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RecruitingPhase 3

A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2 - 17 Years With Moderately to Severely Active Ulcerative Colitis

Who can join

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

Age
2 Years to 17 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 safe afimkibart (RO7790121) is and how well it works in children with moderate to severe active ulcerative colitis, a disease that causes swelling and sores in the large intestine. It also looks at how the body processes the drug.

This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).

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

Eligibility

Who can join

  • Weigh at least 10 kilograms (about 22 pounds).
  • Have a confirmed diagnosis of ulcerative colitis.
  • Have moderate to severe active disease, with a modified Mayo score of 5 to 9 and a scope test score of 2 or 3. A central review team must confirm the scope test results.
  • Have tried at least one of these types of medicines without enough benefit, or could not tolerate it: steroids that treat the whole body, medicines that change immune activity, or biologic medicines.

Who can't join

  • Have a single-gene disorder linked to inflammatory bowel disease that starts in infancy.
  • Have Crohn’s disease, an unclear type of inflammatory bowel disease, or another listed type of colon swelling caused by tiny tissue changes, low blood flow, infection, or radiation.
  • Have an abnormal tunnel or pocket of pus in the belly or near the anus, or active disease in small pouches of the colon.
  • Have an ostomy, a surgically made opening for waste, or a surgically made pouch connecting the small intestine to the anus.
  • Have or may have primary sclerosing cholangitis, a disease that scars the tubes carrying bile from the liver.
  • Had major surgery within 6 weeks before screening, or plan to have major surgery during the study.
  • Have signs of active tuberculosis (TB) based on tests, symptoms, or chest scans.

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

Official eligibility criteria

Inclusion Criteria: * Bodyweight \>= 10 kilogram (kg) * Confirmed diagnosis of UC * Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy) * Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol Exclusion Criteria: * Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD) * Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease * Presence of an ostomy or ileoanal pouch * Current diagnosis or suspicion of primary sclerosing cholangitis * Any major surgery within 6 weeks prior to screening or a major planned surgery during the study * Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)

Study sites (8)

CO

CT

FL

GA

MO

NY

PA