A Study to Assess the Efficacy and Safety of Afimkibart for Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Phase 3 · Testing Afimkibart · Sites not listed yet · Hoffmann-La Roche
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Afimkibart (a drug) as a possible treatment. Condition(s) listed: Moderately to Severely Active Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 16 to 80
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 350 participants are expected to take part.
- The study has 2 groups.
- Start date: 2026-11-15 (planned).
- Main results expected around 2028-05-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Groups in this study
- Afimkibart (listed as: experimental group)
- Placebo (listed as: placebo group)
Main thing being measured
- Percentage of Participants With Clinical Remission (At Week 12)
In the researchers’ words
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).
Words you might see
- Placebo: a look-alike pill or injection with no active drug, used for comparison.
- Mayo score: a score used to measure how active ulcerative colitis is.
- Remission: a period when the disease is quiet or under control.
- Induction: the first phase of treatment, aimed at getting the disease under control.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Moderately to Severely Active Ulcerative Colitis |
| Lead sponsor | Hoffmann-La Roche |
| Collaborators | Chugai Pharmaceutical; Pfizer |
| Enrollment | 350 (estimated) |
| Start date | 2026-11-15 |
| Primary completion (est.) | 2028-05-31 |
| First posted | 2026-09-29 |
| Last updated | 2026-09-29 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07846683 |
Interventions
- Afimkibart (Drug)
Afimkibart will be administered as SC injection. - Placebo (Drug)
Placebo will be administered as SC injection.
Full eligibility criteria (from the record)
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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.