Clinical trial NCT06819891: A Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction 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: 425
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 study will evaluate the efficacy and safety of induction 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
* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* 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 12
measure: Percentage of Participants with Endoscopic Response
timeFrame: At Week 12
Secondary outcomes:
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: Bowel Urgency
timeFrame: Baseline to Week 12
measure: Fatigue
timeFrame: Baseline to Week 12
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Score
timeFrame: Baseline to Week 12
measure: Percentage of Participants with Clinical Remission: 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 12
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 and 12
measure: Overall Severity in CD Symptoms
timeFrame: Baseline to Weeks 2, 6 and 12
measure: Change in General Well-being
timeFrame: Baseline through Week 12
measure: Incidence and Severity of Adverse Events (AEs)
timeFrame: Up to 30 Weeks after Baseline
measure: Presence of Draining Fistulas
timeFrame: Baseline through Week 12
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Doral
country: United States
facility: J&A Clinical Research
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute, Inc
state: Florida
city: Miramar
country: United States
facility: Eminat Research Group
state: Florida
city: Orlando
country: United States
facility: Digestive and Liver Center of Florida
state: Florida
city: Shreveport
country: United States
facility: Louisiana Research Center - GastroIntestinal Associates
state: Louisiana
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology, P.L.L.C
state: North Carolina
city: Macquarie Park
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Mackay
country: Australia
facility: Coral Sea Clinical Research Institute
state: Queensland
city: London
country: Canada
facility: London Health Sciences Centre Uni Campus
state: Ontario
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
state: Jiangxi
city: Kunming
country: China
facility: The First Affilliated Hospital of Kunming Medical University
state: Yunnan
city: Beijing
country: China
facility: Beijing Union Hospital
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
city: Huizhou
country: China
facility: Huizhou First Hospital
city: Jinhua
country: China
facility: Jinhua municipal central hospital
city: Nanchang City
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: ShenYang
country: China
facility: Shengjing Hospital of China Medical University
city: Shijiazhuang City
country: China
facility: Hebei Medical University - The Second Hospital
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
city: Monteria
country: Colombia
facility: Oncomedica S.A.
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand - Hôtel Dieu
city: Limoges
country: France
facility: Hopital Dupuytren
city: Montpellier
country: France
facility: Hopital Saint-Eloi
city: Pozna?
country: Poland
facility: Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
city: Warszawa
country: Poland
facility: Centrum Zdrowia-MDM
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: