garcia de Orta, EPE
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Coimbra, Portugali, 3000-075
- Centro Hospitalar e Universitário de Coimbra, EPE
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Lisbon, Portugali, 1998-018
- Hospital CUF Descobertas
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Porto, Portugali, 4099-001
- Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
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Porto, Portugali, 4200-319
- Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
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Bialystok, Puola, 15-879
- ClinicMed Daniluk Nowak Spolka Komandytowa
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Chorzów, Puola, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
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Gdansk, Puola, 80-214
- Uniwersyteckie Centrum Kliniczne
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Krakow, Puola, 31-530
- Centermed krakow sp zoo
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Lodz, Puola, 90-349
- AppleTreeClinics Network Spzoo
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Lodz, Puola, 90-338
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
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Lodz, Puola, 91-495
- Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
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Lublin, Puola, 20-078
- Clinical Best Solutions Sp zoo Spolka komandytowa
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Poznan, Puola, 61-731
- Clinical Research Center Spzoo Medic-R Spolka Komandytowa
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Warsaw, Puola, 02-625
- Evimed sp zoo centrum medyczne evimed
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Bucharest, Romania, 020125
- Spitalul Clinic Colentina
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Stockholm, Ruotsi, 171 76
- Karolinska Universitetssjukhuset Solna
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Bad Bentheim, Saksa, 48455
- Fachklinik Bad Bentheim
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Berlin, Saksa, 10247
- Hautzentrum Friedrichshain - Dermatologie
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Berlin, Saksa, 13672
- Clinical Research Services Berlin GmbH
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Halle, Saksa, 06120
- Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
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Hamburg, Saksa, 20354
- Dermatologikum Hamburg
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Kiel, Saksa, 24105
- Universitaetsklinikum Schleswig-Holstein
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Leipzig, Saksa, 04103
- Velocity Clinical Research
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Münster, Saksa, 48149
- Universitaetsklinikum Muenster
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Osnabrück, Saksa, 49074
- KliFOs Klinische Forschung Osnabrueck
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Remscheid, Saksa, 42897
- Hautarztpraxis Mortazawi
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Wuppertal, Saksa, 42283
- Helios Klinikum Wuppertal
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Helsinki, Suomi, 00180
- CRST Helsinki
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Helsinki, Suomi, 00180
- CRST Turku
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Oulu, Suomi, 90029
- Oulun Yliopistollinen sairaala (OYS)
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Tampere, Suomi, 33100
- Terveystalo Tampere
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Hellerup, Tanska, 2900
- Gentofte Hospital
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Odense, Tanska, 5000
- Odense University Hospital
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Ankara, Turkki (Türkiye), 06230
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Gaziantep, Turkki (Türkiye), 27310
- Gaziantep Universitesi Tip Fakultesi Hastanesi
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Istanbul, Turkki (Türkiye), 34093
- Bezmialem Vakif Universitesi Hastanesi
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Izmir, Turkki (Türkiye), 35620
- Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
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Kayseri, Turkki (Türkiye), 38030
- Erciyes Universitesi Tip Fakultesi Hastanesi
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Kocaeli, Turkki (Türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi Hastanesi
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Sakarya, Turkki (Türkiye), 54050
- Sakarya Egitim ve Arastirma Hastanesi
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Kutná Hora, Tšekki, 284 01
- Kozni ambulance Kutna Hora sro
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Nový Jičín, Tšekki, 741 01
- Nemocnice Novy Jicin as
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Pardubice, Tšekki, 530 02
- CCR Czech as
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Pilsen, Tšekki, 305 99
- Fakultni Nemocnice Plzen
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Prague, Tšekki, 130 00
- CCR Prague sro
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Prague, Tšekki, 120 00
- Dermamedest sro
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Prague, Tšekki, 106 00
- Kozni ambulance Fialova sro
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Prague, Tšekki, 150 00
- Praglandia sro
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Svitavy, Tšekki, 568 02
- Dermatologicka ambulance MUDr Petr Trestik
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Tallinn, Viro, 13419
- North Estonia Medical Centre
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Tartu, Viro, 50106
- Clinical Research Centre
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Corby, Yhdistynyt kuningaskunta, NN17 2UR
- Lakeside Healthcare
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London, Yhdistynyt kuningaskunta, SE1 9RT
- Guys Hospital
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Southampton, Yhdistynyt kuningaskunta, SO16 6YD
- Southampton General Hospital
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Arizona
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Litchfield Park, Arizona, Yhdysvallat, 85340
- Research Solutions of Arizona, PC
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Scottsdale, Arizona, Yhdysvallat, 85260
- Center for Dermatology and Plastic Surgery
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Arkansas
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Fayetteville, Arkansas, Yhdysvallat, 72703
- Clinical Trials Institute of Northwest Arkansas
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Hot Springs, Arkansas, Yhdysvallat, 71913
- Burke Pharmaceutical Research
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California
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Chula Vista, California, Yhdysvallat, 91911
- Velocity Clinical Research Chula Vista
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Dublin, California, Yhdysvallat, 94568
- West Coast Research LLC
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Encinitas, California, Yhdysvallat, 92024
- California Dermatology and Clinical Research Institute
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Fremont, California, Yhdysvallat, 94538
