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RecruitingPhase 3

A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease

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 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
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 afimkibart in children with moderate to severe active Crohn’s disease. It looks at how well the drug works, its safety, and how the body processes it during starting and ongoing treatment.

This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children 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

  • Weigh at least 10 kilograms (about 22 pounds).
  • Have active Crohn’s disease confirmed by a camera exam of the colon and the last part of the small intestine.
  • Have moderate to severe disease: a children’s Crohn’s disease score (PCDAI) of at least 30 and a camera exam score (SES-CD) of at least 6, or at least 4 if only the last part of the small intestine is affected.
  • Have tried at least one standard or advanced Crohn’s medicine that did not work well enough, stopped working, or caused side effects you could not tolerate.

Who can't join

  • Have a disorder caused by a change in one gene that is linked to inflammatory bowel disease starting in infancy.
  • Have had at least 3 surgeries to remove parts of the bowel, with more than 2 of the 5 listed bowel sections missing.
  • Have ulcerative colitis or another listed type of colon inflammation: unclear or unclassified, seen only under a microscope, or caused by low blood flow, infection, or radiation.
  • Have active disease in small pouches in the bowel wall (diverticular disease).
  • Have an abnormal tunnel (fistula) or a pocket of pus (abscess) in the belly or around the anus.
  • Have narrowed bowel areas that cause symptoms, severe and sudden colon inflammation, or a dangerously swollen colon.
  • Have or may have primary sclerosing cholangitis, a disease that scars the tubes carrying bile from the liver.

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

Official eligibility criteria

Inclusion Criteria: * Body weight \>= 10 kilogram (kg) * Active CD confirmed by endoscopy (ileocolonoscopy) * Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \>= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) \>=6 (or \>=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy * Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors) Exclusion Criteria: * Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD) * History of \>= 3 bowel resections: \> 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum * Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease. * Symptomatic bowel strictures, fulminant colitis, or toxic megacolon * Presence of abdominal or perianal abscess * Current diagnosis or suspicion of primary sclerosing cholangitis

Study sites (1)

NY