350 Participants NeededMy employer runs this trial

Afimkibart for Ulcerative Colitis

(AMETRINE-SC Trial)

Fr
RS
Overseen ByReference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below.
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Hoffmann-La Roche
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for people with a confirmed diagnosis of moderately to severely active ulcerative colitis who haven't responded well or can't tolerate at least one standard UC treatment. Participants must weigh at least 40 kg, be up-to-date on colon cancer screening, and women of childbearing age must use contraception.

Inclusion Criteria

I have been diagnosed with ulcerative colitis.
I did not respond well or could not tolerate at least one standard UC treatment.
I am a woman who can have children and I follow the required birth control guidelines.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Afimkibart

Trial Overview

The study compares afimkibart (given as an injection under the skin) to a placebo in people with moderate to severe ulcerative colitis. The goal is to see how effective and safe afimkibart is when used as an initial treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: AfimkibartExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Chugai Pharmaceutical

Industry Sponsor

Trials
105
Recruited
25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical University

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University