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)

Autoimmune Disorder
Inflammatory Bowel Disease (IBD)
Ulcerative Colitis

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Trial Identifier NCT07846683, CA46523

Condition Moderately to Severely Active Ulcerative Colitis

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

Study 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).

Eligibility Criteria

Gender

All

Age

≥16 Years & ≤ 80 Years

Healthy Volunteers

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.

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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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)

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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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)

For the latest version of this information please go to www.forpatients.roche.com