Active not recruitingPHASE3INTERVENTIONAL

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

This research is investigating risankizumab, a treatment for Crohn's disease already approved for adults. The study focuses on how effective and safe giving risankizumab as an injection under the skin (subcutaneous, or SC) is for adults with moderate to severe Crohn's disease. Crohn's disease causes inflammation in the digestive system, leading to symptoms like tummy pain and tiredness. Participants will receive either risankizumab or a dummy treatment (placebo) for up to 24 weeks, followed by an open-label period where everyone receives risankizumab. The study will last around 93 weeks and involves about 276 adult patients worldwide to understand its impact on disease activity and any side effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

289

Start

15 Nov 2023

Estimated completion

01 Mar 2027

Crohn's Disease

What is this study about?

Crohn's disease is a condition that causes long-lasting inflammation, or soreness and swelling, in your digestive system, most commonly in your bowels. This can lead to various uncomfortable symptoms such as tummy pain, diarrhoea, feeling very tired, and losing weight. This study is looking into a medicine called risankizumab, which is already used to treat Crohn's disease in adults.

The main goal of this particular study is to understand how well risankizumab works and how safe it is when given as an injection under the skin. This type of injection is called 'subcutaneous' or 'SC'. The study is specifically recruiting adults who have Crohn's disease that is considered moderately to severely active – meaning their symptoms are significantly affecting them.

Participants will be part of the study for about 93 weeks, which is roughly a year and nine months. Initially, some participants will receive risankizumab injections under the skin, while others will receive a 'placebo', which looks like risankizumab but doesn't contain the active medicine. This helps researchers fairly compare the effects. Later in the study, eligible participants will all receive risankizumab. The study hopes to gather important information about how this treatment can help manage Crohn's disease.

Key takeaways

This study evaluates risankizumab given as an injection under the skin for moderate to severe Crohn's disease.
It aims to see how safe and effective this treatment method is.
Participants will receive either risankizumab or a dummy treatment (placebo) initially.
The study involves regular medical checks and lasts about 93 weeks.
It includes adult patients with Crohn's disease who haven't responded well to other treatments.
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 would need to have a confirmed diagnosis of Crohn's disease for at least three months. Your Crohn's disease should be considered moderate to severe based on medical assessments, and there should be signs of inflammation in your bowel when doctors look inside with a camera (endoscopy). Also, previous treatments for your Crohn's disease should not have worked well for you, or you might have found them difficult to tolerate.

There are also some reasons why you might not be able to join. For example, if you have a different bowel condition like ulcerative colitis, or if your Crohn's disease has certain complications, or if you have an ostomy (a bag to collect waste) or an internal pouch after surgery. Also, if you've previously had specific treatments called 'p19 inhibitors', you might not be eligible. Doctors will review all your medical information carefully to see if this study is suitable for you.

Quick self-check

Do you have a medical diagnosis of Crohn's disease?
Has your Crohn's disease been diagnosed for at least 3 months?
Is your Crohn's disease considered moderate to severe by your doctor?
Have your previous Crohn's disease treatments not worked well or caused problems?
Are you 18 years old or older?
Do you not have an ostomy or internal pouch from surgery?

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

What does participation involve?

If you take part in this study, you will first be placed into one of two groups: one receiving the risankizumab injection under the skin, and the other receiving a 'placebo' injection (which looks the same but contains no active medicine). This initial phase lasts up to 24 weeks. After this, depending on how your condition has responded, you may move into a longer phase where all eligible participants receive risankizumab injections for about 52 weeks.

You will have regular appointments and medical checks throughout the study to monitor your Crohn's disease activity and track any side effects. An injection under the skin is usually given by a healthcare professional, but sometimes people can learn to give it to themselves. The total duration of your participation in this study, including all treatments and follow-up, will be around 93 weeks, which is about a year and nine months.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical attention. For this study, if you receive risankizumab, your Crohn's disease symptoms might improve. However, as with any medicine, there are potential risks, including side effects from the treatment, or the treatment might not work for you. Placebo groups are used to understand the true effect of the medicine, meaning some participants may not receive the active drug initially. You will be fully informed about known risks before deciding to join, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (179)

Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178
Sun City, United States
Kindred Medical Institute - Corona /ID# 262075
Corona, United States
Southern California Res. Ctr. /ID# 256612
Coronado, United States
Valley Clinical Trials, LLC dba Flourish Research /ID# 256610
Covina, United States
Newport Huntington Medical Group /ID# 256622
Huntington Beach, United States
Om Research LLC /ID# 259645
Lancaster, United States
Om Research LLC /ID# 267523
Lancaster, United States
Clinnova Research - Orange /ID# 270138
Orange, United States
University of California, Irvine Medical Center /ID# 259677
Orange, United States
Prospective Research Innovations Inc. /ID# 267856
Rancho Cucamonga, United States
University of California San Francisco - Mission Bay /ID# 267529
San Francisco, United States
Amicis Research Center - Valencia /ID# 269158
Valencia, United States

+167 more sites — see the official record for the full list.

Common questions

What is Risankizumab?

Risankizumab is a medication that helps reduce inflammation in the body. It's already approved for adults with Crohn's disease.

What does 'subcutaneous' mean?

Subcutaneous (SC) means the medicine is given as an injection just under your skin, like a small jab.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the actual medicine but doesn't contain any active ingredients. It helps researchers fairly compare a new treatment's effects.

How long will the study last?

The full study will last for approximately 93 weeks, which is about a year and nine months.

Will I have to pay to join the study?

No, you will not have to pay to participate in the study. All study-related treatments and assessments are provided at no cost, though you may need to cover your travel to appointments.