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RecruitingPhase 3

A Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase III, Multicenter, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Patients 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
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 works and how safe it is as a starting treatment given by shots under the skin. It is for people with moderate to severe active ulcerative colitis (UC), a disease that causes swelling and sores in the large intestine.

The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely 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

  • Have a confirmed diagnosis of UC.
  • Have moderate to severe active UC, based on a study scoring tool.
  • Weigh at least 40 kilograms (about 88 pounds).
  • Be up to date on colon and rectal cancer screening under local guidelines.
  • Have tried at least one UC treatment listed in the study rules that did not work well enough, stopped working, or caused side effects you could not tolerate.
  • If able to become pregnant, meet the study’s birth control rules.

Who can't join

  • Have serious UC complications, such as very severe colon swelling, or have Crohn’s disease or another listed type of colon inflammation instead of UC.
  • Have an ostomy (a bowel opening through the belly) or an ileoanal pouch (an internal pouch made from the small intestine).
  • Have or may have primary sclerosing cholangitis, a disease that scars the bile ducts.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have or have had abnormal colon cells, or colon growths or tumors that were not fully removed.
  • Have had cancer within the past 5 years, except certain skin cancers that had not spread or early cervical cancer, adequately treated by surgery.
  • Have evidence of C. difficile, CMV, HIV, hepatitis B, or hepatitis C infection; or have active tuberculosis (TB), untreated or unsuccessfully treated inactive TB, or inadequately treated TB.
  • Have received medicines banned by the study rules, including any past treatment with an anti-TL1A medicine.

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

Official eligibility criteria

Inclusion Criteria: * Confirmed diagnosis of UC. * Moderately to severely active UC assessed by modified Mayo Score (mMS). * Bodyweight \>= 40 kilogram (kg). * Up to date with colorectal cancer (CRC) screening performed according to local standards. * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy. * Females of childbearing potential must meet protocol criteria for contraception requirements. Exclusion Criteria: * Currently known complications of UC (e.g. fulminant colitis, toxic megacolon). * Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis. * Presence of an ostomy or ileoanal pouch. * Current diagnosis or suspicion of primary sclerosing cholangitis. * Pregnancy or breastfeeding, or intention of becoming pregnant during the study. * Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed. * History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell 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). * 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 (1)

TN