A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Participants With Moderately to Severely Active Crohn's Disease
- Conditions
- Moderately to Severely Active Crohns Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT06819878
- 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 induction and maintenance therapy with RO7790121 in participants with moderately to severely active Crohn's disease (CD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Confirmed diagnosis of CD
- Moderately to severely active CD
- Bodyweight >= 40 kilogram (kg)
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
- Males and females of childbearing potential must meet protocol criteria for contraception requirements
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
- Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
- Diagnosis of short gut or short bowel syndrome
- Presence of an ileostomy, colostomy or ileoanal pouch
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Presence of abdominal or perianal abscess
- Presence of rectovaginal fistulas or perianal fistulas with >3 openings
- 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 Arm 3: Placebo Placebo Participants will receive placebo IV followed by placebo SC. Arm 1: RO7790121 RO7790121 Participants will receive RO7790121 intravenously (IV) followed by RO7790121 subcutaneous (SC) injection. Arm 2: RO7790121 RO7790121 Participants will receive RO7790121 IV followed by RO7790121 SC injection.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Endoscopic Response At Week 52 Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>=50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score At Week 52 Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
- Secondary Outcome Measures
Name Time Method Average of Daily Abdominal Pain Scores in the Past Week (APS) Baseline through Week 12 The average daily rating of abdominal pain in the past 7 days. The pain is assessed on a scale of 0-3 with 0 indicating no pain and 3 indicating severe pain.
Percentage of Participants with Corticosteroid-free Clinical Remission At Week 52 Percentage of participants with clinical remission at Week 52 and no use of corticosteroids for CD at least 8 weeks prior to Week 52.
Inflammatory Bowel Disease Questionnaire (IBDQ) Score Baseline to Week 12 and Week 52 Change in IBDQ score from baseline to week 12 and 52. The IBDQ is a 32-item questionnaire that measures four domains: bowel symptoms (10 questions); systemic symptoms (5 questions); emotional function (12 questions); and social function (5 questions). The total score ranges from 32-224, with a higher score indicating a better quality of life.
Percentage of Participants with Clinical Remission At Week 12 Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Percentage of Participants with Symptomatic Remission At Week 52 Percentage of participants with the daily number of liquid or very soft stools \<=2.8 and the average of daily abdominal pain scores in the past week \<=1, with neither being greater than baseline.
Percentage of Participants with Ulcer-free Endoscopy At Week 52 Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF) Baseline through Week 12 Daily average number of liquid or very soft stools over 7 days.
Maintenance of Clinical Remission At Weeks 12 and 52 Percentage of participants with clinical remission at both Weeks 12 and 52.
Maintenance of Endoscopic Response At Weeks 12 and 52 Percentage of participants with endoscopic response at both Weeks 12 and 52.
Percentage of Participants with Endoscopic Response At Week 12 Percentage of participants achieving a decrease in SES-CD of \>=50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Percentage of Participants with Endoscopic Remission At Week 52 Percentage of participants with SES-CD=0 to 4 with decrease from baseline \>=2 and no subscore \>1 .
Bowel Urgency Baseline through Week 12 and Week 52 Bowel urgency from baseline through week 12 and week 52. Bowel urgency is a single-item self-reported assessment of sudden or immediate need to have a bowel movement in the past 24 hours. The item response is reported on a 4-point Likert scale, from "None" to "Severe."
Percentage of Participants with Clinical Remission and Endoscopic Remission at Week 52 At Week 52 Percentage of participants achieving a CDAI score of \<150 and SES-CD of 0 to 4 with a decrease from baseline \>=2 and no subscore \>1 at Week 52.
Fatigue Baseline to Week 12 and Week 52 Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12 and Week 52. FACIT-F is a 13-item self-reported assessment of fatigue. Each item response option indicates the degree to which a given statement describing the level or impact of fatigue applies in the past 7 days. Response options are graded on a 5-point Likert-type scale, from "Not at all" to "Very much."
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants At Week 52 Percentage of participants achieving a CDAI score of \<150 at Week 52 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Percentage of Participants with Clinical Response At Week 12 Percentage of participants with a decrease \>=100 in CDAI from baseline.
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants At Week 52 Percentage of participants achieving a decrease in SES-CD of \>=50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Overall Change in CD Symptoms Baseline to Weeks 2, 6, 12 and 52 Overall change in CD symptoms, as measured by the Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 6, 12 and 52. PGIC measures overall change in Crohn's disease symptoms from "Much better" to "Much worse".
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.
Percentage of Participants with Symptomatic Response At Week 12 Percentage of participants with a decrease \>=30% in both SF and APS, with neither being greater than baseline.
Percentage of Participants with a Presence of Draining Fistulas Baseline through Week 12 and Week 52 Fistulas will be assessed for draining or closed status, where closed fistulas will be assessed by the investigator as no longer draining.
Overall Severity in CD Symptoms Baseline to Weeks 2, 6, 12 and 52 Overall severity in CD symptoms, as measured by the Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 6, 12 and 52. PGIS measures severity of Crohn's disease symptoms from "None" to "Very severe".
Change in General Well-being Baseline through Week 52 The average daily rating of general well-being in the past 7 days. Well-being is assessed on a scale of 0-4 with 0 indicating generally well and 4 indicating terrible.
