Et fase 3, placebokontrolleret, dobbeltblindt studie, der vurderer rocatinlimab (AMG 451) monoterapi ved moderat til svær atopisk dermatitis (AD) (ROCKET-Horizon) (ROCKET-Horizon)
2. juni 2026 opdateret af: Amgen
Et fase 3, randomiseret, 24-ugers, placebokontrolleret, dobbeltblindt studie for at vurdere effektiviteten, sikkerheden og tolerabiliteten af rocatinlimab (AMG 451) monoterapi hos voksne forsøgspersoner med moderat til svær atopisk dermatitis (AD) (ROCKET- Horisont)
De primære mål med undersøgelsen er at:
- Evaluer effektiviteten af rocatinlimab sammenlignet med placebo i uge 24, vurderet ved hjælp af Validated Investigators Global Assessment for Atopisk Dermatitis (vIGA-AD).
- Evaluer effekten af rocatinlimab sammenlignet med placebo i uge 24, vurderet ved hjælp af Eczema Area and Severity Index (EASI).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
726
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New South Wales
-
Darlinghurst, New South Wales, Australien, 2010
- St George Dermatology and Skin Cancer Centre
-
Kogarah, New South Wales, Australien, 2217
- Premier Specialists
-
-
Victoria
-
Box Hill, Victoria, Australien, 3128
- Box Hill Hospital
-
Carlton, Victoria, Australien, 3053
- Skin Health Institute
-
East Melbourne, Victoria, Australien, 3002
- Sinclair Dermatology
-
Melbourne, Victoria, Australien, 3004
- The Alfred Hospital
-
Parkville, Victoria, Australien, 3050
- The Royal Melbourne Hospital
-
-
-
-
-
Brussels, Belgien, 1070
- Hopital Erasme
-
Herstal, Belgien, 4040
- Clinique Andre Renard
-
Maldegem, Belgien, 9990
- Dermatologie Maldegem
-
-
-
-
Paraná
-
Curitiba, Paraná, Brasilien, 80030-110
- CETI - Centro de Estudo em Terapias Inovadoras
-
-
São Paulo
-
São Bernardo do Campo, São Paulo, Brasilien, 09715-090
- Centro Multidisciplinar de Estudos Clínicos - CEMEC
-
São José dos Campos, São Paulo, Brasilien, 12243-280
- ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
-
-
-
-
Alberta
-
Calgary, Alberta, Canada, T3E 0B2
- Beacon Dermatology
-
-
British Columbia
-
Surrey, British Columbia, Canada, V3R 6A7
- Doctor Chih-Ho Hong Medical Incorporated
-
-
Ontario
-
Etobicoke, Ontario, Canada, M8X 1Y9
- Kingsway Clinical Research
-
Markham, Ontario, Canada, L3P 1X3
- Lynderm Research Inc
-
Oakville, Ontario, Canada, L6J 7W5
- The Centre for Clinical Trials Inc
-
Peterborough, Ontario, Canada, K9J 5K2
- Skin Centre for Dermatology
-
Richmond Hill, Ontario, Canada, L4B 1A5
- The Centre for Dermatology
-
Toronto, Ontario, Canada, M4W 2N4
- Research Toronto
-
Windsor, Ontario, Canada, N8T 1E6
- XLR8 Medical Research, Incorporated
-
-
Quebec
-
Québec, Quebec, Canada, G1V 4X7
- Centre De Recherche Dermatologique Du Quebec Metropolitain
-
Sherbrooke, Quebec, Canada, J1G 1X9
- Clinique Dermatologique de Sherbrooke
-
-
-
-
-
Hellerup, Danmark, 2900
- Gentofte Hospital
-
Odense, Danmark, 5000
- Odense University Hospital
-
-
-
-
-
Corby, Det Forenede Kongerige, NN17 2UR
- Lakeside Healthcare
-
London, Det Forenede Kongerige, SE1 9RT
- Guys Hospital
-
Southampton, Det Forenede Kongerige, SO16 6YD
- Southampton General Hospital
-
-
-
-
-
Tallinn, Estland, 13419
- North Estonia Medical Centre
-
Tartu, Estland, 50106
- Clinical Research Centre
-
-
-
-
-
Helsinki, Finland, 00180
- CRST Helsinki
-
Helsinki, Finland, 00180
- CRST Turku
-
Oulu, Finland, 90029
- Oulun Yliopistollinen sairaala (OYS)
-
Tampere, Finland, 33100
- Terveystalo Tampere
-
-
-
-
Arizona
-
Litchfield Park, Arizona, Forenede Stater, 85340
- Research Solutions of Arizona, PC
-
Scottsdale, Arizona, Forenede Stater, 85260
- Center for Dermatology and Plastic Surgery
