RecruitingPHASE3INTERVENTIONAL

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

This clinical trial is designed for people who have Crohn's disease that is moderately to severely active. Crohn's is a long-term condition affecting the gut. The main goal is to test a new medicine, JNJ-78934804, to understand how well it helps control Crohn's symptoms and if it's safe to use. We’ll be comparing it against another approved medicine called guselkumab over 48 weeks (around 11 months). By doing this, we hope to find new and effective ways to help people living with Crohn's disease manage their condition better.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

460

Start

22 May 2026

Estimated completion

12 Jul 2030

Crohn Disease

What is this study about?

Crohn's disease is a type of inflammatory bowel disease (IBD) that causes inflammation in your digestive tract. This can lead to belly pain, severe diarrhoea, tiredness, weight loss, and sometimes serious problems. It’s a long-term condition that can get worse over time, and while there's no cure, medicines can help manage the symptoms and improve quality of life. This study is focusing on people whose Crohn's disease is currently active and causing moderate to severe symptoms.

The main aim of this study is to explore a new treatment called JNJ-78934804. We want to see how effective it is at reducing inflammation and relieving symptoms of Crohn's disease. We'll also be carefully checking for any side effects to make sure it's safe. To do this, we'll compare it with a medicine already approved for similar conditions, called guselkumab. By comparing the two, we can understand if JNJ-78934804 offers a new, effective option for people living with this challenging condition.

Taking part in a study like this is important because it helps scientists and doctors discover new ways to treat diseases. If successful, new medicines can offer hope and better health for many people in the future. The study will last for about 48 weeks, and during this time, your health and Crohn's symptoms will be carefully monitored.

Key takeaways

This study is testing a new medicine (JNJ-78934804) for active Crohn's disease.
It aims to see if the new medicine works well and is safe compared to an existing treatment (guselkumab).
The study is for adults (18+) with moderately to severely active Crohn's disease.
Participation involves regular clinic visits and health checks over about 11 months.
You will receive study medicine (likely injections) and be closely monitored.
You can withdraw from the study at any time without affecting your normal care.

Who may be eligible?

To be considered for this study, you need to be an adult (18 years or older) and have been diagnosed with Crohn's disease for at least 12 weeks. Your doctor must have confirmed this diagnosis with a camera test (endoscopy) and tissue samples (biopsy). Your Crohn's disease should currently be moderately to severely active, meaning you have noticeable symptoms like frequent loose stools or belly pain.

Also, a recent camera test of your bowel (colonoscopy or similar) needs to show signs of active Crohn's disease in your small or large intestine. It's important that previous treatments for your Crohn's, such as certain tablets or injections, either haven't worked well enough, stopped working, or caused side effects that meant you couldn't continue with them.

There are also some reasons why you might not be able to join. For example, if you have other types of bowel inflammation like ulcerative colitis, or serious complications of Crohn's disease like blockages that need surgery soon. If you have an ostomy bag, or certain other medical conditions that could make it difficult to properly assess your Crohn's disease, you might also not be suitable. The study team will review all your medical information carefully to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a confirmed diagnosis of Crohn's disease (not ulcerative colitis)?
Is your Crohn's disease currently causing moderate to severe symptoms?
Have your previous Crohn's treatments not worked well enough or caused problems?
Do you not have serious Crohn's complications like blockages or an ostomy bag?
Are you able to attend regular clinic appointments for about 11 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic over approximately 48 weeks (about 11 months). These visits will involve various health checks, such as physical exams, blood tests, and possibly stool samples. You might also have repeat camera tests of your bowel at certain times to see how your Crohn's is responding to the treatment.

During the study, you will receive one of the study medicines – either JNJ-78934804 or guselkumab. These will likely be given as injections. You'll be given clear instructions on how and when to take your medicine, and the study team will be there to support you and answer any questions you have. Throughout the study, your symptoms and general health will be closely monitored to see how you are responding to the treatment and to identify any side effects. You'll also have follow-up calls or visits after your last dose of study medicine.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of joining this study is that you might receive a new treatment that could improve your Crohn's symptoms and overall quality of life. You will also receive careful medical monitoring throughout the study. However, there's no guarantee the new medicine will work for you, and it might not be better than your current treatment. Potential risks could include side effects from the study medicines, which will be carefully explained to you by the study team. You might also need to attend frequent appointments and have various medical tests, which can be time-consuming. It’s very important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (252)

Clinnova Research
Verified postcode
Anaheim, United States· Recruiting
Gastro SB Clinic
Verified postcode
Chula Vista, United States· Recruiting
United Medical Doctors
Verified postcode
Los Alamitos, United States· Recruiting
Medical Associates Research Group, Inc.
Verified postcode
San Diego, United States· Recruiting
Peak Gastroenterology Associates
Verified postcode
Colorado Springs, United States· Recruiting
Florida Research Center Inc.
Verified postcode
Lakewood Rch, United States· Recruiting
Sanchez Clinical Research, Inc
Verified postcode
Miami, United States· Recruiting
GCP Clinical Research
Verified postcode
Tampa, United States· Recruiting
Atlanta Gastroenterology Specialists
Verified postcode
Suwanee, United States· Recruiting
Tri-State Gastroenterology Assoc
Verified postcode
Crestview Hills, United States· Recruiting
Gastroenterology Clinic of Acadiana
Verified postcode
Lafayette, United States· Recruiting
GIA Metairie
Verified postcode
Metairie, United States· Recruiting

Common questions

What is Crohn's disease?

Crohn's disease is a long-term condition that causes inflammation in your digestive system, leading to symptoms like tummy pain, diarrhoea, and tiredness.

What is JNJ-78934804?

JNJ-78934804 is a new medicine being tested to see if it can help control the inflammation and symptoms of Crohn's disease.

How long will the study last?

The main part of the study will last for about 48 weeks, which is roughly 11 months.

Will I know which medicine I'm getting?

In this type of study, participants usually don't know whether they are receiving the new medicine or the comparison medicine (guselkumab) until after the study is over. This helps ensure fair results.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any point, for any reason, and it will not affect your regular medical care.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

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