Recruiting
Phase 3

Afimkibart

Sponsor:

Hoffmann-La Roche

Code:

NCT07846683

Conditions

Moderately to Severely Active Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

Afimkibart

Placebo

Study Details

Brief summary:

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).

Conditions

Moderately to Severely Active Ulcerative Colitis

Study ID

NCT07846683

Start date

Nov 15, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afimkibart

Participants will receive afimkibart administered as subcutaneous (SC) injection.

placebo comparator: Placebo

Participants will receive placebo adminsitered as SC injection.

Interventions

Afimkibart

Afimkibart will be administered as SC injection.

Placebo

Placebo will be administered as SC injection.

Primary outcome measure

  • Percentage of Participants With Clinical Remission [ Time Frame: At Week 12 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com

Locations

Gastro One

Recruiting

Cordova, Tennessee, United States, 38018

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.