-
-
Arkansas
-
Fayetteville, Arkansas, Forenede Stater, 72703
- Clinical Trials Institute of Northwest Arkansas
-
Hot Springs, Arkansas, Forenede Stater, 71913
- Burke Pharmaceutical Research
-
-
California
-
Chula Vista, California, Forenede Stater, 91911
- Velocity Clinical Research Chula Vista
-
Dublin, California, Forenede Stater, 94568
- West Coast Research LLC
-
Encinitas, California, Forenede Stater, 92024
- California Dermatology and Clinical Research Institute
-
Fremont, California, Forenede Stater, 94538
- Center for Dermatology Clinical Research Inc
-
La Mesa, California, Forenede Stater, 91942
- Velocity Clinical Research - San Diego
-
North Hollywood, California, Forenede Stater, 91606
- Velocity Clinical Research - North Hollywood
-
Palmdale, California, Forenede Stater, 93551
- Cura Clinical Research
-
San Francisco, California, Forenede Stater, 94115
- University of California at San Francisco, Dermatology Clinic at Mount Zion
-
Santa Monica, California, Forenede Stater, 90404
- Clinical Science Institute
-
-
Colorado
-
Castle Rock, Colorado, Forenede Stater, 80109
- Clarity Dermatology
-
Denver, Colorado, Forenede Stater, 80209
- Velocity Clinical Research - Denver
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater, 20016
- Foxhall Research Center
-
-
Florida
-
Cape Coral, Florida, Forenede Stater, 33991
- Renaissance Research and Medical Group
-
Coral Gables, Florida, Forenede Stater, 33134
- Driven Research LLC
-
Doral, Florida, Forenede Stater, 33172
- Saint Jude Clinical Research
-
Hialeah, Florida, Forenede Stater, 33012
- Direct Helpers Research Center
-
Margate, Florida, Forenede Stater, 33063
- Glick Skin Institute
-
Miami, Florida, Forenede Stater, 33176
- Miami Dade Medical Research Institute, LLC
-
Palmetto Bay, Florida, Forenede Stater, 33157
- Innovation Medical Research Center Inc
-
Tampa, Florida, Forenede Stater, 33612
- University of South Florida Health Morsani Center for Advanced Healthcare
-
-
Georgia
-
Sandy Springs, Georgia, Forenede Stater, 30328
- Advanced Medical Research PC
-
-
Illinois
-
Normal, Illinois, Forenede Stater, 61761
- Sneeze, Wheeze, and Itch Associates, LLC
-
-
Indiana
-
South Bend, Indiana, Forenede Stater, 46617
- The South Bend Clinic LLP
-
West Lafayette, Indiana, Forenede Stater, 47906
- Options Research Group LLC
-
-
Kansas
-
Overland Park, Kansas, Forenede Stater, 66223
- Dermatology and Skin Cancer Center of Overland Park
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40241
- DS Research
-
Murray, Kentucky, Forenede Stater, 42071
- Kentucky Advanced Medical Research LLC
-
-
Massachusetts
-
Brighton, Massachusetts, Forenede Stater, 02135
- MetroBoston Clinical Partners
-
-
Michigan
-
Farmington Hills, Michigan, Forenede Stater, 48334
- Wendy Sadoff MD Dermatology PC
-
Troy, Michigan, Forenede Stater, 48084
- Somerset Skin Centre
-
Troy, Michigan, Forenede Stater, 48084
- Revival Research Institute LLC
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater, 68144
- Advanced Dermatology of the Midlands
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89117
- James Del Rosso Dermatology Research
-
Reno, Nevada, Forenede Stater, 89509
- Skin Cancer and Dermatology Institute
-
-
New Hampshire
-
Lebanon, New Hampshire, Forenede Stater, 03766
- Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Riverdale, New Jersey, Forenede Stater, 07457
- Weiss Medical
-
-
New York
-
Horseheads, New York, Forenede Stater, 14845
- Corning Center for Clinical Research
-
Kew Gardens, New York, Forenede Stater, 11415
- Forest Hills Dermatology Group
