이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

중등도 내지 중증 활동성 궤양성 대장염 참가자를 대상으로 RO7790121을 이용한 유도 요법의 효능과 안전성을 평가하기 위한 연구 (Ametrine-2)

2026년 10월 1일 업데이트: Hoffmann-La Roche

중등도에서 중증 활동성 궤양성 대장염 환자를 대상으로 RO7790121 유도 요법의 효능과 안전성을 평가하기 위한 제3상, 다기관, 이중 맹검, 위약 대조 연구

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

350

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 네덜란드
      • Tilburg, 네덜란드, 5022 GC
        • ETZ Elisabeth
  • 대만
      • Taichung, 대만, 40447
        • China Medical University Hospital
  • 덴마크
      • Aalborg, 덴마크, 9000
        • Ålborg Universitets Hospital
  • 독일
      • Lüneburg, 독일, 21339
        • Medizinisches Zentrum Klinikum Lueneburg
  • 멕시코
      • Veracruz, 멕시코, 91900
        • FAICIC S de R.L. de C.V
    • Mexico CITY (federal District)
      • Miguel Hidalgo, Mexico CITY (federal District), 멕시코, 01120
        • Boca Clinical Trials Mexico S.C. (Cd. Mexico)
  • 미국
    • Alabama
      • Dothan, Alabama, 미국, 36305
        • Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
    • Arizona
      • Scottsdale, Arizona, 미국, 85259
        • Mayo Clinic Hospital
      • Sun City, Arizona, 미국, 85351
        • Arizona Digestive Health, P.C (ADH)
    • California
      • Apple Valley, California, 미국, 92307
        • Om Research LLC
      • Garden Grove, California, 미국, 92845
        • Valley View Internal Medicine
      • Lancaster, California, 미국, 93534
        • Gastro Care Associates
      • Redwood City, California, 미국, 94063
        • Stanford Medicine Outpatient Center
    • Colorado
      • Colorado Springs, Colorado, 미국, 80907
        • Peak Gastroenterology Associates
    • Florida
      • Coral Gables, Florida, 미국, 33134
        • Hi Tech and Global Research, LLC
      • Hialeah, Florida, 미국, 33013
        • The Sister Life Research
      • Miami, Florida, 미국, 33155
        • Allied Biomedical Research Institute
      • Miami, Florida, 미국, 33126
        • LCC Medical Research Institute, LLC
      • Orlando, Florida, 미국, 32825
        • Digestive and Liver Center of Florida
      • Orlando, Florida, 미국, 32807
        • Integrity Trials LLC
      • Port Orange, Florida, 미국, 32127
        • Advanced Medical Research Center
      • Tampa, Florida, 미국, 33612
        • University of South Florida School of Medicine Morsani Center for Advanced Health Care
      • Tampa, Florida, 미국, 33615
        • Santos Research Center, CORP
      • Tampa, Florida, 미국, 33614
        • Guardian Angel Research Center, LLC
      • Weston, Florida, 미국, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, 미국, 30342
        • Atlanta Gastroenterology Associates
      • Atlanta, Georgia, 미국, 30308
        • Randomize Now, LLC
      • Macon, Georgia, 미국, 31201
        • Gastroenterology Associates of Central Georgia
    • Illinois
      • Glenview, Illinois, 미국, 60026
        • Illinois Gastroenterology Group-Glenview powered by GI Alliance
      • Gurnee, Illinois, 미국, 60031
        • GI Alliance - Gurnee
    • Indiana
      • New Albany, Indiana, 미국, 47150
        • Gastro Health Partners, LLC
    • Kansas
      • Wichita, Kansas, 미국, 67226
        • Kansas Gastroenterology, LLC under Clinical Trials Network
    • Kentucky
      • Louisville, Kentucky, 미국, 40218
        • One GI: GHP - Gastroenterology Health Partners Louisville
    • Louisiana
      • Shreveport, Louisiana, 미국, 71105
        • Louisiana Research Center - GastroIntestinal Associates
    • Mississippi
      • Flowood, Mississippi, 미국, 39232
        • Allied Gastrointestinal Associates, PA
    • New Hampshire
      • Lebanon, New Hampshire, 미국, 03756
        • Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
