RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

This research study, called a Phase 3 trial, is investigating a new medicine named Afimkibart for children and teenagers (from 2 to 17 years old) who have ulcerative colitis that is moderate to severe. Ulcerative colitis is a long-term condition where the large intestine becomes inflamed. Participants will receive either Afimkibart or a placebo (a dummy medicine) to see how well it works and if it has any side effects. The study will last for a period of time, checking on how participants respond and if their symptoms improve. This type of study is important for finding new ways to help young people manage their condition better and improve their quality of life.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

100

Start

15 Apr 2026

Estimated completion

31 Mar 2031

Moderately to Severely Active Ulcerative Colitis

What is this study about?

This study is looking into a new medicine called Afimkibart for children and teenagers (from ages 2 to 17) who have a condition called ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease where the lining of the large intestine (colon and rectum) becomes inflamed and develops tiny open sores (ulcers). This can cause tummy pain, urgent trips to the toilet, and blood in their poo, making daily life very difficult. When we say 'moderately to severely active', it means their symptoms are quite noticeable and affecting them a lot.

The main goal of this study is to find out if Afimkibart is a safe and effective treatment for these young people. It's a 'Phase 3' study, which means it’s one of the final stages of testing before a medicine can be considered for wider use. During this study, some participants will receive the new medicine, while others will get a 'placebo' (a dummy medicine that looks the same but contains no active drug). This helps the researchers accurately compare how well the new medicine works.

By taking part, children and their families would be contributing to important medical research that could lead to new and better treatments for ulcerative colitis. The information gathered will help doctors understand more about how to manage this condition in young people, potentially improving their health and wellbeing in the future.

Key takeaways

A study for children/teens (2-17) with moderate to severe ulcerative colitis.
Investigating a new medicine called Afimkibart.
Aims to check safety and how well it works compared to a dummy treatment.
Participation involves regular clinic visits and health checks.
Could help find better treatments for young people with UC.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, children and teenagers generally need to be between 2 and 17 years old and weigh at least 10 kilograms. They must have a clear diagnosis of ulcerative colitis that is currently moderate to severe. Importantly, they should have tried other common treatments for ulcerative colitis, such as steroid medicines, immune-suppressing drugs, or biological therapies, but these treatments didn't work well enough for them or caused problems they couldn't tolerate.

There are also some reasons why a child or teenager might not be able to join the study. For example, if they have certain other bowel conditions like Crohn's disease, or if they have an active infection like tuberculosis. Children who've recently had major surgery or are planning significant surgery during the study period also wouldn't be eligible. The medical team will check all these details carefully to make sure the study is safe and appropriate for everyone involved.

Quick self-check

Is your child aged between 2 and 17 years old?
Does your child weigh at least 10 kilograms (about 22 pounds)?
Does your child have a confirmed diagnosis of moderate to severe ulcerative colitis?
Have other treatments for your child's ulcerative colitis not worked well or caused problems?
Does your child NOT have other specific bowel conditions like Crohn's disease?
Has your child NOT had major surgery recently or isn't planning one during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, your child will first go through an initial check-up (called screening) to make sure they meet all the study requirements. Once enrolled, they will be randomly assigned to receive either the new medicine, Afimkibart, or a placebo (a dummy medicine). Neither you nor the study doctors will know which treatment your child is receiving.

Throughout the study, your child will have regular visits to the clinic. These visits will involve various assessments such as physical examinations, blood tests, and sometimes stool samples to monitor their health, how they are responding to the treatment, and to check for any side effects. You will be given detailed instructions on how to administer the study medication, and you'll have regular contact with the study team. The study will involve an initial treatment phase, followed by a longer period where the treatment is continued if it's found to be helpful. The total duration of participation will be explained fully by the study team.

Potential risks and benefits

Taking part in a clinical study offers the potential benefit of accessing a new treatment that is not yet widely available, which might help improve your child's ulcerative colitis symptoms. However, like all medicines, Afimkibart may have side effects, and some are not yet fully known. There is also no guarantee that the treatment will work for your child. The study team will explain all known potential risks and side effects in detail. You and your child are entirely free to withdraw from the study at any time, for any reason, without it affecting your child's usual medical care.

Locations (12)

Children's Healthcare of Atlanta
Atlanta, United States· Recruiting
NYU Langone Health
New York, United States· Recruiting
Royal Children's Hospital
Parkville, Australia· Recruiting
Perth Children's Hospital
Nedlands, Australia· Recruiting
Children's Hospital ZheJiang University School of Medicine
Hangzhou, China· Recruiting
National Taiwan University Hospital
Taipei, Taiwan· Recruiting
Chulalongkorn University
Bangkok, Thailand· Recruiting
Siriraj Hospital
Bangkok, Thailand· Recruiting
Ramathibodi Hospital
Bangkok, Thailand· Recruiting
Birmingham Children's Hospital
Birmingham, United Kingdom· Recruiting
Addenbrooke's Hospital
Cambridge, United Kingdom· Recruiting
Sheffield Childrens Hospital
Sheffield, United Kingdom· Recruiting

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the large intestine (colon and rectum) becomes inflamed and develops small sores, leading to symptoms like tummy pain and urgent trips to the toilet.

What is Afimkibart?

Afimkibart is a new medicine being tested to see if it can help reduce the inflammation and symptoms of ulcerative colitis in children and teenagers.

What does 'Phase 3' mean for a study?

Phase 3 means this is one of the final stages of research before a new medicine can be considered for general use. It aims to confirm safety and effectiveness on a larger group of people.

Will my child definitely get the new medicine?

No, participants will be randomly assigned to receive either Afimkibart or a placebo (a dummy medicine that looks identical) to fairly compare its effects. You and your doctors won't know which one your child is getting.

Can we stop participating if we change our mind?

Yes, you can choose to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

How to find out more

Reference Study ID Number: CA45905 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. and Canada) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.