-
Monroe, New York, Forenede Stater, 10950
- Crystal Run Healthcare
-
New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
-
New York, New York, Forenede Stater, 10022
- Ace Clinical Trials
-
New York, New York, Forenede Stater, 10128
- OptiSkin Medical
-
The Bronx, New York, Forenede Stater, 10467
- Montefiore Medical Center
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27713
- Duke South Durham
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45219
- University of Cincinnati
-
Cincinnati, Ohio, Forenede Stater, 45236
- Bernstein Clinical Research Center LLC
-
Gahanna, Ohio, Forenede Stater, 43230
- The Ohio State University Dermatology East
-
-
Oregon
-
Grants Pass, Oregon, Forenede Stater, 97527
- Velocity Clinical Research - Grants Pass
-
Portland, Oregon, Forenede Stater, 97223
- Oregon Medical Research Center
-
-
Rhode Island
-
Warwick, Rhode Island, Forenede Stater, 02886
- Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
-
-
Texas
-
Bellaire, Texas, Forenede Stater, 77401
- Bellaire Dermatology Associates
-
Cedar Park, Texas, Forenede Stater, 78613
- US Dermatology Partners Cedar Park
-
Dallas, Texas, Forenede Stater, 75225
- Alina Clinical Trials, LLC
-
Dallas, Texas, Forenede Stater, 75230
- Zenos Clinical Research, LLC
-
Houston, Texas, Forenede Stater, 77030
- The University of Texas Health Science Center at Houston
-
Houston, Texas, Forenede Stater, 77037
- MedCare Pharma - Houston
-
Lampasas, Texas, Forenede Stater, 76550
- FMCScience LLC
-
Lewisville, Texas, Forenede Stater, 75057
- Epic Clinical Research Incorporated
-
Missouri City, Texas, Forenede Stater, 77459
- Sienna Dermatology Research
-
San Antonio, Texas, Forenede Stater, 78218
- Texas Dermatology and Laser Specialists
-
San Antonio, Texas, Forenede Stater, 78229
- Dermatology Clinical Research Center of San Antonio
-
San Antonio, Texas, Forenede Stater, 78229
- Andante Research
-
-
Utah
-
Murray, Utah, Forenede Stater, 84107
- University of Utah MidValley Dermatology
-
-
Virginia
-
Norfolk, Virginia, Forenede Stater, 23507
- Eastern Virginia Medical School
-
-
Washington
-
Spokane, Washington, Forenede Stater, 99202
- MultiCare Institute for Research and Innovation
-
-
-
-
Chiba
-
Matsudo-shi, Chiba, Japan, 271-0092
- Miyata Dermatology Clinic
-
Narita-shi, Chiba, Japan, 286-8520
- International University of Health and Welfare Narita Hospital
-
-
Hyōgo
-
Kobe, Hyōgo, Japan, 650-0017
- Kobe University Hospital
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, Japan, 216-8511
- St Marianna University Hospital
-
Sagamihara-shi, Kanagawa, Japan, 252-0392
- National Hospital Organization Sagamihara National Hospital
-
Yokohama, Kanagawa, Japan, 224-8503
- Showa University Northern Yokohama Hospital
-
-
Nagasaki
-
Nagasaki, Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
-
-
Osaka
-
Habikino-shi, Osaka, Japan, 583-8588
- Osaka Habikino Medical Center
-
Sakai-shi, Osaka, Japan, 593-8324
- Dermatology and Ophthalmology Kume Clinic
-
-
Shizuoka
-
Hamamatsu, Shizuoka, Japan, 431-3192
- Hamamatsu University Hospital
-
-
Tokyo
-
Minato-ku, Tokyo, Japan, 108-0014
- Mita Dermatology Clinic
-
Shinagawa-ku, Tokyo, Japan, 142-8666
- Showa University Hospital
-
Shinjuku-ku, Tokyo, Japan, 161-8521
- Seibo International Catholic Hospital
-
Toshima-ku, Tokyo, Japan, 170-0002
- Sugamo Kobayashi Derma Clinic
-
-
Toyama
-
Takaoka-shi, Toyama, Japan, 933-0871
- Shirasaki dermatology clinic
-
-
-
-
-
Chihuahua City, Mexico, 31203
- SCIENTIA Investigacion Clinica SC
-
Cuautitlán Izcalli, Mexico, 54750
- Phylasis Clínicas Research S. De R. L. De C. V.
