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ACTIVE NOT RECRUITINGPhase3

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Sponsor: Hoffmann-La Roche

NCT ID: NCT06588855

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Afimkibart (drug), Placebo (drug)
How long the study runs
Study runs about 73 months (dates as stated)
About the drug or intervention
Afimkibart — drug: Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection. · Placebo — drug: Placebo matching IV afimkibart.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
16 Years to 80 Years
Who
All
Number of participants
350
Started
2024-12-11
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for moderately to severely active ulcerative colitis
  • • Phase3 - 350 participants
  • • This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC)

Who can take part?

  • • Ages 16 Years to 80 Years
  • • Diagnosed with moderately to severely active ulcerative colitis

Where?

  • • Leicester - Leicester General Hospital
  • • Llanrhystud - Bronglais General Hospital
  • • London - King College Hospital NHS Foundation Trust
  • • Stockport - Stepping Hill Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Moderately to Severely Active Ulcerative Colitis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years - 80 Years
  • Who can join: All genders

What the study is looking for

  • ✓Confirmed diagnosis of UC
  • ✓Moderately to severely active UC assessed by 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...

Who cannot take part

  • ✗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,...
  • ✗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
See the full criteria
Inclusion Criteria: * Confirmed diagnosis of UC * Moderately to severely active UC assessed by 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 * Males and 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

Where Is This Study? (4 UK sites)

Leicester General Hospital

Leicester LE5 4PW, United Kingdom

Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Bronglais General Hospital

Llanrhystud SY23 1ER, United Kingdom

King College Hospital NHS Foundation Trust

London SE5 9RS, United Kingdom

Stepping Hill Hospital

Stockport SK2 7JE, United Kingdom

Hospital R&D contact (matched)

Research, Development & Innovation Office

research.development@stockport.nhs.uk0161 419 5893
Data sourced from ClinicalTrials.gov · Last verified: 2026-10