Active not recruitingPHASE3INTERVENTIONAL

A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease

This study is looking into a new medicine called obexelimab for people with IgG4-related disease. The main goal is to find out if obexelimab can prevent future flare-ups of the condition and if it's safe. Participants will be randomly given either obexelimab or a placebo (a dummy medicine) for one year. Everyone will also start reducing their steroid medication. After the first year, participants can choose to continue in the study for another three years, where everyone will receive obexelimab. The study will carefully monitor for any flare-ups and check how participants are feeling throughout. This research could help improve how IgG4-related disease is managed in the future.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Zenas BioPharma (USA), LLC

Enrolment target

194

Start

09 Jan 2023

Estimated completion

15 Feb 2029

IgG4 Related Disease

What is this study about?

This study is about a condition called IgG4-related disease (IgG4-RD). This disease can cause inflammation and damage in different parts of the body. Doctors are looking for better ways to prevent flare-ups, which are periods when the disease becomes more active and causes symptoms.

This study is testing a new medicine called obexelimab. The main aims are to see if this medicine can effectively stop flare-ups from happening and if it is safe for people to use. If successful, obexelimab could offer a new treatment option for people living with IgG4-RD, potentially reducing the need for steroid medications.

Taking part in this kind of research is very important because it helps us learn more about diseases and discover new and better treatments. Your involvement, if you choose to participate, would contribute significantly to medical knowledge that could help many others in the future.

Key takeaways

This study is testing a new medicine, obexelimab, for IgG4-related disease.
It aims to see if the medicine can prevent disease flare-ups and is safe.
You'll either get the new medicine or a dummy treatment for the first year.
Steroid medicine will be gradually reduced, aiming for you to stop it.
The study involves regular clinic visits for monitoring.
Participation could last over four years, but you can leave at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of IgG4-related disease. Importantly, at the time you consider joining, you should be experiencing active symptoms or a flare-up of your IgG4-related disease that requires starting new steroid treatment or increasing your current steroid dose.

There are also some reasons why you might not be able to join. For example, if your disease only affects one organ and mainly causes scarring (fibrosis), if you've recently taken very high doses of steroids, or if you've recently used certain other medicines that affect your immune system. You also can't have had a live vaccine recently or have certain active infections like tuberculosis or hepatitis. The study team will review all your medical information carefully to make sure it's safe and appropriate for you to participate.

Quick self-check

Are you 18 years or older?
Do you have a confirmed diagnosis of IgG4-related disease?
Are you currently having an active flare-up of your IgG4-related disease that needs steroid treatment?
Have you avoided certain strong immune-suppressing medicines or live vaccines recently?
Do you not have certain active infections like tuberculosis or hepatitis?

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, the study will last for up to 224 weeks, which is about four years and three months. This includes a one-month screening period to check if you're suitable. Once you're in, the main part of the study lasts for one year. During this year, you will be randomly assigned to receive either the new medicine, obexelimab, or a placebo (a dummy treatment, which looks the same but contains no active medicine). Both obexelimab and the placebo will be given as injections under the skin.

During this first year, you will also gradually reduce your steroid medication until you stop it completely around eight weeks into the study. You will have regular visits to the clinic so doctors can monitor your health and check for any flare-ups. After this first year, if you wish, you can continue in an 'open-label' period for another three years. In this part, everyone will receive obexelimab. There might also be an optional sub-study to see how your body reacts to vaccines while on obexelimab. If you choose not to continue after the first year, you'll have one final safety check-up visit eight weeks later.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new medicine that could help manage your IgG4-related disease, or getting very close medical attention from a team of specialists. However, there are also potential risks; for example, the new medicine might not work for you, or it could cause side effects. The placebo group might not see any benefit from the study treatment. All possible side effects will be explained to you in detail before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (65)

Stanford Medicine
Stanford, United States
GI PROS Research - Dedicated Research Facility
Naples, United States
Emory Univeristy
Atlanta, United States
Massachusetts General Hospital
Boston, United States
Henry Ford Hospital
Detroit, United States
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Artus Health Centre
Vancouver, Canada
Center for Clinical Research (Nova Scotia Health)
Halifax, Canada
Centre Hospitalier Universitaire de Sherbrooke CHUS
Sherbrooke, Canada
Chinese PLA General Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China

+53 more sites — see the official record for the full list.

Common questions

What is IgG4-related disease?

IgG4-related disease is a condition where your immune system causes inflammation and often swelling in different organs in your body.

What is a 'flare-up'?

A flare-up is when your IgG4-related disease becomes more active, causing your symptoms to return or get worse.

What does 'randomised' mean?

Randomised means that you will be put into one of the treatment groups by chance, like flipping a coin. This ensures the study results are fair.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It's used to fairly compare the new medicine's effects.

Will I have to stop my current medicines?

You will be asked to gradually reduce your steroid medicine during the early part of the study. The study team will discuss all your medications with you.