Related Research Topics
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Trial Locations
- Locations (81)
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
🇺🇸Dothan, Alabama, United States
Arizona Digestive Health, P.C (ADH)
🇺🇸Sun City, Arizona, United States
Valley View Internal Medicine
🇺🇸Garden Grove, California, United States
310 Clinical Research
🇺🇸Inglewood, California, United States
Gastro Care Associates
🇺🇸Lancaster, California, United States
Om Research LLC
🇺🇸Lancaster, California, United States
Peak Gastroenterology Surgery Center
🇺🇸Lone Tree, Colorado, United States
Access Research Institute
🇺🇸Brooksville, Florida, United States
Hi Tech and Global Research, LLC
🇺🇸Coral Gables, Florida, United States
Clinical Research of Osceola, LLC
🇺🇸Kissimmee, Florida, United States
Florida Research Institute - Lakewood
🇺🇸Lakewood Ranch, Florida, United States
LCC Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
Ambert Medical Research
🇺🇸Miami, Florida, United States
Nodal Medical Center Research - NMC
🇺🇸Tampa, Florida, United States
Guardian Angel Research Center, LLC
🇺🇸Tampa, Florida, United States
Theia Clinical Research Centers, LLC
🇺🇸Temple Terrace, Florida, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia
🇺🇸Macon, Georgia, United States
Grand Teton Research Group, PLLC
🇺🇸Idaho Falls, Idaho, United States
Illinois Gastroenterology Group-Glenview powered by GI Alliance
🇺🇸Glenview, Illinois, United States
GI Alliance - Gurnee
🇺🇸Gurnee, Illinois, United States
Gastroenterology Health Partners, PLLC
🇺🇸Louisville, Kentucky, United States
Kansas Gastroenterology, LLC under Clinical Trials Network
🇺🇸Wichita, Kansas, United States
Tri-State Gastroenterology Associates
🇺🇸Crestview Hills, Kentucky, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Gastroenterology Associates and Endoscopy Center of North Mississippi
🇺🇸Oxford, Mississippi, United States
Delta Gastroenterology & Endoscopy Center
🇺🇸Southaven, Mississippi, 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
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Dayton Gastroenterology, Inc.
🇺🇸Beavercreek, Ohio, United States
Ohio Gastroenterology Group
🇺🇸Columbus, Ohio, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Gastro Intestinal Research Institute of Northern Ohio
🇺🇸Westlake, Ohio, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Frontier Clinical Re search, LLC
🇺🇸Uniontown, Pennsylvania, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Quality Medical Research
🇺🇸Nashville, Tennessee, United States
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
Amel Med LLC
🇺🇸Georgetown, Texas, United States
Cano Medical Center
🇺🇸Harlingen, Texas, United States
TDDC dba GI Alliance Research
🇺🇸Mansfield, Texas, United States
Gastroenterology Research of America, LLC
🇺🇸San Antonio, Texas, United States
GI Alliance - Southlake
🇺🇸Southlake, Texas, United States
Tyler Research Institute, LLC
🇺🇸Tyler, Texas, United States
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
🇺🇸Chesapeake, Virginia, United States
Emeritas Research Group
🇺🇸Lansdowne Town Center, Virginia, United States
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
🇺🇸Roanoke, Virginia, United States
AZ Sint Lucas (Sint Lucas)
🇧🇪Gent, Belgium
South Edmonton Gastroenterology
🇨🇦Edmonton, Alberta, Canada
Medwal
🇨🇱Santiago, Chile
the First Hospital of Jilin University
🇨🇳Changchun, China
Chongqing General Hospital
🇨🇳Chongqing City, China
The second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou City, China
The sixth affiliated hospital of Sun Yat-Sen University
🇨🇳Guangzhou City, China
Zhejiang Province Traditional Chinese Medical Hospital
🇨🇳Hangzhou City, China
Sir Run Run Shaw Hospital Zhejiang University
🇨🇳Hangzhou City, China
Anhui Provincial Hospital
🇨🇳Hefei, China
Huizhou Central People's Hospital
🇨🇳Huizhou, China
The 1st Affiliated Hospital of Nanchang Unversity
🇨🇳Nanchang City, China
The First Affiliate Hospital of Guangxi Medical University
🇨🇳Nanning, China
The First Affiliated Hospital of Ningbo University
🇨🇳Ningbo City, China
Shanghai East Hospital
🇨🇳Shanghai City, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, China
Taizhou Hospital Of Zhejiang Province
🇨🇳Taizhou City, China
The Central Hospital of Wuhan
🇨🇳Wuhan City, China
Ren Min Hospital Affiliated Wu Han University
🇨🇳Wuhan, China
Wuxi People's Hospital
🇨🇳Wuxi, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, China
Zhuzhou Central Hospital
🇨🇳Zhuzhou, China
CHU Nice - Hopital de l'Archet 2
🇫🇷Nice, France
Boca Clinical Trials Mexico S.C. (Guadalajara)
🇲🇽Guadalajara, Jalisco, Mexico
Medical Care & Research SA de CV
🇲🇽Mérida, Yucatan, Mexico
Centrum Medyczne "Medis"
🇵🇱Bydgoszcz, Poland
WIP Warsaw IBD Point Profesor Kierkus
🇵🇱Warszawa, Poland
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
🇵🇱Wroc?aw, Poland
Klinical Investigations Group LLC
🇵🇷San Juan, Puerto Rico
Queen Anne Street Medical Centre
🇬🇧London, United Kingdom