-
-
Michoacán
-
Morelia, Michoacán, Mexico, 58249
- Clinica de Enfermedades Crónicas y de Procedimientos Especiales
-
-
-
-
-
Bialystok, Polen, 15-879
- ClinicMed Daniluk Nowak Spolka Komandytowa
-
Chorzów, Polen, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
-
Gdansk, Polen, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Krakow, Polen, 31-530
- Centermed krakow sp zoo
-
Lodz, Polen, 90-349
- AppleTreeClinics Network Spzoo
-
Lodz, Polen, 90-338
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
-
Lodz, Polen, 91-495
- Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
-
Lublin, Polen, 20-078
- Clinical Best Solutions Sp zoo Spolka komandytowa
-
Poznan, Polen, 61-731
- Clinical Research Center Spzoo Medic-R Spolka Komandytowa
-
Warsaw, Polen, 02-625
- Evimed sp zoo centrum medyczne evimed
-
-
-
-
-
Almada, Portugal, 2801-951
- Hospital Garcia de Orta, EPE
-
Coimbra, Portugal, 3000-075
- Centro Hospitalar e Universitário de Coimbra, EPE
-
Lisbon, Portugal, 1998-018
- Hospital CUF Descobertas
-
Porto, Portugal, 4099-001
- Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
-
Porto, Portugal, 4200-319
- Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
-
-
-
-
-
Bucharest, Rumænien, 020125
- Spitalul Clinic Colentina
-
-
-
-
-
Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal
-
Madrid, Spanien, 28046
- Hospital Universitario La Paz
-
Majadahonda, Spanien, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
-
-
Andalusia
-
Seville, Andalusia, Spanien, 41009
- Hospital Universitario Virgen Macarena
-
-
Navarre
-
Pamplona, Navarre, Spanien, 31008
- Clinica Universidad de Navarra
-
-
Valencia
-
Alicante, Valencia, Spanien, 03010
- Hospital General Universitario de Alicante
-
Manises, Valencia, Spanien, 46940
- Hospital de Manises
-
Valencia, Valencia, Spanien, 46015
- Hospital Arnau de Vilanova de Valencia
-
-
-
-
-
Stockholm, Sverige, 171 76
- Karolinska Universitetssjukhuset Solna
-
-
-
-
-
Durban, Sydafrika, 3630
- Hiway Medical Centre
-
-
Gauteng
-
Centurion, Gauteng, Sydafrika, 0157
- RYEXO Clinical Research
-
Johannesburg, Gauteng, Sydafrika, 2057
- About Allergy
-
-
-
-
-
Ansansi, Gyeonggido, Sydkorea, 15355
- Korea University Ansan Hospital
-
Bucheon-si, Gyeonggi-do, Sydkorea, 14584
- Soon Chun Hyang University Bucheon Hospital
-
Busan, Sydkorea, 49241
- Pusan National University Hospital
-
Daegu, Sydkorea, 41944
- Kyungpook National University Hospital
-
Gwangju, Sydkorea, 61453
- Chosun University Hospital
-
Incheon, Sydkorea, 22332
- Inha University Hospital
-
Incheon, Sydkorea, 21431
- The Catholic University of Korea Incheon St Marys Hospital
-
Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Seoul National University Bundang Hospital
-
Seoul, Sydkorea, 03080
- Seoul National University Hospital
-
Seoul, Sydkorea, 05505
- Asan Medical Center
-
Seoul, Sydkorea, 03722
- Severance Hospital, Yonsei University Health System
-
Seoul, Sydkorea, 05278
- Kyung Hee University Hospital at Gangdong
-
Seoul, Sydkorea, 02841