    • New York
      • Brooklyn, New York, 미국, 11215
        • Ellipsis Research Group
      • New York, New York, 미국, 10021
        • Weill Cornell Medical College
      • New York, New York, 미국, 10016
        • NYU Inflammatory Bowel Disease Center
      • North Massapequa, New York, 미국, 11758
        • DiGiovanna Inst for Med Ed&Res
      • Queens Village, New York, 미국, 11428
        • Queens Village Medical Care
      • Rochester, New York, 미국, 14618
        • Gastroenterology Group Of Rochester, LLP
    • North Carolina
      • Charlotte, North Carolina, 미국, 28207
        • Charlotte Gastroenterology and Hepatology, P.L.L.C
      • Fuquay-Varina, North Carolina, 미국, 27526
        • Omega Research North Carolina, LLC
      • High Point, North Carolina, 미국, 27260
        • Peters Medical Research (PMR), LLC
    • Ohio
      • Beavercreek, Ohio, 미국, 45440
        • Dayton Gastroenterology, Inc.
      • Cincinnati, Ohio, 미국, 45267
        • University of Cincinnati Hospital
      • Cleveland, Ohio, 미국, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, 미국, 43210
        • Ohio State University
      • Columbus, Ohio, 미국, 43202
        • Ohio Gastroenterology Group
      • Westlake, Ohio, 미국, 44145
        • Gastro Intestinal Research Institute of Northern Ohio
    • Pennsylvania
      • Uniontown, Pennsylvania, 미국, 15401
        • Frontier Clinical Re search, LLC
    • Rhode Island
      • Providence, Rhode Island, 미국, 02904
        • University Gastroenterology
    • South Carolina
      • Greenville, South Carolina, 미국, 29607
        • Gastroenterology Associates
    • Tennessee
      • Cordova, Tennessee, 미국, 38018
        • Gastro One
    • Texas
      • Galveston, Texas, 미국, 77555
        • Uni of Texas Medical Branch
      • Garland, Texas, 미국, 75044
        • GI Alliance
      • Georgetown, Texas, 미국, 78628
        • Amel Med LLC
      • Harlingen, Texas, 미국, 78550
        • Texas Digestive Specialists
      • Harlingen, Texas, 미국, 78550
        • Cano Medical Center
      • Lubbock, Texas, 미국, 79410
        • GI Alliance - Bay Area Gastroenterology
      • Mansfield, Texas, 미국, 76063
        • TDDC dba GI Alliance Research
      • San Antonio, Texas, 미국, 78229
        • Southern Star Research Institute, LLC.
      • Temple, Texas, 미국, 76508
        • Baylor Scott and White Medical Center
      • Tyler, Texas, 미국, 75708
        • University of Texas Health Center at Tyler
      • Tyler, Texas, 미국, 75701
        • Tyler Research Institute, LLC
      • Webster, Texas, 미국, 77598
        • TDDC GI Alliance research Webster
    • Virginia
      • Chesapeake, Virginia, 미국, 23320
        • Gastroenterology Associates of Tidewater
      • Lansdowne Town Center, Virginia, 미국, 20176
        • Emeritas Research Group
      • Roanoke, Virginia, 미국, 24018
        • Gastroenterology Consultants of SWVA
  • 벨기에
      • Brussels, 벨기에, 1000
        • CHU St Pierre (St Pierre)
      • Brussels, 벨기에, 1200
        • Cliniques Universitaires St-Luc
  • 불가리아
      • Plovdiv, 불가리아, 4003
        • MC " Sveti Ivan Rilski Chudotvorets- 2010
      • Sofia, 불가리아, 1407
        • "City Clinic UMHAC" EOOD
  • 브라질
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, 브라질, 90035-000
        • Hospital Moinhos de Vento
    • Rio de Janeiro
      • Volta Redonda, Rio de Janeiro, 브라질, 27258-000
        • Instituto Lobus Unimed Volta Redonda
    • Sergipe
      • Aracaju, Sergipe, 브라질, 49055-000
        • Newdata Clinical Trials
    • São Paulo
      • Jaú, São Paulo, 브라질, 17210-190
        • CECIP - Centro de Estudos Clínicos do Interior Paulista
      • São Paulo, São Paulo, 브라질, 04266-010
        • Centro Paulista de Investigacao Clinica - CEPIC
  • 세르비아
      • Zrenjanin, 세르비아, 23000
        • General Hospital "Djordje Joanovic"
  • 스페인
      • Zaragoza, 스페인, 50009
        • Hospital Universitario Miguel Servet
    • Madrid
      • Majadahonda, Madrid, 스페인, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
  • 아르헨티나
      • Ciudad Autonoma Bs As, 아르헨티나, C1280AEB
        • Hospital Britanico
      • Quilmes, 아르헨티나, B1878DVB
        • Instituto Medico CER
  • 영국
      • Leicester, 영국, LE5 4PW
        • Leicester General Hospital
      • Llanrhystud, 영국, SY23 1ER
        • Bronglais General Hospital
      • London, 영국, SE5 9RS
        • King College Hospital NHS Foundation Trust
      • Stockport, 영국, SK2 7JE
        • Stepping Hill Hospital
  • 오스트리아
      • Linz, 오스트리아, 4010
        • Ordensklinikum Linz Barmherzige Schwestern
  • 이스라엘
      • Beersheba, 이스라엘, 8410101
        • Soroka Medical Center
      • Ramat Gan, 이스라엘, 5265601
        • The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
  • 이탈리아
    • Lazio
      • Rome, Lazio, 이탈리아, 00128
        • Policlinico Universitario Campus Biomedico Di Roma
      • Rome, Lazio, 이탈리아, 00186
        • Ospedale Isola Tiberina Gemelli
    • Lombardy
      • Brescia, Lombardy, 이탈리아, 25123
        • Asst Degli Spedali Civili Di Brescia
      • Milan, Lombardy, 이탈리아, 20132
        • IRCCS Ospedale San Raffaele
      • Monza MI, Lombardy, 이탈리아, 20900
        • Azienda Ospedaliera San Gerardo di Monza
      • Rozzano (MI), Lombardy, 이탈리아, 20089
        • Istituto Clinico Humanitas
    • Veneto
      • Negrar, Veneto, 이탈리아, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria
  • 인도
    • Gujarat
      • Surat, Gujarat, 인도, 395002
        • Surat Institute of Digestive Sciences Hospitals
      • Surat, Gujarat, 인도, 395009
        • Gujarat Gastro and Vascular Hospital
    • Maharashtra
      • Nagpur (urban), Maharashtra, 인도, 440001
        • Kingsway Hospital
      • Nagpur (urban), Maharashtra, 인도, 440018
        • MIDAS Multispeciality Hospital
    • Rajasthan
      • Jaipur, Rajasthan, 인도, 302006
        • SR Kalla Memorial Gastro & General Hospital
      • Jaipur, Rajasthan, 인도, 302007
        • SMS Superspeciality Hospital
    • Telangana
      • Secunderabad, Telangana, 인도, 500003
        • Yashoda Hospitals
  • 중국
      • Changsha, 중국, 410013
        • Third Xiangya Hospital Centrel South University
      • Chengdu, 중국, 610041
        • West China Hospital of Sichuan University
      • Guangzhou, 중국, 510180
        • Guangzhou First People's Hospital
      • Guangzhou, 중국, 510260
        • The second Affiliated Hospital of Guangzhou Medical University
      • Hangzhou, 중국, 310016
        • Sir Run Run Shaw Hospital Zhejiang University
      • Huizhou, 중국, 516001
        • Huizhou Central People's Hospital
      • Nanning, 중국, 530021
        • The First Affiliate Hospital of Guangxi Medical University
      • Ningbo, 중국, 315000
        • The First Affiliated Hospital of Ningbo University
      • Qingdao, 중국, 266000
        • The Affiliated Hospital of Medical College Qingdao University
      • Shanghai, 중국, 200092
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shanghai, 중국, 200025
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
      • Shenyang, 중국, 110004
        • Shengjing Hospital of China Medical University
      • Suzhou, 중국, 215006
        • First Affiliated Hospital of Soochow University
      • Xiamen, 중국, 361004
        • Zhongshan Hospital Xiamen University
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100007
        • Beijing No.6 Hospital
    • Yunnan
      • Kunming, Yunnan, 중국, 650032
        • The First Affilliated Hospital of Kunming Medical University
  • 체코
      • Hradec Králové, 체코, 500 12
        • Hepato-Gastroenterologie HK, s.r.o.
      • Prague, 체코, 170 04
        • ISCARE a.s.
  • 칠레
      • Santiago, 칠레, 8330034
        • Centro de Investigación Clínica UC-CICUC
  • 캐나다
    • Ontario
      • Barrie, Ontario, 캐나다, L4M 7G1
        • Barrie GI Associates
      • London, Ontario, 캐나다, N6A 5A5
        • London Health Sciences Centre Uni Campus
      • London, Ontario, 캐나다, N6K 1M6
        • LDDI Clinical Trials Inc.
      • Toronto, Ontario, 캐나다, M6A 3B4
        • TIDHI Innovation Inc.
    • Quebec
      • Montreal, Quebec, 캐나다, H1T 2M4
        • CIUSSS-de-l?Est-de-l?Île-de-Montréal
  • 크로아티아
      • Osijek, 크로아티아, 31000
        • Borzan Polyclinic
  • 태국
      • Chiang Mai, 태국, 50200
        • Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
      • Chon Buri, 태국, 20131
        • Burapha University Hospital
      • Ubonratchathani, 태국, 34000
        • Sunpasitthiprasong Hospital
  • 포르투갈
      • Braga, 포르투갈, 4710-243
        • Hospital de Braga
      • Lisbon, 포르투갈, 1500-650
        • Hospital da Luz Lisboa
      • Portimão, 포르투갈, 8500-338
        • Centro Hospitalar do Algarve - Hospital de Portimao
      • Porto, 포르투갈, 4202-451
        • Hospital de Sao Joao
      • Santa Maria da Feira, 포르투갈, 4520-211
        • Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
      • Viseu, 포르투갈, 3504-509
        • Hospital Sao Teotonio
  • 폴란드
      • ?ód?, 폴란드, 93-357
        • Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
      • Bydgoszcz, 폴란드, 85-231
        • Medical Center Kermed
      • Elblag, 폴란드, 82-300
        • Szpital Miejski sw. Jana Paw?a II w Elblagu
      • I?awa, 폴란드, 14-200
        • Osrodek Badan Klinicznych Bd Research
      • Knurów, 폴란드, 44-190
        • MZ Badania Slowik Zymla Sp.j.
      • Krakow, 폴란드, 31-513
        • Centrum Medyczne Promed
      • Lublin, 폴란드, 20-582
        • Medrise sp z o.o
      • Poznan, 폴란드, 61-731
        • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
      • Późna, 폴란드, 60-309
        • EMC Instytut Medyczny SA
      • Późna, 폴란드, 61-441
        • Gabinety Lekarskie Rivermed
      • Sopot, 폴란드, 81-756
        • Endoskopia Sp. z o.o.
      • Szczecin, 폴란드, 71-685
        • Sonomed Sp. z o.o.
      • Warsaw, 폴란드, 00-189
        • Centrum Zdrowia-MDM
      • Warsaw, 폴란드, 02-679
        • Medon Clinical Research sp. z o.o
      • Warsaw, 폴란드, 03-580
        • Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
      • Wroc?aw, 폴란드, 52-210
        • PlanetMed sp. z o.o.
      • Wroclaw, 폴란드, 52-416
        • Centrum Medyczne Oporow
  • 푸에르토 리코
      • San Juan, 푸에르토 리코, 00909
        • Klinical Investigations Group LLC
  • 프랑스
      • Chambray-lès-Tours, 프랑스, 37170
        • CHU Tours - Hôpital Trousseau
      • Clermont-Ferrand, 프랑스, 63000
        • CHU Clermont Ferrand - Hôtel Dieu
      • Créteil, 프랑스, 94000
        • Hôpital Henri Mondor
      • Nîmes, 프랑스, 30900
        • Polyclinique Grand Sud
      • Vandœuvre-lès-Nancy, 프랑스, 54511
        • Hôpital de Brabois Adultes
  • 헝가리
      • Budapest, 헝가리, 1082
        • Semmelweis Egyetem
      • Debrecen, 헝가리, 4025
        • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
      • Szombathely, 헝가리, 9700
        • Vas-Oxy Egeszsegugyi Kft
      • Székesfehérvár, 헝가리, 8000
        • Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
  • 호주
    • New South Wales
      • Macquarie Park, New South Wales, 호주, 2109
        • Macquarie University Hospital
    • Victoria
      • Parkville, Victoria, 호주, 3050
        • Royal Melbourne Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

16년 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Confirmed diagnosis of UC
  • Moderately to severely active UC assessed by mMS
  • Bodyweight >= 40 kilogram (kg)
  • Up to date with colorectal cancer (CRC) screening performed according to local standards
  • Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
  • Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion Criteria:

  • Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
  • Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
  • Presence of an ostomy or ileoanal pouch
  • Current diagnosis or suspicion of primary sclerosing cholangitis
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study
  • Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
  • History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
  • Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
  • Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
  • Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Afimkibart

Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
의약품: Afimkibart

Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.

다른 이름들:
  • RVT-3101
  • PF-06480605
  • RG6631
  • RO7790121
위약 비교기: Placebo

Participants will receive placebo IV followed by placebo SC.
의약품: Placebo

Placebo matching IV afimkibart. Placebo matching SC afimkibart.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants with Clinical Remission
기간: At Week 12

Percentage of participants achieving Modified Mayo Score (mMS) <=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.
At Week 12

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Partial Modified Mayo Score (pmMS)
기간: From baseline to Week 2

Change in pmMS from baseline to Week 2. pmMS is a composite score of ulcerative colitis signs and symptoms activity given by the sum of the SFS and RBS. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed).
From baseline to Week 2
Percentage of Participants with Endoscopic Improvement
기간: At Week 12

Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12.
At Week 12
Percentage of Participants with Endoscopic Remission
기간: At Week 12

Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12.
At Week 12
Percentage of Participants with Clinical Response
기간: At Week 12

Percentage of participants achieving a decrease in mMS of at least 2 points and 30% from baseline and either a decrease in RBS >= 1 or RBS = 0 or 1 (no blood seen or stool with streaks of blood) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed). ES is measured on a scale from 0 (normal appearance of mucosa) to 3 (severe disease).
At Week 12
Percentage of Participants with Histologic Improvement
기간: At Week 12

Percentage of participants achieving a histologic improvement, defined as Geboes <=3.1 at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
At Week 12
Percentage of Participants with Histologic Remission
기간: At Week 12

Percentage of participants achieving a histologic remission, defined as Geboes <2B at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
At Week 12
Participants with Histologic-Endoscopic Mucosal Improvement
기간: At Week 12

Percentage of participants achieving Geboes <= 3.1 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
At Week 12
Percentage of Participants with Histologic-Endoscopic Remission
기간: At Week 12

Percentage of participants achieving Geboes < 2 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
At Week 12
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
기간: At Week 12

Percentage of participants achieving mMS <= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.
At Week 12
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
기간: At Week 12

Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups.
At Week 12
Change in Bowel Urgency
기간: Baseline through Week 12

Change in bowel urgency from baseline through Week 12. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe).
Baseline through Week 12
Change in Abdominal Pain
기간: Baseline through Week 12

Change in abdominal pain from baseline through Week 12. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe).
Baseline through Week 12
Change in Fatigue
기간: Baseline to Week 12

Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue.
Baseline to Week 12
Change in Health-Related Quality of Life
기간: Baseline to Week 12

Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life.
Baseline to Week 12
Overall Change in UC Symptoms
기간: Baseline to Week 2 and Week 12

Patient Global Impression of Change (PGIC) from baseline to Weeks 2 and 12. PGIC measures overall change in ulcerative colitis symptoms from "Much better" to"Much worse".
Baseline to Week 2 and Week 12
Overall Severity in UC Symptoms
기간: Baseline to Week 2 and Week 12

Patient Global Impression of Severity (PGIS) from baseline to Weeks 2 and 12. PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe".
Baseline to Week 2 and Week 12
Incidence and Severity of Adverse Events (AEs)
기간: Up to 30 Weeks after Baseline

Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
Up to 30 Weeks after Baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

수사관

  • 연구 책임자: Clinical Trials, Hoffmann-La Roche

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 12월 11일

기본 완료 (추정된)

2026년 10월 29일

연구 완료 (추정된)

2031년 1월 30일

연구 등록 날짜

최초 제출

2024년 9월 6일

QC 기준을 충족하는 최초 제출

2024년 9월 6일

처음 게시됨 (실제)

2024년 9월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 1일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • GA45330
  • 2024-513015-27-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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