Clinical trial NCT06819878: 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
Official title: A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Moderately to Severely Active Crohns Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Chugai Pharmaceutical
First posted: 2025-02-11
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
timeFrame: At Week 52
measure: Percentage of Participants with Endoscopic Response
timeFrame: At Week 52
Secondary outcomes:
measure: Percentage of Participants with Clinical Remission
timeFrame: At Week 12
measure: Percentage of Participants with Endoscopic Response
timeFrame: At Week 12
measure: Percentage of Participants with Symptomatic Remission
timeFrame: At Week 12
measure: Percentage of Participants with Endoscopic Remission
timeFrame: At Week 12
measure: Percentage of Participants with Ulcer-free Endoscopy
timeFrame: At Week 12
measure: Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
timeFrame: Baseline through Week 12
measure: Average of Daily Abdominal Pain Scores in the Past Week (APS)
timeFrame: Baseline through Week 12
measure: Percentage of Participants with Endoscopic Remission
timeFrame: At Week 52
measure: Percentage of Participants with Symptomatic Remission
timeFrame: At Week 52
measure: Percentage of Participants with Corticosteroid-free Clinical Remission
timeFrame: At Week 52
measure: Maintenance of Clinical Remission
timeFrame: At Weeks 12 and 52
measure: Maintenance of Endoscopic Response
timeFrame: At Weeks 12 and 52
measure: Percentage of Participants with Clinical Remission and Endoscopic Remission at Week 52
timeFrame: At Week 52
measure: Percentage of Participants with Ulcer-free Endoscopy
timeFrame: At Week 52
measure: Bowel Urgency
timeFrame: Baseline through Week 12 and Week 52
measure: Fatigue
timeFrame: Baseline to Week 12 and Week 52
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Score
timeFrame: Baseline to Week 12 and Week 52
measure: Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
timeFrame: At Week 12
measure: Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
timeFrame: At Week 52
measure: Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
timeFrame: At Week 12
measure: Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
timeFrame: At Week 52
measure: Percentage of Participants with Clinical Response
timeFrame: At Week 12
measure: Percentage of Participants with Symptomatic Response
timeFrame: At Week 12
measure: Overall Change in CD Symptoms
timeFrame: Baseline to Weeks 2, 6, 12 and 52
measure: Overall Severity in CD Symptoms
timeFrame: Baseline to Weeks 2, 6, 12 and 52
measure: Change in General Well-being
timeFrame: Baseline through Week 52
measure: Incidence and Severity of Adverse Events (AEs)
timeFrame: Up to 70 Weeks after Baseline
measure: Percentage of Participants with a Presence of Draining Fistulas
timeFrame: Baseline through Week 12 and Week 52
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
state: Alabama
city: Sun City
country: United States
facility: Arizona Digestive Health, P.C (ADH)
state: Arizona
city: Garden Grove
country: United States
facility: Valley View Internal Medicine
state: California
city: Inglewood
country: United States
facility: 310 Clinical Research
state: California
city: Lancaster
country: United States
facility: Gastro Care Associates
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Lone Tree
country: United States
facility: Peak Gastroenterology Surgery Center
state: Colorado
city: Brooksville
country: United States
facility: Access Research Institute
state: Florida
city: Coral Gables
country: United States
facility: Hi Tech and Global Research, LLC
state: Florida
city: Kissimmee
country: United States
facility: Clinical Research of Osceola, LLC
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute - Lakewood
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Ambert Medical Research
state: Florida
city: Tampa
country: United States
facility: Nodal Medical Center Research - NMC
state: Florida
city: Tampa
country: United States
facility: Guardian Angel Research Center, LLC
state: Florida
city: Temple Terrace
country: United States
facility: Theia Clinical Research Centers, LLC
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group, PLLC
state: Idaho
city: Glenview
country: United States
facility: Illinois Gastroenterology Group-Glenview powered by GI Alliance
state: Illinois
city: Gurnee
country: United States
facility: GI Alliance - Gurnee
state: Illinois
city: New Albany
country: United States
facility: Gastroenterology Health Partners, PLLC
state: Indiana
city: Wichita
country: United States
facility: Kansas Gastroenterology, LLC under Clinical Trials Network
state: Kansas
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology Associates
state: Kentucky
city: Louisville
country: United States
facility: Gastroenterology Health Partners, PLLC
state: Kentucky
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Oxford
country: United States
facility: Gastroenterology Associates and Endoscopy Center of North Mississippi
state: Mississippi
city: Southaven
country: United States
facility: Delta Gastroenterology & Endoscopy Center
state: Mississippi
city: North Massapequa
country: United States
facility: DiGiovanna Inst for Med Ed&Res
state: New York
city: Queens Village
country: United States
facility: Queens Village Medical Care
state: New York
city: Rochester
country: United States
facility: Gastroenterology Group of Rochester under CTNx
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Beavercreek
country: United States
facility: Dayton Gastroenterology, Inc.
state: Ohio
city: Columbus
country: United States
facility: Ohio Gastroenterology Group
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Westlake
country: United States
facility: Gastro Intestinal Research Institute of Northern Ohio
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Uniontown
country: United States
facility: Frontier Clinical Re search, LLC
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Georgetown
country: United States
facility: Amel Med LLC
state: Texas
city: Harlingen
country: United States
facility: Cano Medical Center
state: Texas
city: Mansfield
country: United States
facility: TDDC dba GI Alliance Research
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of America, LLC
state: Texas
city: Southlake
country: United States
facility: GI Alliance - Southlake
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Chesapeake
country: United States
facility: Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
state: Virginia
city: Lansdowne Town Center
country: United States
facility: Emeritas Research Group
state: Virginia
city: Roanoke
country: United States
facility: Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
state: Virginia
city: Gent
country: Belgium
facility: AZ Sint Lucas (Sint Lucas)
city: Edmonton
country: Canada
facility: South Edmonton Gastroenterology
state: Alberta
city: Santiago
country: Chile
facility: Medwal
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Chongqing City
country: China
facility: Chongqing General Hospital
city: Guangzhou City
country: China
facility: The second Affiliated Hospital of Guangzhou Medical University
city: Guangzhou City
country: China
facility: The sixth affiliated hospital of Sun Yat-Sen University
city: Hangzhou City
country: China
facility: Zhejiang Province Traditional Chinese Medical Hospital
city: Hangzhou City
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
city: Nanchang City
country: China
facility: The 1st Affiliated Hospital of Nanchang Unversity
city: Nanning
country: China
facility: The First Affiliate Hospital of Guangxi Medical University
city: Ningbo City
country: China
facility: The First Affiliated Hospital of Ningbo University
city: Shanghai City
country: China
facility: Shanghai East Hospital
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Taizhou City
country: China
facility: Taizhou Hospital Of Zhejiang Province
city: Wuhan City
country: China
facility: The Central Hospital of Wuhan
city: Wuhan
country: China
facility: Ren Min Hospital Affiliated Wu Han University
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
city: Nice
country: France
facility: CHU Nice - Hopital de l'Archet 2
city: Guadalajara
country: Mexico
facility: Boca Clinical Trials Mexico S.C. (Guadalajara)
state: Jalisco
city: Mérida
country: Mexico
facility: Medical Care & Research SA de CV
state: Yucatan
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne "Medis"
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Wroc?aw
country: Poland
facility: Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group LLC
city: London
country: United Kingdom
facility: Queen Anne Street Medical Centre
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: