A Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Participants With Moderately to Severely Active Ulcerative Colitis
- Conditions
- Moderately to Severely Active Ulcerative Colitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT06588855
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo IV followed by placebo SC. RO7790121 RO7790121 Participants will receive RO7790121 intravenously (IV) followed by RO7790121 subcutaneous (SC) injection.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Clinical Remission 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.
- Secondary Outcome Measures
Name Time Method Change in Partial Modified Mayo Score (pmMS) 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).
Percentage of Participants with Endoscopic Improvement At Week 12 Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12.
Percentage of Participants with Endoscopic Remission At Week 12 Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12.
Percentage of Participants with Clinical Response 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).
Percentage of Participants with Histologic Improvement 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).
Percentage of Participants with Histologic Remission 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).
Participants with Histologic-Endoscopic Mucosal Improvement 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).
Percentage of Participants with Histologic-Endoscopic Remission 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).
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants 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.
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants 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.
Change in Bowel Urgency 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).
Change in Abdominal Pain 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).
Change in Fatigue 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.
Change in Health-Related Quality of Life 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.
Overall Change in UC Symptoms 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".
Overall Severity in UC Symptoms 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".
Incidence and Severity of Adverse Events (AEs) Up to 30 Weeks after Baseline Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
Trial Locations
- Locations (112)
West China Hospital of Sichuan University
🇨🇳Chengdu City, China
MZ Badania Slowik Zymla Sp.j.
🇵🇱Knurów, Poland
Borzan Polyclinic
ðŸ‡ðŸ‡·Osijek, Croatia
Semmelweis Egyetem
ðŸ‡ðŸ‡ºBudapest, Hungary
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
🇵🇱?ód?, Poland
Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
🇵🇱Grudzadz, Poland
Guangzhou First People's Hospital
🇨🇳Guangzhou, China
Sir Run Run Shaw Hospital Zhejiang University
🇨🇳Hangzhou City, China
Huizhou Central People's Hospital
🇨🇳Huizhou, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang City, China
Endoskopia Sp. z o.o.
🇵🇱Sopot, Poland
Sonomed Sp. z o.o.
🇵🇱Szczecin, Poland
Centrum Zdrowia-MDM
🇵🇱Warszawa, Poland
Hospital Sao Teotonio
🇵🇹Viseu, Portugal
Centrum Medyczne Promed
🇵🇱Kraków, Poland
Medrise sp z o.o
🇵🇱Lublin, Poland
EMC Instytut Medyczny SA
🇵🇱Pozna?, Poland
Gabinety Lekarskie Rivermed
🇵🇱Pozna?, Poland
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Beijing No.6 Hospital
🇨🇳Beijing, Beijing, China
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Lombardia, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Veneto, Italy
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Gastro Care Associates
🇺🇸Lancaster, California, United States
Om Research LLC
🇺🇸Apple Valley, California, United States
Valley View Internal Medicine
🇺🇸Garden Grove, California, United States
Hi Tech and Global Research, LLC
🇺🇸Coral Gables, Florida, United States
LCC Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
Ambert Medical Research
🇺🇸Miami, Florida, United States
Gastroenterology Institute of Orlando
🇺🇸Orlando, Florida, United States
Digestive and Liver Center of Florida
🇺🇸Orlando, Florida, United States
Guardian Angel Research Center, LLC
🇺🇸Tampa, Florida, United States
Santos Research Center, CORP
🇺🇸Tampa, Florida, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Illinois Gastroenterology Group-Glenview powered by GI Alliance
🇺🇸Glenview, Illinois, United States
GI Alliance - Gurnee
🇺🇸Gurnee, Illinois, United States
Kansas Gastroenterology, LLC under Clinical Trials Network
🇺🇸Wichita, Kansas, United States
Delta Gastroenterology & Endoscopy Center
🇺🇸Southaven, Mississippi, United States
Ellipsis Research Group
🇺🇸Brooklyn, New York, United States
DiGiovanna Inst for Med Ed&Res
🇺🇸North Massapequa, New York, United States
Queens Village Medical Care
🇺🇸Queens Village, New York, United States
Gastroenterology Group of Rochester under CTNx
🇺🇸Rochester, New York, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
🇺🇸Charlotte, North Carolina, United States
Omega Research North Carolina, LLC
🇺🇸Fuquay-Varina, North Carolina, United States
Dayton Gastroenterology, Inc.
🇺🇸Beavercreek, Ohio, United States
University of Cincinnati Hospital
🇺🇸Cincinnati, Ohio, United States
Ohio State University
🇺🇸Hilliard, Ohio, United States
Frontier Clinical Re search, LLC
🇺🇸Uniontown, Pennsylvania, United States
Gastroenterology Associates, PA PA of Greenville
🇺🇸Greenville, South Carolina, United States
Amel Med LLC
🇺🇸Georgetown, Texas, United States
Cano Medical Center
🇺🇸Harlingen, Texas, United States
Texas Digestive Specialists
🇺🇸Harlingen, Texas, United States
Emeritas Research Group
🇺🇸Lansdowne Town Center, Virginia, United States
Hospital Britanico
🇦🇷Ciudad Autonoma Bs As, Argentina
Instituto Medico CER
🇦🇷Quilmes, Argentina
Macquarie University Hospital
🇦🇺Macquarie Park, New South Wales, Australia
Coral Sea Clinical Research Institute
🇦🇺Mackay, Queensland, Australia
Footscray Hospital
🇦🇺Footscray, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Ordensklinikum Linz Barmherzige Schwestern
🇦🇹Linz, Austria
Klinikum Wels-Grieskirchen
🇦🇹Wels, Austria
AZORG Campus Aalst-Moorselbaan
🇧🇪Aalst, Belgium
CHU St Pierre (St Pierre)
🇧🇪Brussels, Belgium
Cliniques Universitaires St-Luc
🇧🇪Bruxelles, Belgium
London Health Sciences Centre Uni Campus
🇨🇦London, Ontario, Canada
Centro de Investigación ClÃnica UC-CICUC
🇨🇱Santiago, Chile
The First Affilliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Third Xiangya Hospital Centrel South University
🇨🇳Changsha, China
The second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou City, China
The First Affiliate Hospital of Guangxi Medical University
🇨🇳Nanning, China
The First Affiliated Hospital of Ningbo University
🇨🇳Ningbo City, China
The Affiliated Hospital of Medical College Qingdao University
🇨🇳Qingdao, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai City, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Shengjing Hospital of China Medical University
🇨🇳ShenYang, China
First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, China
Fakultni nemocnice Ostrava
🇨🇿Ostrava - Poruba, Czechia
Ã…lborg Universitets Hospital
🇩🇰Ålborg, Denmark
CHU Tours - Hôpital Trousseau
🇫🇷Chambray les Tours, France
CHU Clermont Ferrand - Hôtel Dieu
🇫🇷Clermont-Ferrand, France
Hôpital Henri Mondor
🇫🇷Créteil, France
Polyclinique Grand Sud
🇫🇷Nimes, France
Hôpital de Brabois Adultes
🇫🇷Vandoeuvre-les-nancy, France
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Medizinisches Zentrum Klinikum Lueneburg
🇩🇪Lueneburg, Germany
Észak-Pesti Centrumkórház-Honvédkórház
ðŸ‡ðŸ‡ºBudapest, Hungary
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
ðŸ‡ðŸ‡ºDebrecen, Hungary
Vas-Oxy Egeszsegugyi Kft
ðŸ‡ðŸ‡ºSzombathely, Hungary
Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
ðŸ‡ðŸ‡ºSzékesfehérvár, Hungary
Policlinico Universitario Campus Biomedico Di Roma
🇮🇹Roma, Lazio, Italy
Ospedale Isola Tiberina Gemelli
🇮🇹Roma, Lazio, Italy
FAICIC S de R.L. de C.V
🇲🇽Veracruz, Mexico
ETZ Elisabeth
🇳🇱Tilburg, Netherlands
Medical Center Kermed
🇵🇱Bydgoszcz, Poland
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
🇵🇱Pozna?, Poland
Medon Clinical Research sp. z o.o
🇵🇱Warszawa, Poland
PlanetMed sp. z o.o.
🇵🇱Wroc?aw, Poland
Hospital de Braga
🇵🇹Braga, Portugal
Hospital da Luz Lisboa
🇵🇹Lisboa, Portugal
Centro Hospitalar do Algarve - Hospital de Portimao
🇵🇹Portimao, Portugal
Hospital de Sao Joao
🇵🇹Porto, Portugal
Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
🇵🇹Santa Maria Da Feira, Portugal
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
🇹ðŸ‡Chiang Mai, Thailand
Burapha University Hospital
🇹ðŸ‡Chonburi, Thailand
Sunpasitthiprasong Hospital
🇹ðŸ‡Ubonratchathani, Thailand
Leicester General Hospital
🇬🇧Leicester, United Kingdom
Bronglais General Hospital
🇬🇧Llanrhystud, United Kingdom
Stepping Hill Hospital
🇬🇧Stockport, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom