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RecruitingPhase 3

A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

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

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 for people with moderate to severe active Crohn’s disease. It compares afimkibart with a placebo, a treatment with no active drug, for starting and continuing treatment.

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance 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 well, stopped working, or caused side effects you could not tolerate.
  • Follow the study’s birth control rules if you can become pregnant or cause a pregnancy.

Who can't join

  • Have ulcerative colitis or certain other types of colitis (swelling in the colon).
  • Have had at least 3 bowel removal surgeries, with more than 2 of the listed bowel sections missing; have short bowel syndrome; or have an ileostomy, colostomy, or ileoanal pouch (surgically made bowel openings or pouch).
  • Have bowel narrowing that causes symptoms, very severe colon swelling, an enlarged and swollen colon, pockets of infection in the belly or near the anus, or certain fistulas (abnormal tunnels between organs or to the skin).
  • Have or may have primary sclerosing cholangitis, a disease that damages bile ducts.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have ever had digestive tract cancer or certain abnormal colon cells. Most other past cancers also exclude you, except certain fully treated skin cancers that have not spread or early cervical cancer.
  • Have evidence of C. difficile, CMV, HIV, hepatitis B, or hepatitis C infection at screening; or have active tuberculosis (TB) or TB that was not treated successfully.
  • Have received medicines not allowed by the study, including any past 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 * 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

Study sites (95)

AL

  • Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan · Dothan, AL 36305More trials in Dothan

AZ

CA

CO

FL

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