RECRUITINGPhase 3INTERVENTIONAL
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
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
About This Trial
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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, enterovaginal, high output enterocutaneous fistula, enterovesical 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
- Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
- History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer
- Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human weakened immune system virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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, enterovaginal, high output enterocutaneous fistula, enterovesical 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
* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening
* 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
Treatments Being Tested
DRUG
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
DRUG
Placebo
Placebo matching IV afimkibart.
Locations (20)
Sun City Clinical Research
Glendale, Arizona, United States
Om Research LLC
Lancaster, California, United States
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach, California, United States
Empire Clinical Research
Pomona, California, United States
Stanford Medicine Outpatient Center
Redwood City, California, United States
Amicis Research Center
Santa Clarita, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
J&A Clinical Research
Doral, Florida, United States
Homestead Associates in Research, Inc.
Miami, Florida, United States
Allied Biomedical Research Institute, Inc
Miami, Florida, United States
Rejuvaline Medical Research
Miami, Florida, United States
Miami Beach Clinical Research Center
Miami Beach, Florida, United States
Eminat Research Group
Miramar, Florida, United States
Digestive and Liver Center of Florida
Orlando, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
Santos Research Center, CORP
Tampa, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Robley Rex VA Medical Center
Louisville, Kentucky, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana, United States