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

October 22, 2026 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

  • Name: Reference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below.
  • Phone Number: 888-662-6728 (U.S. and Canada)
  • Email: global-roche-genentech-trials@gene.com

Study Locations

  • United States
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Gastro One

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afimkibart

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

Afimkibart will be administered as SC injection.

Other Names:
  • RVT-3101
  • PF-06480605
  • RO7790121
Placebo Comparator: Placebo

Participants will receive placebo adminsitered as SC injection.
Drug: Placebo

Placebo will be administered as SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Clinical Remission
Time Frame: At Week 12
At Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Stool Frequency Subscore (SFS)
Time Frame: From Baseline up to Week 12

The Stool Frequency Subscore (SFS) is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal)
From Baseline up to Week 12
Change From Baseline in Rectal Bleeding Subscore (RBS)
Time Frame: From Baseline up to Week 12

The Rectal Bleeding Subscore (RBS) is measured on a scale from 0 (no blood seen) to 3 (blood alone passed)
From Baseline up to Week 12
Percentage of Participants With Symptomatic Response
Time Frame: At Week 4
At Week 4
Percentage of Participants With Endoscopic Improvement
Time Frame: At Week 12 and Week 24
At Week 12 and Week 24
Percentage of Participants With Endoscopic Remission
Time Frame: At Week 12 and Week 24
At Week 12 and Week 24
Percentage of Participants With Clinical Response
Time Frame: At Week 12
At Week 12
Percentage of Participants With Histologic-Endoscopic Mucosal Improvement
Time Frame: At Week 12 and Week 24
At Week 12 and Week 24
Percentage of Participants With Clinical Remission
Time Frame: At Week 24
At Week 24
Percentage of Participants With Maintenance of Remission
Time Frame: At Week 12 and Week 24
At Week 12 and Week 24
Percentage of Participants With Histologic Improvement
Time Frame: At Week 24
At Week 24
Change From Baseline in Bowel Urgency
Time Frame: From Baseline through Week 12 and Week 24

Bowel urgency will be assessed using two self-reported items over the past 24 hours: presence of bowel urgency (Yes/No) and severity on an 11-point numerical rating scale from 0 (no urgency) to 10 (worst possible urgency)
From Baseline through Week 12 and Week 24
Change From Baseline in Abdominal Pain
Time Frame: From Baseline through Week 12 and Week 24

Abdominal pain will be assessed using two self-reported items over the past 24 hours: presence of abdominal pain (Yes/No) and severity on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain)
From Baseline through Week 12 and Week 24
Change From Baseline in Fatigue
Time Frame: From Baseline through Week 12 and Week 24

Change in fatigue will be assessed by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue
From Baseline through Week 12 and Week 24
Change From Baseline in Health-Related Quality of Life
Time Frame: From Baseline through Week 12 and Week 24

Change in health-related quality of life will be assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) score. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life
From Baseline through Week 12 and Week 24
Change From Baseline in Overall UC Symptoms
Time Frame: Baseline, Week 2, Week 12 and Week 24

Change in overall UC symptoms will be assessed by Patient Global Impression of Change (PGIC). PGIC measures overall change in ulcerative colitis symptoms from "Much better" to "Much worse"
Baseline, Week 2, Week 12 and Week 24
Change From Baseline in Overall Severity in UC Symptoms
Time Frame: Baseline, Week 2, Week 12 and Week 24

Change in overall severity of UC symptoms will be assessed by Patient Global Impression of Severity (PGIS). PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe"
Baseline, Week 2, Week 12 and Week 24
Incidence and Severity of Adverse Events (AEs)
Time Frame: From Baseline up to approximately 42 Weeks
From Baseline up to approximately 42 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Pfizer
Chugai Pharmaceutical

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 22, 2026

First Posted (Actual)

September 29, 2026

Study Record Updates

Last Update Posted (Actual)

October 26, 2026

Last Update Submitted That Met QC Criteria

October 22, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CA46523
  • 2026-526684-37-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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