- Korea University Anam Hospital
-
Seoul, Sydkorea, 05030
- Konkuk University Medical Center
-
Seoul, Sydkorea, 06973
- Chung-Ang University Hospital
-
Seoul, Sydkorea, 07441
- Hallym University Kangnam Sacred Heart Hospital
-
Seoul, Sydkorea, 04564
- National Medical Center
-
Seoul, Sydkorea, 07804
- Ewha Womans University Seoul Hospital
-
Seoul, Sydkorea, 06591
- The Catholic Univ of Korea Seoul St Marys Hospital
-
Suwon-si, Gyeonggi-do, Sydkorea, 16499
- Ajou University Hospital
-
-
-
-
-
Kutná Hora, Tjekkiet, 284 01
- Kozni ambulance Kutna Hora sro
-
Nový Jičín, Tjekkiet, 741 01
- Nemocnice Novy Jicin as
-
Pardubice, Tjekkiet, 530 02
- CCR Czech as
-
Pilsen, Tjekkiet, 305 99
- Fakultni nemocnice Plzen
-
Prague, Tjekkiet, 130 00
- CCR Prague sro
-
Prague, Tjekkiet, 120 00
- Dermamedest sro
-
Prague, Tjekkiet, 106 00
- Kozni ambulance Fialova sro
-
Prague, Tjekkiet, 150 00
- Praglandia sro
-
Svitavy, Tjekkiet, 568 02
- Dermatologicka ambulance MUDr Petr Trestik
-
-
-
-
-
Ankara, Tyrkiet (Türkiye), 06230
- Hacettepe Universitesi Tip Fakultesi Hastanesi
-
Gaziantep, Tyrkiet (Türkiye), 27310
- Gaziantep Universitesi Tip Fakultesi Hastanesi
-
Istanbul, Tyrkiet (Türkiye), 34093
- Bezmialem Vakif Universitesi Hastanesi
-
Izmir, Tyrkiet (Türkiye), 35620
- Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
-
Kayseri, Tyrkiet (Türkiye), 38030
- Erciyes Universitesi Tip Fakultesi Hastanesi
-
Kocaeli, Tyrkiet (Türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi Hastanesi
-
Sakarya, Tyrkiet (Türkiye), 54050
- Sakarya Egitim ve Arastirma Hastanesi
-
-
-
-
-
Bad Bentheim, Tyskland, 48455
- Fachklinik Bad Bentheim
-
Berlin, Tyskland, 10247
- Hautzentrum Friedrichshain - Dermatologie
-
Berlin, Tyskland, 13672
- Clinical Research Services Berlin GmbH
-
Halle, Tyskland, 06120
- Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
-
Hamburg, Tyskland, 20354
- Dermatologikum Hamburg
-
Kiel, Tyskland, 24105
- Universitaetsklinikum Schleswig-Holstein
-
Leipzig, Tyskland, 04103
- Velocity Clinical Research
-
Münster, Tyskland, 48149
- Universitaetsklinikum Muenster
-
Osnabrück, Tyskland, 49074
- KliFOs Klinische Forschung Osnabrueck
-
Remscheid, Tyskland, 42897
- Hautarztpraxis Mortazawi
-
Wuppertal, Tyskland, 42283
- Helios Klinikum Wuppertal
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Alder ≥ 18 år med diagnose AD i henhold til AAD Consensus Criteria (2014) til stede i mindst 6 måneder
- Anamnese med utilstrækkelig respons på TCS (topisk kortikosteroid) af middel eller højere styrke inden for 6 måneder (med eller uden topiske calcineurinhæmmere [TCI])
- EASI-score ≥16
- vIGA-AD-score ≥3
- ≥10 % kropsoverfladeareal (BSA) af AD-involvering
- Værste pruritus numerisk vurderingsskala ≥ 4
Ekskluderingskriterier:
- Behandling med et biologisk produkt inden for 12 uger eller 5 halveringstider, alt efter hvad der er længst, før dag 1
Behandling med nogen af følgende medikamenter eller terapier inden for 4 uger eller 5 halveringstider, alt efter hvad der er længst, før dag 1:
