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RecruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well afimkibart (RO7790121) works and how safe it is as a starting treatment for Crohn’s disease. It compares the drug with a placebo, a treatment with no active drug. It is for people with moderate to severe active Crohn’s disease whose past treatment did not work well or caused side effects they could not tolerate.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of Crohn’s disease.
  • Have moderate to severe active disease.
  • Weigh at least 40 kilograms (about 88 pounds).
  • Have tried at least one Crohn’s treatment listed in the study rules that did not work, stopped working, or caused side effects you could not tolerate.
  • Meet the study’s birth control rules if you could become pregnant or cause a pregnancy.

Who can't join

  • Have another listed type of colon inflammation, such as ulcerative colitis, or have known or suspected primary sclerosing cholangitis, a disease that scars the bile ducts.
  • Have had at least 3 bowel removal surgeries, with more than 2 of the 5 listed bowel sections missing; have short bowel syndrome; or have an ileostomy, colostomy, or surgically made pouch for stool.
  • Have bowel narrowing that causes symptoms, severe colon inflammation, a dangerously swollen colon, or a pocket of infection in the belly or near the anus.
  • Have certain fistulas (abnormal tunnels): bowel-to-vagina, bowel-to-bladder, bowel-to-skin with high drainage, or tunnels near the anus with more than 3 openings.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have current or past digestive tract cancer or high-grade abnormal colon cells. Low-grade abnormal cells are allowed if fully removed. Past cancer outside the digestive tract is excluded, except certain fully treated skin cancers that have not spread or early cervical cancer that has not spread.
  • Have C. difficile, CMV, HIV, hepatitis B, or hepatitis C infection at screening. Active tuberculosis (TB), untreated or unsuccessfully treated inactive TB, or inadequately treated TB also excludes you.
  • Have received medicines banned by the study, including any anti-TL1A treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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, 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, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed * 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

Study sites (61)

AL

AZ

CA

CO

FL

GA

IL

KS

KY

LA

MA

MD

MI

MO

MS

NC

NH

NJ

NY

OH

PA

RI

TN

TX

VA

WV