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Phase III: Afimkibart in UC (AMETRINE-2)

Clinical Trial Overview

A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With afimkibart (R07790121) in Patients With Moderately to Severely Active Ulcerative Colitis

Objective

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with afimkibart (R07790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Primary Endpoints

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

Secondary Endpoints

Change in Partial Modified Mayo Score (pmMS) [Time Frame: From baseline to Week 2]
Percentage of Participants with Endoscopic Improvement [Time Frame: At Week 12]
Percentage of Participants with Endoscopic Remission [Time Frame: At Week 12]
Percentage of Participants with Clinical Response [Time Frame: At Week 12]
Participants with Histologic-Endoscopic Mucosal Improvement [Time Frame: At Week 12]
Percentage of Participants with Histologic-Endoscopic Remission [Time Frame: At Week 12]
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants [Time Frame: At Week 12]
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants [Time Frame: At Week 12]
Change in Bowel Urgency [Time Frame: Baseline through Week 12]
Change in Abdominal Pain [Time Frame: Baseline through Week 12]
Change in Fatigue [Time Frame: Baseline to Week 12]
Change in Health-Related Quality of Life [Time Frame: Baseline to Week 12]
Overall Change in UC Symptoms [Time Frame: Baseline to Week 2 and Week 12]
Overall Severity in UC Symptoms [Time Frame: Baseline to Week 2 and Week 12]
Incidence and Severity of Adverse Events (AEs) [Time Frame: Up to 30 Weeks after Baseline]

AE=adverse events; pmMS=partial modified Mayo Score; UC=ulcerative colitis

Afimkibart

Other names: RG6631, R07790121
Modality: Anti-TL1A monoclonal antibody

QUICK LINKS

Clinical Trial Overview

Inclusion and Exclusion Criteria

Enrollment and Resources

View on ClinicalTrials.gov

Inclusion and Exclusion Criteria

Key Inclusion Criteria

Key Exclusion Criteria

Confirmed diagnosis of UC
Moderately to severely active UC assessed by mMS
Bodyweight >= 40 kilogram (kg)
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

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

CD=Crohn's disease; CMV=cytomegalovirus; HIV=human immunodeficiency virus; HBV= Hepatitis B; HCV= Hepatitis C; mMS=modified Mayo Score; TB=tuberculosis; TL1A=tumor necrosis factor-like ligand 1A; UC=ulcerative colitis

Enrollment & Resources

Enrollment

For more information on eligibility criteria, view the study or reach out to our team.

Web

ClinicalTrials.gov
Identifier: NCT06588855

Phone

1-888-662-6728
(US and Canada)

Email

[email protected]

Clinical Trial Site Locations

Clinical Trial Site Locations

For more information on recruitment status, or where the study is being conducted

Visit ClinicalTrials.gov

Information is consistent with ClinicalTrials.gov as of April 17, 2025. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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Submit a Request

Call the Trial Information Support Team: 1-888-662-6728 Hours: Monday-Friday, 5am-5pm PT