- Systemiske kortikosteroider
- Systemiske immunsuppressiva
- Fototerapi
- Janus kinase hæmmere
Behandling med nogen af følgende medikamenter eller terapier inden for 1 uge før dag 1:
- TCS af enhver styrke
- TCI
- Topiske phosphodiesterase type 4-hæmmere
- Andre topiske immunsuppressive midler
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Rocatinlimab
Rocatinlimab dosis 1 hver 4. uge (Q4W) i 24 uger med en startdosis i uge 2.
|
Rocatinlimab vil blive administreret gennem en subkutan (SC) injektion.
Andre navne:
|
|
Placebo komparator: Placebo
Placebo Q4W i 24 uger med en startdosis i uge 2.
|
Den matchende placebo vil blive administreret gennem en SC-injektion.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: MD, Amgen
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. december 2022
Primær færdiggørelse (Faktiske)
5. juni 2024
Studieafslutning (Faktiske)
27. august 2024
Datoer for studieregistrering
Først indsendt
7. december 2022
Først indsendt, der opfyldte QC-kriterier
7. december 2022
Først opslået (Faktiske)
15. december 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20210143
- 2022-501538-44 (Anden identifikator: EU CT Number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Afidentificerede individuelle patientdata for variabler, der er nødvendige for at løse det specifikke forskningsspørgsmål i en godkendt anmodning om datadeling.
IPD-delingstidsramme
Anmodninger om datadeling i forbindelse med denne undersøgelse vil blive overvejet begyndende 18 måneder efter, at undersøgelsen er afsluttet, og enten 1) produktet og indikationen er blevet udstedt markedsføringstilladelse i både USA og Europa eller 2) den kliniske udvikling af produktet og/eller indikationen ophører og dataene vil ikke blive indsendt til de regulerende myndigheder.
Der er ingen slutdato for berettigelse til at indsende en anmodning om datadeling for denne undersøgelse.
IPD-delingsadgangskriterier
Kvalificerede forskere kan indsende en anmodning, der indeholder forskningsmålene, Amgen-produktet/-erne og Amgen-undersøgelsen/-undersøgelserne i omfang, endepunkter/resultater af interesse, statistisk analyseplan, datakrav, publikationsplan og forskerens/forskernes kvalifikationer.
Generelt imødekommer Amgen ikke eksterne anmodninger om individuelle patientdata med det formål at revurdere sikkerheds- og effektivitetsspørgsmål, der allerede er behandlet i produktmærkningen.
Anmodninger gennemgås af et udvalg af interne rådgivere.
Hvis den ikke godkendes, vil et uafhængigt datadelingspanel mægle og træffe den endelige beslutning.
Efter godkendelse vil oplysninger, der er nødvendige for at løse forskningsspørgsmålet, blive leveret i henhold til vilkårene i en datadelingsaftale.
Dette kan omfatte anonymiserede individuelle patientdata og/eller tilgængelige understøttende dokumenter, der indeholder fragmenter af analysekode, hvor det er angivet i analysespecifikationerne.
Yderligere detaljer er tilgængelige på URL'en nedenfor.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .