A Study to Assess the Efficacy and Safety of RO7790121 for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
- Conditions
- Interventions
- Registration Number
- NCT06589986
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of 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
- 400
- Confirmed diagnosis of UC
- Moderately to severely active UC assessed by mMS
- Bodyweight >= 40 kilogram (kg)
- 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 RO7790121 RO7790121 Participants will receive RO7790121 intravenously (IV) followed by RO7790121 subcutaneous (SC) injection. Placebo Placebo Participants will receive placebo IV followed by placebo SC.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Clinical Remission at Week 12 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...
Percentage of Participants with Clinical Remission at Week 52 At Week 52 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 52. 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...
- Secondary Outcome Measures
Name Time Method Change in Partial Modified Mayo Score (pmMS) 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 52 Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 52.
Percentage of Participants with Endoscopic Remission At Week 52 Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 52.
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...
Percentage of Participants with Histologic-Endoscopic Mucosal Improvement At Week 52 Percentage of participants achieving Geboes \<= 3.1 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 52. 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 52 Percentage of participants achieving Geboes \< 2 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 52. 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 Maintenance of Remission Week 12 and Week 52 Percentage of participants with clinical remission at both Week 12 and Week 52. Clinical remission is defined as 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). mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subs...
Percentage of Participants with Corticosteroid-Free Remission At Week 52 Percentage of participants in clinical remission at Week 52 with no corticosteroid use at least 8 weeks prior to Week 52. Clinical remission is defined as 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). mMS is a composite score of ulcerative colitis diseas...
Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants At Week 52 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 52 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 subsc...
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants At Week 52 Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 52 in biomarker-defined subgroups.
Change in Bowel Urgency Baseline through Week 52 Change in bowel urgency from baseline through Week 52. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe).
Change in Abdominal Pain Baseline through Week 52 Change in abdominal pain from baseline through Week 52. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe).
Change in Fatigue Baseline to Week 12 and Week 52 Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12 and Week 52. 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 ...
Change in Health-Related Quality of Life Baseline to Week 12 and Week 52 Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12 and Week 52. 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, Week 12, and Week 52 Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 12 and 52. PGIC measures overall change in ulcerative colitis symptoms from "Much better" to "Much worse".
Overall Severity in UC Symptoms Baseline to Week 2, Week 12, and Week 52 Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 12 and 52. PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe".
Incidence and Severity of Adverse Events (AEs) Up to 70 Weeks after Baseline Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
Trial Locations
- Locations (32)
Digestive Health Specialists
🇺🇸Dothan, Alabama, United States
Clinical Research of Osceola, LLC
🇺🇸Kissimmee, Florida, United States
Miami Beach Clinical Research Center
🇺🇸Miami Beach, Florida, United States
Florida Medical Clinic
🇺🇸Zephyrhills, Florida, United States
Gastroenterology Health Partners, PLLC
🇺🇸New Albany, Indiana, United States
Tri-State Gastroenterology Associates
🇺🇸Crestview Hills, Kentucky, United States
Michigan Center of Medical Research
🇺🇸Farmington Hills, Michigan, United States
Gastroenterology Associates and Endoscopy Center of North Mississippi
🇺🇸Oxford, Mississippi, United States
Intercity Gastroenterology
🇺🇸Fresh Meadows, New York, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Digestive Disease Consultants
🇺🇸Brunswick, Ohio, United States
Ohio Gastroenterology Group
🇺🇸Columbus, Ohio, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Gastrointestinal Associates of Northeast Tennessee
🇺🇸Johnson City, Tennessee, United States
GI Alliance - Mansfield
🇺🇸Mansfield, Texas, United States
GI Alliance - Southlake
🇺🇸Southlake, Texas, United States
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
🇺🇸Chesapeake, Virginia, United States
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
🇺🇸Roanoke, Virginia, United States
AZ Maria Middelares
🇧🇪Gent, Belgium
AZ Delta (Campus Rumbeke)
🇧🇪Roeselare, Belgium
CHU Bordeaux - Hôpital Haut-Lévêque
🇫🇷Pessac, France
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, BE, Germany
Centro Hospitalar do Algarve - Hospital de Portimao
🇵🇹Portimao, Portugal
Hospital de Sao Joao
🇵🇹Porto, Portugal
Amicis Research Center
🇺🇸Santa Clarita, California, United States
Homestead Associates in Research, Inc.
🇺🇸Homestead, Florida, United States
Gastroenterology Associates of Central Georgia
🇺🇸Macon, Georgia, United States
Grand Teton Research Group, PLLC
🇺🇸Idaho Falls, Idaho, United States
Louisiana Research Center - GastroIntestinal Associates
🇺🇸Shreveport, Louisiana, United States
Gastro Intestinal Research Institute of Northern Ohio
🇺🇸Westlake, Ohio, United States
Gastro One
🇺🇸Cordova, Tennessee, United States
Tyler Research Institute, LLC
🇺🇸Tyler, Texas, United States