- Center for Dermatology Clinical Research Inc
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La Mesa, California, Yhdysvallat, 91942
- Velocity Clinical Research - San Diego
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North Hollywood, California, Yhdysvallat, 91606
- Velocity Clinical Research - North Hollywood
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Palmdale, California, Yhdysvallat, 93551
- Cura Clinical Research
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San Francisco, California, Yhdysvallat, 94115
- University of California at San Francisco, Dermatology Clinic at Mount Zion
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Santa Monica, California, Yhdysvallat, 90404
- Clinical Science Institute
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Colorado
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Castle Rock, Colorado, Yhdysvallat, 80109
- Clarity Dermatology
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Denver, Colorado, Yhdysvallat, 80209
- Velocity Clinical Research - Denver
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District of Columbia
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Washington D.C., District of Columbia, Yhdysvallat, 20016
- Foxhall Research Center
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Florida
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Cape Coral, Florida, Yhdysvallat, 33991
- Renaissance Research and Medical Group
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Coral Gables, Florida, Yhdysvallat, 33134
- Driven Research LLC
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Doral, Florida, Yhdysvallat, 33172
- Saint Jude Clinical Research
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Hialeah, Florida, Yhdysvallat, 33012
- Direct Helpers Research Center
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Margate, Florida, Yhdysvallat, 33063
- Glick Skin Institute
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Miami, Florida, Yhdysvallat, 33176
- Miami Dade Medical Research Institute, LLC
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Palmetto Bay, Florida, Yhdysvallat, 33157
- Innovation Medical Research Center Inc
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Tampa, Florida, Yhdysvallat, 33612
- University of South Florida Health Morsani Center for Advanced Healthcare
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Georgia
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Sandy Springs, Georgia, Yhdysvallat, 30328
- Advanced Medical Research Pc
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Illinois
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Normal, Illinois, Yhdysvallat, 61761
- Sneeze, Wheeze, and Itch Associates, LLC
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Indiana
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South Bend, Indiana, Yhdysvallat, 46617
- The South Bend Clinic LLP
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West Lafayette, Indiana, Yhdysvallat, 47906
- Options Research Group LLC
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Kansas
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Overland Park, Kansas, Yhdysvallat, 66223
- Dermatology and Skin Cancer Center of Overland Park
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Kentucky
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Louisville, Kentucky, Yhdysvallat, 40241
- DS Research
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Murray, Kentucky, Yhdysvallat, 42071
- Kentucky Advanced Medical Research LLC
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Massachusetts
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Brighton, Massachusetts, Yhdysvallat, 02135
- MetroBoston Clinical Partners
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Michigan
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Farmington Hills, Michigan, Yhdysvallat, 48334
- Wendy Sadoff MD Dermatology PC
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Troy, Michigan, Yhdysvallat, 48084
- Somerset Skin Centre
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Troy, Michigan, Yhdysvallat, 48084
- Revival Research Institute LLC
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Nebraska
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Omaha, Nebraska, Yhdysvallat, 68144
- Advanced Dermatology of the Midlands
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Nevada
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Las Vegas, Nevada, Yhdysvallat, 89117
- James Del Rosso Dermatology Research
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Reno, Nevada, Yhdysvallat, 89509
- Skin Cancer and Dermatology Institute
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New Hampshire
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Lebanon, New Hampshire, Yhdysvallat, 03766
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Riverdale, New Jersey, Yhdysvallat, 07457
- Weiss Medical
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New York
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Horseheads, New York, Yhdysvallat, 14845
- Corning Center for Clinical Research
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Kew Gardens, New York, Yhdysvallat, 11415
- Forest Hills Dermatology Group
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Monroe, New York, Yhdysvallat, 10950
- Crystal Run Healthcare
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New York, New York, Yhdysvallat, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, Yhdysvallat, 10022
- Ace Clinical Trials
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New York, New York, Yhdysvallat, 10128
- OptiSkin Medical
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The Bronx, New York, Yhdysvallat, 10467
- Montefiore Medical Center
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North Carolina
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Durham, North Carolina, Yhdysvallat, 27713
- Duke South Durham
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Ohio
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Cincinnati, Ohio, Yhdysvallat, 45219
- University of Cincinnati
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Cincinnati, Ohio, Yhdysvallat, 45236
- Bernstein Clinical Research Center LLC
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Gahanna, Ohio, Yhdysvallat, 43230
- The Ohio State University Dermatology East
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Oregon
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Grants Pass, Oregon, Yhdysvallat, 97527
- Velocity Clinical Research - Grants Pass
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Portland, Oregon, Yhdysvallat, 97223
- Oregon Medical Research Center
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Rhode Island
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Warwick, Rhode Island, Yhdysvallat, 02886
- Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
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Texas
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Bellaire, Texas, Yhdysvallat, 77401
- Bellaire Dermatology Associates
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Cedar Park, Texas, Yhdysvallat, 78613
- US Dermatology Partners Cedar Park
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Dallas, Texas, Yhdysvallat, 75225
- Alina Clinical Trials, LLC
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Dallas, Texas, Yhdysvallat, 75230
- Zenos Clinical Research, LLC
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Houston, Texas, Yhdysvallat, 77030
- The University of Texas Health Science Center at Houston
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Houston, Texas, Yhdysvallat, 77037
- MedCare Pharma - Houston
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Lampasas, Texas, Yhdysvallat, 76550
- FMCScience LLC
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Lewisville, Texas, Yhdysvallat, 75057
- Epic Clinical Research Incorporated
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Missouri City, Texas, Yhdysvallat, 77459
- Sienna Dermatology Research
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San Antonio, Texas, Yhdysvallat, 78218
- Texas Dermatology and Laser Specialists
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San Antonio, Texas, Yhdysvallat, 78229
- Dermatology Clinical Research Center of San Antonio
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San Antonio, Texas, Yhdysvallat, 78229
- Andante Research
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Utah
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Murray, Utah, Yhdysvallat, 84107
- University of Utah Midvalley Dermatology
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Virginia
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Norfolk, Virginia, Yhdysvallat, 23507
- Eastern Virginia Medical School
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Washington
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Spokane, Washington, Yhdysvallat, 99202
- MultiCare Institute for Research and Innovation
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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
18 vuotta - 100 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Sisällyttämiskriteerit:
- Ikä ≥ 18 vuotta ja AD-diagnoosi AAD-konsensuskriteerien (2014) mukaan vähintään 6 kuukautta
- Aikaisempi riittämätön vaste keskitehoiselle tai tehokkaammalle TCS:lle (paikallinen kortikosteroidi) 6 kuukauden sisällä (paikallisten kalsineuriinin estäjien kanssa tai ilman niitä)
- EASI-pisteet ≥16
- vIGA-AD pisteet ≥3
- ≥10 % kehon pinta-alasta (BSA) AD:n vaikutuksesta
- Pahin kutina numeerinen luokitusasteikko ≥ 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:
- Systeemiset kortikosteroidit
- Systeemiset immunosuppressantit
- Valohoito
- Janus-kinaasin estäjät
Hoito jollakin seuraavista lääkkeistä tai hoidoista 1 viikon sisällä ennen päivää 1:
- Kaiken tehon TCS
- TCI
- Paikalliset fosfodiesteraasin tyypin 4 estäjät
- 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: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Rokatinlimabi
Rokatinlimabi annos 1 4 viikon välein (Q4W) 24 viikon ajan, kyllästysannos viikolla 2.
|
Rokatinlimabi annetaan ihonalaisena (SC) injektiona.
Muut nimet:
|
|
Placebo Comparator: Plasebo
Placebo Q4W 24 viikon ajan, kyllästysannos viikolla 2.
|
Vastaava lumelääke annetaan SC-injektiona.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
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
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," 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
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 vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (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
|
|
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 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.
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 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
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 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
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 Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
Aikaikkuna: 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
Aikaikkuna: 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
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 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 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
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 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 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
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 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
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 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
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
|
|
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
Aikaikkuna: 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
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
|
|
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Aikaikkuna: 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
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 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
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 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
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 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
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 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
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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
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
- Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
- Guttman-Yassky E, Kabashima K, Worm M, Luna PC, Hong HC, Chovatiya R, Bernstein JA, Kern JS, Ehst BD, Magnolo N, Herranz-Pinto P, Stein Gold L, Sofen H, Pink AE, Esfandiari E, Arai T, Yang Y, Shi R, Barragan C, Kricorian G, Schwartz-Sagi L, Bissonnette R. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials. Lancet. 2026 Jan 3;407(10523):53-66. doi: 10.1016/S0140-6736(25)01865-3. Epub 2025 Nov 25.
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)
Keskiviikko 14. joulukuuta 2022
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 5. kesäkuuta 2024
Opintojen valmistuminen (Todellinen)
Tiistai 27. elokuuta 2024
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 7. joulukuuta 2022
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 7. joulukuuta 2022
Ensimmäinen Lähetetty (Todellinen)
Torstai 15. joulukuuta 2022
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 26. kesäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 2. kesäkuuta 2026
Viimeksi vahvistettu
Perjantai 1. toukokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Geneettiset sairaudet, synnynnäiset
- Immuunijärjestelmän sairaudet
- Yliherkkyys, välitön
- Yliherkkyys
- Ihosairaudet
- Ihosairaudet, geneettiset
- Ihosairaudet, eksematoottiset
- Dermatiitti
- Synnynnäiset, perinnölliset ja vastasyntyneiden sairaudet ja poikkeavuudet
- Iho- ja sidekudostaudit
- Dermatiitti, atooppinen
- Ekseema
- Dermatologiset aineet
- KHK4083
Muut tutkimustunnusnumerot
- 20210143
- 2022-501538-44 (Muu tunniste: EU CT Number)
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/-tutkimuksen laajuuden, päätepisteet/kiinnostavat tulokset, tilastollisen analyysisuunnitelman, tietovaatimukset, julkaisusuunnitelman ja 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 .